Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults (FLU-A)

Sanofi

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Biological: Saline placebo; Biological: Influenza A Vaccine: ACAM FLU-A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00819013

H-261-001

Details and patient eligibility

About

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.

Full description

All subjects will be followed up for 60 days post-randomization and through the influenza season. Following the influenza season, a subset of the subjects will receive a booster vaccine at the 12 month time point. The subjects will further be assessed at 2 days, 7 days, 15 days, 30 days and 6 months following the booster vaccination.

Enrollment: 87 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult males or females 18 - 40 years of age in good general health

Exclusion criteria

• Known allergies or severe reactions to any of the vaccine components including those to adjuvants
• History of severe allergic reactions, including angioedema;
• History of asthma or recurrent wheezing; (current or within past 2 years);
• History of neurological symptoms or signs following administration of any vaccine;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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87 participants in 4 patient groups, including a placebo group

Study Group 1

Experimental group

Description:

ACAM-FLU-A low dose + Adjuvant 1

Treatment:

Biological: Influenza A Vaccine: ACAM FLU-A

Biological: Influenza A Vaccine: ACAM FLU-A

Biological: Influenza A Vaccine: ACAM FLU-A

Study Group 2

Experimental group

Description:

ACAM-FLU-A low dose + Adjuvant 2

Treatment:

Biological: Influenza A Vaccine: ACAM FLU-A

Biological: Influenza A Vaccine: ACAM FLU-A

Biological: Influenza A Vaccine: ACAM FLU-A

Study Group 3

Experimental group

Description:

ACAM-FLU-A low dose

Treatment:

Biological: Influenza A Vaccine: ACAM FLU-A

Biological: Influenza A Vaccine: ACAM FLU-A

Biological: Influenza A Vaccine: ACAM FLU-A

Study Group 4

Placebo Comparator group

Description:

Saline placebo

Treatment:

Biological: Saline placebo