At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 607 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.
A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV), Administered to Subjects Previously Vaccinated in Trial V118_05
In Brief
A Phase 3 clinical trial evaluating Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) and non-adjuvanted Quadrivalent Influenza Vaccine (QIV) for Influenza. Completed, enrolled 607 participants across 28 sites in 2 countries.
Detailed Summary
Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously Vaccinated in Trial V118\_05
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesFinland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartOct 2014
First PostedOct 2014
Primary CompletionJan 2016
TodayJul 2026
First PostedOct 2, 2014
Enrollment StartOct 1, 2014
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.8 years ago
Interventions
Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)biological
1 dose 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months
non-adjuvanted Quadrivalent Influenza Vaccine (QIV)biological
1 dose 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months