CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,250 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/NCT01011049
NCT01011049Phase 2Completed
CompareCT.gov

Safety and Immunogenicity of Revaccination With Influenza Vaccine in Healthy Adult Subjects Aged 18 to 64 Years Who Were Previously Vaccinated With Fluzone ID or Fluzone IM

Sanofi Pasteur, a Sanofi Company·interventional·Posted Nov 11, 2009·Updated Apr 14, 2016

In Brief

A Phase 2 clinical trial evaluating Influenza Virus Vaccine USP Trivalent Types A and B for Influenza. Completed, enrolled 1,250 participants across 45 sites in 2 countries.

Detailed Summary

The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine. Primary Objective: * To evaluate and describe the safety profile of revaccination with Fluzone ID for all participants. Secondary Objective: * To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 11, 2009
Enrollment StartSep 1, 2009
Primary CompletionMay 1, 2010
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.6 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

0.5 mL, Intramuscular

Influenza Virus Vaccine USP Trivalent Types A and Bbiological

0.5 mL, Intramuscular

Influenza Virus Vaccine USP Trivalent Types A and Bbiological

0.1 mL, Intradermal