Clinical Trials Logo
  1. Home
  2. Pneumococcal Infections
  3. NCT03550313

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

Pneumococcal Infections Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03550313
Study type Interventional
Source Pfizer
Contact
Status Terminated
Phase Phase 2
Start date June 1, 2018
Completion date November 5, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT02201030 - Immunogenicity and Safety Study of NBP606 in Healthy Infants Phase 3
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Completed NCT04031846 - Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025) Phase 3
Recruiting NCT05920499 - The Effect of AUDIT and Feedback on Pneumococcal Vaccination Coverage N/A
Completed NCT01215175 - Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001) Phase 1
Completed NCT02892812 - A Phase I Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine and 14-valent Pneumococcal Conjugate Vaccine in Adults Phase 1
Completed NCT02116998 - Safety, Tolerability, and Efficacy Study of Prophylactic S. Pneumoniae Vaccine Following Challenge With S. Pneumoniae Phase 2
Completed NCT01446926 - Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants Phase 1
Completed NCT01193582 - A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria Phase 4
Completed NCT00744263 - Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults Phase 4
Completed NCT00492557 - Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults Phase 3
Completed NCT00195611 - Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media Phase 4
Completed NCT00137605 - Early Versus Delayed Pneumococcal Vaccination in HIV Phase 1/Phase 2
Completed NCT00205803 - Study Evaluating Pneumococcal Vaccine in Healthy Infants Phase 1/Phase 2
Completed NCT02531373 - A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005) Phase 1/Phase 2
Completed NCT03615482 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (V114-021/PNEU-FLU) Phase 3
Completed NCT03565900 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM) Phase 3
Completed NCT04989465 - A Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine Phase 4
Completed NCT02547649 - Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006) Phase 2
Completed NCT02573181 - Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007) Phase 2