Comparative evaluation of immunogenicity of Monovalent Type 1 Oral Poliovirus Vaccine (mOPV1) versus trivalent OPV (tOPV): a randomised double-blind trial set in India (Panacea Biotec Ltd mOPV1 study)

Completed

• Conditions: Polio; Infections and Infestations

• Registration Number: ISRCTN80143849
• Lead Sponsor: Panacea Biotec Ltd (India)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-01
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Healthy newborns (greater than or equal to 2.75 kg birth weight, apgar score at 5 minutes, greater than or equal to 9) at the study site(s) (large maternity hospitals)
2. Residing within a relatively short and easily accessible distance (less than 30 km)
3. Not planning to travel away during entire the study period (birth - 2 months)

Exclusion Criteria

1. Newborns requiring hospitalisation
2. Birth weight below 2.75 kg
3. Apgar score at 5 minutes less than 9
4. Residence greater than 30 km from study site
5. Families expecting to be absent during the 60-day study period
6. 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified