CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 10,644 enrolled
Drug / intervention
Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) +1 morebiological
Likely dose
Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) 0.25 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/NCT01964989
NCT01964989Phase 3Completed
CompareCT.gov

A Phase III, Stratified, Randomized, Observer Blind, Controlled, Multicenter Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to < 72 Months of Age.

Seqirus·interventional·Posted Oct 17, 2013·Updated Mar 27, 2023

In Brief

A Phase 3 clinical trial evaluating Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) and Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV) for Influenza Virus. Completed, enrolled 10,644 participants across 167 sites in 11 countries.

Detailed Summary

Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to \<72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza Virus
CountriesCanada, Finland, Italy, Mexico, Philippines, Poland, Puerto Rico, Spain, Taiwan, Thailand, United States
CollaboratorsNovartis Vaccines

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 17, 2013
Enrollment StartNov 1, 2013
Primary CompletionOct 1, 2015
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 12.7 years ago

Interventions

Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)biological

1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months

Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)biological

1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months