SARS-CoV-2 InfectionPhase 3NCT05310084

Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age

A Phase 3 study testing BNT162b2 and Seasonal Inactivated Influenza Vaccine in people with SARS-CoV-2 Infection and COVID-19, run by BioNTech SE at 26 sites in 2 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 study will assess the safety and immunogenicity of a fourth dose (booster) of BNT162b2 when coadministered with SIIV compared to separate administration of the vaccines when given 1 month apart (SIIV followed by BNT162b2), in participants who have received 3 prior doses of 30 µg BNT162b2, with the third dose… Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: SARS-CoV-2 Infection, COVID-19
What is being tested?: BNT162b2 and Seasonal Inactivated Influenza Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,134 participants
Where: 26 sitesin 2 countries
Study dates: 20 Apr 2022to 5 Oct 2022
Phase: Phase 3
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 18 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participants 18 through 64 years of age, inclusive, at the time of consent.
Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of study intervention.
Have received 3 prior doses of 30 µg BNT162b2, with the third dose being at least 90 days before Visit 1 (Day 1). Documented confirmation of prior BNT162b2 receipt must be obtained prior to randomization.
Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Who cannot join

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.
Allergy to egg proteins (egg or egg products) or chicken proteins.
History of Guillain-Barré syndrome.
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
A positive SARS-CoV-2 test result (either by NAAT or rapid antigen test) within 28 days of Visit 1 (Day 1).
Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.

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Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Women who are pregnant or breastfeeding.
Vaccination with any influenza vaccine <6 months before study intervention administration, or planned receipt of any licensed or investigational nonstudy influenza vaccine during study participation.
Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), eg, for COPD, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
Receipt of any passive antibody therapy specific to COVID-19 from 90 days before study intervention administration or planned receipt throughout the study.
Prior receipt of any COVID-19 vaccine other than BNT162b2 or receipt of more than 3 prior doses of BNT162b2.
Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
Investigator site staff or Pfizer/BioNTech 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

26 sites in 2 countries.

Country

City, postcode or hospital

26 sites in 2 countries

New Zealand19 sites

Southern Clinical Trials Waitemata Ltd
Auckland, 0626
Aotearoa Clinical Trials
Auckland, 2025
Middlemore Clinical Trials
Auckland, 2025
New Zealand Clinical Research (Christchurch)
Christchurch, Canterbury, 8011
Pacific Clinical Research Network - Forte
Christchurch, Canterbury, 8013
Lakeland Clinical Trials Wellington
Ebdentown. Upper Hutt, Wellington Region, 5018
New Zealand Clinical Research (Auckland)
Grafton, Auckland, 1010
Optimal Clinical Trials
Grafton, Auckland, 1010
Lakeland Clinical Trials Waikato
Hamilton, Waikato Region, 3200
P3 Research - Hawke's Bay
Havelock North, Hawke's Bay Region, 4130
Southern Clinical Trials Tasman
Nelson, 7011
Southern Clinical Trials Totara
New Lynn, Auckland, 0600
P3 Research - Palmerston North
Palmerston North, Manawatu-Wanganui, 4414
Lakeland Clinical Trials Culloden
Papamoa Beach, Bay of Plenty, 3118
P3 Research - Kapiti
Paraparaumu, Wellington Region, 5032
Pacific Clinical Research Network - Rotorua
Rotorua, Bay of Plenty, 3010
P3 Research - Tauranga
Tauranga, Bay of Plenty, 3110
Capital, Coast and Hutt Valley District - Wellington Regional Hospital
Wellington, 6021
P3 Research - Wellington
Wellington, 6021

Other trials in New Zealand

Australia7 sites

Paratus Clinical Research Brisbane
Albion, Queensland, 4010
Northern Beaches Clinical Research
Brookvale, New South Wales, 2100
Emeritus Research
Camberwell, Victoria, 3124
Barwon Health
Geelong, Victoria, 3220
Australian Clinical Research Network
Sydney, New South Wales, NSW 2035
AusTrials - Wellers Hill
Wellers Hill, Queensland, 4121
Westmead Hospital
Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official title: A PHASE 3, RANDOMIZED, OBSERVER-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF BNT162b2 WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE (SIIV) IN ADULTS 18 THROUGH 64 YEARS OF AGE

Healthy adults 18 through 64 years of age will be randomized 1:1 to either the co-administration group, or the separate administration group
The duration of the study for each participant will be approximately 2 months
There are 3 scheduled study visits each about 1 month apart
The study will be conducted in New Zealand and Australia.

Conditions: SARS-CoV-2 Infection, COVID-19
Being tested: BNT162b2, Placebo, Seasonal Inactivated Influenza Vaccine
Keywords: COVID-19, 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
PlaceboOther
Saline intramuscular injection
Seasonal Inactivated Influenza VaccineBiological
SIIV intramuscular injection

Study groups in NCT05310084
Study group	Role	What they receive
Coadministration Group	Experimental	BNT162b2 and SIIV followed by placebo a month later Receives: Biological: BNT162b2; Other: Placebo; Biological: Seasonal Inactivated Influenza Vaccine
Separate Administration Group	Experimental	Placebo and SIIV followed by BNT162b2 a month later Receives: Biological: BNT162b2; Other: Placebo; Biological: Seasonal Inactivated Influenza Vaccine

What is being measured

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

Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Local reactions included redness, swelling, and pain at the injection site occurring at the BNT162b2 or placebo injection site. Local reactions were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (>) 2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, severe: >10.0 cm, and potentially life threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, and potentially life threatening (Grade 4): emergency room visit or hospitalization for severe pain. Exact 2-sided confidence interval (CI), based on the Clopper and Pearson method was used.
Measured: Within 7 Days After Vaccination 1
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Local reactions included redness, swelling, and pain at the injection site occurring at the BNT162b2 or placebo injection site. Local reactions were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: greater than >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, severe: >10.0 cm, and potentially life threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, and potentially life threatening (Grade 4): emergency room visit or hospitalization for severe pain. Exact 2-sided CI, based on the Clopper and Pearson method was used.
Measured: Within 7 Days After Vaccination 2
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain recorded by participants in an e-diary. Fever was defined as temperature: >=38.0 degrees (deg) Celsius (C), and 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 were graded as mild: did not interfere with activity, moderate: some interference with activity, and severe: prevented daily routine activity. Vomiting graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h, severe: required intravenous hydration, and grade 4: emergency room (ER) visit or hospitalization for hypotensive shock. Diarrhea graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h, severe: 6 or more loose stools in 24h, and grade 4: ER visit or hospitalization for severe diarrhea.
Measured: Within 7 Days After Vaccination 1
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain recorded by participants in an e-diary. Fever was defined as temperature: >=38.0 deg C, and 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 were graded as mild: did not interfere with activity, moderate: some interference with activity, and severe: prevented daily routine activity. Vomiting graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h, severe: required intravenous hydration, and grade 4: ER visit or hospitalization for hypotensive shock. Diarrhea graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h, severe: 6 or more loose stools in 24h, and grade 4: ER visit or hospitalization for severe diarrhea. Exact 2-sided CI, based on Clopper and Pearson method used.
Measured: Within 7 Days After Vaccination 2
Percentage of Participants With Adverse Events Within 1 Month After Vaccination 1
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. Exact 2-sided CI was calculated using 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: Within 1 month after Vaccination 1
Percentage of Participants With Adverse Events Within 1 Month After Vaccination 2
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. Exact 2-sided CI was calculated using 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: Within 1 month after Vaccination 2
Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 1
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. Exact 2-sided CI was calculated using the Clopper and Pearson method. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; or that was considered to be an important medical event.
Measured: Within 1 Month After Vaccination 1
Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 2
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. Exact 2-sided CI was calculated using the Clopper and Pearson method. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; or that was considered to be an important medical event.
Measured: Within 1 Month After Vaccination 2
Geometric Mean Ratio (GMR) Based on Geometric Mean Concentration (GMC) of Full-Length S-binding Immunoglobulin G (IgG) at 1 Month After BNT162b2 Vaccination
GMCs of full-length S-binding IgG level for the coadministration group and separate administration group were reported in this outcome measure in descriptive data section. GMC and the 2-sided 95% CI were calculated by exponentiating the LSMeans of the concentrations and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of vaccine group, age group, and the corresponding baseline assay results (log scale). Assay results below the LLOQ were set to 0.5*LLOQ. Geometric mean ratio (GMR) was reported in the statistical analysis section and was calculated as ratio of GMCs in the coadministration group to the separate administration group. Here, "Number of participants analyzed" signifies number of participants evaluable for this outcome measure.
Measured: 1 Month After BNT162b2 vaccination
Geometric Mean Ratio (GMR) Based on Geometric Mean Titer (GMT) of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After SIIV Vaccination
GMTs of strain-specific HAI titers for the coadministration group and separate administration group were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the LSMeans of the titers and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of vaccine group, age group, and the corresponding baseline assay results (log scale). Assay results below the LLOQ were set to 0.5*LLOQ, and results above the ULOQ were set to ULOQ+1. Geometric mean ratio (GMR) was reported in the statistical analysis section and was calculated as ratio of GMT in the coadministration group to the separate administration group.
Measured: 1 Month After SIIV vaccination

Secondary outcomes (6)

Geometric Mean Concentration (GMC) of Full-Length S-binding IgG Levels Before Vaccination and 1 Month After BNT162b2 Vaccination
GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t-distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ. Here, "Number of participants analyzed" signifies number of participants evaluable for this outcome measure''.
Measured: Before BNT162b2 vaccination, and 1 month After BNT162b2 vaccination
Geometric Mean Fold Rise (GMFR) of Full-Length S-binding IgG Levels From Before Vaccination to 1 Month After BNT162b2 Vaccination
GMFR was defined as the geometric mean of the ratios of IgG concentrations at 1 month after BNT162b2 vaccination to that before BNT162b2 vaccination. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student's t-distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Here, "Number of participants analyzed" signifies number of participants evaluable for this outcome measure''.
Measured: From before BNT162b2 vaccination to 1 month After BNT162b2 vaccination
Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Titers Before Vaccination and 1 Month After BNT162b2 Vaccination
GMTs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student's t-distribution). Assay results below LLOQ were set to 0.5*LLOQ. Here, "Number of participants analyzed" signifies number of participants evaluable for this outcome measure''. Analysis was performed in a subset of 100 participants from each group.
Measured: Before BNT162b2 vaccination, and 1 month after BNT162b2 vaccination
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Titers From Before Vaccination to 1 Month After BNT162b2 Vaccination
GMFR was defined as the geometric mean of the ratios of SARS-CoV-2 neutralizing titers at 1 month after BNT162b2 vaccination to that before BNT162b2 vaccination. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student's t-distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Here, "Number of participants analyzed" signifies number of participants evaluable for this outcome measure''. Analysis was performed in a subset of 100 participants from each group.
Measured: From before BNT162b2 vaccination to 1 month after BNT162b2 vaccination
Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination
GMTs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student's t-distribution). Assay results below the LLOQ were set to 0.5*LLOQ, and results above the ULOQ were set to ULOQ+1. The analysis was performed on the influenza strains: H1N1 A/Victoria, H3N2 A/Darwin, B/Austria, and B/Phuket.
Measured: Before SIIV vaccination, and 1 month after SIIV vaccination
Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 1 Month After SIIV Vaccination
GMFR was defined as ratio of the geometric mean of strain-specific HAI titers at 1 month after SIIV vaccination to the geometric mean of strain-specific HAI titers before SIIV vaccination. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student's t-distribution). Assay results below the LLOQ were set to 0.5*LLOQ, and results above the ULOQ were set to ULOQ+1. The analysis was performed on the influenza strains: H1N1 A/Victoria, H3N2 A/Darwin, B/Austria, and B/Phuket.
Measured: From before vaccination to 1 month after SIIV vaccination

Timeline

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

20 Apr 20225 Oct 2022

First posted4 Apr 2022
Study start20 Apr 2022
Primary completion5 Oct 2022
Study completion5 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
More trials run by BioNTech SEThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05310084
Sponsor's protocol ID: C4591030
Status last verified: May 2024
First submitted: 25 Mar 2022
Last updated: 12 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Murdoch L, Quan K, Baber JA, Ho AWY, Zhang Y, Xu X, Lu C, Cooper D, Koury K, Lockhart SP, Anderson AS, Tureci O, Sahin U, Swanson KA, Gruber WC, Kitchin N; C4591030 Clinical Trial Group. Safety and Immunogenicity of the BNT162b2 Vaccine Coadministered with Seasonal Inactivated Influenza Vaccine in Adults. Infect Dis Ther. 2023 Sep;12(9):2241-2258. doi: 10.1007/s40121-023-00863-5. Epub 2023 Sep 12.
PubMed 37698774

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 3, RANDOMIZED, OBSERVER-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF BNT162b2 WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE (SIIV) IN ADULTS 18 THROUGH 64 YEARS OF AGE
ClinicalTrials.gov ID: NCT05310084
Acronym / sponsor ID: C4591030
Conditions: SARS-CoV-2 Infection, COVID-19
Keywords: COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,134 participants (actual)
Lead sponsor: BioNTech SEIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: 20 Apr 2022 (actual)
Primary completion: 5 Oct 2022 (actual)
Study completion: 5 Oct 2022 (actual)
First posted: 4 Apr 2022 (actual)
Results: Posted 24 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Healthy adults 18 through 64 years of age will be randomized 1:1 to either the co-administration group, or the separate administration group
The duration of the study for each participant will be approximately 2 months
There are 3 scheduled study visits each about 1 month apart
The study will be conducted in New Zealand and Australia.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Coadministration Group	Experimental	Biological: BNT162b2, Other: Placebo, Biological: Seasonal Inactivated Influenza VaccineBNT162b2 and SIIV followed by placebo a month later
Separate Administration Group	Experimental	Biological: BNT162b2, Other: Placebo, Biological: Seasonal Inactivated Influenza VaccinePlacebo and SIIV followed by BNT162b2 a month later

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Participants 18 through 64 years of age, inclusive, at the time of consent.
Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of study intervention.
Have received 3 prior doses of 30 µg BNT162b2, with the third dose being at least 90 days before Visit 1 (Day 1). Documented confirmation of prior BNT162b2 receipt must be obtained prior to randomization.
Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Key exclusion criteria (15 listed)

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.
Allergy to egg proteins (egg or egg products) or chicken proteins.
History of Guillain-Barré syndrome.
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
A positive SARS-CoV-2 test result (either by NAAT or rapid antigen test) within 28 days of Visit 1 (Day 1).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BNT162b2Intramuscular injection	Biological	Coadministration Group, Separate Administration Group
PlaceboSaline intramuscular injection	Other	Coadministration Group, Separate Administration Group
Seasonal Inactivated Influenza VaccineSIIV intramuscular injection	Biological	Coadministration Group, Separate Administration Group

Primary outcome

Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Time frame: Within 7 Days After Vaccination 1
Local reactions included redness, swelling, and pain at the injection site occurring at the BNT162b2 or placebo injection site. Local reactions were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (>) 2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, severe: >10.0 cm, and potentially life threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, and potentially life threatening (Grade 4): emergency room visit or hospitalization for severe pain. Exact 2-sided confidence interval (CI), based on the Clopper and Pearson method was used.
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Time frame: Within 7 Days After Vaccination 2
Local reactions included redness, swelling, and pain at the injection site occurring at the BNT162b2 or placebo injection site. Local reactions were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: greater than >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, severe: >10.0 cm, and potentially life threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, and potentially life threatening (Grade 4): emergency room visit or hospitalization for severe pain. Exact 2-sided CI, based on the Clopper and Pearson method was used.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Time frame: Within 7 Days After Vaccination 1
Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain recorded by participants in an e-diary. Fever was defined as temperature: >=38.0 degrees (deg) Celsius (C), and 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 were graded as mild: did not interfere with activity, moderate: some interference with activity, and severe: prevented daily routine activity. Vomiting graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h, severe: required intravenous hydration, and grade 4: emergency room (ER) visit or hospitalization for hypotensive shock. Diarrhea graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h, severe: 6 or more loose stools in 24h, and grade 4: ER visit or hospitalization for severe diarrhea.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Time frame: Within 7 Days After Vaccination 2
Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain recorded by participants in an e-diary. Fever was defined as temperature: >=38.0 deg C, and 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 were graded as mild: did not interfere with activity, moderate: some interference with activity, and severe: prevented daily routine activity. Vomiting graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h, severe: required intravenous hydration, and grade 4: ER visit or hospitalization for hypotensive shock. Diarrhea graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h, severe: 6 or more loose stools in 24h, and grade 4: ER visit or hospitalization for severe diarrhea. Exact 2-sided CI, based on Clopper and Pearson method used.
Percentage of Participants With Adverse Events Within 1 Month After Vaccination 1
Time frame: Within 1 month after Vaccination 1
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. Exact 2-sided CI was calculated using 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.
Percentage of Participants With Adverse Events Within 1 Month After Vaccination 2
Time frame: Within 1 month after Vaccination 2
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. Exact 2-sided CI was calculated using 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.
Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 1
Time frame: Within 1 Month After Vaccination 1
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. Exact 2-sided CI was calculated using the Clopper and Pearson method. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; or that was considered to be an important medical event.
Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 2
Time frame: Within 1 Month After Vaccination 2
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. Exact 2-sided CI was calculated using the Clopper and Pearson method. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; or that was considered to be an important medical event.
Geometric Mean Ratio (GMR) Based on Geometric Mean Concentration (GMC) of Full-Length S-binding Immunoglobulin G (IgG) at 1 Month After BNT162b2 Vaccination
Time frame: 1 Month After BNT162b2 vaccination
GMCs of full-length S-binding IgG level for the coadministration group and separate administration group were reported in this outcome measure in descriptive data section. GMC and the 2-sided 95% CI were calculated by exponentiating the LSMeans of the concentrations and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of vaccine group, age group, and the corresponding baseline assay results (log scale). Assay results below the LLOQ were set to 0.5*LLOQ. Geometric mean ratio (GMR) was reported in the statistical analysis section and was calculated as ratio of GMCs in the coadministration group to the separate administration group. Here, "Number of participants analyzed" signifies number of participants evaluable for this outcome measure.
Geometric Mean Ratio (GMR) Based on Geometric Mean Titer (GMT) of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After SIIV Vaccination
Time frame: 1 Month After SIIV vaccination
GMTs of strain-specific HAI titers for the coadministration group and separate administration group were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the LSMeans of the titers and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of vaccine group, age group, and the corresponding baseline assay results (log scale). Assay results below the LLOQ were set to 0.5*LLOQ, and results above the ULOQ were set to ULOQ+1. Geometric mean ratio (GMR) was reported in the statistical analysis section and was calculated as ratio of GMT in the coadministration group to the separate administration group.

6 secondary outcomes

Geometric Mean Concentration (GMC) of Full-Length S-binding IgG Levels Before Vaccination and 1 Month After BNT162b2 Vaccination
Time frame: Before BNT162b2 vaccination, and 1 month After BNT162b2 vaccination
Geometric Mean Fold Rise (GMFR) of Full-Length S-binding IgG Levels From Before Vaccination to 1 Month After BNT162b2 Vaccination
Time frame: From before BNT162b2 vaccination to 1 month After BNT162b2 vaccination
Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Titers Before Vaccination and 1 Month After BNT162b2 Vaccination
Time frame: Before BNT162b2 vaccination, and 1 month after BNT162b2 vaccination
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Titers From Before Vaccination to 1 Month After BNT162b2 Vaccination
Time frame: From before BNT162b2 vaccination to 1 month after BNT162b2 vaccination
Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination
Time frame: Before SIIV vaccination, and 1 month after SIIV vaccination
Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 1 Month After SIIV Vaccination
Time frame: From before vaccination to 1 month after SIIV vaccination

Results and safety

Results posted to the registry on 24 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Coadministration Group	568	560
Separate Administration Group	566	555

Primary outcome: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1

Time frame: Within 7 Days After Vaccination 1. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Coadministration Group n = 564	Separate Administration Group n = 563
Redness: Any	7.6 (5.6 to 10.1)	0.5 (0.1 to 1.6)
Redness: Mild	6.2 (4.4 to 8.5)	0.5 (0.1 to 1.6)
Redness: Moderate	1.2 (0.5 to 2.5)	0 (0.0 to 0.7)
Redness: Severe	0.2 (0.0 to 1.0)	0 (0.0 to 0.7)
Redness: Grade 4	0 (0.0 to 0.7)	0 (0 to 0.7)
Swelling: Any	9.2 (7.0 to 11.9)	1.1 (0.4 to 2.3)
Swelling: Mild	6.2 (4.4 to 8.5)	0.4 (0.0 to 1.3)
Swelling: Moderate	3.0 (1.8 to 4.8)	0.7 (0.2 to 1.8)

Population analysed: Safety population included all participants who received any of the study intervention. Here, ''Number of participants analyzed'' (N) signifies number of participants evaluable and "Number Analyzed" (n) signifies number of participants evaluable for specified rows for this outcome measure.

Primary outcome: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2

Time frame: Within 7 Days After Vaccination 2. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Coadministration Group n = 557	Separate Administration Group n = 553
Redness: Any	0.2 (0.0 to 1.0)	4.7 (3.1 to 6.8)
Redness: Mild	0.2 (0.0 to 1.0)	4.3 (2.8 to 6.4)
Redness: Moderate	0 (0.0 to 0.7)	0.4 (0.0 to 1.3)
Redness: Severe	0 (0.0 to 0.7)	0 (0.0 to 0.7)
Redness: Grade 4	0 (0.0 to 0.7)	0 (0.0 to 0.7)
Swelling: Any	0.4 (0.0 to 1.3)	8.9 (6.6 to 11.5)
Swelling: Mild	0.4 (0.0 to 1.3)	5.8 (4.0 to 8.1)
Swelling: Moderate	0 (0.0 to 0.7)	3.1 (1.8 to 4.9)

Population analysed: Safety population included all participants who received any of the study intervention. Here, "Number of participants analyzed" included participants who received Vaccination 2 and signifies number of participants evaluable for this outcome measure.

Primary outcome: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1

Time frame: Within 7 Days After Vaccination 1. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Coadministration Group n = 564	Separate Administration Group n = 563
Fever: >=38.0 deg C	2.0 (1.0 to 3.5)	1.1 (0.4 to 2.3)
Fever: >=38.0 deg C to 38.4 deg C	1.2 (0.5 to 2.5)	0.4 (0.0 to 1.3)
Fever: >38.4 deg C to 38.9 deg C	0.4 (0.0 to 1.3)	0.4 (0.0 to 1.3)
Fever: >38.9 deg C to 40.0 deg C	0.4 (0.0 to 1.3)	0.4 (0.0 to 1.3)
Fever: >40.0 deg C	0.0 (0.0 to 0.7)	0.0 (0.0 to 0.7)
Fatigue: Any	64.0 (59.9 to 68.0)	42.1 (38.0 to 46.3)
Fatigue: Mild	31.9 (28.1 to 35.9)	24.7 (21.2 to 28.5)
Fatigue: Moderate	30.9 (27.1 to 34.8)	16.3 (13.4 to 19.7)

Population analysed: Safety population included all participants who received any of the study intervention. Here, "Number of participants analyzed" signifies number of participants evaluable and "Number Analyzed" (n) signifies number of participants evaluable for specified rows for this outcome measure.

Primary outcome: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2

Time frame: Within 7 Days After Vaccination 2. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Coadministration Group n = 557	Separate Administration Group n = 553
Fever: >=38.0 deg C	1.1 (0.4 to 2.3)	1.6 (0.7 to 3.1)
Fever: >=38.0 deg C to 38.4 deg C	0.5 (0.1 to 1.6)	1.1 (0.4 to 2.3)
Fever: >38.4 deg C to 38.9 deg C	0.5 (0.1 to 1.6)	0.5 (0.1 to 1.6)
Fever: >38.9 deg C to 40.0 deg C	0 (0.0 to 0.7)	0 (0.0 to 0.7)
Fever: >40.0 deg C	0. (0.0 to 0.7)	0 (0.0 to 0.7)
Fatigue: Any	21.7 (18.4 to 25.4)	50.8 (46.6 to 55.1)
Fatigue: Mild	12.4 (9.8 to 15.4)	27.3 (23.6 to 31.2)
Fatigue: Moderate	8.6 (6.4 to 11.3)	22.1 (18.7 to 25.8)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Coadministration Group (Visit 1)	2 of 564 (0.4%)	532 of 564 (94.3%)	0 of 564
Coadministration Group (Visit 2)	3 of 562 (0.5%)	261 of 562 (46.4%)	0 of 562
Separate Administration Group (Visit 1)	1 of 564 (0.2%)	364 of 564 (64.5%)	0 of 564
Separate Administration Group (Visit 2)	4 of 557 (0.7%)	502 of 557 (90.1%)	0 of 557

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37698774Murdoch L, Quan K, Baber JA, Ho AWY, Zhang Y, Xu X, Lu C, Cooper D, Koury K, Lockhart SP, Anderson AS, Tureci O, Sahin U, Swanson KA, Gruber WC, Kitchin N; C4591030 Clinical Trial Group. Safety and Immunogenicity of the BNT162b2 Vaccine Coadministered with Seasonal Inactivated Influenza Vaccine in Adults. Infect Dis Ther. 2023 Sep;12(9):2241-2258. doi: 10.1007/s40121-023-00863-5. Epub 2023 Sep 12.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

26 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BNT162b2 and Seasonal Inactivated Influenza Vaccine in people with SARS-CoV-2 Infection and COVID-19, run by BioNTech SE at 26 sites in 2 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 5 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 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in New Zealand, Australia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 24 Nov 2023). 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?

Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (time frame: Within 7 Days After Vaccination 1). The study lists 10 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 NCT05310084, which also lists 1 linked publication.

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 12 Jun 2024.