Comparative evaluation of immunogenicity of various schedules and delivery options to provide fractional Dose Inactivated Poliovirus Vaccine in routine immunizatio
- Registration Number
- CTRI/2017/02/007793
- Lead Sponsor
- Panacea Biotec Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 800
1.All infants visiting study site immunization clinic for OPV1/Penta1 immunization
2.The infant should be 6-7 completed weeks of age at OPV1/Penta1 contact
3.Infants with documentary evidence having taken birth dose of bOPV
4.Weight at enrolment visit of >= 3.2 Kgs
5.Judged to be healthy by the investigator for study participation
6.Parents judged to be able to attend all scheduled study visits and comply with the study procedures
7.Parent or Legally Acceptable Representative (LAR) provides written informed consent for the babyâ??s inclusion in the study
1.Not fulfilling any of the inclusion criteria
2.Taken any polio vaccine/s other than birth dose of bOPV
3.Any diagnosed/suspected medical condition which requires active management or hospitalization; as judged by the investigator
4.A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family)
5.Thrombocytopenia or a bleeding disorder
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.The primary endpoint is the seroconversion against type 2 poliovirus, four weeks after completion of doses given in the routine immunization schedule in all the study arms.Timepoint: 6, 10 and 14 week
- Secondary Outcome Measures
Name Time Method 4.Number of adverse events (AEs) occurred during the studyTimepoint: through out the study