CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 402 enrolled
Drug / intervention
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV) +1 morebiological
Likely dose
Not stated in 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/NCT02212106
NCT02212106Phase 4Completed
CompareCT.gov

A Phase IV, Multicenter, Randomized, Observer-blind, Parallel-arm Study to Evaluate the Safety and Tolerability of CSL's Trivalent Influenza Virus Vaccine (CSL TIV) in Children 5 to Less Than 9 Years of Age.

Seqirus·interventional·Posted Aug 8, 2014·Updated Oct 16, 2015

In Brief

A Phase 4 clinical trial evaluating bioCSL Trivalent Influenza Virus Vaccine (CSL TIV) and Comparator Quadrivalent Influenza Virus Vaccine for Influenza, Human. Completed, enrolled 402 participants across 11 sites.

Detailed Summary

This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years. Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Human
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 8, 2014
Enrollment StartSep 1, 2014
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.9 years ago

Interventions

bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)biological

Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.

Comparator Quadrivalent Influenza Virus Vaccinebiological

Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.