A clinical study on Pentavalent vaccine
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2009/091/000375
- Lead Sponsor
- Serum Institute Of India Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 600
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.
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.
Simultaneous participation in any other clinical study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the immunogenicity-efficacy following administration of the Pentavac (DTP-HB+Hib) vaccine manufactured using scaled up process and its comparison with the one produced by the small scale process in Indian infants.Timepoint: Pre and post-vaccination
- Secondary Outcome Measures
Name Time Method To assess reactogenicity of Pentavac vaccine manufactured using scaled up process and its comparison with the one produced by the small scale process.Timepoint: One month after each dose of the vaccine