Immunogenicity, Tolerability and Safety of One or Two Doses of an Adjuvanted Swine-origin A H1N1 Influenza Vaccine in Healthy Subjects 18 or More Years of Age Both Vaccinated and Not Yet Vaccinated Against Seasonal Influenza 2009/10

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00992212
First received: October 8, 2009
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

This present study, a phase II, open label study will evaluate the immunogenicity, tolerability and safety of an adjuvanted, inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in healthy subjects aged 18 years and above. This study will explore the effect of the previous and concomitant exposure to a seasonal influenza vaccination to the immunogenicity and safety profile of two different doses of an adjuvanted H1N1sw vaccine.


Condition Intervention Phase
Pandemic Influenza Disease
Biological: Monovalent A/H1N1 influenza vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II, Open Label Study to Evaluate the Immunogenicity, Tolerability and Safety of an Adjuvanted, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects Aged 18 Years and Above

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To evaluate the immunogenicity, safety and tolerability of 1 and 2 IM doses of MF59-H1N1sw flu vaccine in adult-elderly subjects previously exposed to 09/10 NH TIV and in those not yet vaccinated against flu season 09/10. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 418
Study Start Date: August 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A (Seasonal TIV + 7.5mcg HA+ full dose MF59) Biological: Monovalent A/H1N1 influenza vaccine
This trial will be performed at multiple sites; appr. 160 subjects exposed to the annual vaccine registration will be invited to take part into this study. In addition, a total of 224 healthy subjects not yet exposed to the seasonal influenza vaccines will be enrolled.
Experimental: Group B (Ajuvanted Seasonal TIV + 7.5mcg HA+ full dose MF59) Biological: Monovalent A/H1N1 influenza vaccine
This trial will be performed at multiple sites; appr. 160 subjects exposed to the annual vaccine registration will be invited to take part into this study. In addition, a total of 224 healthy subjects not yet exposed to the seasonal influenza vaccines will be enrolled.
Experimental: Group C (7.5mcg HA+ full dose MF59) Biological: Monovalent A/H1N1 influenza vaccine
This trial will be performed at multiple sites; appr. 160 subjects exposed to the annual vaccine registration will be invited to take part into this study. In addition, a total of 224 healthy subjects not yet exposed to the seasonal influenza vaccines will be enrolled.
Experimental: Group D (7.5mcg HA+ full dose MF59 + Seasonal TIV) Biological: Monovalent A/H1N1 influenza vaccine
This trial will be performed at multiple sites; appr. 160 subjects exposed to the annual vaccine registration will be invited to take part into this study. In addition, a total of 224 healthy subjects not yet exposed to the seasonal influenza vaccines will be enrolled.
Experimental: Group E (3.75mcg HA+ ½ dose MF59+ Seasonal TIV) Biological: Monovalent A/H1N1 influenza vaccine
This trial will be performed at multiple sites; appr. 160 subjects exposed to the annual vaccine registration will be invited to take part into this study. In addition, a total of 224 healthy subjects not yet exposed to the seasonal influenza vaccines will be enrolled.

Detailed Description:

At enrolment, subjects were stratified into two age strata (18 to 60 years, over 60 years). Total duration of the study is eight weeks, which include two weeks for enrolment and 6 weeks for study participation. Vaccinations were to be administered on day 1 and day 22. Blood samples were collected at day 1 (baseline, before the first vaccination), at day 22 (before the second vaccination), at day 29 (one week after the second vaccination) and at day 43 (three weeks after the second vaccination). Sera were tested by Hemagglutination Inhibition (HI) and Microneutralization (MN) assays. Safety was assessed until 3 weeks after the first and second vaccination.

  Eligibility

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

Inclusion Criteria:

  1. For study Groups A and B : subjects aged 18 years and above on the day of enrollment, who took part to the seasonal trials for the 2009/10 vaccine registration; For study Groups C to E: subjects aged 18 years and above on the day of enrollment, not yet exposed to the current seasonal formulation (2009/10 for NH) of the influenza vaccines;
  2. Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator;
  3. Documented consent obtained after the nature of the study has been explained according to local regulatory requirements;
  4. Individuals are able to comply with all study procedures and are available for all clinic visits scheduled in the study.
  5. 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. Individuals who are not able to comprehend and to follow all required study procedures; 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;
  2. 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;
  3. Individuals who have had received an influenza vaccine for the 2009/10 NH influenza season (for subjects to be included in Groups C to E only) prior to Visit 1;
  4. Individuals who have had documented confirmed or suspected influenza disease within 6 months prior to Day 1.
  5. 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;
  6. Individuals who received any other vaccines within 4 weeks prior to enrollment in this study and individuals who have ever received blood, blood products and/or plasma derivatives in the past 12 weeks;
  7. Individuals with axillary temperature ≥ 38.0°C within 3 days of study vaccination;
  8. Known or suspected impairment/alteration of immune function, for example resulting from:

    • receipt of immunosuppressive therapy,
    • cancer chemotherapy,
    • receipt of immunostimulants within 60 days prior to Visit 1,
    • receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study,
    • known HIV infection or HIV-related disease.
  9. Surgery planned during the study period;
  10. If female, of childbearing potential, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry;
  11. Females who are pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who are sexually active and have not used or do not plan to use acceptable birth control measures during the first 3 weeks after vaccination.
  12. Members of the research staff or their relatives (research staff are individuals with direct or indirect contact with trial subjects, or study site personnel who have access to any study documents containing subject information, including: e.g. receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians); hospital personnel and health care providers not involved in the study can be enrolled.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992212

Locations
Italy
01
Chieti, 66100, Italy
05
Ferrara 44100, Italy
04
Genova 16132, Italy
02
Lanciano,66034, Italy
03
Mira 30034 Pianiga,, Italy
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

Publications:
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00992212     History of Changes
Other Study ID Numbers: V111_04
Study First Received: October 8, 2009
Last Updated: January 4, 2012
Health Authority: Italy: Italian Authority AIFA

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 July 20, 2014