Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two(Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines in Non-Elderly Adult and Elderly Subjects

Pandemic Influenza Disease Clinical Trial

Official title:

A Phase II, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two (Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines Containing 7.5 mg or 15 mg of H5N1 Influenza Antigen, in Non-Elderly Adult and Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311480
• Other study ID #: V87P1
• Secondary ID: Eudract:2005-005
• Status: Completed
• Phase: Phase 2
• First received: April 4, 2006
• Last updated: March 12, 2007
• Start date: March 2006

Study information

• Verified date: March 2007
• 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, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, in non-elderly adult and elderly subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female volunteers 18 years of age or older

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, infections requiring systemic antibiotic or antiviral therapy.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza, Human
• Pandemic Influenza Disease

Intervention

Biological:
• Influenza vaccine surface antigen adjuvanted with MF59

Locations

Country	Name	City	State
Italy	G. D'Annunzio University	Chieti
Italy	Department of Health Sciences	Genoa
Italy	ASL Lanciano-Vasto	Lanciano
Italy	University Hospital of Siena	Siena

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Novartis Vaccines

Country where clinical trial is conducted

Italy, 

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
Secondary	Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Thought the Study.