Comparative evaluation of immunogenicity and reactogenicity of monovalent type 2 and 3 oral poliovirus vaccines (mOPV 2 and mOPV3) versus trivalent oral poliovirus vaccine (tOPV), and bivalent oral poliovirus vaccine (bOPV) versus monovalent types 1 and 3 oral poliovirus vaccines, respectively: a randomised double-blind trial

Completed

• Conditions: Poliomyelitis; Infections and Infestations; Other viral encephalitis, not elsewhere classified

• Registration Number: ISRCTN64725429
• Lead Sponsor: Panacea Biotec Limited (India)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-26
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

1. Healthy newborns (either sex) (greater than or equal to 2.50 kg birth weight, apgar score at 5 min greater than or equal to 9) at the study sites (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 2.50 kg
3. Apgar score at 5 min 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