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OpenTrials
Completed

NCT Number: NCT02091908

Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Underlying Medical Conditions

Evaluate the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18 through 60 years of age) and elderly (≥61 years of age) subjects with and without underlying medical conditions.

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Key information

Conditions

Influenza, Human Animal Diseases Bird Diseases Infections Influenza in Birds 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 3

Primary location

001, Novartis Investigational Site, Berlin, Germany

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • - Male and female individuals 18 years of age and older at the time of enrollment who are mentally competent, willing and able to understand the nature and risks of the proposed study, and able to sign the consent form prior to study entry;
  • Individuals who are able to comply with all study procedures and requirements;
  • Healthy volunteers and volunteers specifically with underlying COPD, cardiovascular disease, diabetes mellitus, peripheral vascular disease, or renal impairment may be eligible;
  • Please contact the site for additional eligibility criteria.

Exclusion criteria

  • Individuals who are not able to follow all the required study procedures for the whole period of the study;
  • Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject's ability to participate in the study;
  • Please contact the site for additional eligibility criteria.

Treatment and study plan

Novartis Investigational H5N1 vaccine

Biological

2 doses of 0.5 ml, 3 weeks apart

Novartis Seasonal Influenza Vaccine

Biological

2 doses of 0.5 ml, 3 weeks apart

Primary outcomes

  1. Percentage of subjects achieving seroconversion

    Time frame: day 43

    Seroconversion is defined as hemagglutination inhibition (HI) ≥1:40 for subjects who were seronegative at baseline [day 1 HI titer <1:10] or a minimum 4-fold increase in HI titer for subjects who were seropositive at baseline [day 1 HI titer ≥1:10])

  2. Geometric mean ratios (GMRs) as determined by HI assay

    Time frame: day 43

  3. Percentage of subjects with an HI titer ≥1:40

    Time frame: day 43

  4. Solicited and unsolicited adverse events

    Time frame: day 202

    In pooled age groups 18 years of age and older subjects who are healthy or with underlying medical condition who have received aTIV or aH5N1 vaccine.

Secondary outcomes

  1. Geometric mean titers (GMTs) as determined by HI

    Time frame: day 1

    HI assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first vaccination (day 22) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition

  2. Geometric mean ratios (GMRs) as determined by SRH

    Time frame: day 22

  3. Percentage of subjects with an HI titer ≥1:40

    Time frame: day 22

  4. Percentage of subjects achieving seroconversion

    Time frame: day 22

    Seroconversion is defined as SRH area ≥25 mm2 for subjects who were seronegative at baseline [day 1 SRH area ≤3.997 mm2] or a significant increase [at least 50% increase] in SRH area for subjects who were seropositive at baseline [SRH area >3.997 mm2])

  5. Percentage of subjects with geometric mean area ≥25 mm2

    Time frame: day 43

  6. Percentage of subjects achieving seroconversion

    Time frame: day 22

    Seroconversion is defined as HI ≥1:40 for subjects who were seronegative at baseline [day 1 HI titer <1:10] or a minimum 4-fold increase in HI titer for subjects who were seropositive at baseline [day 1 HI titer ≥1:10])

  7. GMTs as determined by SRH

    Time frame: day 43 (3 weeks after the second vaccination)

    Serial radial haemolysis (SRH) assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first and second vaccinations (day 22 and day 43) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition

  8. GMRs as determined by HI

    Time frame: day 22

  9. Geometric mean titers (GMTs) as determined by HI

    Time frame: day 43 (3 weeks after the second vaccination)

    HI assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first vaccination (day 22) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition

  10. Geometric mean titers (GMTs) as determined by HI

    Time frame: day 22 (3 weeks after the first vaccination)

    HI assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first vaccination (day 22) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition

  11. GMRs as determined by SRH

    Time frame: day 43

  12. Percentage of subjects with an HI titer ≥1:40

    Time frame: day 1

  13. Percentage of subjects with geometric mean area ≥25 mm2

    Time frame: day 1

  14. Percentage of subjects with geometric mean area ≥25 mm2

    Time frame: day 22

  15. Percentage of subjects achieving seroconversion

    Time frame: day 43

    Seroconversion is defined as SRH area ≥25 mm2 for subjects who were seronegative at baseline [day 1 SRH area ≤3.997 mm2] or a significant increase [at least 50% increase] in SRH area for subjects who were seropositive at baseline [SRH area >3.997 mm2])

  16. GMTs as determined by SRH

    Time frame: day 1

    Serial radial haemolysis (SRH) assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first and second vaccinations (day 22 and day 43) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition

  17. Geometric mean ratios (GMRs) as determined by SRH

    Time frame: day 43 (3 weeks after the second vaccination)

Sponsors and collaborators

Lead sponsor

Seqirus

Industry

Collaborators

  • Novartis Vaccines

Registry information

Official study title

Phase III, Stratified, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Doses of aH5N1 When Administered to Adult and Elderly Subjects With and Without Underlying Medical Conditions.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 19, 2014
Registry last updated
Nov 4, 2016

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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