Pneumococcal Infections Clinical Trial
Official title:
A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults 50 Years of Age or Older (PNEU-TRUE)
The primary objectives are to evaluate the safety and tolerability of V114 and to compare the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) across 3 different lots of V114. The primary hypothesis is that all 3 lots of V114 are equivalent as measured by the serotype-specific OPA GMTs for 15 serotypes in V114 at 30 days postvaccination.
n/a
| 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 |