20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04379713 |
Recruitment Status :
Completed
First Posted : May 7, 2020
Last Update Posted : October 5, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 : | 1511 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 OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS |
Actual Study Start Date : | May 21, 2020 |
Actual Primary Completion Date : | August 31, 2022 |
Actual Study Completion Date : | August 31, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: 20-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
|
Biological: 20-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine |
Active Comparator: 13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
|
Biological: 13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine |
- Percentage of participants reporting prompted local reactions within 7 days after each dose in each group (redness, swelling, and pain at the injection site) [ 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 dose in each group (fever, decreased appetite, irritability, and drowsiness/increased sleep) [ Time Frame: Day 7 ]Prompted systemic reactions after each dose in each group
- Percentage of participants reporting adverse events from Dose 1 through 1 month after Dose 3 in each group [ Time Frame: 1 month after Dose 3 ]Adverse events occurring from Dose 1 through 1 month after Dose 3 in each group
- Percentage of participants reporting adverse events from Dose 4 through 1 month after Dose 4 in each group [ Time Frame: 1 month after Dose 4 ]Adverse events occurring from Dose 4 through 1 month after Dose 4 in each group
- Percentage of participants reporting SAEs up to 6 months after Dose 4 in each group [ Time Frame: 6 months after Dose 4 ]SAEs occurring up to 6 months after Dose 4 in each group
- Percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 months after Dose 4 in each group [ Time Frame: 6 months after Dose 4 ]NDCMCs occurring up to 6 months after Dose 4 in each group

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 42 Days to 98 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male or female infants born at ≥34 weeks of gestation and who are 2 months of age (≥42 to ≤98 days) at the time of consent (the day of birth is considered day of life 1).
- Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Exclusion Criteria:
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
- Major known congenital malformation or serious chronic disorder.

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): NCT04379713

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT04379713 |
Other Study ID Numbers: |
B7471013 2019-003307-35 ( EudraCT Number ) |
First Posted: | May 7, 2020 Key Record Dates |
Last Update Posted: | October 5, 2022 |
Last Verified: | October 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 |