Safety, Reactogenicity and Immunogenicity of an H5N1 VLP

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novavax
ClinicalTrials.gov Identifier:
NCT00519389
First received: August 20, 2007
Last updated: June 12, 2013
Last verified: March 2012

August 20, 2007
June 12, 2013
July 2007
November 2008   (final data collection date for primary outcome measure)
Safety and reactogenicity of H5N1 VLP Vaccine [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Safety and reactogenicity of H5N1 VLP Vaccine
Complete list of historical versions of study NCT00519389 on ClinicalTrials.gov Archive Site
Immunogenicity of H5N1 VLP Influenza vaccine [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Immunogenicity of H5N1 VLP Influenza vaccine
Not Provided
Not Provided
 
Safety, Reactogenicity and Immunogenicity of an H5N1 VLP
A Phase I/IIa Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of an H5N1 Virus-Like Particle (VLP) Influenza Vaccine (Recombinant)

This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or placebo in healthy adults 18 to 40 years of age.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Pandemic Influenza
  • Biological: H5N1 VLP Vaccine
    Two doses - Day 0 & Day 28
  • Biological: Placebo
    Two doses - Day 0 & Day 28
  • Experimental: Low dose H5N1 VLP Vaccine
    Intervention: Biological: H5N1 VLP Vaccine
  • Experimental: Mid dose H5N1 VLP Vaccine
    Intervention: Biological: H5N1 VLP Vaccine
  • Experimental: High dose H5N1 VLP Vaccine
    Intervention: Biological: H5N1 VLP Vaccine
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
230
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female 18 to 40 years of age at the time of the vaccination.
  2. Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visits and completion of the data collection tool).
  3. Available by telephone.
  4. Free of obvious health problems as established by medical history and clinical examination before entering the study.
  5. If subject is of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception) for 30 days prior to vaccination. She must also have a negative pregnancy test at study entry and must agree to continue such precautions for two months after completion of vaccination.
  6. Must provide written, informed consent.

Exclusion Criteria:

  1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
  2. Has received any other licensed vaccines within 4 weeks prior to enrollment in this study.
  3. Has received any influenza vaccine within the prior 12 month period.
  4. Has received any investigational vaccine designed for protection against avian influenza.
  5. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. The use of inhaled and nasal steroids will be permitted.
  6. Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
  7. Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
  8. Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever ≥ 100.5º F.
  9. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  10. Major congenital defects or serious chronic illness.
  11. History of any neurological disorders or seizures, with the exception of febrile seizures during childhood.
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00519389
H5N1 VLP-1
Yes
Novavax
Novavax
Not Provided
Principal Investigator: George Atiee, M.D. Healthcare Discoveries, Inc.
Novavax
March 2012

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