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

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

Official Title
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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

Conditions
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Pneumococcal Infections, Pneumococcal Conjugate Vaccine

Intervention / Treatment
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* Biological: 13vPnC
* Biological: Hib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 42 Days
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)<br>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<br>* suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose<br>|
| Active Comparator: Haemophilus influenzae type b (Hib)<br>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<br>* suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotype-specific IgG geometric mean concentrations(GMCs) for each of the pneumococcal serotypes compared to IgG GMCs | The serotype-specific IgG geometric mean concentrations (GMCs) for each of the pneumococcal serotypes measured 1 month after the last dose of 13vPnC in Cohort 2, 3, 4 compared to IgG GMCs measured 1 month after the infant series in Cohort 1. | 1 month after the last dose of 13vPnC in cohorts 2, 3 and 4 and 1 month after the infant series in cohort 1 | 
| Number of local reactions and systemic events in Cohorts 2, 3 and 4 | The incidence of local reactions and systemic events (including the use of antipyretic medication) in the 7 days after each vaccination (13vPnC or Hib) in Cohorts 2, 3 and 4. | 7 days after each vaccination | 
| Number of Adverse Events (AE) from the signing of the informed consent document (ICD) to 1 month after the last vaccination (13vPnC or Hib) in Cohort 2, 3 and 4 |  | 1 month after the last vaccination (13vPnC or Hib) in Cohort 2, 3 and 4 | 
| Number of newly diagnosed chronic medical conditions in Cohort 2, 3 and 4 | The incidence of newly diagnosed chronic medical conditions from 1 month after the last study vaccination (13vPnC or Hib) to 6 months after the last study vaccination in Cohort 2, 3 and 4. | 1 month after the last study vaccination to 6 months after the last study vaccination | 
| Number of serious adverse events (SAEs) from the signing of the informed consent document (ICD) to 6 months after the last study vaccination (13vPnC or Hib) in Cohort 2, 3 and 4 |  | Up to 6 months after the last study vaccination (13vPnC or Hib) in Cohort 2, 3 and 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opsonophagocytic activity (OPA) to the vaccine specific serotypes compared to vaccine specific responses OPA | The serotype-specific OPA geometric mean titers (GMTs) for each of the pneumococcal serotypes measured in a subset of approximately 50 subjects per cohort measured 1 month after the last dose of 13vPnC in Cohort 2, 3, 4 compared to OPA GMTs measured 1 month after the infant series in Cohort 1. | 1 month after the last dose of 13vPnC in cohorts 2,3, 4 and 1 month after infant series in cohort 1 | 
| Serotype specific IgG GMC and OPA GMTs for each of the pneumococcal serotypes compared to IgG and OPA | Serotype specific IgG GMC in all subjects and OPA GMTs in approximately 50 subjects per cohort vaccinated with 13vPnC (Cohorts 1,2 ,3 4) and approximately 25 subjects per cohorts vaccinated with Hib (Cohort 2, 3, 4) using blood drawn at the following visits: Cohort 2: Visit 1, Visit 4 Cohort 3: Visit 1, Visit 3 Cohort 4: Visit 1, Visit 2 | 1 month after the last vaccination in Cohort 2, 3, 4, whichever comes last, up to 9 months | 
| Serotype specific IgG GMC for each of the pneumococcal serotypes | Serotype specific IgG GMC in all subjects and OPA GMTs in approximately 50 subjects at all times points in Cohort 1. | Before vaccination through 5 years of age | 
| Number of AEs from the signing of the informed consent document (ICD) to 1 month after vaccination 3 in Cohort 1 |  | Up to 1 month after vaccination 3 in Cohort 1 | 
| Number of newly diagnosed chronic medical conditions from 1 month after vaccination 3 to vaccination 4 in Cohort 1 |  | 1 month after vaccination 3 to vaccination 4 in Cohort 1 | 
| Number of AEs from vaccination 4 to 1 month after vaccination 4 in Cohort 1 |  | Vaccination 4 to 1 month after vaccination 4 in Cohort 1 | 
| Number of newly diagnosed chronic medical conditions from 1 month after vaccination 4 to 6 months after vaccination 4 in Cohort 1 |  | 1 month after vaccination 4 to 6 months after vaccination 4 in Cohort 1 | 
| Number of serious adverse events (SAEs) from the signing of the informed consent document (ICD) to 6 months after vaccination 4 in Cohort 1 |  | Up to 6 months after vaccination 4 in Cohort 1 |