At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,601 enrolled
Drug / intervention
Adjuvanted QIV (aQIV) +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.
A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to Either the Same or Alternate Type of Vaccine, Adjuvanted or Non-adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV or QIV), Administered to Subjects Previously Vaccinated in Trial V118_05 (NCT01964989)
In Brief
A Phase 3 clinical trial evaluating Adjuvanted QIV (aQIV) and Non-adjuvanted QIV for Influenza. Completed, enrolled 1,601 participants across 17 sites in 3 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. Subjects will receive either the Same or Alternate Type of Vaccine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesFinland, Philippines, Thailand
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 2015
Enrollment StartJan 2016
Primary CompletionNov 2016
Study CompletionMay 2017
TodayJul 2026
First PostedOct 22, 2015
Enrollment StartJan 29, 2016
Primary CompletionNov 15, 2016
Study CompletionMay 9, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.7 years ago
Interventions
Adjuvanted QIV (aQIV)biological
Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
Non-adjuvanted QIVbiological
Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)