Comparison of immunogenicity and reactogenicity of bivalent oral poliovirus vaccine versus pre-qualified bivalent oral poliovirus vaccine: a randomized double-blind trial

COMPARATIVE EVALUATION OF IMMUNOGENICITY AND REACTOGENICITY OF BIVALENT ORAL POLIOVIRUS VACCINE (bOPV from Sanofi Pasteur bulk) VERSUS PRE QUALIFIED BIVALENT ORAL POLIOVIRUS VACCINE (bOPV from PT BioFarma bulk): A RANDOMIZED DOUBLE-BLIND TRIAL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000591

Enrollment

272

Registered

2010-07-15

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: bOPV (from Sanofi Pasteur bulk): single dose() at 6 to 10 weeks of infants, oral Control Intervention1: bOPV (from PT BioFarma),: single dose at 6 to 10 weeks of infants, oral

Eligibility

Inclusion criteria

Inclusion criteria: Infants between 6 weeks to 10 weeks of age born healthy (2.50 kg birth weight,) and has received a single birth dose of tOPV at least 4 weeks before, residing within a relatively short and easily accessible distance ( <30 km), and not planning to travel away during the entire study period (birth-1 months)

Exclusion criteria

Exclusion criteria: Newborns requiring hospitalization, birth weight below 2.50 kg, residence >30 km from study site, or families expecting to be absent during the 30-day study period. A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family) will render the newborn ineligible for the study.

Design outcomes

Primary

Measure	Time frame
Single dose of bOPV (from Sanofi Pasteur bulk) induces similar levels of seroconversion against poliovirus types 1 or 3, respectively than does one dose of bOPV (from PT BioFarma bulk)Timepoint: Sera collected at enrollment and 30 day visit, will be examined for the presence (detectable) or absence of neutralizing antibodies to type 1 and 3 poliovirus serotypes	—

Secondary

Measure	Time frame
monitor adverse events following vaccine administrationTimepoint: follow up of 30 days post vaccination	—

Countries

India

Contacts

Public ContactDr Arani Chatterjee

Panacea Biotec Limited

aranichatterjee@panaceabiotec.com91-1141679000

Outcome results