Safety and Immunogenicity of a Cell Culture-derived Influenza Vaccine in Healthy Adults and Elderly

Condition(s) targeted: Influenza

Intervention: Cell culture-derived trivalent subunit influenza vaccine (cTIV) (Biological); Egg-derived trivalent subunit influenza vaccine (TIV) (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Vaccines

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

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.

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

Primary outcome:

Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines

Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV

Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV

Secondary outcome: Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination

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

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 plans 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 is acceptable) or experienced fever ≥ 38°C within the past 3 days 13. pregnant women or women who refuse to use a reliable contraceptive method throughout the study (180 days) 14. any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Centrum Farmakologii Klinicznej, Krakow 30-969, Poland

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

N ZOZ Jagiellonskie, Centrum Medyczne Sp. z o.o., os. Jagiellonskie 1, Kraków 31-832, Poland

Praktyka Grupowa Lekarzy POZ "Familia", Pl. Sikorskiego 6a, Kraków 31-115, Poland

Szpital Jana Pawła II, ul. Pradnicka 80, Kraków 31-202, Poland

Starting date: September 2004
Last updated: January 18, 2013