Clinical trial NCT00310804: Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)
Official title: A Phase III, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of Three Lots of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Or of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult Subjects Aged >=18 to <=60
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Flu
Cell-Derived
Egg-Derived
Healthy Adults
Safety
Immunogenicity
Vaccination
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-04-05
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a conventional egg-derived control vaccine licensed in Europe.


Eligibility criteria: Inclusion Criteria:

1. 18 to \<61 years of age
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. in good health as determined by:

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

Exclusion Criteria:

1. unwilling or unable to give written informed consent to participate in the study
2. participation in another clinical trial of an investigational agent within 90 days prior to Visit 1 and throughout the entire study
3. currently experiencing an acute infectious disease
4. any serious disease, such as, for example:

   1. cancer,
   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
5. surgery planned during the study period
6. bleeding diathesis
7. history of hypersensitivity to any component of the study medication or chemically related substances
8. history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine component
9. known or suspected impairment/alteration of immune function, for example resulting from:

   1. receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy),
   2. receipt of immunostimulants,
   3. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study,
   4. high risk for developing an immunocompromising disease
10. history of drug or alcohol abuse
11. laboratory-confirmed influenza disease within 6 months prior to Visit 1
12. receipt of influenza vaccine within 6 months prior to Visit 1
13. receipt of another vaccine within 60 days prior to Visit 1, or planned vaccination within 3 weeks following study vaccination
14. any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever (i.e., axillary temperature ≥ 38 degree C) within 5 days prior to Visit 1
15. if female, pregnant or breastfeeding
16. if female, refusal to use a reliable contraceptive method during the three weeks following vaccination
17. planned relocation abroad during the study period
18. any condition that, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

Primary outcomes:
measure: Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
timeFrame: Day 22 postvaccination
measure: Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
timeFrame: Day 22 postvaccination
measure: Percentage of Subjects With HI Titers ≥40
timeFrame: Day 22 postvaccination
measure: Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine
timeFrame: Day 22 postvaccination
Secondary outcomes:
measure: Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.
timeFrame: Day 1 to Day 7 postvaccination
measure: Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine
timeFrame: Day 1 - Day 181 postvaccination
Other outcomes:
Locations:
city: Panevezys
country: Lithuania
facility: 2nd Department of Internal Diseases, Panevezys Hospital,
city: Vilnius
country: Lithuania
facility: Dept. Infectious Diseases and Microbiology of Vilnius University
Study officials:
affiliation: Novartis Vaccines & Diagnostics
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Ambrozaitis A, Groth N, Bugarini R, Sparacio V, Podda A, Lattanzi M. A novel mammalian cell-culture technique for consistent production of a well-tolerated and immunogenic trivalent subunit influenza vaccine. Vaccine. 2009 Oct 9;27(43):6022-9. doi: 10.1016/j.vaccine.2009.07.083. Epub 2009 Aug 8.