Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults

Novartis

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: MF59 adjuvanted H5N1 influenza vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00382187

V87P2

Eudract number 2006-004063-66

Details and patient eligibility

About

The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, and of a non-adjuvanted influenza vaccine containing 15 micrograms of H5N1 influenza antigen, in adults

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female volunteers 18-60 years of age

Exclusion criteria

• Any auto-immune disease or other serious acute, chronic or progressive disease
• Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine
• History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
• Within the past 7 days, they have experienced any acute disease or infections requiring systemic antibiotic or antiviral therapy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 3 patient groups

MF59 adjuvant H5N1 influenza vaccine 7.5 micrograms

Experimental group

Treatment:

Biological: MF59 adjuvanted H5N1 influenza vaccine

MF59 adjuvant H5N1 influenza vaccine 15 micrograms

Experimental group

Treatment:

Biological: MF59 adjuvanted H5N1 influenza vaccine

non-adjuvanted influenza vaccine 15 micrograms of H5N1 antigen

Experimental group

Treatment:

Biological: MF59 adjuvanted H5N1 influenza vaccine