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

Novartis

Status and phase: Completed; Phase 4

Conditions: Vaccine; Seasonal Influenza

Treatments: Biological: Egg-derived influenza vaccine; Biological: Cell-derived influenza vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00560066

V58P14

2007-002872-32

Details and patient eligibility

About

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.

Enrollment: 1,398 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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1,398 participants in 2 patient groups

cTIV

Experimental group

Description:

Subjects received one vaccination of cell culture-derived influenza vaccine

Treatment:

Biological: Cell-derived influenza vaccine

TIV

Active Comparator group

Description:

Subjects received one vaccination of egg-derived influenza vaccine

Treatment:

Biological: Egg-derived influenza vaccine