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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

Tracking Information
First Submitted Date  ICMJE September 2, 2009
First Posted Date  ICMJE September 9, 2009
Results First Submitted Date  ICMJE December 7, 2010
Results First Posted Date  ICMJE May 25, 2011
Last Update Posted Date December 7, 2015
Study Start Date  ICMJE September 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2011)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2009)
HI antibody responses after 1 and/or 2 vaccinations [ Time Frame: 21 days after each vaccination ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2011)
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2009)
Surveillance for solicited local & systemic reactions & AEs during treatment period & surveillance for 21 d after each study vacc, & SAE, medically attended visits, new onset of chronic diseases will be collected through the treatment & follow-up periods [ Time Frame: 12 months following last vaccination ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE Biological: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Study Arms  ICMJE
  • Experimental: 3.75_(50)MF59
    50% of MF59 with 3.75 µg A/H1N1 antigen
    Intervention: Biological: MF59-eH1N1_f
  • Experimental: 7.5 w/o MF59
    0% of MF59 with 7.5 µg A/H1N1 antigen
    Intervention: Biological: MF59-eH1N1_f
  • Experimental: 7.5_(50)MF59
    50% of MF59 with 7.5 µg A/H1N1 antigen
    Intervention: Biological: MF59-eH1N1_f
  • Experimental: 7.5_(100)MF59
    100% of MF59 with 7.5 µg A/H1N1 antigen
    Intervention: Biological: MF59-eH1N1_f
  • Experimental: 15 w/o MF59
    0% of MF59 with 15 µg A/H1N1 antigen
    Intervention: Biological: MF59-eH1N1_f
  • Experimental: 15_(50)MF59
    50% of MF59 with 15 µg A/H1N1 antigen
    Intervention: Biological: MF59-eH1N1_f
  • Experimental: 15_(100)MF59
    100% of MF59 with 15 µg A/H1N1 antigen
    Intervention: Biological: MF59-eH1N1_f
  • Experimental: 30 w/o MF59
    0% of MF59 with 30 µg A/H1N1 antigen
    Intervention: Biological: MF59-eH1N1_f
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2011)
2719
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2009)
2720
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00973349
Other Study ID Numbers  ICMJE V112_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Novartis Vaccines
Investigators  ICMJE
Study Director: Novartis Vaccine and Diagnostics Novartis
PRS Account Novartis
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP