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Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)

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ClinicalTrials.gov Identifier: NCT00973700
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : May 23, 2011
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Tracking Information
First Submitted Date  ICMJE September 2, 2009
First Posted Date  ICMJE September 9, 2009
Results First Submitted Date  ICMJE October 20, 2010
Results First Posted Date  ICMJE May 23, 2011
Last Update Posted Date December 2, 2015
Study Start Date  ICMJE August 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2015)
  • Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age [ Time Frame: Day 1 to day 387 ]
    Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS).
  • Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age [ Time Frame: Day 1 to day 387 ]
    Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. Analyses were performed on the Per-Protocol set (PPS).
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: October 29, 2015)
  • Age Distribution at Baseline [ Time Frame: Baseline ]
  • Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years [ Time Frame: Day 1 to day 387 ]
    Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS).
  • HI GMRs, in 3 to <9 Years and 9 to 17 Years [ Time Frame: Day 1 to day 387 ]
    Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the the per-protocol set (PPS).
  • HI GMR, in Adults 18 to 64 Years [ Time Frame: Day 1 to day 387 ]
    Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the Per-Protocol Set (PPS).
  • Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years [ Time Frame: 7 days and 21 days after each vaccination ]
    Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the per-protocol set (PPS).
  • Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age [ Time Frame: 7 days after each vaccination ]
    Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to <9 years of age). Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination
  • Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age [ Time Frame: 7 days after each vaccination ]
    Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age). Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination.
  • Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age [ Time Frame: 7 days after each vaccination ]
    Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age). Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination. The analyses were performed on the safety set.
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 Children, Adolescents and Adults (3 to 64 Years)
Official Title  ICMJE A Randomized, Open Label, Single Center, Dose- and Regimen-Ranging 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 Children and Adults Ages 3 to 64 Years
Brief Summary This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Novel 2009 Influenza H1N1
Intervention  ICMJE
  • Biological: MF59-eH1N1_f
    MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
  • Biological: eH1N1_f
    Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal
Study Arms  ICMJE
  • Experimental: 2x7.5adj
    Two doses of MF59 adjuvanted (adj) A/H1N1
    Intervention: Biological: MF59-eH1N1_f
  • Experimental: 7.5adj_1_8
    MF59 adjuvanted (adj) A/H1N1 on days 1 and 8
    Intervention: Biological: MF59-eH1N1_f
  • Experimental: 7.5adj_1_22
    MF59 adjuvanted (adj) A/H1N1 on study days 1 and 22
    Intervention: Biological: MF59-eH1N1_f
  • Experimental: 15_1_22
    A/H1N1 on study days 1 and 22
    Intervention: Biological: eH1N1_f
  • Experimental: 2x15_1_22
    Two doses of A/H1N1 (one in each arm) on study days 1 and 22
    Intervention: Biological: eH1N1_f
Publications * Arguedas A, Soley C, Abdelnour A, Sales V, Lindert K, Della Cioppa G, Clemens R; Costa Rican H1N1 Vaccine Study Group. Assessment of the safety, tolerability and kinetics of the immune response to A/H1N1v vaccine formulations with and without adjuvant in healthy pediatric subjects from 3 through 17 years of age. Hum Vaccin. 2011 Jan 1;7(1):58-66. Epub 2011 Jan 1.

*   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: September 7, 2009)
784
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children, adolescents, and adults 3 to 64 years of age 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.

For additional entry criteria, please refer to protocol.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 64 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Costa Rica
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00973700
Other Study ID Numbers  ICMJE V112_04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Vaccines )
Study Sponsor  ICMJE Novartis Vaccines
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Vaccines Novartis Vaccines
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