A comparison of the immune response to two different oral polio vaccine regimes in Pakista

Phase 4

Withdrawn

• Conditions: Poliomyelitis; Public Health - Epidemiology; Infection - Other infectious diseases; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12611000824965
• Lead Sponsor: Department of Paediatrics and Child Health, Aga Khan University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• 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. Subjects will be re-screened for eligibility at the 6 week visit before randomization to study arms. Infants with illness requiring hospitalization, weight <2.5 kg, family planning to be away during the next 10 weeks, or unwilling to have another blood draw will be excluded from randomization. The families of babies with exclusion criteria will be informed about immediate treatment options if their baby is sick (hospital referral and in case of refusal centre-based outpatient care), need for receipt of routine immunizations, and reassured about long term continued assessment and primary level care at the PHC.

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 (i) a schedule of two doses of mOPV1; or (ii) two doses of bOPV1,3 administered at a standard interval of 30 days apart.<br>The principal purpose of the study is to demonstrate the non-inferiority of shorter intervals (7 or 14 days) between two doses of mOPV1 vaccine compared to 2 doses of mOPV1 and bOPV1,3 administered at standard intervals (30 days apart). This is a phase IV study, and the data generated by this clinical trial are intended to guide programmatic action.[Blood sample at birth, 42 days, 79 days, 86 days, and 102 days]