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

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2012
INTERVENTION: 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 CONDITION: poliomyelitis PRIMARY OUTCOME: 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 a schedule of two doses of mOPV1 given at a standard interval of 30 days apart SECONDARY OUTCOME: 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 a schedule of two doses of bOPV1&3 administered at a standard interval of 30 days apart. 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).
Epistemonikos ID: f73b6e85d65d037a8d2a6d34e63dc1aba02d8ca7
First added on: Aug 22, 2024