InfluenzaPhase 1NCT00943358
Safety and Immunogenicity of A/H1N1v Vaccines in Healthy Adults
A Phase 1 study testing MF59 H1N1 vaccine and Plain H1N1 vaccine in people with Influenza, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the antibody response to one and two doses of influenza A/H1N1v vaccine in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- MF59 H1N1 vaccine and Plain H1N1 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2009to Dec 2009
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mentally competent adults, who have signed an informed consent form after having received a detailed explanation of the study protocol.
- Male or female subjects 18-50 years who are either healthy or have a stable medical condition.
- Able to understand and comply with all study procedures and to complete study diaries
- Individuals who can be contacted throughout the study and are available for all study visits
- Females should either be using secure contraceptive precautions including:
- the oral contraceptive pill
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- condom/barrier contraception
- partner has had a vasectomy
- be surgically sterilised, or
- post-menopausal (defined as at least two years since the last menstrual period)
Who cannot join
- Any clinically significant concurrent illness or unstable medical condition including: malignant tumours, autoimmune illnesses (including rheumatoid arthritis), acute or progressive renal or hepatic pathology, chronic obstructive pulmonary disease requiring oxygen therapy, and any active neurological disorder.
- Individuals with a history of anaphylaxis or serious reactions to vaccines; hypersensitivity to influenzal viral protein, neomycin or polymixin, or products containing mercury.
- Persons with known immunosuppressive disease or who use systemic immunosuppressive drugs or other drugs listed in section 8 of the British National Formulary (BNF) or chloroquine, gold or penicillamine or other drugs listed in section 10.1.3 of the BNF to suppress a chronic disease process, or have received in the last 6 months radiotherapy or chemotherapy.
- Subjects who are at high risk of developing illnesses of the immune system.
- Individuals who are taking immunostimulant therapy or interferon
- Individuals who have received blood products or immunoglobulins parenterally during the preceding three months.
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- Women should not be pregnant or lactating.
- Women who refuse to use a reliable contraceptive method throughout the study
- Known or suspected drug abuse.
- Individuals who have received another vaccine or investigational medicinal product in the preceding 2 weeks.
- Unable to lead an independent life either physically or mentally
- Regularly drink more than 40 units of alcohol weekly
- Individuals who have had acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy during the preceding 7 days (chronic antibiotic therapy for prevention of urinary tract infections is acceptable).
- Individuals who had a temperature >38oC in the preceding 3 days.
- Individuals who, in the opinion of the investigator, have conditions that might complicate interpretation of the study results.
- Individuals who have had confirmed pandemic influenza H1 infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Immunogenicity of Cell-culture Non-adjuvanted and MF59-adjuvanted Influenza H1N1 Vaccines in Healthy Adults
The purpose of this study is to evaluate the antibody response to one and two doses of influenza A/H1N1v vaccine in healthy adults.
Read the detailed description
An observer-blind, single-centre study in which 7 groups of 25-30 male and female adults ≥18-50 years of age will be randomly allocated to receive two doses of cell culture non-adjuvanted or MF59-adjuvanted influenza A/California/4/2009 (H1N1) surface antigen vaccine containing 3.75, 7.5 or 15µg haemagglutinin by intramuscular injection. A second dose of the same vaccine containing the same quantity of antigen as in the first dose will be administered 21 days later. Three additional groups will receive two doses of MF59-adjuvanted influenza A/California/4/2009 (H1N1) surface antigen vaccine containing 7.5 µg haemagglutinin by intramuscular injection on day 0 or separated by 7 or 14 days. Subjects will be observed for local and systemic reactions for 30 minutes after each immunisation and will be monitored for any reactions and other adverse events for 7 days after each immunisation.
- Conditions
- Influenza
- Being tested
- MF59 H1N1 vaccine, Plain H1N1 vaccine
- Keywords
- influenza, immunogenicity, vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF59 H1N1 vaccineBiological
3.75-7.5ug dose
Plain H1N1 vaccineBiological
7.5-15ug
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Active comparator | adjuvanted influenza vaccine Receives: Biological: MF59 H1N1 vaccine |
| Vaccine 2 | Active comparator | non-adjuvanted vaccine Receives: Biological: Plain H1N1 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMT antibody rises
Measured: 42 days
Secondary outcomes (1)
frequency of adverse reactions
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2009
- Study completionDec 2009
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
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health England, Novartis Vaccines
- Responsible party
- Sponsor
- Investigators
- Iain Stephenson, FRCP, Principal investigator, University Hospitals, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943358
- Sponsor's protocol ID
- UHL10763
- Status last verified
- Aug 2012
- First submitted
- 20 Jul 2009
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, Stephenson I. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med. 2009 Dec 17;361(25):2424-35. doi: 10.1056/NEJMoa0907650. Epub 2009 Sep 10.
PubMed 19745215
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Cell-culture Non-adjuvanted and MF59-adjuvanted Influenza H1N1 Vaccines in Healthy Adults
- ClinicalTrials.gov ID
- NCT00943358
- Acronym / sponsor ID
- UHL10763
- Conditions
- Influenza
- Keywords
- influenza, immunogenicity, vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- Public Health England, Novartis Vaccines
- Study start
- Jul 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Jul 2009 (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 purpose of this study is to evaluate the antibody response to one and two doses of influenza A/H1N1v vaccine in healthy adults.
Detailed description
An observer-blind, single-centre study in which 7 groups of 25-30 male and female adults ≥18-50 years of age will be randomly allocated to receive two doses of cell culture non-adjuvanted or MF59-adjuvanted influenza A/California/4/2009 (H1N1) surface antigen vaccine containing 3.75, 7.5 or 15µg haemagglutinin by intramuscular injection. A second dose of the same vaccine containing the same quantity of antigen as in the first dose will be administered 21 days later. Three additional groups will receive two doses of MF59-adjuvanted influenza A/California/4/2009 (H1N1) surface antigen vaccine containing 7.5 µg haemagglutinin by intramuscular injection on day 0 or separated by 7 or 14 days. Subjects will be observed for local and systemic reactions for 30 minutes after each immunisation and will be monitored for any reactions and other adverse events for 7 days after each immunisation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Active comparator | Biological: MF59 H1N1 vaccineadjuvanted influenza vaccine |
| Vaccine 2 | Active comparator | Biological: Plain H1N1 vaccinenon-adjuvanted vaccine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Mentally competent adults, who have signed an informed consent form after having received a detailed explanation of the study protocol.
- Male or female subjects 18-50 years who are either healthy or have a stable medical condition.
- Able to understand and comply with all study procedures and to complete study diaries
- Individuals who can be contacted throughout the study and are available for all study visits
- Females should either be using secure contraceptive precautions including:
Key exclusion criteria (16 listed)
- Any clinically significant concurrent illness or unstable medical condition including: malignant tumours, autoimmune illnesses (including rheumatoid arthritis), acute or progressive renal or hepatic pathology, chronic obstructive pulmonary disease requiring oxygen therapy, and any active neurological disorder.
- Individuals with a history of anaphylaxis or serious reactions to vaccines; hypersensitivity to influenzal viral protein, neomycin or polymixin, or products containing mercury.
- Persons with known immunosuppressive disease or who use systemic immunosuppressive drugs or other drugs listed in section 8 of the British National Formulary (BNF) or chloroquine, gold or penicillamine or other drugs listed in section 10.1.3 of the BNF to suppress a chronic disease process, or have received in the last 6 months radiotherapy or chemotherapy.
- Subjects who are at high risk of developing illnesses of the immune system.
- Individuals who are taking immunostimulant therapy or interferon
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 |
|---|---|---|
| MF59 H1N1 vaccine3.75-7.5ug dose | Biological | Vaccine |
| Plain H1N1 vaccine7.5-15ug | Biological | Vaccine 2 |
Primary outcome
GMT antibody rises
Time frame: 42 days
1 secondary outcome
frequency of adverse reactions
Time frame: 42 days
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 8 Aug 2012.
- Derived from this study: PubMed 19745215Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, Stephenson I. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med. 2009 Dec 17;361(25):2424-35. doi: 10.1056/NEJMoa0907650. Epub 2009 Sep 10.
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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.
Iain Stephenson, FRCP principal investigator
University Hospitals, Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MF59 H1N1 vaccine and Plain H1N1 vaccine in people with Influenza, run by University Hospitals, Leicester at 1 site in United Kingdom.
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 10 inclusion and 16 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 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
GMT antibody rises (time frame: 42 days). 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 NCT00943358, 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 8 Aug 2012.