Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00973349
First received: September 2, 2009
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.


Condition Intervention Phase
Influenza
Biological: MF59-eH1N1_f
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Adult Subjects 18 or More Years of Age

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age [ Time Frame: 21 days after each vaccination ] [ Designated as safety issue: No ]
    Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.

  • Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age [ Time Frame: 21 days after each vaccination ] [ Designated as safety issue: No ]
    Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.


Secondary Outcome Measures:
  • Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age [ Time Frame: 21 days after each vaccination ] [ Designated as safety issue: No ]
    Geometric mean hemagglutinin inhibition (HI) titer = GMT

  • Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age [ Time Frame: 21 days after each vaccination ] [ Designated as safety issue: No ]
    Immunogenicity evaluation after each vaccination by vaccine group according to CHMP (Committee for Medicinal Products for Human Use) criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.

  • Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age [ Time Frame: 21 days after each vaccination ] [ Designated as safety issue: No ]
    Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.

  • Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age [ Time Frame: 21 days after vaccination ] [ Designated as safety issue: No ]
    Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers.

  • Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age [ Time Frame: 7 days after vaccination ] [ Designated as safety issue: Yes ]
    Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.

  • Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age [ Time Frame: 7 days after vaccination ] [ Designated as safety issue: Yes ]
    Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.

  • Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age [ Time Frame: 7 days after vaccination ] [ Designated as safety issue: Yes ]
    Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.

  • Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age [ Time Frame: 7 days after vaccination ] [ Designated as safety issue: Yes ]
    Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.


Enrollment: 2719
Study Start Date: September 2009
Study Completion Date: December 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3.75_(50)MF59
50% of MF59 with 3.75 µg A/H1N1 antigen
Biological: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Experimental: 7.5 w/o MF59
0% of MF59 with 7.5 µg A/H1N1 antigen
Biological: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Experimental: 7.5_(50)MF59
50% of MF59 with 7.5 µg A/H1N1 antigen
Biological: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Experimental: 7.5_(100)MF59
100% of MF59 with 7.5 µg A/H1N1 antigen
Biological: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Experimental: 15 w/o MF59
0% of MF59 with 15 µg A/H1N1 antigen
Biological: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Experimental: 15_(50)MF59
50% of MF59 with 15 µg A/H1N1 antigen
Biological: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Experimental: 15_(100)MF59
100% of MF59 with 15 µg A/H1N1 antigen
Biological: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Experimental: 30 w/o MF59
0% of MF59 with 30 µg A/H1N1 antigen
Biological: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant

  Eligibility

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

Inclusion Criteria:

  • Adults 18 years of age and older in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.

Exclusion Criteria:

  • History of serious disease.
  • History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
  • Known or suspected impairment/alteration of immune function.
  • Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
  • Sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study.
  • For additional entry criteria, please refer to protocol.
  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: NCT00973349

Locations
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33143
United States, Kansas
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
United States, Nebraska
Meridien Clinical Research
Omaha, Nebraska, United States, 68134
United States, New York
Regional Clinical Research
Endwell, New York, United States, 13760
Rochester Clinical Research, Inc
Rochester, New York, United States, 14609
United States, North Carolina
Triangle Medical Research Associates
Cary, North Carolina, United States, 27518
Triangle Medical Research Associates
Raleigh, North Carolina, United States, 27609
Carolina Medical Trials
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Prestige Clinical Research
Franklin, Ohio, United States, 45005
United States, Oklahoma
IPS Research
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
West Ridge Family Practice (adult)
Erie, Pennsylvania, United States, 16506
Primary Physicians Research Inc. (adult)
Jefferson Hills, Pennsylvania, United States, 15025
United States, Rhode Island
Omega Clinical Research
Warwick, Rhode Island, United States, 02886
United States, Texas
Research Across America
Dallas, Texas, United States, 75234
West Houston Clinical Research Service
Houston, Texas, United States, 77055
United States, Utah
J. Lewis Research, Inc./Foothill Family Clinic South
Salt Lake City, Utah, United States, 84121
J.Lewis Research, Inc./Foothill Family Clinic
Salt Lake City, Utah, United States, 84109
United States, Virginia
PI-Coor Clinical Research
Burke, Virginia, United States, 22015
PI Coor Clinical Research
Fairfax, Virginia, United States, 22030
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Mexico
Instituto Nacional de Ciencias
Tlalpan, Mexico, 14000
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Director: Novartis Vaccine and Diagnostics Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00973349     History of Changes
Other Study ID Numbers: V112_01
Study First Received: September 2, 2009
Results First Received: December 7, 2010
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Swine Flu
Flu
Vaccine
Adults
Elderly
Non-Elderly
Adjuvant

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 August 26, 2014