Safety and Immunogenicity of a Booster Dose of -H5N1 Influenza Vaccine

Novartis

Status and phase: Completed; Phase 2

Conditions: Avian Influenza

Treatments: Biological: H5N1 influenza vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00561184

V87P1E1

2007-000165-38

Details and patient eligibility

About

To assess persistence of antibody titers 17-18 months after primary immunization with two 0.5mL intramuscular (IM) doses of H5N1 influenza vaccine containing H5N1 influenza antigen, as measured by Hemagglutination Inhibition (HI), Single Radial Hemolysis (SRH), and Microneutralization (MN) test

Enrollment: 47 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects who previously participated in study V87P1, but did not receive the booster dose on day 202

Exclusion criteria

• Pregnant or breastfeeding
• Receipt of another vaccine or any investigational agent within the past 4 weeks
• Surgery planned during the study period

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

1

Experimental group

Treatment:

Biological: H5N1 influenza vaccine

Biological: H5N1 influenza vaccine

2

Experimental group

Treatment:

Biological: H5N1 influenza vaccine

Biological: H5N1 influenza vaccine