Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age

Novartis

Status and phase

Completed

Phase 3

Conditions

Pandemic Influenza

Treatments

Biological: Monovalent A/H1N1 influenza vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00971906

2009-013671-21 (EudraCT Number)

V111_02

Details and patient eligibility

About

This present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of an adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy adult and elderly subjects. A booster dose will be administered 12 months after the first vaccination.

Enrollment

660 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Males and females 18 years of age and above on the day of enrollment;
Individuals in good health
Individuals are able to comply with all study procedures
Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.

Exclusion criteria

Individual not able to comprehend and to follow all required study procedures;
History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
Any serious chronic or progressive disease according to judgment of the investigator
History of any anaphylaxis, serious vaccine reactions, to any excipients.
Adjuvanted influenza vaccine or documented confirmed or suspected influenza disease within 3 months prior to Day 1;
Receipt of another investigational agent within 4 weeks prior to enrollment, or before completion of the safety follow-up period in this or in another study; unwilling to refuse participation in another clinical study through the end of this study;
Any other vaccines within 4 weeks prior to enrollment or who are planning to receive any vaccine within 4 weeks from the study vaccines; only exception being plain seasonal influenza vaccines which are allowed until 1 week prior to and after 1 week study vaccinations.
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks;
Axillary temperature ≥ 38°C or oral temperature ≥ 38.5°C within 3 days of intended study vaccination;
Known or suspected impairment/alteration of immune function, for example resulting from a receipt of immunosuppressive therapy within 60 days prior to Visit 1;
History of progressive or severe neurological disorders;
Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule;
Female of childbearing potential, not used any acceptable contraceptive methods for at least 2 months prior to study entry;
Female pregnant or nursing (breastfeeding) mothers or females of childbearing potential do not plan to use acceptable birth control measures during the first 3 weeks after vaccination;
Members of the research staff or their relatives.