A randomized, open label, multicenter study to evaluate the immunogenicity and safety of BBILs trivalent type 1, 2 & 3 oral polio vaccine

A randomized, open label, multicenter study to evaluate the immunogenicity and safety of BBILs trivalent type 1, 2 & 3 oral polio vaccine - BioPolio

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2015/06/005856

Enrollment

200

Registered

2015-06-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: topv: vaccine is administered in two doses 0.1ml (2 drops) per dose by oral route at 30Â±2 dayâ??s interval. Control Intervention1: panacia bitech,tOPV: Compred with previous phase II

Eligibility

Inclusion criteria

Inclusion criteria: Written and signed informed consent by subject parents or legally acceptable guardian. Healthy male or female full term neonate aged less than three hours at time of enrollment. The delivery was not high-risk The APGAR score was greater than 7 when measure 1 minute after birth Subjects should have been born after 36-week term and are not less than 2500 gms, at the time of inclusion. Family does not plan to move during the study period, and housed not further that 50km away from the study site.

Exclusion criteria

Exclusion criteria: Fever of any origin or infections. Any confirmed or suspected immunosuppressive condition. Any treatment with immunosuppressive or Immuno stimulant therapy Use of any marketed or investigational medicine or non-registered drug or vaccine for polio. Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.

Design outcomes

Primary

Measure	Time frame
To compare and demonstrate that the Immunogenicity of the investigational product BIOPOLIO is not clinically inferior to that of WHO pre-qualified Trivalent OPV vaccine. To assess the antibodies titers for type 1, 2 & 3 poliovirus after two doses of trivalent oral polio. a)Seroconversion; A fourfold rise in antibody titer of type 1, 2 & 3 polio virus from baseline pre- vaccination titers and 14Â±2 days after second dose of vaccination. Timepoint: Baseline (Day 0) 14 days after second dose of vaccination(Day 44)	—

Measure

Time frame

To compare and demonstrate that the Immunogenicity of the investigational product BIOPOLIO is not clinically inferior to that of WHO pre-qualified Trivalent OPV vaccine. To assess the antibodies titers for type 1, 2 & 3 poliovirus after two doses of trivalent oral polio. a)Seroconversion; A fourfold rise in antibody titer of type 1, 2 & 3 polio virus from baseline pre- vaccination titers and 14Â±2 days after second dose of vaccination. Timepoint: Baseline (Day 0) 14 days after second dose of vaccination(Day 44)

—

Secondary

Measure	Time frame
to evaluate the safety, local and systemic reaction of two doses of BIOPOLIO OPV vaccine as compared to WHO pre-qualified Trivalent OPV vaccine administered as two doses, given 30Â±2 days apart. Timepoint: 2 years	—

Countries

India

Contacts

Public ContactDr B N Patnaik

Bharat biotech Int Ltd

badri2299@bharatbiotech.com04023480567

Outcome results