At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 1,200 enrolled

Drug / intervention

Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV) +3 morebiological

Likely dose

Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV) 0.5mlfrom 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/NCT00310804

NCT00310804Phase 3Completed

Compare CT.gov

A Phase III, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of Three Lots of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Or of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult Subjects Aged >=18 to <=60

Novartis Vaccines·interventional·Posted Apr 5, 2006·Updated Aug 15, 2019

In Brief

A Phase 3 clinical trial evaluating Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV), Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV), and 2 other interventions for Influenza. Completed, enrolled 1,200 participants across 2 sites.

Detailed Summary

The present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a conventional egg-derived control vaccine licensed in Europe.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfluenza

CountriesLithuania

Collaborators--

Timeline

Phase 3CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartSep 2005

Primary CompletionOct 2005

Study CompletionApr 2006

First PostedApr 2006

TodayJul 2026

First PostedApr 5, 2006

Enrollment StartSep 1, 2005

Primary CompletionOct 1, 2005

Study CompletionApr 1, 2006

TodayJul 2, 2026

Enrollment to primary: 1 monthPosted 20.2 years ago

Interventions

Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV)biological

One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1

Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV)biological

One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2

Cell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV)biological

One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3

Egg-Derived Trivalent Subunit Influenza Vaccine (TIV)biological

One single 0.5ml intramuscular injection of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).