Pneumococcal Infection Clinical Trial
Official title:
A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults
This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine ([Prevnar 20™ / APEXXNAR™]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02463539 -
Residual Anti-pneumococcal Immunity After Pneumococcal Immunization in ANCA-associated Vasculitis
|
N/A | |
| Completed |
NCT03095326 -
Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia
|
Phase 4 | |
| Completed |
NCT02260882 -
Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902)
|
Phase 4 | |
| Completed |
NCT02572635 -
A Phase I Study to Evaluate the Safety and Immunogenicity of PnuBioVax
|
Phase 1 | |
| Completed |
NCT01654263 -
A Phase IIb, Open-Label, Dose Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine
|
Phase 2 | |
| Completed |
NCT01531322 -
A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects
|
Phase 1 | |
| Completed |
NCT00496093 -
Safety, Tolerability and Immunogenicity of Pneumovax 23 in Healthy Adults in India (V110-011)
|
Phase 3 | |
| Completed |
NCT02062281 -
Study of Evaluating Safety and Immunogenicity of 23-Valent Pneumococcal Polysaccharide Vaccine With Influenza Vaccine in Children and Adults
|
Phase 4 | |
| Completed |
NCT00133549 -
9-valent CRM 197 Pneumococcal
|
Phase 2 | |
| Completed |
NCT03467984 -
A Study to Evaluate the Safety and Immunogenecity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy Infants
|
Phase 2 | |
| Active, not recruiting |
NCT03489018 -
The Effect of Fractional Doses of Pneumococcal Conjugate Vaccines on Immunogenicity and Carriage in Kenyan Infants
|
Phase 4 | |
| Recruiting |
NCT02463578 -
Immunogenicity of a Combined Anti-pneumococcal Vaccine Schedule in Patients With ANCA-associated Vasculitis
|
N/A | |
| Completed |
NCT00535730 -
ZOSTAVAX™ Administered Concomitantly With PNEUMOVAX™ 23 (V211-012)(COMPLETED)
|
Phase 3 | |
| Completed |
NCT02558751 -
Pneumonia Vaccine in Aging HIV Positive Individuals
|
Phase 0 | |
| Completed |
NCT02515240 -
Immune Response to Pneumococcal Vaccination in HIV Infected Individuals
|
Phase 0 | |
| Completed |
NCT00560950 -
Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)
|
Phase 3 | |
| Completed |
NCT03619252 -
Pneumococcal Vaccination of Multiple Myeloma Patients on Novel Agents
|
Phase 4 | |
| Not yet recruiting |
NCT03549208 -
A Study to Evaluate the Safety and Immunogeneicity of Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults
|
Phase 1 | |
| Not yet recruiting |
NCT03341195 -
Mobile Phone SMS Messages and Automated Calls in Improving Vaccine Coverage Among Children in Pakistan
|
N/A | |
| Recruiting |
NCT06177912 -
A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)
|
Phase 3 |