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

A Randomized, Single-blind, Dose-Ranging, Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and Non Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects 18 or More Years of Age

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.

Study Overview

• Status: Completed
• Conditions: Pandemic Influenza
• Intervention / Treatment: Biological: Monovalent A/H1N1 influenza vaccine

• Study Type: Interventional
• Enrollment (Actual): 812
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Gent, Antwerpen, Belgium
• Germany
  • Munchen, Germany
    • Wurzburg, Fulda, Neumunster, Balve, Leipzig, Magdeburg
• Switzerland
  • Zurich, Switzerland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males and females 18 years of age and above on the day of enrollment;
2. Individuals in good health
3. Individuals are able to comply with all study procedures
4. 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:

1. Individual not able to comprehend and to follow all required study procedures;
2. 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;
3. Any serious chronic or progressive disease according to judgment of the investigator
4. History of any anaphylaxis, serious vaccine reactions, to any excipients.
5. Adjuvanted influenza vaccine or documented confirmed or suspected influenza disease within 3 months prior to Day 1;
6. 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;
7. 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.
8. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks;
9. Axillary temperature ≥ 38°C or oral temperature ≥ 38.5°C within 3 days of intended study vaccination;
10. Known or suspected impairment/alteration of immune function, for example resulting from a receipt of immunosuppressive therapy within 60 days prior to Visit 1;
11. History of progressive or severe neurological disorders;
12. Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule;
13. Female of childbearing potential, not used any acceptable contraceptive methods for at least 2 months prior to study entry;
14. 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;
15. Members of the research staff or their relatives.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low dose of antigen + low dose of adjuvant	Biological: Monovalent A/H1N1 influenza vaccine; This trial will be performed at multiple study sites in a population of healthy adults and elderly. Subjects will be randomized to receive two IM injections of low dose of antigen & adjuvant, or high dose of antigen & adjuvant, or high dose of antigen, according to the study groups.
Experimental: high dose of antigen + high dose of adjuvant	Biological: Monovalent A/H1N1 influenza vaccine; This trial will be performed at multiple study sites in a population of healthy adults and elderly. Subjects will be randomized to receive two IM injections of low dose of antigen & adjuvant, or high dose of antigen & adjuvant, or high dose of antigen, according to the study groups.
Experimental: high dose of antigen	Biological: Monovalent A/H1N1 influenza vaccine; This trial will be performed at multiple study sites in a population of healthy adults and elderly. Subjects will be randomized to receive two IM injections of low dose of antigen & adjuvant, or high dose of antigen & adjuvant, or high dose of antigen, according to the study groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To identify the preferred vaccine formulation, dosage (antigen & adjuvant), schedule (one or two administrations) of the H1N1 sw monovalent vaccine in adults.	43 days after first vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate immunogenicity against A/California H1N1sw strain after booster dose of egg-derived seasonal trivalent, MF59 adjuvanted vaccine Fluad, recommended for 2010/2011 season, administered 12 months after primary course according to CHMP criteria.	3 weeks after booster vaccination

Collaborators and Investigators

• Sponsor: Novartis Vaccines

Publications and helpful links

General Publications

• Hatz C, Cramer JP, Vertruyen A, Schwarz TF, von Sonnenburg F, Borkowski A, Lattanzi M, Hilbert AK, Cioppa GD, Leroux-Roels G. A randomised, single-blind, dose-range study to assess the immunogenicity and safety of a cell-culture-derived A/H1N1 influenza vaccine in adult and elderly populations. Vaccine. 2012 Jul 6;30(32):4820-7. doi: 10.1016/j.vaccine.2012.05.013. Epub 2012 May 22.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: September 1, 2009
• First Submitted That Met QC Criteria: September 1, 2009
• First Posted (Estimate): September 2, 2009

Study Record Updates

• Last Update Posted (Estimate): December 1, 2016
• Last Update Submitted That Met QC Criteria: November 30, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Pandemic influenza vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: V110_03; 2009-013639-39 (EudraCT Number)