Clinical trial NCT00560066: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Influenza
Vaccine
Keywords: influenza
vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-11-19
Enrollment: 1398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV
timeFrame: From Day 1 up to and including Day 7 post-vaccination
Secondary outcomes:
measure: Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV
timeFrame: From Day 1 through Day 7 post-vaccination
measure: Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV
timeFrame: From Day 1 through Day 7 post-vaccination
measure: Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV
timeFrame: Before vaccination (Day 1) and three weeks after vaccination (Day 22)
measure: Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV
timeFrame: Three weeks post-vaccination (Day 22)
measure: Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV
timeFrame: Before vaccination (Day 1) and three weeks after vaccination (Day 22)
measure: Geometric Mean Ratio of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV
timeFrame: Three weeks post-vaccination (Day 22)
Other outcomes:
Locations:
city: Balve
country: Germany
city: Duisberg
country: Germany
city: Garmisch-Partenkirchen
country: Germany
city: Hannover
country: Germany
city: Herborn
country: Germany
city: Illingen
country: Germany
city: Kiel
country: Germany
city: Laufach
country: Germany
city: Marburg
country: Germany
city: Midlum
country: Germany
city: Olpe
country: Germany
city: Potsdam
country: Germany
city: Regensburg
country: Germany
city: Unterschleißheim
country: Germany
city: Wiesbaden
country: Germany
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References: