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

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Primary Purpose

Status

Active

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

13vPnC

Hib

About this trial

This is an interventional prevention trial for Pneumococcal Infections

Eligibility Criteria

42 Days - 5 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Huaiyin District Center for Disease Prevention and Control
Guanyun County Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

13-valent Pneumococcal Conjugate Vaccine (13vPnC)

Haemophilus influenzae type b (Hib)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

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

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.

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

Secondary Outcome Measures

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.

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

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.

Number of AEs from the signing of the informed consent document (ICD) 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

Number of AEs from 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

Number of serious adverse events (SAEs) from the signing of the informed consent document (ICD) to 6 months after vaccination 4 in Cohort 1

Full Information

NCT ID

NCT03574389

First Posted

May 22, 2018

Last Updated

December 17, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT03574389

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 23, 2018 (Actual)

Primary Completion Date

August 23, 2021 (Actual)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumococcal Infections, Pneumococcal Conjugate Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

936 (Actual)

8. Arms, Groups, and Interventions

Arm Title

13-valent Pneumococcal Conjugate Vaccine (13vPnC)

Arm Type

Experimental

Arm Description

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.

Arm Title

Haemophilus influenzae type b (Hib)

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

13vPnC

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Hib

Intervention Description

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

Primary Outcome Measure Information:

Title

Serotype-specific IgG geometric mean concentrations(GMCs) for each of the pneumococcal serotypes compared to IgG GMCs

Description

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.

Time Frame

1 month after the last dose of 13vPnC in cohorts 2, 3 and 4 and 1 month after the infant series in cohort 1

Title

Number of local reactions and systemic events in Cohorts 2, 3 and 4

Description

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.

Time Frame

7 days after each vaccination

Title

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

Time Frame

1 month after the last vaccination (13vPnC or Hib) in Cohort 2, 3 and 4

Title

Number of newly diagnosed chronic medical conditions in Cohort 2, 3 and 4

Description

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.

Time Frame

1 month after the last study vaccination to 6 months after the last study vaccination

Title

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

Time Frame

Up to 6 months after the last study vaccination (13vPnC or Hib) in Cohort 2, 3 and 4

Secondary Outcome Measure Information:

Title

Opsonophagocytic activity (OPA) to the vaccine specific serotypes compared to vaccine specific responses OPA

Description

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.

Time Frame

1 month after the last dose of 13vPnC in cohorts 2,3, 4 and 1 month after infant series in cohort 1

Title

Serotype specific IgG GMC and OPA GMTs for each of the pneumococcal serotypes compared to IgG and OPA

Description

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

Time Frame

1 month after the last vaccination in Cohort 2, 3, 4, whichever comes last, up to 9 months

Title

Serotype specific IgG GMC for each of the pneumococcal serotypes

Description

Serotype specific IgG GMC in all subjects and OPA GMTs in approximately 50 subjects at all times points in Cohort 1.

Time Frame

Before vaccination through 5 years of age

Title

Number of AEs from the signing of the informed consent document (ICD) to 1 month after vaccination 3 in Cohort 1

Time Frame

Up to 1 month after vaccination 3 in Cohort 1

Title

Number of newly diagnosed chronic medical conditions from 1 month after vaccination 3 to vaccination 4 in Cohort 1

Time Frame

1 month after vaccination 3 to vaccination 4 in Cohort 1

Title

Number of AEs from vaccination 4 to 1 month after vaccination 4 in Cohort 1

Time Frame

Vaccination 4 to 1 month after vaccination 4 in Cohort 1

Title

Number of newly diagnosed chronic medical conditions from 1 month after vaccination 4 to 6 months after vaccination 4 in Cohort 1

Time Frame

1 month after vaccination 4 to 6 months after vaccination 4 in Cohort 1

Title

Number of serious adverse events (SAEs) from the signing of the informed consent document (ICD) to 6 months after vaccination 4 in Cohort 1

Time Frame

Up to 6 months after vaccination 4 in Cohort 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

42 Days

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Huaiyin District Center for Disease Prevention and Control

City

Huaian

State/Province

Jiangsu

ZIP/Postal Code

223300

Country

China

Facility Name

Guanyun County Disease Control and Prevention

City

Lianyungang

State/Province

Jiangsu

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=B1851178

Description

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

Pneumococcal Infections, Pneumococcal Conjugate Vaccine

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial