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
  Purpose

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children


Condition Intervention Phase
Influenza
Biological: MF59-eH1N1_f
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 654
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3.75_(50)MF59
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
Biological: MF59-eH1N1_f
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
Experimental: 7.5_(0)MF59
7.5 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 without MF59 adjuvant administered on study day 1 and day 22.
Experimental: 7.5_(50)MF59
7.5 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 with 50% MF59 adjuvant administered on study day 1 and day 22.
Experimental: 15_(0)MF59
15 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.

  Eligibility

Ages Eligible for Study:   6 Months to 35 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996307

  Show 29 Study Locations
Sponsors and Collaborators
Novartis Vaccines
Novartis
Investigators
Study Director: Novartis Vaccines and Diagnostics Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00996307     History of Changes
Other Study ID Numbers: V112_06
Study First Received: October 15, 2009
Results First Received: April 28, 2011
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Swine Flu
Flu
Vaccine
Children
Adjuvant
A/H1N1 2009 Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
MF59 oil emulsion
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014