Dose Ranging Study to Evaluate Immunogenicity and Safety of Adjuvanted or Non-adjuvanted Cell Culture-derived H5N1 Influenza Vaccine in Young Adults (18-40 Years Old)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00812019
First received: December 18, 2008
Last updated: October 10, 2011
Last verified: October 2011
  Purpose

The aim of the present dose ranging study is to evaluate the safety, tolerability and immunogenicity of two doses of twelve different formulations of a Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine, adjuvanted with MF59 or non-adjuvanted, given three weeks apart and followed by a booster dose after 12 months in healthy adults 18 to 40 years of age.


Condition Intervention Phase
Influenza
Biological: FCC H5N1 3,75 µg
Biological: FCC H5N1 7,5 µg
Biological: FCC H5N1 15 µg
Biological: FCC H5N1 3,75 µg + 25% MF59
Biological: FCC H5N1 7,5 µg + 25% MF59
Biological: FCC H5N1 15 µg + 25% MF59
Biological: FCC H5N1 3,75 µg + 50% MF59
Biological: FCC H5N1 7,5 µg + 50% MF59
Biological: FCC H5N1 15 µg + 50% MF59
Biological: FCC H5N1 3,75 µg + 100% MF59
Biological: FCC H5N1 7,5 µg + 100% MF59
Biological: FCC H5N1 15 µg + 100% MF59
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Phase I/II, Randomized, Observer-blind, Multicenter, Dose Ranging Study to Evaluate the Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted or Non-Adjuvanted Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine in Healthy Subjects 18 - 40 Years of Age.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • immunogenicity, safety and reactogenicity of cell culture-derived H5N1 subunit influenza virus vaccines containing different amounts of antigen and adjuvant. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • identification of the optimal adjuvant-antigen dose combination considering antibody titers against the H5N1 strain observed three weeks after two intramuscular doses. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • immunogenicity against heterologous strains of a cell culture-derived H5N1 subunit influenza virus vaccine containing different amounts of antigen and adjuvant. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 753
Study Start Date: November 2008
Study Completion Date: November 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: FCC H5N1 3,75 µg
2 doses of Cell Culture-Derived H5N1 3,75 µg Subunit Influenza Vaccine
Experimental: 2 Biological: FCC H5N1 7,5 µg
2 doses of Cell Culture-Derived H5N1 7,5 µg Subunit Influenza Vaccine
Experimental: 3 Biological: FCC H5N1 15 µg
2 doses of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine
Experimental: 4 Biological: FCC H5N1 3,75 µg + 25% MF59
2 doses of Cell Culture-Derived H5N1 3,75 µg Subunit Influenza Vaccine containing 25% of MF59
Experimental: 5 Biological: FCC H5N1 7,5 µg + 25% MF59
2 doses of Cell Culture-Derived H5N1 7,5 µg Subunit Influenza Vaccine containing 25% of MF59
Experimental: 6 Biological: FCC H5N1 15 µg + 25% MF59
2 doses of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 25% of MF59
Experimental: 7 Biological: FCC H5N1 3,75 µg + 50% MF59
2 doses of Cell Culture-Derived H5N1 3,75 µg Subunit Influenza Vaccine containing 50% of MF59
Experimental: 8 Biological: FCC H5N1 7,5 µg + 50% MF59
2 doses of Cell Culture-Derived H5N1 7,5 µg Subunit Influenza Vaccine containing 50% of MF59
Experimental: 9 Biological: FCC H5N1 15 µg + 50% MF59
2 doses of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 50% of MF59
Experimental: 10 Biological: FCC H5N1 3,75 µg + 100% MF59
2 doses of Cell Culture-Derived H5N1 3,75 µg Subunit Influenza Vaccine containing 100% of MF59
Experimental: 11 Biological: FCC H5N1 7,5 µg + 100% MF59
2 doses of Cell Culture-Derived H5N1 7,5 µg Subunit Influenza Vaccine containing 100% of MF59
Experimental: 12 Biological: FCC H5N1 15 µg + 100% MF59
2 doses of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 100% of MF59

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects aged 18-40 years, mentally competent, who have signed an informed consent form after having received a detailed explanation of the study protocol;
  • Able to understand and comply with all study procedures and to complete study diaries, to be contacted, and to be available for study visits.

Exclusion Criteria:

  • Receipt of another investigational agent within 4 weeks prior to enrollment or before completion of the safety follow-up period in this or in another study; unwilling to refuse participation in another clinical study through the end of this study;
  • Receipt of an H5N1 vaccine;
  • Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination before Visit 5, or within 3 weeks prior to Visit 7 or before Visit 9;
  • Influenza vaccination for the current season within 2 months prior to enrollment (seasonal influenza vaccination is allowed after Visit 5, but no later than 2 months before the booster dose);
  • Experience of any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within 7 days prior to enrollment and prior to the booster dose or fever within 3 days prior to Visit 1 and Visit 7;
  • Pregnant or breastfeeding, or females of childbearing potential who refuse to use an acceptable method of birth control during the study period for at least 6 weeks following the booster dose; and, if sexually active, who have not used a reliable birth control method for at least two months prior to study entry;
  • Any serious disease, such as: cancer; autoimmune disease; diabetes mellitus type I; diabetes mellitus type II; diabetes relating to genetic defects/syndromes, diseases of the exocrine pancreas or infections; advanced arteriosclerotic disease; moderate or severe chronic obstructive pulmonary disease (COPD); asthma that is greater than mild in severity and/or has exacerbations more than 2 days per week; acute or progressive hepatic disease; acute or progressive renal disease; hyperthyroidism; medically significant bleeding disorders; history of neurological disorders;
  • Body mass index (BMI) ≥ 35 kg/m2 where BMI is for obese and not for high muscle mass;
  • History of (or current) drug or alcohol abuse, surgery planned during the study period or any other condition that in the investigator's opinion would interfere with safety of the subject or the evaluation of study objectives or the visit schedule;
  • Hypersensitivity to any component of the study vaccine;
  • Known or suspected impairment/alteration of immune function;
  • Members of the research staff or their relatives.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812019

Locations
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, TX 77030
Germany
Universitätsklinikum Gießen und Marburg GmbH
Gießen, Germany, 35392
Sponsors and Collaborators
Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00812019     History of Changes
Other Study ID Numbers: V89P1, 2007-003715-32
Study First Received: December 18, 2008
Last Updated: October 10, 2011
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institute

Keywords provided by Novartis:
H5N1 Influenza
Pandemic Flu
MF59 Adjuvant
Cell Culture-Derived
Safety
Immunogenicity
Vaccination
H5N1 influenza pandemic

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases
MF59 oil emulsion
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014