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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00970177
First received: September 1, 2009
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Pandemic Influenza
Biological: Monovalent A/H1N1 influenza vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To identify the preferred vaccine formulation, dosage (antigen & adjuvant), schedule (one or two administrations) of the H1N1 sw monovalent vaccine in adults. [ Time Frame: 43 days after first vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 3 weeks after booster vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 812
Study Start Date: August 2009
Study Completion Date: March 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970177

Locations
Belgium
Gent, Antwerpen, Belgium
Germany
Wurzburg, Fulda, Neumunster, Balve, Leipzig, Magdeburg
Munchen, Germany
Switzerland
Zurich, Switzerland
Sponsors and Collaborators
Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00970177     History of Changes
Other Study ID Numbers: V110_03, 2009-013639-39
Study First Received: September 1, 2009
Last Updated: September 10, 2013
Health Authority: Germany: Paul-Ehrlich-Institut
Belgium: Federal Agency for Medicinal Products and Health Products
Switzerland: Swissmedic

Keywords provided by Novartis:
Pandemic influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014