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Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants

A PHASE 2, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN WITH, OR SEPARATELY FROM, 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

NCT03550313•Pfizer

View on ClinicalTrials.gov

Summary

This is a Phase 2, randomized, active-controlled, open-label study with a 3-arm parallel design. Healthy 2-month old infants (42 to 98 days of age) with no history of pneumococcal vaccination will be randomized in a 1:1:1 ratio to receive a 4-dose series of: multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13 (Group 1); multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13 (Group 2); or Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine (Group 3).

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male or female infant born at \>36 weeks of gestation and aged 2 months (42 to 98 days) at the time of consent (the day of birth is considered day of life 1).
•Healthy infant determined by medical history, physical examination, and clinical judgment.

Exclusion Criteria

•Previous vaccination with licensed or investigational pneumococcal vaccine.
•Prior receipt of routine pediatric vaccines, with the exception of hepatitis B vaccine.
•Previous receipt of \>1 dose of hepatitis B vaccine.
•Prior hepatitis B vaccine must have been administered at age \<30 days.
•Major known congenital malformation or serious chronic disorder.
•Receipt of blood/plasma products or immunoglobulins.

Locations (48)

Mobile Pediatric Clinic

Mobile, Alabama, United States

Harrisburg Family Medical Center

Harrisburg, Arkansas, United States

Emmaus Research Center, Inc.

Anaheim, California, United States

Hoag Memorial Hospital Presbyterian

Huntington Beach, California, United States

Madera Family Medical Group

Madera, California, United States

Orange County Research Institute

Ontario, California, United States

Center for Clinical Trials, LLC

Paramount, California, United States

Center for Clinical Trials

Paramount, California, United States

Gentle Medicine Associates

Boynton Beach, Florida, United States

Avail Clinical Research, LLC

DeLand, Florida, United States

Key Dates

Start Date

June 1, 2018

Primary Completion Date

November 5, 2020

Completion Date

November 5, 2020

Last Updated

November 30, 2021

Enrollment

565

ACTUAL participants

Conditions

Pneumococcal Infections

Interventions

Multivalent

BIOLOGICAL

Prevnar 13

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 30, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants

Inclusion Criteria

Exclusion Criteria

In-depth Analysis of the Immune Responses in the Upper Respiratory Tract in Older Adults Infected or Colonized With Streptococcus Pneumoniae (Spn)

Immunogenicity and Safety PCV-20 of the Vaccine Administered During an Acute Febrile Illness in Adults

The Effect of AUDIT and Feedback on Pneumococcal Vaccination Coverage

Immunization To Prevent Acute COPD Exacerbations

Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i)

Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)