Pakistan Short Interval mOPV1 Compared With Standard Interval mOPV1 and bOPV 1,3

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Globally, polio cases have decreased by over 99% since 1988. However, wild poliovirus cases continue in Pakistan. Conflict and lack of access to children due to on-going insecurity in tribal areas present special challenges in interrupting transmission rapidly. There exists limited knowledge on the effect of shorter intervals of mOPV vaccination on immunogenicity levels in young children. The aim of this study is to demonstrate the non-inferiority of shorter intervals (7 and 14 days) between doses of mOPV1 vaccine compared to the customary interval (30 days). A 4th arm will receive bivalent (bOPV) vaccine at standard intervals beginning at 6 weeks of age.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Aga Khan University
• Collaborator: World Health Organization
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• Infants > 2.5 kg birth weight

• Immediate cry

• No neonatal IMCI danger signs

• Not planning to travel away during entire the study period (birth-102 days)

Exclusion Criteria:

• High-risk newborns will be excluded, as well as newborns requiring hospitalization

• Birth weight below 2.5 kg

• Cry >2 minutes

• With any neonatal IMNCI danger signs

• Residence >30 km from study site

• Family is planning to be absent during the birth - 102 day study period.

• A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family - e.g. several early infant deaths, household member on chemotherapy) will render the newborn ineligible for the study.