Clinical trial NCT00492063: Safety and Immunogenicity of a Cell Culture-derived Influenza Vaccine in Healthy Adults and Elderly
Official title: A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture and of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: safety
immunogenicity
non-inferiority
MDCK
cell culture-derived
subunit influenza vaccine
influenza prevention
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-06-27
Enrollment: 2654
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study aims to evaluate the safety and immunogenicity of the new influenza subunit vaccine produced in Madin Darby Canine Kidney (MDCK) cells in healthy adult and elderly subjects.


Eligibility criteria: Inclusion Criteria:

1. 18 to 60 years of age (first age group) OR over 60 years of age (second age group)
2. mentally competent to understand the nature, the scope and the consequences of the study
3. able and willing to give written informed consent prior to study entry
4. available for all the visits scheduled in the study
5. residence in the study area
6. in good health as determined by:

   1. medical history,
   2. physical examination,
   3. clinical judgment of the investigator.

Exclusion Criteria:

1. unable or unwilling to give written informed consent to participate in the study
2. suffering from an acute infectious disease
3. any serious disease such as:

   1. cancer (except for benign or localized skin cancer and non metastatic prostate cancer not currently treated with chemotherapy),_
   2. autoimmune disease (including rheumatoid arthritis),
   3. advanced arteriosclerotic disease or complicated diabetes mellitus,
   4. chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,
   5. acute or progressive hepatic disease,
   6. acute or progressive renal disease,
   7. congestive heart failure
4. surgery planned during the study period
5. bleeding diathesis
6. history of hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
7. known or suspected impairment/alteration of immune function resulting from:

   1. receipt of immunosuppressive therapy (any cortical steroid or cancer chemotherapy),
   2. receipt of immunostimulants,
   3. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,
   4. high risk for developing an immunocompromising disease within the past 6 months
8. history of drug or alcohol abuse
9. laboratory confirmed influenza disease in the past 6 months
10. received influenza vaccine within the past 6 months
11. received another vaccine or any investigational agent within the past 60 days, or planned vaccination within 3 weeks following the study vaccination
12. any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) or experienced fever ≥ 38°C within the past 3 days
13. pregnant women or women who refused to use a reliable contraceptive method throughout the study (180 days)
14. any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.

Primary outcomes:
measure: Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines
timeFrame: Before vaccination (day 1) and three weeks after vaccination (day 22)
measure: Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV
timeFrame: Three weeks after vaccination (day 22)
measure: Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV
timeFrame: Three weeks after vaccination (day 22)
Secondary outcomes:
measure: Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
timeFrame: Up to 7 days postvaccination
Other outcomes:
Locations:
city: ul. Langiewicza 2
country: Poland
facility: Wojewódzki Szpital Dzieciecy
state: Kielce
city: os. Jagiellonskie 1
country: Poland
facility: N ZOZ Jagiellonskie, Centrum Medyczne Sp. z o.o.
state: Kraków
city: Pl. Sikorskiego 6a
country: Poland
facility: Praktyka Grupowa Lekarzy POZ "Familia"
state: Kraków
city: ul. Pradnicka 80
country: Poland
facility: Szpital Jana Pawła II
state: Kraków
city: Krakow
country: Poland
facility: Centrum Farmakologii Klinicznej
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Szymczakiewicz-Multanowska A, Groth N, Bugarini R, Lattanzi M, Casula D, Hilbert A, Tsai T, Podda A. Safety and immunogenicity of a novel influenza subunit vaccine produced in mammalian cell culture. J Infect Dis. 2009 Sep 15;200(6):841-8. doi: 10.1086/605505.