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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 May 2021
• Main ID: NCT00841763
• Date of registration: 10/02/2009
• Prospective Registration: No
• Primary sponsor: Novartis
• Public title: Safety, Tolerability and Immunogenicity of Two Doses of Adjuvanted Monovalent Influenza Vaccine Administered to Healthy Adult and Elderly Subjects
• Scientific title: A Phase III, Randomized, Controlled, Observer-blind, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of a Monovalent A/H5N1 Influenza Vaccine Adjuvanted With MF59 (Fluad-H5N1) in Adult and Elderly Subjects
• Date of first enrolment: October 2008
• Target sample size: 3647
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00841763
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Finland, Germany

Contacts

• Name: Novartis Vaccines
• Affiliation: Novartis Vaccines

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pandemic Influenza Disease

Intervention(s)

Biological: Adjuvanted trivalent influenza virus vaccine (aTIV)

Biological: Placebo (PL)

Biological: Adjuvanted monovalent influenza virus vaccine (aH5N1)

Biological: Trivalent influenza virus vaccine (TIV)

Primary Outcome(s)

Number of Subjects Exposed to Adjuvanted Pandemic Influenza Vaccine. [Time Frame: Upto Day 224 post vaccination]

Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. [Time Frame: Up to 6 days after each vaccination.]

Secondary Outcome(s)

Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. [Time Frame: Day 43/Day 22, Day 64/Day 22]

Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. [Time Frame: Day 22, Day 43, Day 64]

The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. [Time Frame: Up to 6 days after each vaccination.]

Percentages of Subjects With HI = 40 and GMAs = 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. [Time Frame: Day 22, Day 43 and Day 64]

GMAs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. [Time Frame: Day 22, Day 43 and Day 64]

GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. [Time Frame: Day 22, Day 43 and Day 64]

Percentages of Subjects With HI Titers = 40 and GMAs = 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. [Time Frame: Day 22, Day 43 and Day 64]

Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Homologous Strains. [Time Frame: Day 43/Day 22 and Day 64/Day 22]

Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. [Time Frame: Day 43/Day 22 and Day 64/Day 22)]

GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. [Time Frame: Day 43/Day 22 and Day 64/Day 22]

Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. [Time Frame: Day 43/Day 22 and Day 64/Day 22]

Number of Subjects Reporting Unsolicited AEs After Vaccination. [Time Frame: Day 1 through Day 224 post vaccination]

Percentages of Subjects With MN Titers =20, =40, =80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. [Time Frame: Day 22, Day 43 and Day 64]

Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Heterologous Strains. [Time Frame: Day 43/Day 22 and Day 64/Day 22]

Geometric Mean Areas (GMAs) After Two Doses of the Adjuvanted Pandemic Vaccine (aH5N1). [Time Frame: Day 22, Day 43, Day 64]

Percentages of Subjects With MN Titers =20, =40, =80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. [Time Frame: Day 22, Day 43 and Day 64]

Secondary ID(s)

V87P13

2008-003871-32

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis Vaccines

Results

• Results available: Yes
• Date Posted: 18/01/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00841763