At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 87 enrolled
Drug / intervention
Influenza A Vaccine: ACAM FLU-A +3 morebiological
Likely dose
Influenza A Vaccine: ACAM FLU-A 0.5 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 1, Randomized, Placebo-Controlled, Double-Blind, Safety, Reactogenicity, and Immunogenicity of Recombinant M2e Influenza-A Vaccine Candidate ACAM FLU-A) in Healthy Adults
In Brief
A Phase 1 clinical trial evaluating Influenza A Vaccine: ACAM FLU-A and Saline placebo for Influenza. Completed, enrolled 87 participants across 3 sites.
Detailed Summary
This multi-center study will be conducted in the United States with up to 80 healthy adult subjects. Subjects will be scheduled to receive a total of two (2) injections with 1 injection each administered. Subjects will be randomized according to a randomization scheme.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2007
Primary CompletionJan 2009
First PostedJan 2009
Study CompletionFeb 2009
TodayJul 2026
First PostedJan 8, 2009
Enrollment StartJul 1, 2007
Primary CompletionJan 1, 2009
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.5 years ago
Interventions
Influenza A Vaccine: ACAM FLU-Abiological
0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
Influenza A Vaccine: ACAM FLU-Abiological
0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular
Influenza A Vaccine: ACAM FLU-Abiological
0.5 mL ACAM FLU-A low dose, Intramuscular
Saline placebobiological
0.5 mL, Intramuscular