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

NCT00841763 | Completed Phase 3 Results

• 2 other identifiers: V87P132008-003871-32
• Study Type: interventional
• Target: 3,647
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Pandemic Influenza Disease

Keywords

virus; pandemic influenza; vaccine

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.

  To assess the safety and tolerability profile of two doses of the MF59-adjuvanted A/Vietnam/1194/2004 pandemic influenza vaccine (aH5N1), each containing 7.5 μg of H5N1 antigen in terms of the number of participants who reported local and systemic reactions up to 6 days after each vaccination per vaccination group.

  Up to 6 days after each vaccination.

• Number of Subjects Exposed to Adjuvanted Pandemic Influenza Vaccine.

  To report safety data from a large enough number of subjects exposed to adjuvanted pandemic influenza vaccine aH5N1 capable of detecting rare adverse events (AEs), i.e. events occurring at a frequency of \<=0.1%, \& uncommon AEs in elderly, i.e. occurring at a frequency of \<=1% of subjects.

  Upto Day 224 post vaccination

Secondary Outcomes (16)

• 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.

  Up to 6 days after each vaccination.

• Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.

  Day 22, Day 43, Day 64

• Geometric Mean Areas (GMAs) After Two Doses of the Adjuvanted Pandemic Vaccine (aH5N1).

  Day 22, Day 43, Day 64

• Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.

  Day 43/Day 22, Day 64/Day 22

• 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.

  Day 22, Day 43 and Day 64

Study Arms (2)

TIV + aH5N1

EXPERIMENTAL

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

Biological: Trivalent influenza virus vaccine (TIV); Biological: Adjuvanted monovalent influenza virus vaccine (aH5N1)

PL + aTIV

ACTIVE COMPARATOR

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

Biological: Placebo (PL); Biological: Adjuvanted trivalent influenza virus vaccine (aTIV)

Interventions

Placebo (PL) BIOLOGICAL

One dose of 0.5 ml IM injection of isotonic saline solution was administered in the deltoid muscle, preferably of the non-dominant arm.

PL + aTIV

Trivalent influenza virus vaccine (TIV) BIOLOGICAL

A single IM injection of a 0.5 ml dose of non-adjuvanted trivalent influenza virus vaccine administered in the deltoid muscle, preferably of the non-dominant arm.

TIV + aH5N1

Adjuvanted monovalent influenza virus vaccine (aH5N1) BIOLOGICAL

Two intramuscular (IM) injections of a 0.5 ml dose administered three weeks apart in the deltoid muscle.

TIV + aH5N1

Adjuvanted trivalent influenza virus vaccine (aTIV) BIOLOGICAL

Two IM injections of a 0.5 ml dose of adjuvanted trivalent influenza virus vaccine administered three weeks apart, in the deltoid muscle.

PL + aTIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• medical history,
• physical examination,
• 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;

You may not qualify if:

• 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:
• 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;
• receipt of immunostimulants;

Sponsors & Collaborators

• Novartis: lead
• Novartis Vaccines: collaborator

Study Sites (2)

Tampere Vaccine Research Clinic (15 sites)

Tampere, 33100, Finland

Location

12 Sites

München, 80799, Germany

Location

Related Publications (1)

• Vesikari T, Forsten A, Herbinger KH, Cioppa GD, Beygo J, Borkowski A, Groth N, Bennati M, von Sonnenburg F. Safety and immunogenicity of an MF59((R))-adjuvanted A/H5N1 pre-pandemic influenza vaccine in adults and the elderly. Vaccine. 2012 Feb 8;30(7):1388-96. doi: 10.1016/j.vaccine.2011.12.009. Epub 2011 Dec 20.

  PMID: 22192847 RESULT

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2009
• First Posted: February 11, 2009
• Study Start: October 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 23, 2021
• Results First Posted: January 18, 2013

Record last verified: 2019-08

Locations

FI (1); DE (1)