InfluenzaPhase 1NCT00812019
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 study testing Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%MF59, Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_25%MF59 and Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_50%MF59 in people with Influenza, run by Seqirus at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%MF59, Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_25%MF59 and Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_50%MF59
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 753 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2008to Nov 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
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
- Influenza
- Being tested
- Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%MF59, Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_25%MF59, Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_50%MF59, Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_100%MF59, Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_0%MF59
- Keywords
- H5N1 Influenza, Pandemic Flu, MF59 Adjuvant, Cell Culture-Derived, Safety, Immunogenicity, Vaccination, H5N1 influenza pandemic
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%MF59Biological
Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 0% of MF59.
Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_25%MF59Biological
Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 25% of MF59.
Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_50%MF59Biological
Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 50% of MF59.
Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_100%MF59Biological
Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 100% of MF59.
Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_0%MF59Biological
Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 0% of MF59.
Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_25%MF59Biological
Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 25% of MF59.
Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_50%MF59Biological
Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 50% of MF59.
Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_100%MF59Biological
Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 100% of MF59.
Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_0%MF59Biological
Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 0% of MF59.
Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_25%MF59Biological
Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 25% of MF59.
Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_50%MF59Biological
Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 50% of MF59.
Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_100%MF59Biological
Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 100% of MF59.
| Study group | Role | What they receive |
|---|---|---|
| 3.75_0%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 3.75µg subunit influenza vaccine containing 0% of MF59 three weeks apart. Receives: Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%MF59 |
| 3.75_25%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 3.75µg subunit influenza vaccine containing 25% of MF59 three weeks apart. Receives: Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_25%MF59 |
| 3.75_50%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 3.75µg subunit influenza vaccine containing 50% of MF59 three weeks apart. Receives: Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_50%MF59 |
| 3.75_100%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 3.75µg subunit influenza vaccine containing 100% of MF59 three weeks apart. Receives: Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_100%MF59 |
| 7.5_0%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 7.5µg subunit influenza vaccine containing 0% of MF59 three weeks apart. Receives: Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_0%MF59 |
| 7.5_25%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 7.5µg subunit influenza vaccine containing 25% of MF59 three weeks apart. Receives: Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_25%MF59 |
| 7.5_50%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 7.5µg subunit influenza vaccine containing 50% of MF59 three weeks apart. Receives: Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_50%MF59 |
| 7.5_100%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 7.5µg subunit influenza vaccine containing 100% of MF59 three weeks apart. Receives: Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_100%MF59 |
| 15_0%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 15µg subunit influenza vaccine containing 0% of MF59 three weeks apart. Receives: Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_0%MF59 |
| 15_25%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 15µg subunit influenza vaccine containing 25% of MF59 three weeks apart. Receives: Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_25%MF59 |
| 15_50%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 15µg subunit influenza vaccine containing 50% of MF59 three weeks apart. Receives: Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_50%MF59 |
| 15_100%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 15µg subunit influenza vaccine containing 100% of MF59 three weeks apart. Receives: Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_100%MF59 |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunogenicity, safety and reactogenicity of cell culture-derived H5N1 subunit influenza virus vaccines containing different amounts of antigen and adjuvant.
Measured: 52 weeks
identification of the optimal adjuvant-antigen dose combination considering antibody titers against the H5N1 strain observed three weeks after two intramuscular doses.
Measured: 52 weeks
Secondary outcomes (1)
immunogenicity against heterologous strains of a cell culture-derived H5N1 subunit influenza virus vaccine containing different amounts of antigen and adjuvant.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2009
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 753 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seqirus
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Responsible party
- Sponsor
- Investigators
- Clinical Scientist, Study director, Seqirus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812019
- Sponsor's protocol ID
- V89P1
- Other IDs
- 2007-003715-32
- Status last verified
- Aug 2020
- First submitted
- 18 Dec 2008
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00812019
- Acronym / sponsor ID
- V89P1
- Conditions
- Influenza
- Keywords
- H5N1 Influenza, Pandemic Flu, MF59 Adjuvant, Cell Culture-Derived, Safety, Immunogenicity, Vaccination, H5N1 influenza pandemic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 753 participants (actual)
- Lead sponsor
- SeqirusIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Study start
- Nov 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| 3.75_0%MF59 | Experimental | Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%MF59Subjects received two 0.5mL vaccinations of cell culture derived H5N1 3.75µg subunit influenza vaccine containing 0% of MF59 three weeks apart. |
| 3.75_25%MF59 | Experimental | Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_25%MF59Subjects received two 0.5mL vaccinations of cell culture derived H5N1 3.75µg subunit influenza vaccine containing 25% of MF59 three weeks apart. |
| 3.75_50%MF59 | Experimental | Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_50%MF59Subjects received two 0.5mL vaccinations of cell culture derived H5N1 3.75µg subunit influenza vaccine containing 50% of MF59 three weeks apart. |
| 3.75_100%MF59 | Experimental | Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_100%MF59Subjects received two 0.5mL vaccinations of cell culture derived H5N1 3.75µg subunit influenza vaccine containing 100% of MF59 three weeks apart. |
| 7.5_0%MF59 | Experimental | Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_0%MF59Subjects received two 0.5mL vaccinations of cell culture derived H5N1 7.5µg subunit influenza vaccine containing 0% of MF59 three weeks apart. |
| 7.5_25%MF59 | Experimental | Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_25%MF59Subjects received two 0.5mL vaccinations of cell culture derived H5N1 7.5µg subunit influenza vaccine containing 25% of MF59 three weeks apart. |
| 7.5_50%MF59 | Experimental | Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_50%MF59Subjects received two 0.5mL vaccinations of cell culture derived H5N1 7.5µg subunit influenza vaccine containing 50% of MF59 three weeks apart. |
| 7.5_100%MF59 | Experimental | Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_100%MF59Subjects received two 0.5mL vaccinations of cell culture derived H5N1 7.5µg subunit influenza vaccine containing 100% of MF59 three weeks apart. |
| 15_0%MF59 | Experimental | Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_0%MF59Subjects received two 0.5mL vaccinations of cell culture derived H5N1 15µg subunit influenza vaccine containing 0% of MF59 three weeks apart. |
| 15_25%MF59 | Experimental | Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_25%MF59Subjects received two 0.5mL vaccinations of cell culture derived H5N1 15µg subunit influenza vaccine containing 25% of MF59 three weeks apart. |
| 15_50%MF59 | Experimental | Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_50%MF59Subjects received two 0.5mL vaccinations of cell culture derived H5N1 15µg subunit influenza vaccine containing 50% of MF59 three weeks apart. |
| 15_100%MF59 | Experimental | Biological: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_100%MF59Subjects received two 0.5mL vaccinations of cell culture derived H5N1 15µg subunit influenza vaccine containing 100% of MF59 three weeks apart. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%MF59Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 0% of MF59. | Biological | 3.75_0%MF59 |
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_25%MF59Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 25% of MF59. | Biological | 3.75_25%MF59 |
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_50%MF59Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 50% of MF59. | Biological | 3.75_50%MF59 |
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_100%MF59Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 100% of MF59. | Biological | 3.75_100%MF59 |
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_0%MF59Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 0% of MF59. | Biological | 7.5_0%MF59 |
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_25%MF59Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 25% of MF59. | Biological | 7.5_25%MF59 |
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_50%MF59Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 50% of MF59. | Biological | 7.5_50%MF59 |
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_100%MF59Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 100% of MF59. | Biological | 7.5_100%MF59 |
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_0%MF59Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 0% of MF59. | Biological | 15_0%MF59 |
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_25%MF59Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 25% of MF59. | Biological | 15_25%MF59 |
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_50%MF59Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 50% of MF59. | Biological | 15_50%MF59 |
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_100%MF59Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 100% of MF59. | Biological | 15_100%MF59 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Background: PubMed 19835829Keitel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Scientist study director
Seqirus
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%MF59, Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_25%MF59 and Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_50%MF59 in people with Influenza, run by Seqirus at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immunogenicity, safety and reactogenicity of cell culture-derived H5N1 subunit influenza virus vaccines containing different amounts of antigen and adjuvant. (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00812019, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.