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

NCT ID: NCT00560066

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1398 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-07-31

Brief Summary

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.

Conditions

Seasonal Influenza; Vaccine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

cTIV

Subjects received one vaccination of cell culture-derived influenza vaccine

Group Type: EXPERIMENTAL

Cell-derived influenza vaccine

Intervention Type: BIOLOGICAL

1 dose of 0.5 mL in the deltoid region of the non-dominant arm

TIV

Subjects received one vaccination of egg-derived influenza vaccine

Group Type: ACTIVE_COMPARATOR

Egg-derived influenza vaccine

Intervention Type: BIOLOGICAL

1 dose of 0.5 mL in the deltoid region of the non-dominant arm

Interventions

Cell-derived influenza vaccine

1 dose of 0.5 mL in the deltoid region of the non-dominant arm

Intervention Type: BIOLOGICAL

Egg-derived influenza vaccine

1 dose of 0.5 mL in the deltoid region of the non-dominant arm

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

Balve, , Germany

Duisberg, , Germany

Garmisch-Partenkirchen, , Germany

Hanover, , Germany

Herborn, , Germany

Illingen, , Germany

Kiel, , Germany

Laufach, , Germany

Marburg, , Germany

Midlum, , Germany

Olpe, , Germany

Potsdam, , Germany

Regensburg, , Germany

Unterschleissheim, , Germany

Wiesbaden, , Germany

Countries

Germany

Other Identifiers

2007-002872-32

Identifier Type: -

Identifier Source: secondary_id

V58P14

Identifier Type: -

Identifier Source: org_study_id