CTRI/2009/091/000375
Completed
Phase 4
A Phase IV multicentric, randomized, comparative clinical trial to assess the immunogenicity and Reactogenicity of two different lots of DTwP-HB+Hib (Pentavac) vaccine manufactured by Serum Institute Of India Ltd., Pune in Indian infants.
Serum Institute Of India Ltd0 sites600 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Serum Institute Of India Ltd
- Enrollment
- 600
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy children of either sex aged 6 to 8 weeks at the time of 1st vaccination.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Written, Explained, Signed informed consent of the child parents or guardian.
- •Born after normal gestational period (36\-42 weeks).
- •Born to mothers sero\-negative for HBs Ag (as per current antenatal records or test conducted after informed consent of mother).
- •Born to mothers sero\-negative for HIV (as per current antenatal records or test conducted after informed consent of mother).
- •No evidence of any infection or fever.
- •Available for an observation period of minimum 16 weeks.
Exclusion Criteria
- •Use of any investigational or non\-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of the study vaccine.
- •History of DTwPHB vaccine/Hib vaccination or disease (including Hepatitis B given at birth)
- •Administration of immunoglobulins or any blood products since birth.
- •Planned administration of a vaccine, not foreseen by the study protocol 30 days before and during the study period with the exception of OPV \& BCG vaccine.
- •History of significant and persistent hematological, hepatic, renal, cardiac or respiratory disease.
- •Axillary temperature more than or equal to 38\.5 degrees celsius.
- •History of Neurological disorders or seizure.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Confirmed immunosuppression including HIV infection.
- •Major congenital or hereditary immunodeficiency.
Outcomes
Primary Outcomes
Not specified
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