Phase III clinical study to evaluate the effectivity of Comvac4 vaccine in 6 to 7weeks infants
- Registration Number
- CTRI/2017/01/007706
- Lead Sponsor
- Bharat Biotech International Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 240
1.Parent/guardian of subject willing to give written informed consent and to comply with all study related procedures and visits
2.Healthy male or female infants aged 6 â?? 7 weeks at the time of screening/enrolment.
3.Subjects who are healthy without any history of DTP and Hib vaccination
4.Infants received EPI vaccines at birth (i.e., OPV, BCG and/or Hep B) as well IPV
5.Subjects should have been born after 36-week term and are not less than >=4.00kg, at the time of inclusion
1.Infants aged less than 6 weeks or more than 7 weeks at the time of screening/enrolment.
2.Fever of any origin of duration more than 3 days prior to/at screening visit.
3.Past history of DTP &Hib vaccination.
4.History of acute or chronic auto immune disease
5.Any confirmed or suspected immunosuppressive condition.
6.Any treatment with immunosuppressive or immunostimulant therapy
7.Use of any marketed or investigational or herbal medicine or non-registered drug or vaccine for DTP and Hib.
8.Known hypersensitivity reactions to any of the components of the vaccine.
9.Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the pre vaccination anti diphtheria1 antitetanus antipertussis, and anti Hib (PRP) verses 4weeks titer of after third dose. <br/ ><br>Seroprotection Attainment of antibody titers that corresponds to clinical protection. This is according to WHO established level of titers. <br/ ><br>â?¢Seroconversion:Seroconversion will be considered if the 4 weeks after third dose post-vaccination antibody titer shows a â?¥ 4 fold rise from the pre-vaccination levels <br/ ><br>Timepoint: 0 and 84
- Secondary Outcome Measures
Name Time Method To evaluate the safetyTimepoint: During the study period and 7days active follow up after each vaccination