Pneumococcal InfectionsPhase 3NCT03574389

A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Infants and Young Children

A Phase 3 study testing 13vPnC and Hib in people with Pneumococcal Infections and Pneumococcal Conjugate Vaccine, run by Pfizer at 2 sites in China.

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

The purpose of this study is to assess the safety and immunogenicity of 13-valent Pneumococcal conjugate vaccine in Chinese infant and young children. Read more about this study

Who is it for?: Ages 42 days to 5 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infections, Pneumococcal Conjugate Vaccine
What is being tested?: 13vPnC and Hib
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 936 participants
Where: 2 sitesChina
Study dates: 23 Jun 2018to 13 Oct 2023
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 42 days to 5 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Evidence of a personally signed and dated ICD indicating that the parent(s)/legal guardian has been informed of all pertinent aspects of the study.
Aged 6 weeks (42 days) to <6 years at the time of consent.
Healthy infants and children as determined by medical history, physical examination, and judgment of the investigator.

Who cannot join

Participation in other studies involving investigational drug(s)/vaccine(s) since birth (Cohort 1 only) or in the 6 months prior to study entry (Cohorts 2, 3, and 4) and/or during study participation.
Other acute or chronic medical or psychiatric condition, including recent laboratory abnormality, that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Vaccination with licensed or investigational pneumococcal vaccine.
Previous vaccination with licensed or investigational Hib vaccine.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Huaiyin District Center for Disease Prevention and Control
Huaian, Jiangsu, 223300
Guanyun County Disease Control and Prevention
Lianyungang, Jiangsu

Other trials in China

About this study

Official title: A PHASE 3 OPEN-LABEL TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN INFANTS AND YOUNG CHILDREN IN CHINA WHO ARE NAIVE TO PNEUMOCOCCAL VACCINATION

The purpose of this study is to assess the safety and immunogenicity of 13-valent Pneumococcal conjugate vaccine in Chinese infant and young children.

Conditions: Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Being tested: 13vPnC, Hib
Medical subject headings: Pneumococcal Infections

What participants receive

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

13vPnCBiological
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
HibBiological
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose

Study groups in NCT03574389
Study group	Role	What they receive
13-valent Pneumococcal Conjugate Vaccine (13vPnC)	Experimental	1. Participants in cohort 1 will receive each dose of 13vPnC in months 2, 4 and 6, and then a booster dose during months 12-15. 2. Participants in cohort 2 will receive first dose dose 13vPnC at the age of months 7(included) to months 12 (less than months 12), and the second dose will be given at least 28 days after first dose, and the third dose will be months 12 to 15 (and at least 56 days after the second dose). 3. Participants in cohort 3 will receive the first dose of 13vPnC during 1 (included) to 2 years (less than 2 years of age) of age, and the second dose will be given at least 56 days after first dose. 4. Participants in cohort 4 will receive only one dose at the age of 2 (included) to 6 (less than 6 years of age) years of age. Receives: Biological: 13vPnC
Haemophilus influenzae type b (Hib)	Active comparator	1. No participants in cohort 1 will receive Hib vaccine. 2. Participants in cohort 2 will receive the first dose of Hib vaccine at the age of months 7 (included) to 12 (less than 12 months), and the second dose will be given at least 28 days after the first dose, the third dose will following local practice or national recommendation at the discretion of the investigator. 3. Participants in cohorts 3 and 4 will receive the only one dose Hib vaccine at the age of 1 (included) to 6 (less than 6 years) years of age. Receives: Biological: Hib

What is being measured

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

The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1
Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken 1 month after the infant series in Cohort 1 and the last dose 13vPnC in Cohorts 2, 3, 4. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Measured: Cohort 1: 1 month after the 3rd dose of 13vPnC (infant series dose). Cohort 2, 3, 4: 1 month after the last dose of 13vPnC.
Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2
Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (decreased appetite, drowsiness and irritability) were recorded for 7 days after each investigational product vaccination.
Measured: Within 7 Days After Each Vaccination
Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 3
Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (decreased appetite, drowsiness and irritability) were recorded for 7 days after each investigational product vaccination.
Measured: Within 7 Days After Each Vaccination
Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 4
Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (fatigue, headache, vomiting, diarrhea, muscle pain and joint pain) were recorded for 7 days after each investigational product vaccination.
Measured: Within 7 Days After Each Vaccination
Number of Participants With Adverse Event (AE) From the Signing of the Informed Consent Document (ICD) to 1 Month After the Last Vaccination in Cohorts 2, 3, 4
An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
Measured: From the signing of ICD to 1 month after the last vaccination (13vPnC or Hib) in Cohort 2, 3 and 4.
Number of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From 1 Month to 6 Months After the Last Vaccination in Cohorts 2, 3, 4
Number of participants with NDCMCs from 1 month after the last study vaccination (13vPnC or Hib vaccine) to 6 months after the last study vaccination in Cohorts 2, 3, and 4. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Measured: From 1 month to 6 months (5 months) after the last vaccination in Cohorts 2,3,4.
Number of Participants With SAE From the Signing of the ICD to 6 Months After the Last Vaccination in Cohorts 2, 3, 4
An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event.
Measured: From the signing of ICD to 6 month after the last vaccination (13vPnC or Hib) in Cohorts 2, 3 and 4.

Secondary outcomes (11)

The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1.
Serotype-specific OPA titers to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in a randomly selected subset of about 50 participants receiving 13vPnC from the blood samples taken 1 month after the infant series in Cohort 1 and the last 13vPnC vaccination in each of the 3 cohorts. GMT and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Measured: Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohort 2, 3, 4: 1 month after the last dose of 13vPnC.
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken before vaccination and 1 month after vaccination in each of the 3 cohorts. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Measured: Cohort 2, 3, 4: Before Vaccination and 1 Month After the Last Dose
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype-specific OPA titers to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in a randomly selected subset of approximately 50 participants receiving 13vPnC and approximately 25 participants receiving Hib vaccine from the blood samples taken before vaccination and 1 month after the last 13vPnC vaccination in each of the 3 cohorts.
Measured: Cohort 2, 3, 4: Before Vaccination and 1 Month After the Last Dose
Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken 1 month after the infant series in Cohort 1 and the last dose of vaccination (13vPnC or Hib vaccine) in Cohorts 2, 3, 4.
Measured: Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohorts 2, 3, 4: 1 month after the last dose of 13vPnC and Hib Vaccine.
Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype-specific OPA titers to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in a randomly selected subset of about 50 participants receiving 13vPnC from the blood samples taken 1 month after the infant series in Cohort 1 and the last vaccination (13vPnC or Hib vaccine) in each of the 3 cohorts.
Measured: Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohorts 2, 3, 4: 1 month after the last dose of 13vPnC and Hib Vaccine.
Number of Participants With AE From the Signing of the ICD to 1 Month After the Infant Series in Cohort 1
An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
Measured: From the signing of ICD to 1 month after the 3rd dose of 13vPnC in Cohort 1.
Number of Participants With NDCMCs From 1 Month After Vaccination 3 to Vaccination 4 in Cohort 1
Number of Participants With NDCMCs from 1 month after vaccination 3 to vaccination 4 in Cohort 1. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Measured: From 1 month after Vaccination 3 to Vaccination 4.
Number of Participants With AE From Toddler Dose Until 1 Month After the Toddler Dose in Cohort 1
Number of Participants With AEs from vaccination 4 to 1 month after vaccination 4 in Cohort 1. An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
Measured: From Vaccination 4 to 1 month after Vaccination 4 in Cohort 1.
Number of Participants With NDCMCs From 1 Month to 6 Months After the Toddler Dose in Cohort 1
Number of Participants With NDCMCs from 1 month after vaccination 4 to 6 months after vaccination 4 in Cohort 1. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Measured: From 1 month to 6 months (5 months) after Vaccination 4 in Cohort 1.
Number of Participants With SAEs From the Signing of the ICD to 6 Months After the Toddler Dose in Cohort 1
Number of Participants With SAEs from the signing of the ICD to 6 months after vaccination 4. An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event.
Measured: From the Signing of the ICD to 6 Months After the Vaccination 4.
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken after last vaccination in Cohort 1. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Measured: Cohort 1 (infant series): 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1

Timeline

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

23 Jun 201813 Oct 2023

First posted2 Jul 2018
Study start23 Jun 2018
Primary completion23 Aug 2021
Study completion13 Oct 2023

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 Pneumococcal InfectionsStudies of the same condition, open and under way.
More trials run by PfizerThe 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: None (open label)
Enrolment: 936 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03574389
Sponsor's protocol ID: B1851178
Status last verified: Oct 2024
First submitted: 22 May 2018
Last updated: 5 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Chu K, Hu Y, Pan H, Wu J, Zhu D, Young MM Jr, Luo L, Yi Z, Giardina PC, Gruber WC, Scott DA, Watson W. A randomized, open-label, phase 3 study evaluating safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in Chinese infants and children under 6 years of age. Hum Vaccin Immunother. 2023 Aug 1;19(2):2235926. doi: 10.1080/21645515.2023.2235926.
PubMed 37549923

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 3 OPEN-LABEL TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN INFANTS AND YOUNG CHILDREN IN CHINA WHO ARE NAIVE TO PNEUMOCOCCAL VACCINATION
ClinicalTrials.gov ID: NCT03574389
Acronym / sponsor ID: B1851178
Conditions: Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 936 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 23 Jun 2018 (actual)
Primary completion: 23 Aug 2021 (actual)
Study completion: 13 Oct 2023 (actual)
First posted: 2 Jul 2018 (actual)
Results: Posted 26 Apr 2024

Clinical summary

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

The purpose of this study is to assess the safety and immunogenicity of 13-valent Pneumococcal conjugate vaccine in Chinese infant and young children.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
13-valent Pneumococcal Conjugate Vaccine (13vPnC)	Experimental	Biological: 13vPnC1. Participants in cohort 1 will receive each dose of 13vPnC in months 2, 4 and 6, and then a booster dose during months 12-15. 2. Participants in cohort 2 will receive first dose dose 13vPnC at the age of months 7(included) to months 12 (less than months 12), and the second dose will be given at least 28 days after first dose, and the third dose will be months 12 to 15 (and at least 56 days after the second dose). 3. Participants in cohort 3 will receive the first dose of 13vPnC during 1 (included) to 2 years (less than 2 years of age) of age, and the second dose will be given at least 56 days after first dose. 4. Participants in cohort 4 will receive only one dose at the age of 2 (included) to 6 (less than 6 years of age) years of age.
Haemophilus influenzae type b (Hib)	Active comparator	Biological: Hib1. No participants in cohort 1 will receive Hib vaccine. 2. Participants in cohort 2 will receive the first dose of Hib vaccine at the age of months 7 (included) to 12 (less than 12 months), and the second dose will be given at least 28 days after the first dose, the third dose will following local practice or national recommendation at the discretion of the investigator. 3. Participants in cohorts 3 and 4 will receive the only one dose Hib vaccine at the age of 1 (included) to 6 (less than 6 years) years of age.

Who may qualify

Ages: 42 days to 5 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Evidence of a personally signed and dated ICD indicating that the parent(s)/legal guardian has been informed of all pertinent aspects of the study.
Aged 6 weeks (42 days) to <6 years at the time of consent.
Healthy infants and children as determined by medical history, physical examination, and judgment of the investigator.

Key exclusion criteria (4 listed)

Participation in other studies involving investigational drug(s)/vaccine(s) since birth (Cohort 1 only) or in the 6 months prior to study entry (Cohorts 2, 3, and 4) and/or during study participation.
Other acute or chronic medical or psychiatric condition, including recent laboratory abnormality, that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Vaccination with licensed or investigational pneumococcal vaccine.
Previous vaccination with licensed or investigational Hib vaccine.

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
13vPnCsuspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose	Biological	13-valent Pneumococcal Conjugate Vaccine (13vPnC)
Hibsuspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose	Biological	Haemophilus influenzae type b (Hib)

Primary outcome

The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1
Time frame: Cohort 1: 1 month after the 3rd dose of 13vPnC (infant series dose). Cohort 2, 3, 4: 1 month after the last dose of 13vPnC.
Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken 1 month after the infant series in Cohort 1 and the last dose 13vPnC in Cohorts 2, 3, 4. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2
Time frame: Within 7 Days After Each Vaccination
Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (decreased appetite, drowsiness and irritability) were recorded for 7 days after each investigational product vaccination.
Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 3
Time frame: Within 7 Days After Each Vaccination
Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (decreased appetite, drowsiness and irritability) were recorded for 7 days after each investigational product vaccination.
Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 4
Time frame: Within 7 Days After Each Vaccination
Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (fatigue, headache, vomiting, diarrhea, muscle pain and joint pain) were recorded for 7 days after each investigational product vaccination.
Number of Participants With Adverse Event (AE) From the Signing of the Informed Consent Document (ICD) to 1 Month After the Last Vaccination in Cohorts 2, 3, 4
Time frame: From the signing of ICD to 1 month after the last vaccination (13vPnC or Hib) in Cohort 2, 3 and 4.
An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
Number of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From 1 Month to 6 Months After the Last Vaccination in Cohorts 2, 3, 4
Time frame: From 1 month to 6 months (5 months) after the last vaccination in Cohorts 2,3,4.
Number of participants with NDCMCs from 1 month after the last study vaccination (13vPnC or Hib vaccine) to 6 months after the last study vaccination in Cohorts 2, 3, and 4. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Number of Participants With SAE From the Signing of the ICD to 6 Months After the Last Vaccination in Cohorts 2, 3, 4
Time frame: From the signing of ICD to 6 month after the last vaccination (13vPnC or Hib) in Cohorts 2, 3 and 4.
An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event.

11 secondary outcomes

The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1.
Time frame: Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohort 2, 3, 4: 1 month after the last dose of 13vPnC.
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Time frame: Cohort 2, 3, 4: Before Vaccination and 1 Month After the Last Dose
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Time frame: Cohort 2, 3, 4: Before Vaccination and 1 Month After the Last Dose
Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Time frame: Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohorts 2, 3, 4: 1 month after the last dose of 13vPnC and Hib Vaccine.
Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Time frame: Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohorts 2, 3, 4: 1 month after the last dose of 13vPnC and Hib Vaccine.
Number of Participants With AE From the Signing of the ICD to 1 Month After the Infant Series in Cohort 1
Time frame: From the signing of ICD to 1 month after the 3rd dose of 13vPnC in Cohort 1.
Number of Participants With NDCMCs From 1 Month After Vaccination 3 to Vaccination 4 in Cohort 1
Time frame: From 1 month after Vaccination 3 to Vaccination 4.
Number of Participants With AE From Toddler Dose Until 1 Month After the Toddler Dose in Cohort 1
Time frame: From Vaccination 4 to 1 month after Vaccination 4 in Cohort 1.
Number of Participants With NDCMCs From 1 Month to 6 Months After the Toddler Dose in Cohort 1
Time frame: From 1 month to 6 months (5 months) after Vaccination 4 in Cohort 1.
Number of Participants With SAEs From the Signing of the ICD to 6 Months After the Toddler Dose in Cohort 1
Time frame: From the Signing of the ICD to 6 Months After the Vaccination 4.
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Time frame: Cohort 1 (infant series): 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1

Results and safety

Results posted to the registry on 26 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	125	90
Cohort 2_13vPnC	236	214
Cohort 2_Hib Vaccine	117	107
Cohort 3_13vPnC	165	146
Cohort 3_Hib Vaccine	83	83
Cohort 4_13vPnC	138	138
Cohort 4_Hib Vaccine	68	68

Primary outcome: The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1

Time frame: Cohort 1: 1 month after the 3rd dose of 13vPnC (infant series dose). Cohort 2, 3, 4: 1 month after the last dose of 13vPnC.. Geometric mean (95% Confidence Interval). Unit: mcg/mL

Measure	Cohort 1_Infant Series n = 72	Cohort 2_13vPnC n = 176	Cohort 3_13vPnC n = 127	Cohort 4_vPnC n = 131
Serotype 1	5.40 (4.43 to 6.58)	3.75 (3.26 to 4.32)	4.38 (3.75 to 5.11)	4.40 (3.76 to 5.14)
Serotype 3	0.63 (0.54 to 0.75)	1.19 (1.08 to 1.32)	1.32 (1.16 to 1.51)	1.12 (0.97 to 1.29)
Serotype 4	3.96 (3.24 to 4.84)	2.97 (2.60 to 3.40)	4.04 (3.48 to 4.68)	4.47 (3.92 to 5.10)
Serotype 5	3.50 (2.91 to 4.19)	3.07 (2.73 to 3.46)	2.57 (2.26 to 2.92)	2.92 (2.57 to 3.32)
Serotype 6A	5.35 (4.44 to 6.44)	3.12 (2.74 to 3.57)	3.19 (2.69 to 3.78)	3.39 (2.80 to 4.09)
Serotype 6B	4.62 (3.76 to 5.69)	2.20 (1.91 to 2.54)	2.47 (2.06 to 2.96)	2.96 (2.44 to 3.59)
Serotype 7F	7.14 (6.00 to 8.50)	5.73 (5.10 to 6.44)	7.87 (6.90 to 8.96)	7.08 (6.19 to 8.10)
Serotype 9V	3.66 (2.99 to 4.50)	2.24 (1.99 to 2.51)	3.31 (2.90 to 3.77)	3.68 (3.22 to 4.21)

Population analysed: Evaluable analysis set included all participants evaluable for the study at randomization; received all study vaccinations for Cohort 2-4, received all 3 infant series doses for Cohort 1; had blood draw for assay testing within 27-56 days after 3rd vaccination for Cohort 1, visit 3 for Cohort 2, visit 2 for Cohort 3 and visit 1 for Cohort 4 and the sample from this blood draw provided at least 1 valid and determinate assay result; received no prohibited vaccine; had no major protocol violation.

Primary outcome: Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2

Time frame: Within 7 Days After Each Vaccination. Count of participants. Unit: Participants

Measure	Cohort 2_13vPnC_Vaccination 1 n = 236	Cohort 2_Hib Vaccine_Vaccination 1 n = 117	Cohort 2_13vPnC_Vaccination 2 n = 219	Cohort 2_Hib Vaccine_Vaccination 2 n = 107	Cohort 2_13vPnC_Vaccination 3 n = 194
Local Reactions	66	18	20	14	4
Systemic Events	23	7	23	5	1

Population analysed: The safety population included all participants who received at least 1 dose of the investigational product.

Primary outcome: Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 3

Time frame: Within 7 Days After Each Vaccination. Count of participants. Unit: Participants

Measure	Cohort 3_13vPnC _Vaccination 1 n = 164	Cohort 3_Hib Vaccine_Vaccination 1 n = 83	Cohort 3_13vPnC _Vaccination 2 n = 146
Local Reactions	45	10	9
Systemic Events	26	7	4

Population analysed: The safety population included all participants who received at least 1 dose of the investigational product.

Primary outcome: Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 4

Time frame: Within 7 Days After Each Vaccination. Count of participants. Unit: Participants

Measure	Cohort 4_13vPnC_Vaccination 1 n = 138	Cohort 4_Hib Vaccine_Vaccination 1 n = 68
Local Reactions	48	21
Systemic Events	17	10

Population analysed: The safety population included all participants who received at least 1 dose of the investigational product.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	9 of 125 (7.2%)	13 of 125 (10.4%)	0 of 125
Cohort 2_13vPnC	5 of 236 (2.1%)	182 of 236 (77.1%)	0 of 236
Cohort 2_Hib Vaccine	1 of 117 (0.9%)	74 of 117 (63.2%)	0 of 117
Cohort 3_13vPnC	2 of 165 (1.2%)	99 of 165 (60%)	0 of 165
Cohort 3_Hib Vaccine	0 of 83 (0%)	26 of 83 (31.3%)	0 of 83
Cohort 4_13vPnC	2 of 138 (1.4%)	66 of 138 (47.8%)	0 of 138
Cohort 4_Hib Vaccine	1 of 68 (1.5%)	29 of 68 (42.6%)	0 of 68

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37549923Chu K, Hu Y, Pan H, Wu J, Zhu D, Young MM Jr, Luo L, Yi Z, Giardina PC, Gruber WC, Scott DA, Watson W. A randomized, open-label, phase 3 study evaluating safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in Chinese infants and children under 6 years of age. Hum Vaccin Immunother. 2023 Aug 1;19(2):2235926. doi: 10.1080/21645515.2023.2235926.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 13vPnC and Hib in people with Pneumococcal Infections and Pneumococcal Conjugate Vaccine, run by Pfizer at 2 sites in China.

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 3 inclusion and 4 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 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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 26 Apr 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?

The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 (time frame: Cohort 1: 1 month after the 3rd dose of 13vPnC (infant series dose). Cohort 2, 3, 4: 1 month after the last dose of 13vPnC.). The study lists 7 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 NCT03574389, 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 5 Nov 2024.