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Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00972816
First received: September 2, 2009
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Influenza
 Biological: MF59-eH1N1
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: 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 Pediatric Subjects 3 to < 9 Years of Age

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • HI Titer ≥ 1:40 and Seroconversion After Each Vaccination by Vaccine Group [ Time Frame: day 22, day 43, day 202, day 387 ] [ Designated as safety issue: No ]
    HI: Hemagglutinin inhibition


Secondary Outcome Measures:
  • Geometric Mean Titer After Each Vaccination by Vaccine Group [ Time Frame: day 22, day 43, day 202, day 387 ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination [ Time Frame: 7 days after first vaccination ] [ Designated as safety issue: Yes ]
    Solicited local and systemic reactions were assessed after the first vaccination by vaccine group.

  • Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination [ Time Frame: 7 days after second vaccination ] [ Designated as safety issue: Yes ]
    Solicited local and systemic reactions were assessed after the second vaccination by vaccine group.


Enrollment: 1357
Study Start Date: September 2009
Study Completion Date: October 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3.75_(50)MF59
50% of MF59 with 3.75 µg A/H1N1 antigen
 Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 7.5
1 dose of 7.5 µg A/H1N1
 Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 7.5_(50)MF59
50% of MF59 with 7.5 µg A/H1N1 antigen
 Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 7.5_(100)MF59
100% of MF59 with 7.5 µg A/H1N1 antigen
 Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 15
1 dose of 15 µg A/H1N1
 Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 15_(50)MF59
50% of MF59 with 15 µg A/H1N1 antigen
 Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 5_(100)MF59
100% of MF59 with 15 µg A/H1N1 antigen
 Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 30
1 dose of 30 µg A/H1N1
 Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).

  Eligibility

Ages Eligible for Study:   3 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children 3 to < 9 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972816

  Show 35 Study Locations
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Director: Novartis Vaccines and Diagnostics Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00972816     History of Changes
Other Study ID Numbers: V112_02
Study First Received: September 2, 2009
Results First Received: December 6, 2010
Last Updated: August 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Swine Flu
Flu
Vaccine
Children
Adjuvant

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013