Clinical trial NCT00306527: Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and Elderly
Official title: A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity (in a Subset) Following a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects Who Received Either One or the Other Vaccine One Year Before in the V58P4 Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
adult/elderly
flu cell culture
vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines and Diagnostics S.r.l.
First posted: 2006-03-24
Enrollment: 2235
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: The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine one year before (2004) in the study V58P4.


Eligibility criteria: Inclusion Criteria:

1. 18 to \< 61 years of age (first age group) OR 61 years of age and older (second age group) at enrolment in V58P4
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. in good health as determined by:

   1. Medical history related to the previous six months,
   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. Currently experiencing an acute infectious disease
3. Any serious disease such as, for example:

   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
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 expect to receive another vaccine within 3 weeks following the study vaccination
12. Participation in another clinical trial within 90 days prior to enrollment and throughout the full length of the study
13. Any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever _ 38°C within the past 5 days
14. Pregnant/ breast feeding women or women who refuse to use a reliable contraceptive method during the first three weeks after vaccination
15. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Primary 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
Secondary outcomes:
measure: Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine
timeFrame: Up to 6 months postvaccination
measure: Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects
timeFrame: Day 22 postvaccination
measure: Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects
timeFrame: Day 22 postvaccination
measure: Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine.
timeFrame: Day 22 postvaccination
measure: Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.
timeFrame: Day 22 postvaccination
Other outcomes:
Locations:
city: Ul. Langiewicza 2
country: Poland
facility: Wojewódzki Szpital Dzieci_cy
state: Kielce
city: Ul. Ujastek 3
country: Poland
facility: Centrum Bada_ Farmakologii Klinicznej
state: Krakow
city: Centrum Medyczne Sp. Z O.o., O_. Jagiello_skie 1
country: Poland
facility: NZOZ Jagiello_skie
state: Kraków
city: Pl. Sikorskiego 6a
country: Poland
facility: NZOZ Praktyka Grupowa Lekarzy Rodzinnych, "Familia" Sp. z o.o.
state: Kraków
city: Ul. Pr_dnicka 80
country: Poland
facility: Szpital Jana Pawła II, Oddz. Neuroinfekcji
state: Kraków
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines and Diagnostics
role: STUDY_CHAIR
References:
citation: Szymczakiewicz-Multanowska A, Lattanzi M, Izu A, Casula D, Sparacio M, Kovacs C, Groth N. Safety assessment and immunogenicity of a cell-culture-derived influenza vaccine in adults and elderly subjects over three successive influenza seasons. Hum Vaccin Immunother. 2012 May;8(5):645-52. doi: 10.4161/hv.19493. Epub 2012 May 1.