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Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00996307
First received: October 15, 2009
Last updated: April 19, 2017
Last verified: April 2017
October 15, 2009
April 19, 2017
October 2009
December 2009   (Final data collection date for primary outcome measure)
  • Antibody Responses After the First and Second Vaccinations [ Time Frame: 21 days after each vaccination ]
    CBER guidance (<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.
  • Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination [ Time Frame: Day 1 to 7 ]
    Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.
  • Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination [ Time Frame: Day 22 to 28 ]
    Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.
HI antibody responses after 1 and/or 2 vaccinations [ Time Frame: 21 days after each vaccination ]
Complete list of historical versions of study NCT00996307 on ClinicalTrials.gov Archive Site
  • Immunogenicity Measurement by Geometric Mean Titers (GMT) [ Time Frame: 21 days after each vaccination ]
    Immunogenicity was measured in terms of the GMT at 21 days after each vaccination.
  • Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 [ Time Frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) ]
    Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
  • Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 [ Time Frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) ]
    Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
  • Antibody Response Based on Baseline Seropositivity [ Time Frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) ]
    Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10
  • Geometric Mean Titers (GMTs) Based on Baseline Seropositivity [ Time Frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) ]
    Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10 Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline (Day 1 (pre-vaccination)) as compared to those who are seronegative (HI titer < 1:10).
  • Antibody Persistence by Geometric Mean Titers (GMT) [ Time Frame: 6 months (Day 202) and 12 months (Day 387) after second vaccination ]
    Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination.
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 ]
Not Provided
Not Provided
 
Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1) 2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Influenza
  • Biological: MF59-eH1N1_f
    3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
  • Biological: MF59-eH1N1_f
    7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
  • Biological: MF59-eH1N1_f
    15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
  • Biological: MF59-eH1N1_f
    7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
  • Experimental: 3.75_(50)MF59
    3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
    Intervention: Biological: MF59-eH1N1_f
  • Experimental: 7.5_(0)MF59
    7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
    Intervention: Biological: MF59-eH1N1_f
  • Experimental: 7.5_(50)MF59
    7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
    Intervention: Biological: MF59-eH1N1_f
  • Experimental: 15_(0)MF59
    15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
    Intervention: Biological: MF59-eH1N1_f
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
654
December 2010
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children 6 to 35 months 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

Sexes Eligible for Study: All
6 Months to 35 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico,   United States
 
 
NCT00996307
V112_06
Yes
Not Provided
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Novartis
Study Director: Novartis Vaccines and Diagnostics Novartis
Novartis
April 2017

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