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Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT00630331
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : January 16, 2013
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Tracking Information
First Submitted Date  ICMJE February 28, 2008
First Posted Date  ICMJE March 7, 2008
Results First Submitted Date  ICMJE November 21, 2012
Results First Posted Date  ICMJE January 16, 2013
Last Update Posted Date August 14, 2019
Study Start Date  ICMJE October 2007
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2013)
Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains [ Time Frame: 6 Months ]
The vaccine efficacy of CCI and IVV vaccines was estimated relative to Placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza illness caused by each of three vaccine-like virus strains.
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
Protection of a cell-derived influenza vaccine or of an egg-derived influenza vaccine compared to placebo against illness caused by virus-confirmed community-acquired influenza wild type strains antigenically similar to those contained in the vaccines [ Time Frame: 6 Months ]
Change History Complete list of historical versions of study NCT00630331 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2013)
  • Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains [ Time Frame: 6 Months ]
    The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza A or B illness caused by non-vaccine-like strains.
  • Number of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains [ Time Frame: 6 Months ]
    The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo as the number of subjected prevented against virus-confirmed symptomatic influenza A or B illness caused by vaccine-like and non-vaccine-like strains.
  • Influenza-Associated Days in Bed, All Subjects [ Time Frame: 6 Months ]
    The number of subjects in this analysis included all subjects in the per protocol efficacy population.
  • Influenza-Associated Days in Bed, Subset of Subjects With Virus-Confirmed- Influenza [ Time Frame: 6 Months ]
    The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.
  • Number Of Medical Visits (Inpatient and Outpatient) Due to Influenza Illness or Symptoms of Influenza, All Subjects [ Time Frame: 6 Months ]
    The number of subjects in this analysis included all subjects in the per protocol efficacy population.
  • Number of Medical Visits (Inpatient and Outpatient), Subset of Subjects With Virus-Confirmed-Influenza [ Time Frame: 6 Months ]
    The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.
  • Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost Due to Influenza Disease, All Subjects [ Time Frame: 6 Months ]
    The number of subjects in this analysis included all subjects in the per protocol efficacy population.
  • Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost, Subset of Subjects With Virus-Confirmed-Influenza [ Time Frame: 6 Months ]
    The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.
  • Percentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo [ Time Frame: Before vaccination (day 1) and three weeks after vaccination (day 22) ]
    Immunogenicity was measured as the percentage of subjects achieving HI titers ≥40 at baseline (day 1) and three weeks after (day 22) one vaccination of either cell-culture or egg-derived vaccine or placebo for each of the three influenza vaccine strains (A/H1N1, A/H3N2 and B), evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to US (CBER) guideline if the lower limit of the two-sided 95% CI for the percentage of subjects achieving HI titers ≥40 is ≥70%.
  • Percentages of Subjects Achieving Seroconversion After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo [ Time Frame: Three weeks after vaccination (day 22) ]
    As per the CBER guideline, seroconversion is defined as the percentage of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody titer at day 22 met exceeded 40%.
  • Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination [ Time Frame: Up to 7 days post vaccination ]
    The solicited local and systemic reactogenicity were collected up to 7 days after vaccination for all three vaccine groups.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
  • Protection against illness caused by all virus-confirmed community-acquired influenza wild type strains regardless of antigenic match to those contained in the vaccines [ Time Frame: 6 month ]
  • Collection of local and systemic reactions as well as all AEs and collection of all SAEs. [ Time Frame: 6 Months ]
  • Seroprotection and by percentage of subjects achieving seroconversion [ Time Frame: 6 Months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects
Official Title  ICMJE A Phase III, Randomized, Observer-Blind, Placebo-Controlled, Multicenter Study to Assess Clinical Efficacy of a Cell-Derived Subunit Influenza Vaccine and an Egg-Derived Subunit Influenza Vaccine in the 2007-2008 Influenza Season in Healthy Adult Subjects
Brief Summary The present study will evaluate clinical efficacy, safety, tolerability and immunogenicity of both Novartis Vaccines' cell-derived influenza vaccine and egg-derived influenza vaccine in healthy adults 18 to 49 years of age.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: Cell culture-derived influenza vaccine
    One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle.
  • Biological: Egg-derived influenza virus vaccine
    One dose (0.5 mL) of the trivalent egg-derived influenza virus vaccine, administered in the deltoid muscle.
  • Biological: Placebo
    One dose (0.5 mL) of phosphate buffered solution.
Study Arms  ICMJE
  • Experimental: CCI
    Subjects received one dose of cell culture-derived influenza vaccine.
    Intervention: Biological: Cell culture-derived influenza vaccine
  • Experimental: IVV
    Subjects received one dose of the trivalent egg-derived influenza vaccine.
    Intervention: Biological: Egg-derived influenza virus vaccine
  • Placebo Comparator: Placebo
    Subjects received one dose of phosphate buffered solution (PBS).
    Intervention: Biological: Placebo
Publications * Frey S, Vesikari T, Szymczakiewicz-Multanowska A, Lattanzi M, Izu A, Groth N, Holmes S. Clinical efficacy of cell culture–derived and egg‐derived inactivated subunit influenza vaccines in healthy adults. Clin Infect Dis. 2010 Nov 1;51(9):997-1004. doi: 10.1086/656578.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2011)
11404
Original Estimated Enrollment  ICMJE
 (submitted: March 6, 2008)
11700
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. subjects 18 to 49 years of age;
  2. in good health as determined by medical history and physical examination;
  3. able and willing to provide written informed consent prior to any study procedure;
  4. able to comply with all study procedures, including availability and willingness to be actively followed throughout the ensuing influenza season with weekly telephone calls and to comply with the need for prompt collection of nasal and throat specimens in the event of influenza symptoms.

Exclusion Criteria:

  1. history of anaphylaxis or serious reaction after administration of any vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, kanamycin, or any other vaccine component, chemically related substance, or component of the potential packaging materials;
  2. any health condition for which the inactivated vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP) including chronic diseases of the pulmonary or cardiovascular systems (including asthma), chronic metabolic diseases (including diabetes), renal dysfunction, hemoglobinopathies, immune deficiency disease (including HIV infection) or on-going immunosuppressive therapy;
  3. employment in professions prone to influenza transmission to or from high-risk populations (this exclusion specifically includes nurses, physicians, all other healthcare workers with direct patient contact; and police, fire, and rescue personnel); or living in the same household as an immunocompromised person;
  4. history of Guillain-Barré syndrome;
  5. bleeding diathesis;
  6. receipt of another investigational agent within 90 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and unwilling to refuse participation in another clinical study through the end of the study;
  7. receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1;
  8. laboratory-confirmed influenza disease within 6 months prior to Visit 1;
  9. receipt of an influenza vaccine within 6 months prior to Visit 1 or plans to receive influenza vaccine outside of this study;
  10. experienced a temperature (≥100.0°F / ≥37.8°C) and/or any acute illness within 3 days prior to study vaccination;
  11. pregnant or breast-feeding female;
  12. if female of childbearing potential and sexually active, has not used any of the birth control methods detailed in the section entitled "Females of Childbearing Potential" for at least 2 months prior to study entry;
  13. if female of childbearing potential and sexually active, refusal to use a reliable contraceptive method as detailed in the section entitled "Females of Childbearing Potential" during the first 3 weeks after vaccination;
  14. research staff directly involved with the clinical study or family members or household members of research staff. Research staff are individuals with direct or indirect contact with study subjects, or study site personnel who have access to any study documents containing subject information. This would include receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians, etc.;
  15. any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or with the safety of the study subject.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00630331
Other Study ID Numbers  ICMJE V58P13
2007-002871-15
11580
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Vaccines )
Study Sponsor  ICMJE Novartis Vaccines
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Novartis Vaccines Novartis Vaccines
PRS Account Novartis
Verification Date August 2019

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