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

January 20, 2013
December 3, 2013
January 2013
June 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01776541 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Adults
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.

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Pandemic H5N1 Influenza
Biological: Adjuvanted H5N1 pandemic influenza vaccine
Comparison of two doses of aH5N1c vaccine
  • Experimental: aH5N1c-High Dose
    Intervention: Biological: Adjuvanted H5N1 pandemic influenza vaccine
  • Experimental: aH5N1c-Low dose
    Intervention: Biological: Adjuvanted H5N1 pandemic influenza vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
978
May 2014
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Thailand
 
NCT01776541
V89_04
No
Novartis ( Novartis Vaccines )
Novartis Vaccines
Department of Health and Human Services
Study Chair: Novartis Vaccines and Diagnostics Novartis Vaccines
Novartis
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP