CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 773 enrolled
Drug / intervention
IPV +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03239496
NCT03239496Phase 3Completed
CompareCT.gov

A Phase 3, Open-label, Multicenter Randomized Trial to Evaluate Humoral Immunogenicity of Various Schedules of Intramuscular Full-Dose and Intradermal Fractional Dose of Inactivated Polio Vaccine in Latin American Infants

Fidec Corporation·interventional·Posted Aug 4, 2017·Updated Jul 21, 2023

In Brief

A Phase 3 clinical trial evaluating IPV and f-IPV for Poliomyelitis. Completed, enrolled 773 participants across 4 sites in 2 countries.

Detailed Summary

The study will assess and compare the immune response to full-dose inactivated polio vaccines (IPV) via intramuscular (IM) administration and of the fractional dose of inactivated poliovirus vaccine (f-IPV) via intradermal (ID) administration, in different schedule combinations in the Expanded Program on Immunization (EPI) primary series.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPoliomyelitis
CountriesDominican Republic, Panama
CollaboratorsBill and Melinda Gates Foundation

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 4, 2017
Enrollment StartOct 23, 2017
Primary CompletionNov 13, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.9 years ago

Interventions

IPVbiological

Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)

f-IPVbiological

Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)