At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 1,761 enrolled

Drug / intervention

SIIL Live Attenuated Influenza Vaccine +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/NCT01854632

NCT01854632Phase 3Completed

Compare CT.gov

A Randomized, Double-Blind, Placebo-Controlled Trial of the Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal

PATH·interventional·Posted May 15, 2013·Updated Jun 3, 2015

In Brief

A Phase 3 clinical trial evaluating SIIL Live Attenuated Influenza Vaccine and Matched placebo for Influenza. Completed, enrolled 1,761 participants across 1 site.

Detailed Summary

This study will provide the Senegal Ministry of Health with data on the clinical efficacy of the Live-Attenuated Influenza Vaccine (LAIV). This data will inform future policy considerations for influenza vaccine.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfluenza

CountriesSenegal

CollaboratorsInstitut de Recherche pour le Developpement, Institut Pasteur de Dakar, Centers for Disease Control and Prevention

Timeline

Phase 3CompletedFinished

20132014201520162017201820192020202120222023202420252026

Enrollment StartMay 2013

First PostedMay 2013

Primary CompletionDec 2013

TodayJul 2026

First PostedMay 15, 2013

Enrollment StartMay 1, 2013

Primary CompletionDec 1, 2013

TodayJul 2, 2026

Enrollment to primary: 7 monthsPosted 13.1 years ago

Interventions

SIIL Live Attenuated Influenza Vaccinebiological

Trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010

Matched placebobiological

Matched placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.