Immunogenicity of Combined Bivalent OPV and IPV Vaccines at 9 - 12 months of Age Compared to bOPV alone in Malnourished and Non-Malnourished Pakistani Infants, Aga Khan University, Karachi Pakistan

WHO0 sites840 target enrollmentMarch 2, 2012

Overview

No summary available.

Registry

who.int

Start Date

March 2, 2012

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

WHO

•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

•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