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
  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:


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
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: 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 September 14, 2014