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

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.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infections; Pneumococcal Conjugate Vaccine
• Intervention / Treatment: Biological: 13vPnC; Biological: Hib

• Study Type: Interventional
• Enrollment (Actual): 936
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 5 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 13-valent Pneumococcal Conjugate Vaccine (13vPnC); 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.; 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).; 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.; 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.	Biological: 13vPnC; suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
Active Comparator: Haemophilus influenzae type b (Hib); No participants in cohort 1 will receive Hib vaccine.; 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.; 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.	Biological: Hib; suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	From the signing of ICD to 6 month after the last vaccination (13vPnC or Hib) in Cohorts 2, 3 and 4.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Cohort 1 (infant series): 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2018
• Primary Completion (Actual): August 23, 2021
• Study Completion (Actual): October 13, 2023

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): July 2, 2018

Study Record Updates

• Last Update Posted (Actual): November 5, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Pneumococcal Infections
• Other Study ID Numbers: B1851178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No