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Completed

NCT Number: NCT00973700

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

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Key information

Conditions

Novel 2009 Influenza H1N1 Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

3 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto de Atencion Pediatrica, Avenida 0-2 Calle 22, Paseo Colon del Restaurante La, Bastilla 50 metros Sur, Edificio 5.

San José, Costa Rica

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

MF59-eH1N1_f

Biological

MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal

eH1N1_f

Biological

Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal

Primary outcomes

  1. Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age

    Time frame: Day 1 to day 387

    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).

  2. Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age

    Time frame: Day 1 to day 387

    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 outcomes

  1. Age Distribution at Baseline

    Time frame: Baseline

  2. Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years

    Time frame: Day 1 to day 387

    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).

  3. HI GMRs, in 3 to <9 Years and 9 to 17 Years

    Time frame: Day 1 to day 387

    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).

  4. HI GMR, in Adults 18 to 64 Years

    Time frame: Day 1 to day 387

    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).

  5. 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

    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).

  6. Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age

    Time frame: 7 days after each vaccination

    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. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination

  7. Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age

    Time frame: 7 days after each vaccination

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

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

    Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination.

  8. Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age

    Time frame: 7 days after each vaccination

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

    Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination.

    The analyses were performed on the safety set.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Sep 9, 2009
Registry last updated
Dec 2, 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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