A Phase-III clinical trial to study the safety and immunogenicity of Bharat Biotech monovalent Oral Poliomyelitis Vaccine Type-1 vs. WHO prequalified trivalent Oral Polio Vaccine in healthy neonates

A Randomized, Multi Center, Double Blind, Comparative Phase III Study to Evaluate the Safety and Immunogenicity of BBILs monovalent Type 1 Oral Polio Vaccine Vs Pre-Qualified trivalent Oral Polio Vaccine In Healthy Neonates. (non- inferiority trial)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000203

Enrollment

288

Registered

2010-03-10

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: Bharat Biotech monovalent Oral Poliomyelitis Vaccine Type1, BIOPOLIO M1: 2 doses, each dose of 0.1mL, 30 days apart. Control Intervention1: Panacea Biotec trivalent Oral Polio Vaccine -

Eligibility

Inclusion criteria

Inclusion criteria: 1. Written and signed informed consent by subjects parents or legally acceptable guardian. 2. Healthy male or female full term neonate aged less than three hours at time of enrollment. 3. The delivery was not high-risk 4. The APGAR score was greater than 7 when measured 1 minute after birth 5. Subjects should have been born after 36-week term and are not less than 2500 gms, at the time of inclusion. 6. Family does not plan to move during the study period, and housed not further that 50 km away from the study site.

Exclusion criteria

Exclusion criteria: 1) Fever of any origin or infections. 2) Any confirmed or suspected immunosuppressive condition. 3) Any treatment with immunosuppressive or immuno stimulant therapy 4) Use of any marketed or investigational medicine or non-registered drug or vaccine for polio. 5) 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 Bharat Biotech International Limited monovalent Oral Polio Vaccine M1 is not clinically inferior to that of WHO pre qualified trivalent OPV vaccine. To assess the antibodies titers of Type 1 poliovirus after two doses of monovalent Type 1 Oral Polio Vaccine or two doses trivalent Oral Polio Vaccine in healthy subjects.Timepoint: Serum Antibody titres at pre vaccination, 30 days after first dose administration and 14 days after second dose administration.	—

Measure

Time frame

To compare and demonstrate that the Immunogenicity of the investigational product Bharat Biotech International Limited monovalent Oral Polio Vaccine M1 is not clinically inferior to that of WHO pre qualified trivalent OPV vaccine. To assess the antibodies titers of Type 1 poliovirus after two doses of monovalent Type 1 Oral Polio Vaccine or two doses trivalent Oral Polio Vaccine in healthy subjects.Timepoint: Serum Antibody titres at pre vaccination, 30 days after first dose administration and 14 days after second dose administration.

—

Secondary

Measure	Time frame
To evaluate the safety of two doses of investigational vaccine as compared to control vaccine administered as two doses given 30±2 days apart. The clinical safety evaluation is based on general examination, local examination and subjective evaluation of adverse events. These will be monitored through out the study period. Timepoint: Throughout the study duration.	—

Countries

India

Contacts

Public ContactDr Santhosh Kumar M

Bharat Biotech International Limited,

madhusudhansk@bharatbiotech.com04023480567

Outcome results