A Phase II, Randomized, Controlled, Double-blind, Multi-center, Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two Monovalent H5N1 (Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines Containing 3.75 µg or 7.5 μg of H5N1 Influenza Antigen, in Non-elderly Adult and Elderly Subjects

Novartis Vaccines12 sites in 2 countries722 target enrollmentSeptember 2009

ConditionsPandemic H5N1 Influenza

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Pandemic H5N1 Influenza
Sponsor: Novartis Vaccines
Enrollment: 722
Locations: 12
Primary Endpoint: Day 43 post vaccination ratio of GMTs for the 2 different vaccine groups (3.75µ / 7.5µg) including two-sided 95% confidence intervals as measured by HI and SRH in the adult and elderly population combined.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to demonstrate the non-inferiority of two doses of H5N1 influenza antigen in non-elderly and elderly adult subjects in order to submit an extension application for a lower dose of Focetria.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

December 2009

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Novartis Vaccines

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and females 18 yrs of age and above on the day of enrollment.
•Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator
•Documented consent obtained after the nature of the study has been explained according to local regulatory requirements
•Individuals are able to comply with all study procedures and are available for all clinic visits scheduled in the study

Exclusion Criteria

•Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study or who do not consent to the retention of the subject's serum samples after study completion.
•Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study
•Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
•Individuals who have had influenza vaccine or documented suspected influenza disease within 6 months prior to Day
•Laboratory-confirmed or suspected influenza disease within 6 months prior to Visit
•"Laboratory-confirmed" includes:
•Positive serology result
•Positive viral culture
•Positive rapid antigen test
•"Suspected" influenza disease includes: subjects with influenza-like illness within the past 6 months with a household/intimate contact with "laboratory-confirmed" influenza disease

Outcomes

Primary Outcomes

Day 43 post vaccination ratio of GMTs for the 2 different vaccine groups (3.75µ / 7.5µg) including two-sided 95% confidence intervals as measured by HI and SRH in the adult and elderly population combined.

Time Frame: 43 days

Solicited local reactions: ecchymosis, erythema, induration, swelling and pain at injection site.

Time Frame: 6 weeks

Solicited systemic reactions: headache, arthralgia, chills, fatigue, malaise, myalgia, nausea, sweating and fever as measured by axillary temperature for Day 1 through 7 and Day 22 to 28 of the study.

Time Frame: 6 weeks

Secondary Outcomes

Geometric mean titers/area (GMTs/GMAs) on each blood sampling days as determined by HI and SRH, and the applicable geometric mean ratios.(6 weeks)
Percentage of subjects achieving seroconversion or significant increase in antibody titer on each post-vaccination blood sampling days, as measured by HI and SRH.(6 weeks)
Percentage of subjects achieving an HI titer ≥40/ SRH area ≥25mm² on each blood sampling days.(6 weeks)
Immunogenicity, as determined by HI or SRH, will be assessed according to age-appropriate CHMP criteria (CPMP/BWP/214/96).(6 weeks)
Immunogenicity according to CBER criteria in terms of hemagglutination inhibition test in non-elderly adult and elderly subjects separately, for all post-vaccination blood sampling days and the immunogenicity according to microneutralization test(6 weeks)