Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00973700
First received: September 2, 2009
Last updated: September 2, 2012
Last verified: September 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, adolescents, and adults.


Condition Intervention Phase
Novel 2009 Influenza H1N1
Biological: MF59-eH1N1_f
Biological: eH1N1_f
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized, Open Label, Single Center, Dose- and Regimen-Ranging 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 Children and Adults Ages 3 to 64 Years

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age [ Time Frame: 21 days after each vaccination and 8 days after second vaccination ] [ Designated as safety issue: No ]

    Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.

    The analyses were performed on the Per-Protocol Set (PPS).


  • Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age [ Time Frame: 7 and 21 days after each vaccination ] [ Designated as safety issue: No ]

    Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.

    Analyses were performed on the Per-Protocol set (PPS).



Secondary Outcome Measures:
  • Age Distribution at Baseline [ Time Frame: During the duration of the study, day 1 to day 387 ] [ Designated as safety issue: No ]
  • Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years [ Time Frame: 21 days after each vaccination and 7 days after the second vaccination ] [ Designated as safety issue: No ]

    Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.

    The analyses were performed on the Per-Protocol Set (PPS).


  • HI GMRs, in 3 to <9 Years and 9 to 17 Years [ Time Frame: 21 days after each vaccination and 7 days after the second vaccination ] [ Designated as safety issue: No ]

    Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).

    The analyses were performed on the the per-protocol set (PPS).


  • HI GMR, in Adults 18 to 64 Years [ Time Frame: 7days and 21 days after each vaccination ] [ Designated as safety issue: No ]

    Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).

    The analyses were performed on the Per-Protocol Set (PPS).


  • Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years [ Time Frame: 7 days and 21 days after each vaccination ] [ Designated as safety issue: No ]

    Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.

    The analyses were performed on the per-protocol set (PPS).


  • Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age [ Time Frame: 7 days after each vaccination ] [ Designated as safety issue: Yes ]

    Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to <9 years of age).

    Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set.


  • Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age [ Time Frame: 7 days after each vaccination ] [ Designated as safety issue: Yes ]

    Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age).

    The analyses were performed on the safety set.


  • Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age [ Time Frame: 7 days after each vaccination ] [ Designated as safety issue: Yes ]

    Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age).

    The analyses were performed on the safety set.



Enrollment: 784
Study Start Date: August 2009
Study Completion Date: October 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2x7.5adj
Two doses of MF59 adjuvanted (adj) A/H1N1
Biological: MF59-eH1N1_f
MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
Experimental: 7.5adj_1_8
MF59 adjuvanted (adj) A/H1N1 on days 1 and 8
Biological: MF59-eH1N1_f
MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
Experimental: 7.5adj_1_22
MF59 adjuvanted (adj) A/H1N1 on study days 1 and 22
Biological: MF59-eH1N1_f
MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
Experimental: 15_1_22
A/H1N1 on study days 1 and 22
Biological: eH1N1_f
Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal
Experimental: 2x15_1_22
Two doses of A/H1N1 (one in each arm) on study days 1 and 22
Biological: eH1N1_f
Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal

  Eligibility

Ages Eligible for Study:   3 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children, adolescents, and adults 3 to 64 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: NCT00973700

Locations
Costa Rica
Instituto de Atencion Pediatrica, Avenida 0-2 Calle 22, Paseo Colon del Restaurante La, Bastilla 50 metros Sur, Edificio 5.
San Jose, Costa Rica
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Director: Novartis Vaccines Novartis Vaccines
  More Information

Publications:
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00973700     History of Changes
Other Study ID Numbers: V112_04
Study First Received: September 2, 2009
Results First Received: October 20, 2010
Last Updated: September 2, 2012
Health Authority: Costa Rica: Ministry of Health Costa Rica
United States: Food and Drug Administration

Keywords provided by Novartis:
Swine Flu
Flu
Vaccine
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 April 23, 2014