CompletedNCT00812019Updated Aug 24, 2020

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)

A Phase 1 interventional study of Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%MF59 and Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_25%MF59 in Influenza, sponsored by Seqirus. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-24.

Sponsored by Seqirus · Phase 1, Interventional, and Prevention

Phase: Phase 1
Study type: Interventional
Enrollment: 753
Allocation: Randomized
Ages: 18 Years to 40 Years
Sex: All

Study summary

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.

Conditions studied

Influenza

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Keywords

H5N1 Influenza
Pandemic Flu
MF59 Adjuvant
Cell Culture-Derived
Safety
Immunogenicity
Vaccination
H5N1 influenza pandemic

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.

This study's enrollment of 753 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Seqirus is the lead sponsor of 52 studies on the registry; none are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 753 participants (actual)

Study arms

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.
Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%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.
Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_25%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.
Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_50%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.
Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_100%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.
Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_0%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.
Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_25%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.
Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_50%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.
Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_100%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.
Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_0%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.
Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_25%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.
Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_50%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.
Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_100%MF59

Interventions

BiologicalCell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%MF59
Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 0% of MF59.
BiologicalCell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_25%MF59
Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 25% of MF59.
BiologicalCell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_50%MF59
Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 50% of MF59.
BiologicalCell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_100%MF59
Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 100% of MF59.
BiologicalCell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_0%MF59
Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 0% of MF59.
BiologicalCell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_25%MF59
Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 25% of MF59.
BiologicalCell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_50%MF59
Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 50% of MF59.
BiologicalCell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_100%MF59
Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 100% of MF59.
BiologicalCell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_0%MF59
Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 0% of MF59.
BiologicalCell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_25%MF59
Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 25% of MF59.
BiologicalCell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_50%MF59
Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 50% of MF59.
BiologicalCell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_100%MF59
Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 100% of MF59.

What researchers measure

Primary outcomes

immunogenicity, safety and reactogenicity of cell culture-derived H5N1 subunit influenza virus vaccines containing different amounts of antigen and adjuvant.
Time frame: 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

Secondary outcomes

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

Study locations

2 sites

Baylor College of Medicine
Houston, Texas 77030, United States
Universitätsklinikum Gießen und Marburg GmbH
Gießen, 35392, Germany

References and documents

Publications

Keitel W, Groth N, Lattanzi M, Praus M, Hilbert AK, Borkowski A, Tsai TF. Dose ranging of adjuvant and antigen in a cell culture H5N1 influenza vaccine: safety and immunogenicity of a phase 1/2 clinical trial. Vaccine. 2010 Jan 8;28(3):840-8. doi: 10.1016/j.vaccine.2009.10.019. Epub 2009 Oct 14. PubMed 19835829 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00812019
Lead sponsor: Seqirus
Collaborators: Novartis Vaccines
Responsible party: Sponsor
First posted: Dec 19, 2008
Start date: Nov 2008
Primary completion: Mar 2009
Completion: Nov 2010
Last update: Aug 24, 2020

Study contacts

Clinical Scientist

study director · Seqirus

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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