drugset / Trial / NCT01586572

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

NCT01586572 ↗

RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2012-04
Primary completion
2013-05
Completion
2013-05

Outcome

Met primary endpoint

paper Non-inferiority was shown between groups and no significant differences were noted. PMID 26093979 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject bivalent OPV Vaccine 105.8 unknown Oral
Subject bivalent OPV Vaccine 106 unknown Oral
Subject mOPV1 Vaccine 106 unknown Oral

Indications