CTRI/2009/091/000665CompletedPhase 4
A Phase IV clinical trial to assess the persistence of immunity in children who received DTwP-HB-Hib vaccine (adsorbed) during primary vaccination series and evaluation of immunogenicity & reactogenicity of booster dose of DTwP/Hib vaccine of Serum Institute of India Ltd, Pune.
Serum Institute Of India Ltd Pune0 sites300 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •ï?·Children who received DTwP-HB-Hib vaccine (adsorbed) manufactured by Serum Institute of India Ltd. or Panacea Biotec Ltd. during primary vaccination series during Phase III clinical trial (Protocol ID:DTPw-HB-Hib/SIIL/07/2007).
- •ï?·Age 15 ? 24 months.
- •ï?·Parents willing for participation of their child in the study and sign written informed consent.
Exclusion Criteria
- •History of receipt of booster dose of any of the components of vaccine.
- •History of significant and/or persistent neurological/ developmental disorder or hematological, hepatic, renal, cardiac, respiratory disease.
- • Child under immunosuppressive therapy
- • History of allergic reaction to any vaccine.
- • Receipt of any other vaccine during the study period with exception of
- •Oral Polio Vaccine (OPV) & Measles Mumps and Rubella (MMR) vaccine.
- •Administration of immunoglobulins or any blood products since birth.
- •Axillary temperature 38C.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Major congenital or hereditary immunodeficiency.
- •Simultaneous participation in any other clinical study.
Investigators
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