Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01776541
First received: January 20, 2013
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Pandemic H5N1 Influenza
Biological: Adjuvanted H5N1 pandemic influenza vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official 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 Adult Subjects.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To select a vaccine dose based on the achievement of CBER criteria for further development [ Time Frame: Day 43 (3 weeks after second vaccination) ] [ Designated as safety issue: No ]
    Seroprotection and Seroconversion rate measured 3 weeks after second dose of vaccine administration

  • Percentage of subjects with solicited local and systemic adverse events [ Time Frame: 7 days post vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with unsolicited adverse events [ Time Frame: 3 weeks post vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with serious adverse events, medically attended adverse events, adverse events leading to withdrawal and adverse events of special interest [ Time Frame: Day 1 through Day 732 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Achievement of CHMP criteria 3 weeks after after second dose of vaccine administration [ Time Frame: Day 43 ] [ Designated as safety issue: No ]
    Seroprotection, Seroconversion rate and GMRs measured 3 weeks after second dose of vaccine administration

  • Achievement of CBER and CHMP criteria 3 weeks after first dose of vaccine administration [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
    Seroprotection, Seroconversion rate and GMRs measured 3 weeks after first dose of vaccine administration

  • Achievement of CBER and CHMP criteria 3 weeks after booster dose of vaccine administration [ Time Frame: Day 387 ] [ Designated as safety issue: No ]
    Seroprotection, Seroconversion rate and GMRs measured 3 weeks after booster dose of vaccine administration


Enrollment: 978
Study Start Date: January 2013
Estimated Study Completion Date: May 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aH5N1c-High Dose Biological: Adjuvanted H5N1 pandemic influenza vaccine
Comparison of two doses of aH5N1c vaccine
Experimental: aH5N1c-Low dose Biological: Adjuvanted H5N1 pandemic influenza vaccine
Comparison of two doses of aH5N1c vaccine

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adult subjects 18 to 64 years of age,
  2. Individuals willing to provide written informed consent,
  3. Individuals in good health,
  4. Individuals willing to allow for their serum samples to be stored beyond the study period.

Exclusion Criteria:

  1. Individuals not able to understand and follow study procedures,
  2. History of any significant illness,
  3. History of any chronic medical condition or progressive disease,
  4. Presence of medically significant cancer,
  5. Known or suspected impairment/alteration of immune function,
  6. Presence of any progressive or severe neurologic disorder,
  7. Presence of any bleeding disorders or conditions that prolongs bleeding time,
  8. History of allergy to vaccine components,
  9. Receipt of any other investigational product within 30 days prior to entry into the study,
  10. History of previous H5N1 vaccination,
  11. Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study,
  12. Receipt of any other vaccine within 2 weeks prior to entry into the study
  13. Body temperature ≥38°C.0 (≥100.4° F) and/or acute illness within 3 days of intended study vaccination,
  14. Pregnant or breast feeding,
  15. Females of childbearing potential refusing to use acceptable method of birth control,
  16. Body mass index (BMI) ≥ 35 kg/m2,
  17. History of drug or alcohol abuse,
  18. Any planned surgery during study period,
  19. Individuals conducting the study and their immediate family members,
  20. Individuals with behavioral or cognitive impairment or psychiatric diseases.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776541

Locations
United States, Florida
1 Miami Research Associates
Miami, Florida, United States, 33143
United States, Missouri
2 Mercy Health Research
St. Louis, Missouri, United States, 63141
3 Saint Louis University
St. Louis, Missouri, United States, 63141
United States, Texas
4 Benchmark Medical Research
Austin, Texas, United States, 78705
Australia, New South Wales
48 Hunter Clinical Research
Newcastle, New South Wales, Australia, 2292
Australia, South Australia
46 CMAX
Adelaide, South Australia, Australia, 5000
Australia, Western Australia
47 Linear Clinical Research
Nedlands, Western Australia, Australia, 6009
Thailand
80 Faculty of Tropical Medicine
Bangkok, Thailand, 1040
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines and Diagnostics Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01776541     History of Changes
Other Study ID Numbers: V89_04
Study First Received: January 20, 2013
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration
Thailand: Food and Drug Administration
Australia: Therapeutic Goods Administration

Keywords provided by Novartis:
Influenza, Pandemic, H5N1, Adults

Additional relevant MeSH terms:
Influenza in Birds
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014