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

Comparison of Immunogenicity Of Type 1 Monovalent Oral Polio Vaccine (mOPVl) Administered at Short Intervals with Type 1 Monovalent (mOPVl) And Type 1&3 Bivalent (bOPV1&3) Oral Polio Vaccine Given At Standard Intervals in Healthy Newborns in Pakistan: A Randomized Trial; Aga Khan University, Karachi

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000276853

Enrollment

800

Registered

2012-03-08

Start date

2012-03-15

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In order to generate data on 2-dose seroconversion with short interval monovalent OPV1 administration, and standard interval monovalent OPV1 and bivalent OPV (1&3) administration, we will assess additional programmatic options for short-interval SIA rounds in Pakistan and conduct a clinical trial in Karachi, Pakistan where immunogenicity of supplemental mOPV doses in a naive population (newborns) needs objective evaluation.

Interventions

Three intervention arms: 1) Birth tOPV; day 42 mOPV1, day 49 mOPV1, day 79 tOPV, day 107 tOPV 2) Birth tOPV; day 42 mOPV1, day 56 mOPV1, day 86 tOPV, day 114 tOPV 3) Birth tOPV; day 42 mOPV1, day 72 mOPV1, day 102 tOPV, day 130 tOPV tOPV: trivalent oral polio vaccine; mOPV1: monovalent type 1 oral polio vaccine Dose for all oral polio vaccines: two drops

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Yes

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.

Outcome results