What drugs are being tested in FLU-A?

Interventions: Influenza A Vaccine: ACAM FLU-A, Influenza A Vaccine: ACAM FLU-A, Influenza A Vaccine: ACAM FLU-A, Saline placebo.

Last reviewed 2012-01-16 · How we verify

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

NCT00819013 Phase 1 COMPLETED Results posted

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.

Details

Lead sponsor	Sanofi
Phase	Phase 1
Status	COMPLETED
Enrolment	87
Start date	2007-07
Completion	2009-02

Conditions

Influenza

Interventions

Influenza A Vaccine: ACAM FLU-A
Influenza A Vaccine: ACAM FLU-A
Influenza A Vaccine: ACAM FLU-A
Saline placebo

Primary outcomes

Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. — Day 0 through Day 60 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. — Day 0 through Day 7 post-vaccination
Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash. Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased.
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. — Day 0 through Day 60 post-vaccination 1
Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine — Day 15 through Month 10 Post-vaccination 1
Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. — Day 15 through Month 10 Post-vaccination 1
Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA). A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)

Countries

United States