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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:
ClinicalTrials.gov Identifier:
NCT00560066
First Posted: November 19, 2007
Last Update Posted: February 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
  Purpose
Evaluation of the safety of Trivalent Subunit Influenza Vaccine Produced either in Mammalian Cell Culture or in embryonated Hen Eggs 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
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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 (Optaflu®) or in Embryonated Hen Eggs (Agrippal®) 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 ( Novartis Vaccines ):

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 up to and including Day 7 post-vaccination ]
    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 post-vaccination.


Secondary Outcome Measures:
  • Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV [ Time Frame: From Day 1 through Day 7 post-vaccination ]
    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 post-vaccination ]
    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 Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV [ Time Frame: Before vaccination (Day 1) and three weeks after vaccination (Day 22) ]
    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 Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV [ Time Frame: Three weeks post-vaccination (Day 22) ]
    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) ]
    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 post-vaccination (Day 22) ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00560066     History of Changes
Other Study ID Numbers: V58P14
2007-002872-32
First Submitted: November 16, 2007
First Posted: November 19, 2007
Results First Submitted: November 21, 2012
Results First Posted: April 18, 2013
Last Update Posted: February 17, 2016
Last Verified: January 2016

Keywords provided by Novartis ( Novartis Vaccines ):
influenza
vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs