Comparing immune response to oral polio vaccine administered at short intervals with vaccine administered at standard intervals in healthy newborns in Pakista

Phase 4

Recruiting

• Conditions: poliomyelitis; Infection - Other infectious diseases; Public Health - Other public health

• Registration Number: ACTRN12612000276853
• Lead Sponsor: WHO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Infants born healthy (> 2.5 kg birth weight, immediate cry, no neonatal IMCI danger signs) at the study sites (home or health facility births assisted by study-Trained Birth Attendants/other health personnel) and 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, and with any neonatal IMNCI danger signs, residence >30 km from study site, or 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A schedule of two doses of mOPV1 administered at a 7 or 14 day interval following a previous mOPV1 dose administered at 42 days induces comparable levels of seroconversion against poliovirus type 1 compared to a schedule of two doses of mOPV1 given at a standard interval of 30 days apart[102 days after study enrollment]

Secondary Outcome Measures

Name	Time	Method
A schedule of two doses of mOPV1 administered at a 7 or 14 day interval following a previous mOPV1 dose administered at 42 days induces comparable levels of seroconversion against poliovirus type 1 compared to a schedule of two doses of bOPV1&3 administered at a standard interval of 30 days apart.[102 days after study enrollment]