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AzTrials

SARS-CoV-2 Infection, COVID19Phase 2NCT04895982

Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years

A Phase 2 study testing BNT162b2 in people with SARS-CoV-2 Infection, COVID19, run by BioNTech SE at 29 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a 4 dose study with 124 participants (7 adults ,117 children). Adults are considered to be participants 18 years of age or older. Participants are going to be enrolled based on conditions that make them immunocompromised. Read more about this study

Who is it for?
Ages 2 years and older
Conditions the study is for
SARS-CoV-2 Infection, COVID19
What is being tested?
BNT162b2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
29 sitesin 4 countries
Study dates
15 Oct 2021to 23 Jul 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male or female participants who are ≥2 years of age at the time of enrollment (Visit 1).
  • Participants or participants' parent(s)/legal guardians, as age appropriate, who sign consent, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment (Visit 1).
  • Participants or participant's parent(s)/legal guardians, as age appropriate, who are able to be contacted by telephone throughout the study period.
  • Female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children.
  • Participants who are immunocompromised by virtue of the following:
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  • Having known non-small cell lung cancer (NSCLC) and is ≥18 years of age with at least 1 of the following:
  • Who received chemotherapy at least 2 weeks (14 days) before enrollment (or is treatment naïve), and is not expected to receive chemotherapy within at least 2 weeks (14 days) after dose administration; and/or
  • Receiving checkpoint inhibitor treatment (programmed cell death protein 1 (PD-1)/ programmed death-ligand 1 (PD-L1) inhibitor, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor) and has undergone at least 1 treatment cycle prior to enrollment (at Visit 1); or
  • Receiving targeted drug therapy treatment (epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), proto-oncogene tyrosine-protein kinase (ROS1), v-raf murine sarcoma viral oncogene homolog B1 (BRAF),rearranged during transfection (RET),hepatocyte growth factor receptor (MET), neurotrophic tyrosine kinase (NTRK) inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at Visit 1); or
  • Having known chronic lymphocytic leukemia (CLL) and is ≥18 years of age with at least 1 of the following:
  • Has asymptomatic disease (eg, Rai stage <3, Binet stage A or B) and is undergoing observation and does not receive any treatment for CLL; or
  • Receiving B-cell inhibitory monoclonal antibody treatment (anti-CD20) and has received at least 3 cycles prior to enrollment; and/or
  • Receives a Bruton tyrosine kinase (BTK) inhibitor, phosphoinositide 3-kinase (PI3K) inhibitor, or B-cell lymphoma-2 (BCL-2) inhibitor; or
  • Is currently undergoing maintenance hemodialysis treatment secondary to end-stage renal disease and is ≥18 years of age; or
  • Is on active immunomodulator therapy (eg, tumor necrosis factor alpha (TNFα) inhibitor, or tofacitinib or methotrexate) for an autoimmune or inflammatory disease disorder (eg, inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis, and inflammatory bowel disease, such as ulcerative colitis and Crohn's disease) at a stable* dose
  • Stable dose is defined as receiving the same dose for at least 3 months (84 days) with no changes in the 28 days prior to Visit 1; or
  • Receiving a solid organ transplant at least 3 months (84 days) prior to enrollment (Visit 1) and with no acute rejection episodes within 2 months (60 days) prior to enrollment (Visit 1), and is ≥2 to <18 years of age; or
  • Has had an autologous or allogenic bone marrow or stem cell transplant at least 6 months (182 days) prior to enrollment (Visit 1), with adequate immune reconstitution for immunization, in the investigator's opinion, and is ≥2 to <18 years of age
  • The participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, and assent (as appropriate), which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. The investigator, or a person designated by the investigator, will obtain written informed consent (and assent, as appropriate) from each study participant or participant's parent(s)/legal guardian before any study-specific activity is performed. All parent(s)/legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. The investigator will retain the original copy of each participant's signed consent (and assent, as appropriate) document(s).

Who cannot join

  • Past clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19, or a past clinical diagnosis of multisystem inflammatory syndrome in children (MIS-C).
  • Participants with active graft-vs-host disease (GVHD), transplant rejection, or posttransplant lymphoproliferative disorder (PTLD), or participants who have had treatment for these conditions within 3 months (84 days) prior to study enrollment (Visit 1).
  • Participants <18 years of age whose weight is less than the 5th percentile of age-adjusted ideal body weight.
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
  • Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
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  • Participant who is pregnant or breastfeeding.
  • Participants who may be ineligible because of the number of phlebotomy assessments during this study, in the opinion of the investigator.
  • Participants who do not have adequate deltoid muscle mass to allow intramuscular vaccination, in the opinion of the investigator.
  • Previous vaccination with any coronavirus vaccine.
  • Ongoing, or history of, treatment with blood/plasma products or immunoglobulins within 3 months (84 days) prior to Dose 1 or planned receipt of these medications prior to Dose 4.
  • Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
  • Previous participation in other studies involving study intervention containing lipid nanoparticle (LNPs).
  • Participants who are direct descendants (child or grandchild) of investigational site staff members or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
  • Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Trial locations and contacts

29 sites in 4 countries.

29 sites in 4 countries

United States15 sites

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45206

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Cincinnati Children's Hospital Vaccine Research Center

    Cincinnati, Ohio, 45229

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Henry Ford Hospital - Research Pharmacy

    Detroit, Michigan, 48202

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Ochsner Clinic Foundation

    Jefferson, Louisiana, 70121

  • Ochsner Medical Center - Jefferson Highway

    Jefferson, Louisiana, 70121

  • Ochsner Clinic Foundation

    Kenner, Louisiana, 70065

  • Ochsner Medical Center Kenner

    Kenner, Louisiana, 70065

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Ochsner Medical Center - Jefferson Highway

    New Orleans, Louisiana, 70121

  • Seattle Children's Research Institute: Building Cure

    Seattle, Washington, 98101

  • Seattle Children's Hospital

    Seattle, Washington, 98105

Other trials in United States

Germany7 sites

  • Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)

    Berlin, 13353

  • Charité - Universitaetsmedizin

    Berlin, 13353

  • Charité Campus Virchow-Klinikum

    Berlin, 13353

  • IKF Pneumologie GmbH & Co KG

    Frankfurt am Main, 60596

  • Studiengesellschaft BSF UG.

    Halle, 06108

  • Studiengesellschaft BSF Unternehmergesellschaft

    Halle, 06108

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20359

Other trials in Germany

Brazil5 sites

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90410000

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

  • GRAACC - Grupo de Apoio ao Adolescente e à Criança com Câncer

    São Paulo, 04039-001

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010

Other trials in Brazil

Mexico2 sites

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" de la Universidad Autonoma de Nuevo Leon

    Monterrey, N.L., 64460

  • Centro Médico Zambrano Hellion

    San Pedro Garza García, Nuevo León, 66278

Other trials in Mexico

About this study

Official title: A PHASE 2b, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VACCINE CANDIDATE BNT162b2 IN IMMUNOCOMPROMISED PARTICIPANTS ≥2 YEARS OF AGE

This is a 4 dose study with 124 participants (7 adults ,117 children). Adults are considered to be participants 18 years of age or older. Participants are going to be enrolled based on conditions that make them immunocompromised. Participants are going to be followed up for 6 months after dose 4, and each participant is projected to be on the study for approximately 15 months. This study will be conducted in the United States, Brazil, Germany and Mexico.

Being tested
BNT162b2
Keywords
COVID19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BNT162b2Biological

    Intramuscular Injection

Study groups in NCT04895982
Study groupRoleWhat they receive
BNT162b2ExperimentalIntramuscular Injection
Receives: Biological: BNT162b2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

    GMTs and corresponding 2-sided confidence intervals (CIs) were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below lower limit of quantification (LLOQ) were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 Evaluable Immunogenicity population (EIP).

    Measured: 1 Month after Vaccination 3

  2. GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

    GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 EIP.

    Measured: 1 Month after Vaccination 3

  3. GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

    GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 EIP.

    Measured: 1 Month after Vaccination 3

  4. GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

    GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 EIP.

    Measured: 1 Month after Vaccination 3

  5. GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

    GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP.

    Measured: 1 Month after Vaccination 4

  6. GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

    GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP.

    Measured: 1 Month after Vaccination 4

  7. GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

    GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP.

    Measured: 1 Month after Vaccination 4

  8. GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

    GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below lower limit of quantification (LLOQ) were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP .

    Measured: 1 Month after Vaccination 4

  9. Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years

    Local reactions were collected in an electronic diary (e-diary) or during unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (>0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 1

  10. Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years

    Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 1.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 1

  11. Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years

    Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 1

  12. Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years

    Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 1

  13. Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years

    Local reactions collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate(>2.0 to 7.0 cm), severe(>7.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis[redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate(interfered with activity), severe(prevented daily activity),Grade 4(ER visit or hospitalization for severe pain at injection site).Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 2

  14. Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years

    Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 2

  15. Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years

    Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 2

  16. Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years

    Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 2

  17. Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years

    Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 3

  18. Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years

    Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 3

  19. Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years

    Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild >2.0 to 5.0 cm), moderate(>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate(interfered with activity), severe(prevented daily activity) and Grade 4(ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 3

  20. Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years

    Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 3

  21. Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years

    Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 4

  22. Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years

    Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 4

  23. Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years

    Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 4

  24. Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years

    Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 4

  25. Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years

    Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature >=38.0 degree C (deg C); categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 1

  26. Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years

    Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 1

  27. Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years

    Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 1

  28. Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years

    Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 1

  29. Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years

    Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 2

  30. Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years

    Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 2

  31. Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years

    Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 2

  32. Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years

    Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 2

  33. Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years

    Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 3

  34. Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years

    Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 3

  35. Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years

    Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 3

  36. Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years

    Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 3

  37. Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years

    Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 4

  38. Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years

    Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 de, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 4

  39. Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years

    Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 4

  40. Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years

    Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

    Measured: Day 1 to Day 7 after Vaccination 4

  41. Percentage of Participants Reporting at Least 1 Adverse Event (AE) After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=2 to <5 Years

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

    Measured: From Vaccination 1 to 1 month after Vaccination 2

  42. Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=5 to <12 Years

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

    Measured: From Vaccination 1 to 1 month after Vaccination 2

  43. Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=12 to <18 Years

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

    Measured: From Vaccination 1 to 1 month after Vaccination 2

  44. Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=18 Years

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

    Measured: From Vaccination 1 to 1 month after Vaccination 2

  45. Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=2 to <5 Years

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

    Measured: From Vaccination 3 to 1 month after Vaccination 3

  46. Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=5 to <12 Years

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

    Measured: From Vaccination 3 to 1 month after Vaccination 3

  47. Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=12 to <18 Years

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

    Measured: From Vaccination 3 to 1 month after Vaccination 3

  48. Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=18 Years

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

    Measured: From Vaccination 3 to 1 month after Vaccination 3

  49. Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=2 to <5 Years

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

    Measured: From Vaccination 4 to 1 month after Vaccination 4

  50. Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=5 to <12 Years

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

    Measured: From Vaccination 4 to 1 month after Vaccination 4

  51. Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=12 to <18 Years

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

    Measured: From Vaccination 4 to 1 month after Vaccination 4

  52. Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=18 Years

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

    Measured: From Vaccination 4 to 1 month after Vaccination 4

  53. Percentage of Participants Reporting Serious Adverse Events (SAEs) From Vaccination 1 Through the Duration of the Study in Participants Aged >=2 to <5 Years

    An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

    Measured: From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)

  54. Percentage of Participants Reporting SAEs From Vaccination 1 Through the Duration of the Study in Participants Aged >=5 to <12 Years

    An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

    Measured: From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)

  55. Percentage of Participants Reporting SAEs From Vaccination 1 Through the Duration of the Study in Participants Aged >=12 to <18 Years

    An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

    Measured: From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)

  56. Percentage of Participants Reporting SAEs From Dose 1 Through the Duration of the Study in Participants Aged >=18 Years

    An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

    Measured: From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2021
  2. Study start15 Oct 2021
  3. Primary completion23 Jul 2023
  4. Study completion23 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04895982
Sponsor's protocol ID
C4591024
Other IDs
2021-001290-23
Status last verified
Oct 2024
First submitted
5 May 2021
Last updated
9 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BNT162b2 in people with SARS-CoV-2 Infection, COVID19, run by BioNTech SE at 29 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Germany, Brazil, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection (time frame: 1 Month after Vaccination 3). The study lists 56 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04895982.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.

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