Immune response to polio vaccine in malnourished and normally nourished Pakistani infants

Phase 4

• Conditions: polio vaccine immunogenecity; Infection - Other infectious diseases; Public Health - Other public health

• Registration Number: ACTRN12612000259842
• Lead Sponsor: WHO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

Infant aged 9 - 12 months of age
Resident of the study area for last 3 month at the time of enrolment
Parent/guardian provides informed consent

Nutritional status will be assessed; chronically malnourished children and normally nourished children will be assigned to different study arms

Exclusion Criteria

Infant already enrolled in any other polio intervention study.
Allergic to antibiotics neomycin, streptomycin or polymyxin B (as these antibiotics are the component of IPV and may lead to severe life-threatening events)
Infant found acutely ill at the time of enrolment, requiring emergent medical care
Infant with moderate and severe acute malnutrition, defined by a very low weight for height (below -2z and -3z scores of the median WHO growth standards respectively).
Refusal of blood testing
Receipt of supplementary dose of OPV within 4 weeks of first study visit
Infant with certain medical conditions i.e., cerebral palsy, syndromic infants, infants on corticosteroids because of any medical illness, thrombocytopenia (contraindication of intramuscular injections), malignancies and infant with primary immunodeficiency

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in seropositivity and mean geometric titers between baseline sera and post-intervention sera (after 1 month) in chronically malnourished infants 9-12 month of age who receive bivalent OPV (reference arm) compared to infants who receive single dose of IPV combined with bivalent OPV (intervention arm)[1 month after vaccine introduction]

Secondary Outcome Measures

Name	Time	Method
Difference in seropositivity and mean geometric titers between baseline sera and post-intervention sera (after 1 month) in normally nourished infants 9-12 month of age who receive bivalent OPV (reference arm) compared to infants who receive single dose of IPV combined with bivalent OPV (intervention arm)[1 month after vaccine introduction]