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

Novartis

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: Cell culture derived influenza vaccine; Biological: egg-derived influenza subunit vaccine

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00306527

EUDRACT: 2005-001902-26

V58P4E1

Details and patient eligibility

About

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.

Enrollment: 2,235 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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2,235 participants in 8 patient groups

cTIV\cTIV (adults)

Active Comparator group

Description:

Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.

Treatment:

Biological: Cell culture derived influenza vaccine

cTIV\TIV (adults)

Active Comparator group

Description:

Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.

Treatment:

Biological: egg-derived influenza subunit vaccine

cTIV\cTIV (elderly)

Active Comparator group

Description:

Subjects (≥61 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.

Treatment:

Biological: Cell culture derived influenza vaccine

cTIV\TIV (elderly)

Active Comparator group

Description:

Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.

Treatment:

Biological: egg-derived influenza subunit vaccine

TIV\TIV (adults)

Active Comparator group

Description:

Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.

Treatment:

Biological: egg-derived influenza subunit vaccine

TIV\cTIV (adults)

Active Comparator group

Description:

Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.

Treatment:

Biological: Cell culture derived influenza vaccine

TIV\TIV (elderly)

Active Comparator group

Description:

Subjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.

Treatment:

Biological: egg-derived influenza subunit vaccine

TIV\cTIV (elderly)

Active Comparator group

Description:

Subjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.

Treatment:

Biological: Cell culture derived influenza vaccine