CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 430 enrolled
Drug / intervention
TIVc +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/NCT01998477
NCT01998477Phase 3Completed
CompareCT.gov

A Phase III, Observer-Blind, Randomized Multicenter Study to Evaluate the Safety of Trivalent Subunit Influenza Vaccines, Produced Either in Mammalian Cell Culture (TIVc) or in Embryonated Eggs (TIV), in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications

Novartis Vaccines·interventional·Posted Nov 29, 2013·Updated Apr 21, 2017

In Brief

A Phase 3 clinical trial evaluating TIVc and TIV for Influenza. Completed, enrolled 430 participants across 16 sites in 2 countries.

Detailed Summary

The study is designed to evaluate the safety of TIVc or TIV vaccine in children 3 to \< 18 years of age who are at risk of complications of influenza disease due to underlying diseases.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesItaly, Spain
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 29, 2013
Enrollment StartOct 1, 2013
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.6 years ago

Interventions

TIVcbiological

Madin Darby Canine Kidney (MDCK) cell culture derived subunit influenza vaccine TIVc contained the purified viral envelope glycoproteins, hemagglutinin (HA) and neuraminidase (NA) derived from 3 strains (including HA for each strain \[A/H1N1-like, A/H3N2-like, and B-like\]) intramuscular (IM) injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere

TIVbiological

A conventional egg derived subunit influenza vaccine (TIV) contained the purified viral envelope-glycoproteins, HA and NA derived from 3 strains (including HA for each strain \[A/ H1N1-like, A/H3N2-like, and B-like\]) IM injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere.