Polio virus Infections and Infestations
Conditions
Interventions
This is a randomized, open-label, controlled clinical trial designed to evaluate and compare the immunogenicity and safety of a newly prequalified hexavalent vaccine (Hexasiil®, Serum Institute of Ind
Sponsors
Aga Khan University Hospital
Eligibility
Sex/Gender
All
Age
6 Weeks to 8 Weeks
Inclusion criteria
Inclusion criteria: 1. All healthy full-term infants (born at 37 weeks) at 6-8 weeks old of either gender 2. Not planning to travel away during entire the study period (enrolment- approximately 294 days; 5 weeks – 42 weeks) 3. Parents resident of the study area for the last 3 months at the time of enrolment 4. Parent/guardian provides informed consent
Exclusion criteria
Exclusion criteria: 1. Newborns found acutely ill at the time of enrolment and requiring emergent medical care/hospitalization. 2. Enrolment weight & height 380C in last 3 days or any other indication of acute illness/infection within the past 7 days 6. Having a record of anaphylaxis or allergy to vaccine components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of infants achieving seroprotection against poliovirus types 1, 2, and 3, measured using blood samples will be for antibody assessment at 4 weeks after the third dose The proportion of infants achieving seroprotection against poliovirus types 1, 2, and 3, measured using blood samples will be for antibody assessment at 4 weeks after the third dose The proportion of infants achieving seroprotection against poliovirus types 1, 2, and 3, measured using blood samples will be for antibody assessment at 4 weeks after the fourth (booster) dose | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of infants achieving seroprotection against poliovirus types 1, 2, and 3, measured 4 using blood samples will be for antibody assessment at weeks after the third dose of the Hexavalent vaccine | — |
Countries
Pakistan
Contacts
Public ContactMahjabeen Zehra
Outcome results
None listed