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: December 7, 2011
Last verified: December 2011

October 15, 2009
December 7, 2011
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 ] [ Designated as safety issue: No ]

    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%.

    CHMP Criteria: Percentage of subjects with seroconversion for HI antibody is >40%; percentage of subjects achieving an HI titer ≥1:40 is > 70%; and the Geometric Mean Ratio (GMR) is >2.5.

  • Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination [ Time Frame: Day 1 to 7 ] [ Designated as safety issue: Yes ]
  • Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination [ Time Frame: Day 22 to 28 ] [ Designated as safety issue: Yes ]
HI antibody responses after 1 and/or 2 vaccinations [ Time Frame: 21 days after each vaccination ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    The two-sided confidence intervals (CIs) were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667.(based on CBER guidance against the licensed comparator). Moreover the superiority hypothesis was tested using a margin of 1.
  • Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 [ Time Frame: Past 12 months ] [ Designated as safety issue: No ]
    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: Past 12 months ] [ Designated as safety issue: No ]
  • Antibody Response Based on Baseline Seropositivity [ Time Frame: up to Day 43 ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) Based on Baseline Seropositivity [ Time Frame: up to Day 43 ] [ Designated as safety issue: No ]
  • Antibody Persistence 6 Months and 12 Months After the Second Vaccination [ Time Frame: 6 months and 12 months after second vaccination ] [ Designated as safety issue: No ]
  • Antibody Persistence by Geometric Mean Titers (GMT) [ Time Frame: 6 months and 12 months after second vaccination ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Both
6 Months to 35 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Mexico
 
NCT00996307
V112_06
Yes
Novartis ( Novartis Vaccines )
Novartis Vaccines
Novartis
Study Director: Novartis Vaccines and Diagnostics Novartis
Novartis
December 2011

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