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
  Purpose

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.


Condition Intervention Phase
Seasonal Influenza
Vaccine
Biological: Cell-derived influenza vaccine
Biological: Egg-derived influenza vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 1398
Study Start Date: November 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cTIV
Subjects received one vaccination of cell culture-derived influenza vaccine
Biological: Cell-derived influenza vaccine
1 dose of 0.5 mL in the deltoid region of the non-dominant arm
Active Comparator: TIV
Subjects received one vaccination of egg-derived influenza vaccine
Biological: Egg-derived influenza vaccine
1 dose of 0.5 mL in the deltoid region of the non-dominant arm

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560066

Locations
Germany
Balve, Germany
Duisberg, Germany
Garmisch-Partenkirchen, Germany
Hannover, Germany
Herborn, Germany
Illingen, Germany
Kiel, Germany
Laufach, Germany
Marburg, Germany
Midlum, Germany
Olpe, Germany
Potsdam, Germany
Regensburg, Germany
Unterschleißheim, Germany
Wiesbaden, Germany
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00560066     History of Changes
Other Study ID Numbers: V58P14, 2007-002872-32
Study First Received: November 16, 2007
Results First Received: November 21, 2012
Last Updated: April 17, 2013
Health Authority: Germany: Paul-Ehrlich-Institute

Keywords provided by Novartis:
influenza
vaccine

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

ClinicalTrials.gov processed this record on April 17, 2014