Immunogenicity and Safety Study of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Primed Adults

UMN Pharma

Status and phase

Completed

Phase 2

Conditions

Influenza

Treatments

Biological: Recombinant Influenza HA Vaccine (H5N1)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01195038

JPIP501-01b

Details and patient eligibility

About

The study is designed to assess the immunogenicity and safety of one booster vaccination with 45 μg of a recombinant H5N1 influenza (A/Indonesia/05/2005) HA vaccine in healthy young adults, previously primed with a two-vaccination of 3 different doses of a recombinant H5N1 influenza (A/Vietnam/1203/2004) HA vaccine in a priming study (JPIP501-01a, NCT00980447).

Enrollment

87 estimated patients

Sex

All

Ages

21 to 41 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects who completed a priming study (JPIP501-01a, NCT00980447)
Male and female healthy adults
Written informed consent obtained from the subject before study entry

Exclusion criteria

History of H5N1 influenza or vaccination of other H5N1 influenza vaccines
Clinically diagnosed cardiovascular, hematological, psychological, neurological, hepatic, renal, pulmonary (including asthma), endocrinological or gastrointestinal disorder
Confirmed immune deficiency conditions, or diagnosed autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus
Severe allergic reactions or anaphylaxis to foods or drugs (including vaccines)
Treatment with disallowed drugs including other study drugs
Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply