Pneumococcal Infections Clinical Trial
Official title:
A Postmarketing Surveillance Study Evaluating the Safety and Local Tolerance of PREVENAR in Indian Children
This postmarketing surveillance study will evaluate the safety profile of Prevenar in Indian
children.
Prevenar is indicated for active immunization of infants and children from 6 weeks of age
through 9 years of age against invasive disease (including meningitis, bacteraemic
pneumonia, bacteraemia, sepsis) caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14,
18C, 19F and 23F.
Prevenar has been marketed in India since June 2006. The Board of Health in India has given
restricted permission to import and market Prevenar. The present study is a post-approval
regulatory commitment to the Board of Health in India.
This is an observational study and the protocol for the study has been approved by the Board
of Health.
n/a
Time Perspective: Prospective
| 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 |
NCT00205803 -
Study Evaluating Pneumococcal Vaccine in Healthy Infants
|
Phase 1/Phase 2 | |
| Completed |
NCT00137605 -
Early Versus Delayed Pneumococcal Vaccination in HIV
|
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 |