20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
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ClinicalTrials.gov Identifier: NCT04546425 |
Recruitment Status :
Active, not recruiting
First Posted : September 14, 2020
Last Update Posted : November 4, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pneumococcal Disease | Biological: 20-valent pneumococcal conjugate vaccine Biological: 13-valent pneumococcal conjugate vaccine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1258 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN AS A SERIES OF 2 INFANT DOSES AND 1 TODDLER DOSE IN HEALTHY INFANTS |
Actual Study Start Date : | September 9, 2020 |
Actual Primary Completion Date : | April 22, 2022 |
Estimated Study Completion Date : | February 2, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: 20-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
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Biological: 20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine |
Active Comparator: 13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
|
Biological: 13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine |
- Percentage of participants reporting prompted local reactions within 7 days after each vaccination in each vaccine group [ Time Frame: Day 7 ]Prompted local reactions after each dose in each group
- Percentage of participants reporting prompted systemic events within 7 days after each vaccination in each vaccine group [ Time Frame: Day 7 ]Prompted systemic reactions after each dose in each group
- Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 2 in each vaccine group [ Time Frame: Dose 1 to 1 month after Dose 2 ]AEs occurring from Dose 1 to 1 month after Dose 2 in each group
- Percentage of participants reporting AEs from Dose 3 to 1 month after Dose 3 in each vaccine group [ Time Frame: Dose 3 to 1 month after Dose 3 ]AEs occurring from Dose 3 to 1 month after Dose 3 in each group
- Percentage of participants reporting serious adverse events (SAEs) during the study in each vaccine group [ Time Frame: Dose 1 to 1 month after Dose 3 ]SAEs occurring from Dose 1 to 1 month after Dose 3 in each group
- Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMC) during the study in each vaccine group [ Time Frame: Dose 1 to 1 month after Dose 3 ]NDCMCs occurring from Dose 1 to 1 month after Dose 3 in each group
- Percentages of participants with predefined pneumococcal serotype-specific IgG concentrations at 1 month after Dose 2 [ Time Frame: 1 month after Dose 2 ]IgG concentrations at 1 month after Dose 2
- Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 2 [ Time Frame: 1 month after Dose 2 ]IgG GMCs 1 month after Dose 2
- Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 3 [ Time Frame: 1 month after Dose 3 ]IgG GMCs 1 month after Dose 3
- Percentages of participants with prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3 [ Time Frame: 1 month after Dose 3 ]Antibody levels 1 month after Dose 3
- Percentages of participants with the predefined serotype-specific IgG concentrations 1 month after Dose 3 in each vaccine group [ Time Frame: 1 month after Dose 3 ]IgG concentrations 1 month after Dose 3
- Opsonophagocytic activity (OPA) GMTs 1 month after Dose 2 in each vaccine group [ Time Frame: 1 month after Dose 2 ]OPA GMTs 1 month after Dose 2
- Opsonophagocytic activity (OPA) GMTs 1 month after Dose 3 in each vaccine group [ Time Frame: 1 month after Dose 3 ]OPA GMTs 1 month after Dose 3
- IgG GMFRs from before Dose 3 to 1 month after Dose 3 in each vaccine group [ Time Frame: Before Dose 3 to 1 month after Dose 3 ]IgG GMFRs before Dose 3 to 1 month after Dose 3
- Antibody levels to specific concomitant vaccine antigens 1 month after Dose 2 [ Time Frame: 1 month after Dose 2 ]Antibody levels 1 month after Dose 2

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Ages Eligible for Study: | 42 Days to 112 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male or female infants born at >36 weeks of gestation and 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.
Exclusion Criteria:
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
- 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 investigational product 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04546425

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT04546425 |
Other Study ID Numbers: |
B7471012 2019-003306-27 ( EudraCT Number ) |
First Posted: | September 14, 2020 Key Record Dates |
Last Update Posted: | November 4, 2022 |
Last Verified: | November 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Pneumococcal Infections Streptococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses |
Infections Vaccines Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs |