CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,522 enrolled
Drug / intervention
Cell culture derived seasonal trivalent influenza vaccine (cTIV) +3 morebiological
Likely dose
Cell culture derived seasonal trivalent influenza vaccine (cTIV) 0.5 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/NCT00579345
NCT00579345Phase 3Completed
CompareCT.gov

A Phase III, Single-Blind, Multi-Center, Extension Study to Evaluate Safety and Tolerability of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adult and Elderly Subjects Who Participated in Study V58P4, With Subset Analyses of Immunogenicity and Evaluation of Concomitant Polysaccharide Pneumococcal Vaccine (Elderly).

Novartis·interventional·Posted Dec 24, 2007·Updated Jan 27, 2017

In Brief

A Phase 3 clinical trial evaluating Cell culture derived seasonal trivalent influenza vaccine (cTIV), Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)., and 2 other interventions for Influenza. Completed, enrolled 1,522 participants across 5 sites.

Detailed Summary

The study primarily aims to evaluate immunogenicity and safety of influenza vaccines (cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a)) when administered alone and when administered concomitantly with pneumococcal polysaccharide vaccine (PV) in elderly subjects. The study also aimed to evaluate safety and immunogenicity (subset) of annual vaccination with either cTIV or eTIV\_a in adults and elderly subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesPoland
CollaboratorsNovartis Vaccines

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 24, 2007
Enrollment StartOct 1, 2007
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.5 years ago

Interventions

Cell culture derived seasonal trivalent influenza vaccine (cTIV)biological

cell cultured trivalent influenza vaccine (cTIV) vaccine administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm.

Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).biological

egg based trivalent influenza vaccine (eTIV\_a) administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm.

cTIV or eTIV_abiological

0.5 mL, Single dose of either cell cultured trivalent influenza vaccine (cTIV) or egg based trivalent influenza vaccine eTIV\_a administered.

cTIV+PV OR eTIV_a+PVbiological

0.5 mL, Single dose of either cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) administered concomitantly with 23-valent pneumococcal polysaccharide vaccine (PV).