Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and Elderly

Condition(s) targeted: Influenza

Intervention: Cell culture derived influenza vaccine (Biological); egg-derived influenza subunit vaccine (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Vaccines

Official(s) and/or principal investigator(s):
Novartis Vaccines and Diagnostics, Study Chair, Affiliation: Novartis Vaccines

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.

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome: Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine

Secondary outcome:

Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine

Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects

Geometric Mean Ratios, After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects

Percentages of Adult and Elderly Subjects Achieving HI Titers ≥40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine.

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 enrolment 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.

Wojewódzki Szpital Dzieci_cy, ul. Langiewicza 2, Kielce 25-381, Poland

Centrum Bada_ Farmakologii Klinicznej, ul. Ujastek 3, Krakow 30-969, Poland

NZOZ Jagiello_skie, Centrum Medyczne Sp. z o.o., o_. Jagiello_skie 1, Kraków 31-832, Poland

NZOZ Praktyka Grupowa Lekarzy Rodzinnych, "Familia" Sp. z o.o., Pl. Sikorskiego 6a, Kraków 31-115, Poland

Szpital Jana Pawła II, Oddz. Neuroinfekcji, ul. Pr_dnicka 80, Kraków 31-202, Poland

Starting date: September 2005
Last updated: April 1, 2014