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

Influenza Clinical Trial

Official title:

A Phase II, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, and a Six Month Booster Dose of Two Surface Antigen Adjuvanted With MF59C.1 Influenza Vaccines Containing 7.5 Micrograms or 15 Micrograms of A/H5N1 Influenza Antigen and of a Non-adjuvanted Influenza Vaccine Containing 15 Micrograms of A/H5N1 Influenza Antigen, in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382187
• Other study ID #: V87P2
• Secondary ID: Eudract number 2
• Status: Completed
• Phase: Phase 2
• First received: September 27, 2006
• Last updated: November 30, 2016
• Start date: November 2006
• Est. completion date: January 2008

Study information

• Verified date: February 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• MF59 adjuvanted H5N1 influenza vaccine
MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1 non-adjuvanted influenza vaccine containing 15 ug of H5N1

Locations

Country	Name	City	State
Italy	Presidio Distrettuale N. 8, Azienda USL 7 di Siena, Via Savina Petrilli, 3	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Galli G, Medini D, Borgogni E, Zedda L, Bardelli M, Malzone C, Nuti S, Tavarini S, Sammicheli C, Hilbert AK, Brauer V, Banzhoff A, Rappuoli R, Del Giudice G, Castellino F. Adjuvanted H5N1 vaccine induces early CD4+ T cell response that predicts long-term — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT's and Seroconversion rate at day 0 and day 22 and day 43 following vaccination.		day 1 to day 43	No
Secondary	Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study.		Day 1 to Day 382	Yes

External Links

•   Results for V87P12 from the Novartis Clinical Trials website