Trials / Completed
CompletedNCT00488800
Safety and Local Tolerability of Prevenar in Indian Children
A Postmarketing Surveillance Study Evaluating the Safety and Local Tolerance of PREVENAR in Indian Children
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (planned)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 6 Weeks – 24 Months
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | pneumococcal conjugate vaccine |
Timeline
- Start date
- 2006-07-01
- Primary completion
- 2007-01-01
- Completion
- 2007-01-01
- First posted
- 2007-06-20
- Last updated
- 2007-12-28
Source: ClinicalTrials.gov record NCT00488800. Inclusion in this directory is not an endorsement.