Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00560066
First received: November 16, 2007
Last updated: April 17, 2013
Last verified: April 2013

November 16, 2007
April 17, 2013
November 2007
July 2008   (final data collection date for primary outcome measure)
Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV [ Time Frame: From day 1 upto and including day 7 postvaccination ] [ Designated as safety issue: Yes ]
Safety was assessed as the number of all subjects who reported at least one sign of reactogenicity after one vaccination of egg-derived (TIV) or cell culture-derived (cTIV) influenza virus vaccine from day 1 through day 7 postvaccination.
To compare the safety of a single intramuscular (IM) dose of the cell-derived influenza subunit vaccine with that of the egg-derived influenza subunit vaccine in adult and elderly subjects with and without underlying conditions. [ Time Frame: 21 days ]
Complete list of historical versions of study NCT00560066 on ClinicalTrials.gov Archive Site
  • Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV [ Time Frame: From day 1 through day 7 postvaccination ] [ Designated as safety issue: Yes ]
    Analysis was performed on a subset of safety population which included the healthy adults (≥18 to ≤60 years) and elderly (≥61 years).
  • Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV [ Time Frame: From day 1 through day 7 postvaccination ] [ Designated as safety issue: Yes ]
    Analysis was performed on a subset of safety population which included the adults (≥18 to ≤60 years) and elderly (≥61 years) with underlying medical conditions.
  • Percentages Of Subjects With Underlying Medical Conditions Who Achieved HI Titer ≥40 After One Vaccination of TIV or cTIV [ Time Frame: Before vaccination (day 1) and three weeks after vaccination (day 22) ] [ Designated as safety issue: No ]
    Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (day 1) and three weeks (day 22) after one vaccination of TIV or cTIV for each of three vaccine strains, evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% (≥18 to ≤60 years), or >60% (≥61 years).
  • Percentages Of Subjects With Underlying Medical Conditions Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV [ Time Frame: Three weeks after vaccination (day 22) ] [ Designated as safety issue: No ]
    Seroconversion or significant increase in HI titer as per CHMP criteria for each of the three strains is defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion/significant increase should be >40% (≥18 to ≤60 years) or >30% (≥61 years).
  • Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV [ Time Frame: Before vaccination (day 1) and three weeks after vaccination (day 22) ] [ Designated as safety issue: No ]
    Immunogenicity was measured as HI geometric mean titers (GMTs) of subjects with underlying conditions, directed against each of three vaccine strains at baseline (day 1) and three weeks after vaccination (day 22) in adults (≥18 to ≤60 years) and elderly (≥61 years).
  • Geometric Mean Ratio of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV [ Time Frame: Three weeks after vaccination (day 22) ] [ Designated as safety issue: No ]
    Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI GMTs for each of the three strains, three weeks after one vaccination (day 22) of TIV or cTIV. CHMP criteria is considered fulfilled for each of the three strains if the geometric mean increase GMR (day 22/day 1) in HI antibody titer is >2.5 (≥18 to ≤60 years) or >2.0 (≥61 Years).
To evaluate the immunogenicity of both vaccines for each influenza vaccine strain, as measured by hemagglutination inhibition (HI) test 21 days after vaccination in a subset of adult and elderly subjects with underlying medical conditions. [ Time Frame: 21 days ]
Not Provided
Not Provided
 
Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions
A Phase IV, Multi-Center, Active-Controlled, Observer-Blind Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and to Evaluate the Immunogenicity in a Subset of Subjects With Underlying Medical Conditions

Evaluation of the safety of Trivalent Subunit Influenza Vaccine Produced either in Mammalian Cell Culture in subjects 18 years of age and above with and without underlying medical conditions and evaluation of the immunogenicity in a subset of subjects with underlying medical conditions, compared to an egg-based vaccine in a post marketing setting.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Seasonal Influenza
  • Vaccine
  • Biological: Cell-derived influenza vaccine
    1 dose of 0.5 mL in the deltoid region of the non-dominant arm
  • Biological: Egg-derived influenza vaccine
    1 dose of 0.5 mL in the deltoid region of the non-dominant arm
  • Experimental: cTIV
    Subjects received one vaccination of cell culture-derived influenza vaccine
    Intervention: Biological: Cell-derived influenza vaccine
  • Active Comparator: TIV
    Subjects received one vaccination of egg-derived influenza vaccine
    Intervention: Biological: Egg-derived influenza vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1398
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subjects 18 years of age and above, mentally competent, willing and able to give informed consent prior to study entry;
  2. Able to comply with all study procedures and requirements.

Exclusion Criteria:

  1. History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any vaccine component;
  2. Fatal prognosis of an underlying medical condition (<12 months life expectancy);
  3. History of Guillain-Barre syndrome;
  4. Bleeding diathesis or receiving anticoagulants of the coumarin type;
  5. Hospitalization or residence in a nursing care facility;
  6. Planned to receive seasonal influenza vaccine outside of this study;
  7. Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study;
  8. Fever (defined as axillary temperature ≥38.0°C) or any acute illness within 3 days prior to study vaccination;
  9. Receipt of another investigational agent within 30 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 safety follow up period of the study;
  10. Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives;
  11. Females who were pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who were sexually active and had not used or did not plan to use acceptable birth control measures during the first 3 weeks after vaccination. Oral, injected or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device were considered acceptable forms of birth control.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00560066
V58P14, 2007-002872-32
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
April 2013

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