At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 807 enrolled

Drug / intervention

Influenza Virus Vaccine USP Trivalent Types A and B +4 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/NCT00775450

NCT00775450Phase 2Completed

Compare CT.gov

Safety and Immunogenicity of Revaccination With Influenza Vaccine in Ambulatory Elderly Subjects Previously Vaccinated With Fluzone ID, Fluzone HD, and Fluzone® IM

Sanofi Pasteur, a Sanofi Company·interventional·Posted Oct 20, 2008·Updated Dec 31, 2013

In Brief

A Phase 2 clinical trial evaluating Influenza Virus Vaccine USP Trivalent Types A and B for Influenza and 2 related conditions. Completed, enrolled 807 participants across 28 sites.

Detailed Summary

This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years. Primary Objective: To describe the safety profile for all subjects. Secondary Objective: To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfluenza, Orthomyxovirus Infection, Myxovirus Infection

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

200920102011201220132014201520162017201820192020202120222023202420252026

Enrollment StartOct 2008

First PostedOct 2008

Primary CompletionJun 2009

Study CompletionJul 2009

TodayJul 2026

First PostedOct 20, 2008

Enrollment StartOct 1, 2008

Primary CompletionJun 1, 2009

Study CompletionJul 1, 2009

TodayJul 2, 2026

Enrollment to primary: 8 monthsPosted 17.7 years ago