CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,292 enrolled
Drug / intervention
Influenza Virus Vaccine USP Trivalent Types A and B +3 morebiological
Likely dose
Influenza Virus Vaccine USP Trivalent Types A and B 0.1 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/NCT00772109
NCT00772109Phase 3Completed
CompareCT.gov

Lot Consistency, Immunogenicity, and Safety Study of Three Lots of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® Administered Intramuscularly in Adult Subjects Aged 18 to 64 Years

Sanofi Pasteur, a Sanofi Company·interventional·Posted Oct 15, 2008·Updated Apr 14, 2016

In Brief

A Phase 3 clinical trial evaluating Influenza Virus Vaccine USP Trivalent Types A and B for Orthomyxoviridae Infection and 2 related conditions. Completed, enrolled 4,292 participants across 49 sites in 2 countries.

Detailed Summary

This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route. Primary Objective: * To demonstrate lot consistency of the Fluzone ID manufacturing process. * To provide information concerning the immune response of Fluzone ID. Secondary Objectives: Safety * To describe the safety profile of subjects who receive of Fluzone ID.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOrthomyxoviridae Infection, Influenza, Myxovirus Infection
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 15, 2008
Enrollment StartOct 1, 2008
Primary CompletionMay 1, 2009
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.7 years ago

Interventions

Influenza Virus Vaccine USP Trivalent Types A and Bbiological

0.1 mL, Intradermal

Influenza Virus Vaccine USP Trivalent Types A and Bbiological

0.1 mL, Intradermal

Influenza Virus Vaccine USP Trivalent Types A and Bbiological

0.1 mL, Intradermal

Influenza Virus Vaccine USP Trivalent Types A and Bbiological

0.5 mL, Intramuscular