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

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ClinicalTrials.gov Identifier: NCT00973349
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : May 25, 2011
Last Update Posted : December 7, 2015
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis

Brief Summary:
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 or disease Intervention/treatment Phase
Influenza Biological: MF59-eH1N1_f Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2719 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : September 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age [ Time Frame: 21 days after each vaccination ]
    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.

  2. Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age [ Time Frame: 21 days after each vaccination ]
    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 :
  1. 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 ]
    Geometric mean hemagglutinin inhibition (HI) titer = GMT

  2. 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 ]
    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.

  3. Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age [ Time Frame: 21 days after each vaccination ]
    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.

  4. Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age [ Time Frame: 21 days after vaccination ]
    Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers.

  5. 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 ]
    Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.

  6. 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 ]
    Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.

  7. 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 ]
    Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.

  8. 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 ]
    Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973349


Locations
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Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
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Study Director: Novartis Vaccine and Diagnostics Novartis
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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00973349    
Other Study ID Numbers: V112_01
First Posted: September 9, 2009    Key Record Dates
Results First Posted: May 25, 2011
Last Update Posted: December 7, 2015
Last Verified: October 2015
Keywords provided by Novartis:
Swine Flu
Flu
Vaccine
Adults
Elderly
Non-Elderly
Adjuvant
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases