- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00812019
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)
August 20, 2020 updated by: Seqirus
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%MF59
- Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_25%MF59
- Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_50%MF59
- Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_100%MF59
- Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_0%MF59
- Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_25%MF59
- Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_50%MF59
- Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_100%MF59
- Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_0%MF59
- Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_25%MF59
- Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_50%MF59
- Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_100%MF59
Study Type
Interventional
Enrollment (Actual)
753
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Gießen, Germany, 35392
- Universitätsklinikum Gießen und Marburg GmbH
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-
-
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 3.75_0%MF59
Subjects received two 0.5mL vaccinations of cell culture derived H5N1 3.75µg subunit influenza vaccine containing 0% of MF59 three weeks apart.
|
Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 0% of MF59.
|
EXPERIMENTAL: 3.75_25%MF59
Subjects received two 0.5mL vaccinations of cell culture derived H5N1 3.75µg subunit influenza vaccine containing 25% of MF59 three weeks apart.
|
Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 25% of MF59.
|
EXPERIMENTAL: 3.75_50%MF59
Subjects received two 0.5mL vaccinations of cell culture derived H5N1 3.75µg subunit influenza vaccine containing 50% of MF59 three weeks apart.
|
Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 50% of MF59.
|
EXPERIMENTAL: 3.75_100%MF59
Subjects received two 0.5mL vaccinations of cell culture derived H5N1 3.75µg subunit influenza vaccine containing 100% of MF59 three weeks apart.
|
Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 100% of MF59.
|
EXPERIMENTAL: 7.5_0%MF59
Subjects received two 0.5mL vaccinations of cell culture derived H5N1 7.5µg subunit influenza vaccine containing 0% of MF59 three weeks apart.
|
Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 0% of MF59.
|
EXPERIMENTAL: 7.5_25%MF59
Subjects received two 0.5mL vaccinations of cell culture derived H5N1 7.5µg subunit influenza vaccine containing 25% of MF59 three weeks apart.
|
Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 25% of MF59.
|
EXPERIMENTAL: 7.5_50%MF59
Subjects received two 0.5mL vaccinations of cell culture derived H5N1 7.5µg subunit influenza vaccine containing 50% of MF59 three weeks apart.
|
Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 50% of MF59.
|
EXPERIMENTAL: 7.5_100%MF59
Subjects received two 0.5mL vaccinations of cell culture derived H5N1 7.5µg subunit influenza vaccine containing 100% of MF59 three weeks apart.
|
Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 100% of MF59.
|
EXPERIMENTAL: 15_0%MF59
Subjects received two 0.5mL vaccinations of cell culture derived H5N1 15µg subunit influenza vaccine containing 0% of MF59 three weeks apart.
|
Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 0% of MF59.
|
EXPERIMENTAL: 15_25%MF59
Subjects received two 0.5mL vaccinations of cell culture derived H5N1 15µg subunit influenza vaccine containing 25% of MF59 three weeks apart.
|
Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 25% of MF59.
|
EXPERIMENTAL: 15_50%MF59
Subjects received two 0.5mL vaccinations of cell culture derived H5N1 15µg subunit influenza vaccine containing 50% of MF59 three weeks apart.
|
Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 50% of MF59.
|
EXPERIMENTAL: 15_100%MF59
Subjects received two 0.5mL vaccinations of cell culture derived H5N1 15µg subunit influenza vaccine containing 100% of MF59 three weeks apart.
|
Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 100% of MF59.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
immunogenicity, safety and reactogenicity of cell culture-derived H5N1 subunit influenza virus vaccines containing different amounts of antigen and adjuvant.
Time Frame: 52 weeks
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52 weeks
|
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
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (ACTUAL)
March 1, 2009
Study Completion (ACTUAL)
November 1, 2010
Study Registration Dates
First Submitted
December 18, 2008
First Submitted That Met QC Criteria
December 18, 2008
First Posted (ESTIMATE)
December 19, 2008
Study Record Updates
Last Update Posted (ACTUAL)
August 24, 2020
Last Update Submitted That Met QC Criteria
August 20, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- V89P1
- 2007-003715-32 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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