CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
IMOVAX POLIO®: Inactive Poliovirus Vaccinebiological
Likely dose
IMOVAX POLIO®: Inactive Poliovirus Vaccine 0.5 mLfrom 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/NCT02005536
NCT02005536Phase 4Completed
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Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan

Sanofi Pasteur, a Sanofi Company·interventional·Posted Dec 9, 2013·Updated Mar 30, 2015

In Brief

A Phase 4 clinical trial evaluating IMOVAX POLIO®: Inactive Poliovirus Vaccine for Poliomyelitis and Polio. Completed, enrolled 60 participants across 4 sites.

Detailed Summary

The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO®: Inactive Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose. Primary Objective: * To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one month following the vaccination dose with SP059 as 2nd booster Secondary Objectives: * To investigate seroprotection rates (percentage of subjects presenting poliovirus neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points, Geometric mean titers (GMT) at pre- and post-booster time points and geometric mean of individual titer ratio (GMTR). * To investigate the safety after dosing of SP059 as 2nd booster.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPoliomyelitis, Polio
CountriesJapan
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 9, 2013
Enrollment StartDec 1, 2013
Primary CompletionSep 1, 2014
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.6 years ago

Interventions

IMOVAX POLIO®: Inactive Poliovirus Vaccinebiological

0.5 mL, Subcutaneous