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Completed

NCT Number: NCT01766921

Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects

Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in elderly subjects

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Key information

Conditions

Pandemic H5N1 Influenza Animal Diseases Bird Diseases Infections Influenza in Birds Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

42 Hunter Clinical Research, Newcastle, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy elderly subjects ≥65 years,
  • Individuals willing to provide written informed consent,
  • Individuals in good health,
  • Individuals willing to allow for their serum samples to be stored beyond the study period.

Exclusion criteria

  • Individuals not able to understand and follow study procedures,
  • History of any significant illness,
  • History of any serious chronic medical condition or progressive disease,
  • Presence of medically significant cancer,
  • Known or suspected impairment/alteration of immune function,
  • Presence of any progressive or severe neurologic disorder,
  • Presence of any bleeding disorders or conditions that prolongs bleeding time,
  • History of allergy to vaccine components,
  • Receipt of any other investigational product within 30 days prior to entry into the study,
  • History of previous H5N1 vaccination,
  • Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study,
  • Receipt of any other vaccine within 2 weeks prior to entry into the study
  • Body temperature ≥38°C.0 (≥100.4° F) and/or acute illness within 3 days of intended study vaccination,
  • Body mass index (BMI) ≥ 35 kg/m2,
  • History of drug or alcohol abuse,
  • Any planned surgery during study period,
  • Individuals conducting the study and their immediate family members,
  • Individuals with behavioral or cognitive impairment or psychiatric diseases.

Treatment and study plan

Adjuvanted H5N1 pandemic influenza vaccine

Biological

Comparison of two doses of aH5N1c vaccine

Primary outcomes

  1. The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.

    Time frame: Baseline (day 1) and Three weeks after 2nd vaccination (day 43)

    The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion.

    The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 60%.

  2. The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.

    Time frame: Three weeks after 2nd vaccination (day 43)

    Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion.

    Seroconversion is defined as, a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.

    The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 30%.

  3. Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination.

    Time frame: From day 1 through day 7 after any vaccination.

    Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.

  4. Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.

    Time frame: Day 1 through day 387 after any vaccination

    Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with aH5N1c vaccine

Secondary outcomes

  1. Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.

    Time frame: Day 1; day 22; day 43 and day 387

    Immunogenicity was measured as the GMR. The ratio of postvaccination to prevaccination HI geometric mean titers (GMTs) is reported.

    The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criterion if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.0 for subjects >60 years of age.

  2. Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain

    Time frame: Day 1, day 22, day 43 and day 387.

    Immunogenicity was assessed in terms of percentage of subjects achieving HI titers >40, three weeks after second vaccination with aH5N1c according to the CHMP criterion.

    The European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >60%.

  3. The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain

    Time frame: Day 22, day 43 and day 387

    Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, three weeks after receiving two injections of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.

    Seroconversion is defined as a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.

    The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion is >30%.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

A Phase II, Randomized, Observer-Blind, Multi-Center, Study to Evaluate Safety, Tolerability and Immunogenicity of an Adjuvanted Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine at Two Different Formulations in Healthy Elderly Subjects.

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jan 11, 2013
Registry last updated
Jan 30, 2019

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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