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A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwan

Primary Purpose

Pneumococcal Disease

Status

Active

Phase

Phase 3

Locations

Taiwan

Study Type

Interventional

Intervention

20-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine

About this trial

This is an interventional prevention trial for Pneumococcal Disease

Eligibility Criteria

42 Days - 84 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male or female infants born at ≥36 weeks of gestation and approximately 2 months of age at the time of consent
Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study
Weight of 3.0 kg or greater at the time of randomization

Exclusion Criteria:

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 13vPnC, 20vPnC, or any other diphtheria toxoid-containing vaccine.
Major known congenital malformation or serious chronic disorder
Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study
Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.

Sites / Locations

Mackay Memorial Hospital-Hsinchu
Taichung Veterans General Hospital
National Taiwan University Hospital
Mackay Memorial Hospital
Chang Gung Medical Foundation-Linkou Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

20-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine

Arm Description

Pneumococcal conjugate vaccine (20vPnC)

Pneumococcal conjugate vaccine (13vPnC)

Outcomes

Primary Outcome Measures

Percentage of participants with local reactions (redness, swelling, and pain at the injection site)

Prompted local reactions after each dose

Percentage of participants with systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability)

Prompted systemic reactions after each dose

Percentage of participants with adverse events (AEs) from Dose 1 through 1 month after Dose 3 in each group

Adverse events occurring from Dose 1 to 1 month after Dose 3 in each group

Percentage of participants with AEs from Dose 4 through 1 month after Dose 4 in each group

Adverse events occurring from Dose 4 to 1 month after Dose 4 in each group

Percentage of participants with SAEs from Dose 1 through 1 month after Dose 4 in each group

SAEs occurring up to 1 month after Dose 4 in each group

Secondary Outcome Measures

Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 3 in each vaccine group

IgG GMCs for the 20vPnC serotypes 1 month after Dose 3

Percentages of participants with predefined serotype-specific IgG concentration for the 20vPnC serotypes at approximately 1 month after Dose 3 in each vaccine group

IgG concentrations for 20vPnC serotypes 1 month after Dose 3

GMCs of serotype-specific IgG concentrations 1 month after Dose 4 in each vaccine group

IgG GMCs for the 20vPnC serotypes 1 month after Dose 4

Percentages of participants with predefined serotype-specific IgG concentrations for the 20vPnC serotypes at approximately 1 month after Dose 4 in each vaccine group

IgG concentrations for 20vPnC serotypes 1 month after Dose 4

Full Information

NCT ID

NCT05512819

First Posted

August 22, 2022

Last Updated

September 15, 2023

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT05512819

Brief Title

A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwan

Official Title

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN IN A SERIES OF 3 INFANT DOSES AND 1 TODDLER DOSE IN INFANTS IN INDIA AND TAIWAN

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 16, 2022 (Actual)

Primary Completion Date

February 17, 2024 (Anticipated)

Study Completion Date

February 17, 2024 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in infants and toddlers. This study is enrolling participants who are: Born after at least 36 weeks of pregnancy and about 2 months of age at the time of entering the study Have a bodyweight of at least 3 kg Participants will receive either the study vaccine (20vPnC) or a licensed vaccine (13vPnC) as a 4-dose schedule as a shot in the muscle. Participants will receive Dose 1 on study day 1. Dose 2 will be given 28-70 days after Dose 1, and Dose 3 will be given 28-70 days after Dose 2. Dose 4 will be given at 365-455 days (approximately 12-15 months) of age. Participation in the study will take approximately 15 months, during which participants will come to the study clinic for 6 times. The study team will ask questions about the participant's health and take some blood samples during the visit.

6. Conditions and Keywords

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

Pneumococcal Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

190 (Actual)

8. Arms, Groups, and Interventions

Arm Title

20-valent pneumococcal conjugate vaccine

Arm Type

Experimental

Arm Description

Pneumococcal conjugate vaccine (20vPnC)

Arm Title

13-valent pneumococcal conjugate vaccine

Arm Type

Active Comparator

Arm Description

Pneumococcal conjugate vaccine (13vPnC)

Intervention Type

Biological

Intervention Name(s)

20-valent pneumococcal conjugate vaccine

Intervention Description

20-valent pneumococcal conjugate vaccine

Intervention Type

Biological

Intervention Name(s)

13-valent pneumococcal conjugate vaccine

Intervention Description

13-valent pneumococcal conjugate vaccine

Primary Outcome Measure Information:

Title

Percentage of participants with local reactions (redness, swelling, and pain at the injection site)

Description

Prompted local reactions after each dose

Time Frame

Day 7

Title

Percentage of participants with systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability)

Description

Prompted systemic reactions after each dose

Time Frame

Day 7

Title

Percentage of participants with adverse events (AEs) from Dose 1 through 1 month after Dose 3 in each group

Description

Adverse events occurring from Dose 1 to 1 month after Dose 3 in each group

Time Frame

Dose 1 to 1 month after Dose 3

Title

Percentage of participants with AEs from Dose 4 through 1 month after Dose 4 in each group

Description

Adverse events occurring from Dose 4 to 1 month after Dose 4 in each group

Time Frame

Dose 4 to 1 month after Dose 4

Title

Percentage of participants with SAEs from Dose 1 through 1 month after Dose 4 in each group

Description

SAEs occurring up to 1 month after Dose 4 in each group

Time Frame

Dose 1 to 1 month after Dose 4

Secondary Outcome Measure Information:

Title

Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 3 in each vaccine group

Description

IgG GMCs for the 20vPnC serotypes 1 month after Dose 3

Time Frame

1 month after Dose 3

Title

Percentages of participants with predefined serotype-specific IgG concentration for the 20vPnC serotypes at approximately 1 month after Dose 3 in each vaccine group

Description

IgG concentrations for 20vPnC serotypes 1 month after Dose 3

Time Frame

1 month after Dose 3

Title

GMCs of serotype-specific IgG concentrations 1 month after Dose 4 in each vaccine group

Description

IgG GMCs for the 20vPnC serotypes 1 month after Dose 4

Time Frame

1 month after Dose 4

Title

Percentages of participants with predefined serotype-specific IgG concentrations for the 20vPnC serotypes at approximately 1 month after Dose 4 in each vaccine group

Description

IgG concentrations for 20vPnC serotypes 1 month after Dose 4

Time Frame

1 month after Dose 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

42 Days

Maximum Age & Unit of Time

84 Days

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female infants born at ≥36 weeks of gestation and approximately 2 months of age at the time of consent Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study Weight of 3.0 kg or greater at the time of randomization Exclusion Criteria: History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 13vPnC, 20vPnC, or any other diphtheria toxoid-containing vaccine. Major known congenital malformation or serious chronic disorder Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.

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

Mackay Memorial Hospital-Hsinchu

City

Hsinchu City

State/Province

Hsinchu

ZIP/Postal Code

30071

Country

Taiwan

Facility Name

Taichung Veterans General Hospital

City

Taichung

ZIP/Postal Code

407219

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Mackay Memorial Hospital

City

Taipei

ZIP/Postal Code

10449

Country

Taiwan

Facility Name

Chang Gung Medical Foundation-Linkou Branch

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

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=B7471024

Description

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A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwan

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