At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 627 enrolled
Drug / intervention
Swine Influenzabiological
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.
Phase I Multi-center, Observer-Blind, Randomized, Dose-Ranging Study of Adjuvanted and Non-Adjuvanted Cell Culture-Derived, Inactivated Novel Swine Origin A/H3N2v Monovalent Subunit Influenza Virus Vaccine (H3N2c) in Children Ages 3 to <9 Years, Adolescents 9 to <18 Years, Adults 18 to < 65 Years and Elderly ≥ 65 Years and Older.
In Brief
A Phase 1 clinical trial evaluating Swine Influenza for Prophylaxis of A/H3N2v Influenza. Completed, enrolled 627 participants across 11 sites.
Detailed Summary
Evaluate the safety and immunogenicity of three dosage levels of swine influenza vaccine in children ages 3 to \<9 years, adolescents 9 to \<18 years, adults 18 to \<65 years and elderly 65 years and older.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProphylaxis of A/H3N2v Influenza
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2013
First PostedMay 2013
Primary CompletionSep 2014
TodayJul 2026
First PostedMay 17, 2013
Enrollment StartMay 1, 2013
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.1 years ago
Interventions
Swine Influenzabiological
Comparison of different dosages of vaccines