Safety, Tolerability and Immunogenicity of Two Doses of Adjuvanted Monovalent Influenza Vaccine Administered to Healthy Adult and Elderly Subjects

Novartis

Status and phase: Completed; Phase 3

Conditions: Pandemic Influenza Disease

Treatments: Biological: Placebo (PL); Biological: Adjuvanted trivalent influenza virus vaccine (aTIV); Biological: Adjuvanted monovalent influenza virus vaccine (aH5N1); Biological: Trivalent influenza virus vaccine (TIV)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00841763

2008-003871-32 (EudraCT Number)

V87P13

Details and patient eligibility

About

The present study, phase III, randomized, controlled, observer-blind, multicenter study, will evaluate safety, tolerability and immunogenicity of two doses of an adjuvanted monovalent influenza vaccine compared with an adjuvanted interpandemic trivalent influenza vaccine in a population of healthy adult and elderly subjects.

Enrollment: 3,647 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects 18 years of age and older who were mentally competent and who had signed an informed consent form after having received a detailed explanation of the study protocol;

• In good health as determined by:

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

• Able to understand and comply with all study procedures and to complete study diaries, could be contacted, and were available for study visits;

Exclusion criteria

• Receipt of another investigational agent within 4 weeks;

• Laboratory-confirmed influenza disease within 6 months prior to Visit 1;

• Receipt of influenza vaccination for current season 2008/2009;

• Experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) within the past 7 days;

• Experienced fever (defined as axillary temperature ≥38.0°C) within 7 days prior to Visit 1;

• Pregnant or breastfeeding;

• Females of childbearing potential who were sexually active and had not used or did not plan or refused to use an acceptable method of birth control during the active phase of the study (at least up to three weeks after last vaccine injection);

• Any serious disease, such as: cancer, autoimmune disease (including rheumatoid arthritis); diabetes mellitus type I and type II; diabetes relating to genetic defects/syndromes, diseases of the exocrine pancreas or infections; advanced arteriosclerotic disease; severe chronic obstructive pulmonary disease (COPD), i.e. GOLD stages 3 and 4; acute or progressive hepatic disease and renal disease; congestive heart failure; Body Mass Index (BMI) ≥35 kg/m2 where BMI reflects obesity and not high muscle mass;

• History of progressive or severe neurologic disorders, of any neurological symptoms or signs, or anaphylactic shock following administration of any study vaccine;

• Bleeding diathesis;

• Surgery planned during the study period;

• Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccines;

• Known or suspected impairment/alteration of immune function, for example, resulting from:

  1. receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy) or other immunosuppressive agents within the past 60 days and for the full length of the study;
  2. receipt of immunostimulants;
  3. receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study;
  4. suspected or known HIV infection or HIV-related disease;

• Receipt of non study vaccines (with the exception of post-exposure vaccination in a medical emergency, e.g. hepatitis, rabies, tetanus) within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination;

• History of (or current) drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of study objectives;

• Members of research staff and their relatives;

• 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: Parallel Assignment

Masking: Double Blind

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3,647 participants in 2 patient groups

TIV + aH5N1

Experimental group

Description:

First dose of the non-adjuvanted trivalent influenza virus vaccine (TIV) followed by two doses of the adjuvanted monovalent influenza virus vaccine (aH5N1).

Treatment:

Biological: Adjuvanted monovalent influenza virus vaccine (aH5N1)

Biological: Trivalent influenza virus vaccine (TIV)

PL + aTIV

Active Comparator group

Description:

First dose of placebo (PL-saline) followed by two doses of the adjuvanted trivalent influenza virus vaccine (aTIV).

Treatment:

Biological: Placebo (PL)

Biological: Adjuvanted trivalent influenza virus vaccine (aTIV)