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Completed

NCT Number: NCT00973349

Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults

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

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Instituto Nacional de Ciencias, Tlalpan, Mexico

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults 18 years of age and older 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.
  • Sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study.
  • For additional entry criteria, please refer to protocol.

Treatment and study plan

MF59-eH1N1_f

Biological

8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant

Primary outcomes

  1. Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age

    Time frame: 21 days after each vaccination

    Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.

  2. Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age

    Time frame: 21 days after each vaccination

    Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.

Secondary outcomes

  1. Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age

    Time frame: 21 days after each vaccination

    Geometric mean hemagglutinin inhibition (HI) titer = GMT

  2. Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age

    Time frame: 21 days after each vaccination

    Immunogenicity evaluation after each vaccination by vaccine group according to CHMP (Committee for Medicinal Products for Human Use) criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.

  3. Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age

    Time frame: 21 days after each vaccination

    Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.

  4. Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age

    Time frame: 21 days after vaccination

    Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers.

  5. Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age

    Time frame: 7 days after vaccination

    Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.

  6. Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age

    Time frame: 7 days after vaccination

    Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.

  7. Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age

    Time frame: 7 days after vaccination

    Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.

  8. Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age

    Time frame: 7 days after vaccination

    Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

  • Novartis Vaccines

Registry information

Official study 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 Adult Subjects 18 or More Years of Age

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Sep 9, 2009
Registry last updated
Dec 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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