InfluenzaPhase 2NCT00980850
Swine Flu (Novel Influenza A H1N1) Vaccine Study
A Phase 2 study testing Baxter Novel Influenza A H1N1 Whole Virus Vaccine and GlaxoSmithKline Novel Influenza A H1N1 Split Virion Vaccine in people with Influenza, run by University of Oxford at 5 sites in United Kingdom.
Trial summary
In the first half of this year a novel Influenza A H1N1 virus has resulted in an influenza pandemic. The United Kingdom has seen a particularly high incidence of disease. The highest rates of disease are being seen in young children. Read more about this study
- Who is it for?
- Ages 6 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Baxter Novel Influenza A H1N1 Whole Virus Vaccine and GlaxoSmithKline Novel Influenza A H1N1 Split Virion Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Sep 2009to Dec 2009
- Phase
- Phase 2
- 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 6 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- baby or child aged between 6 months to 12 years of age (i.e., to day before 13th birthday)
- for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained
- available for all the visits scheduled in the study
- willingness to complete all study procedures
Who cannot join
- History of any vaccine against novel influenza A strain H1N1 (based on verbal confirmation from parent/guardian)
- Previous laboratory confirmed case of novel influenza A strain H1N1 or treatment with oseltamivir or zanamivir for novel influenza A strain H1N1 (n.b. a child commenced on treatment with oseltamivir or zanamivir for novel influenza A strain H1N1 whose treatment was stopped following negative microbiological tests for H1N1 on nasal swabs would be allowed to enrol in the study]
- History of severe allergic reaction after previous vaccinations or hypersensitivity to any H1N1 vaccine component
- Current egg allergy
- Known or suspected impairment/alteration of the immune system
- Disorders of coagulation
Show all 11Show fewer
- Immunosuppressive therapy, use of systemic corticosteroids for more than 1 week within the 3 months prior to enrollment
- Receipt of blood, blood products and/or plasma derivatives or any immunoglobulin preparation within 3 months prior to enrollment
- Intent to immunize with any other vaccine(s) against novel influenza A strain H1N1 throughout the study period
- Participation in another clinical trial of an investigational medical product
- Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. Children with chronic, stable medical illnesses that do not result in immunosuppression (e.g., cerebral palsy, epilepsy, cystic fibrosis, congenital heart disease) will be allowed to participate in the study, unless these conditions will in some way interfere with the completion of study procedures. Children with conditions that may alter the immune response to vaccines (e.g., Trisomy 21) or will affect the ability to accurately describe adverse events (e.g., children over 5 years of age but with severe learning difficulties) will be excluded
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Bristol Children's Vaccine Centre
Bristol, Bristol, BS2 8AE
Royal Devon and Exeter NHS Foundation Trust
Exeter, EX2 5DW
St Georges Vaccine Institute
London, London, SW17 ORE
Oxford Vaccine Group
Oxford, OX3 7LJ
University of Southampton Wellcome Trust Clinical Research Facility
Southampton, SO16 6YD
About this study
Official title: Open Label, Randomized, Parallel-Group, Multi-Centre Study to Evaluate the Safety, Tolerability and Immunogenicity of Baxter H1N1 Vaccine and GlaxoSmithKline H1N1 Vaccine in Children 6 Months to 12 Years of Age
In the first half of this year a novel Influenza A H1N1 virus has resulted in an influenza pandemic. The United Kingdom has seen a particularly high incidence of disease. The highest rates of disease are being seen in young children. In anticipation of an influenza pandemic two vaccine manufacturers, Baxter and GlaxoSmithKline, have gained marketing authorization approval from the European Medicines Agency (EMEA) for a pandemic strain vaccine under the "mockup" dossier route based on limited clinical trial data for a candidate H5N1 vaccine. This "mockup" dossier route for pandemic influenza vaccines allows the submission of a core pandemic dossier during the interpandemic period, which results in the approval of a mockup pandemic vaccine. This is followed by a fast track approval of the pandemic vaccine based on the submission of the pandemic variation when the situation arises. The Baxter and GlaxoSmithKline vaccines have now been modified to cover the novel influenza A H1N1 strain.
Given the high rates of swine flu disease in children, this age group is likely to particularly benefit from immunization against this virus, however there are few data on the use of these vaccines in a pediatric population. The proposed study therefore aims to assess the immunogenicity, safety, and tolerability of these two H1N1 vaccines when administered as two doses three weeks apart to children aged 6 months to 12 years of age.
Read the detailed description
The study will be an open label, randomised, parallel group, multicentre clinical trial conducted by a consortium of the leading paediatric vaccine research units in the United Kingdom. The study will recruit healthy children 6 months to 12 years of age. Children with previously laboratory confirmed infection with swine flu will be excluded, as will those that have received a treatment course of oseltamivir. Children with immune deficiencies and egg allergy will also be excluded.
The study will be conducted as a collaboration between the Health Protection Agency and the following study recruitment sites: Oxford Vaccine Group (OVG), Bristol Children's Vaccine Centre (BCVC), the Royal Devon and Exeter Hospital, St George's Vaccine Institute (SGVI) and the University of Southampton Wellcome Trust Clinical Research Facility (USWTCRF). Families in the area of these research sites will be notified of the study by methods including print and electronic media, posters and direct mail out via the child health computer departments. The study visits themselves will be conducted in locations such as hospital outpatients, GP surgeries, or schools. General practitioners will be informed of the study and all immunisations administered during the study, as will the relevant child health computer department.
Participants will be randomised on 1:1 basis to receive 2 doses of either of the H1N1 influenza vaccines being studied. These vaccines will be given 2-3 weeks apart and the blood tests will be taken at baseline and around 3 weeks after completion of the 2 dose immunisation course. If at the start of the trial there is clinical data or a recommendation from JCVI that supports the use of a half dose of either vaccine in children under 3 years of age, this will be used for this age group and the ethics committee will be informed of this change.
Participants' families will be given diary cards to record local and systemic reactions to the vaccines administered, as well as recording daily temperatures for the 7 days after receipt of the vaccines. They will be telephoned 5-7 days after each vaccination to determine if there have been any SAEs since vaccination and to remind them to mail their completed diary cards to the HPA. Participants' families will also receive a memory card on which to record any visits to a doctor or emergency department from the 8th day after vaccine administration to the next study visit and any adverse events recorded in the diary card that are ongoing after day 7.
There will be 4 groups of children in the study:
Group A1: Children aged 6 months to less than 3 years of age will receive 2 doses of the Baxter H1N1 vaccine, 2-3 weeks apart. A blood sample will be taken at baseline and around 3 weeks after the second vaccine dose.
Group B1: Children aged 6 months to less than 3 years of age will receive 2 doses of the GSK H1N1 vaccine, 2-3 weeks apart. A blood sample will be taken at baseline and around 3 weeks after the second vaccine dose.
Group A2: Children aged greater than 3 years of age to 12 years of age will receive 2 doses of the Baxter H1N1 vaccine, 2-3 weeks apart. A blood sample will be taken at baseline and around 3 weeks after the second vaccine dose.
Group B2: Children aged greater than 3 years of age to 12 years of age will receive 2 doses of the GSK H1N1 vaccine, 2-3 weeks apart. A blood sample will be taken at baseline and around 3 weeks after the second vaccine dose.
- Conditions
- Influenza
- Being tested
- Baxter Novel Influenza A H1N1 Whole Virus Vaccine, GlaxoSmithKline Novel Influenza A H1N1 Split Virion Vaccine
- Keywords
- Flu vaccine, H1N1 swine flu virus, Immunogenicity, Reactogenicity
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baxter Novel Influenza A H1N1 Whole Virus VaccineBiological
Also called Celvapan
Two 0.5 ml doses of vaccine given within 3 weeks interval
GlaxoSmithKline Novel Influenza A H1N1 Split Virion VaccineBiological
Also called Pandemrix
Two 0.25 ml doses of vaccine given within 3 weeks interval
| Study group | Role | What they receive |
|---|---|---|
| Groups A1 and A2 | Experimental | Baxter vaccine Receives: Biological: Baxter Novel Influenza A H1N1 Whole Virus Vaccine |
| Groups B1 and B2 | Experimental | GSK vaccine Receives: Biological: GlaxoSmithKline Novel Influenza A H1N1 Split Virion Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with a 4 fold rise in MN titre between the pre-vaccination sample and sample taken 3 weeks after the second dose
Measured: 3 weeks after second vaccine dose
Percentage of participants experiencing each of fever (≥ 38°C per axilla), local tenderness, local swelling or local erythema within the 7 days following each immunisation with the study vaccines
Measured: Within the 7 days following each immunisation with the study vaccines
Secondary outcomes (8)
Percentage of subjects with an HAI titre ≥ 1 in 32
Measured: 3 weeks after the second dose
Percentage of subjects with a 4 fold rise in HAI titre between the pre-vaccination sample and sample taken 3 weeks after the second dose
Measured: 3 weeks after the second dose
The geometric mean fold rises in HAI titres from baseline to after three weeks after 2 doses of the Baxter H1N1 vaccine and the GSK H1N1 vaccine.
Measured: 3 weeks after the second dose
The geometric mean fold rises in MN titres from baseline to three weeks after 2 doses of the Baxter H1N1 vaccine and the GSK H1N1 vaccine.
Measured: 3 weeks after the second dose
The geometric mean HAI and MN titres three weeks after 2 doses of the Baxter H1N1 vaccine and the GSK H1N1 vaccine.
Measured: 3 weeks after the second dose
Percentage of participants experiencing each of: reduced feeding, reduced activity, irritability, persistent crying, vomiting or diarrhoea, receiving medication for pain or temperature (6 month to 5 year olds).
Measured: Up to 3 weeks after the second dose
Percentage of participants experiencing each of: malaise, headache, nausea/ vomiting, diarrhoea, reduced appetite, muscle pain or joint pain, receiving analgesic/ antipyretic medication (5 to 12 year olds).
Measured: Up to 3 weeks after the second dose
The effect of genetic polymorphisms on the immunogenicity and reactogenicity of the H1N1 vaccines.
Measured: Up to 3 weeks after the second dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Investigators
- Andrew Pollard, MRCP, PhD, Study director, Oxford Vaccine Group, University of OxfordLiz Miller, FRCPath, DSc, Principal investigator, Public Health EnglandPaul Heath, FRCPCH, Principal investigator, St Georges Vaccine InstituteAdam Finn, PhD, FRCPCH, Principal investigator, Bristol Children's Vaccine CentreSaul Faust, MRCPCH, PhD, Principal investigator, University of Southampton Wellcome Trust Clinical Research FacilityAndrew Collinson, MRCPCH, MD, Principal investigator, Royal Devon and Exeter NHS Foundation TrustMatthew Snape, FRCPCH, MD, Principal investigator, Oxford Vaccine Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980850
- Sponsor's protocol ID
- 2009/08 H1N1
- Status last verified
- May 2013
- First submitted
- 18 Sep 2009
- Last updated
- 9 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Andrews NJ, Walker WT, Finn A, Heath PT, Collinson AC, Pollard AJ, Snape MD, Faust SN, Waight PA, Hoschler K, Sheasby L, Waddington C, Kerridge S, Chalk J, Reiner A, John T, Fletcher M, Allen R, Fineman N, Wilkins S, Casey M, Michaelis L, Oeser C, Okike I, Ladhani S, Miller E. Predictors of immune response and reactogenicity to AS03B-adjuvanted split virion and non-adjuvanted whole virion H1N1 (2009) pandemic influenza vaccines. Vaccine. 2011 Oct 19;29(45):7913-9. doi: 10.1016/j.vaccine.2011.08.076. Epub 2011 Aug 27.
PubMed 21875635Waddington CS, Walker WT, Oeser C, Reiner A, John T, Wilkins S, Casey M, Eccleston PE, Allen RJ, Okike I, Ladhani S, Sheasby E, Hoschler K, Andrews N, Waight P, Collinson AC, Heath PT, Finn A, Faust SN, Snape MD, Miller E, Pollard AJ. Safety and immunogenicity of AS03B adjuvanted split virion versus non-adjuvanted whole virion H1N1 influenza vaccine in UK children aged 6 months-12 years: open label, randomised, parallel group, multicentre study. BMJ. 2010 May 27;340:c2649. doi: 10.1136/bmj.c2649.
PubMed 20508026Waddington C, Andrews N, Hoschler K, Walker W, Oeser C, Reiner A, John T, Wilkins S, Casey M, Eccleston P, Allen R, Okike I, Ladhani S, Sheasby E, Waight P, Collinson A, Heath P, Finn A, Faust S, Snape M, Miller E, Pollard A. Open-label, randomised, parallel-group, multicentre study to evaluate the safety, tolerability and immunogenicity of an AS03(B)/oil-in-water emulsion-adjuvanted (AS03(B)) split-virion versus non-adjuvanted whole-virion H1N1 influenza vaccine in UK children 6 months to 12 years of age. Health Technol Assess. 2010 Oct;14(46):1-130. doi: 10.3310/hta14460-01.
PubMed 20923610
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized, Parallel-Group, Multi-Centre Study to Evaluate the Safety, Tolerability and Immunogenicity of Baxter H1N1 Vaccine and GlaxoSmithKline H1N1 Vaccine in Children 6 Months to 12 Years of Age
- ClinicalTrials.gov ID
- NCT00980850
- Acronym / sponsor ID
- 2009/08 H1N1
- Conditions
- Influenza
- Keywords
- Flu vaccine, H1N1 swine flu virus, Immunogenicity, Reactogenicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Sep 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.
In the first half of this year a novel Influenza A H1N1 virus has resulted in an influenza pandemic. The United Kingdom has seen a particularly high incidence of disease. The highest rates of disease are being seen in young children. In anticipation of an influenza pandemic two vaccine manufacturers, Baxter and GlaxoSmithKline, have gained marketing authorization approval from the European Medicines Agency (EMEA) for a pandemic strain vaccine under the "mockup" dossier route based on limited clinical trial data for a candidate H5N1 vaccine. This "mockup" dossier route for pandemic influenza vaccines allows the submission of a core pandemic dossier during the interpandemic period, which results in the approval of a mockup pandemic vaccine. This is followed by a fast track approval of the pandemic vaccine based on the submission of the pandemic variation when the situation arises. The Baxter and GlaxoSmithKline vaccines have now been modified to cover the novel influenza A H1N1 strain.
Given the high rates of swine flu disease in children, this age group is likely to particularly benefit from immunization against this virus, however there are few data on the use of these vaccines in a pediatric population. The proposed study therefore aims to assess the immunogenicity, safety, and tolerability of these two H1N1 vaccines when administered as two doses three weeks apart to children aged 6 months to 12 years of age.
Detailed description
The study will be an open label, randomised, parallel group, multicentre clinical trial conducted by a consortium of the leading paediatric vaccine research units in the United Kingdom. The study will recruit healthy children 6 months to 12 years of age. Children with previously laboratory confirmed infection with swine flu will be excluded, as will those that have received a treatment course of oseltamivir. Children with immune deficiencies and egg allergy will also be excluded.
The study will be conducted as a collaboration between the Health Protection Agency and the following study recruitment sites: Oxford Vaccine Group (OVG), Bristol Children's Vaccine Centre (BCVC), the Royal Devon and Exeter Hospital, St George's Vaccine Institute (SGVI) and the University of Southampton Wellcome Trust Clinical Research Facility (USWTCRF). Families in the area of these research sites will be notified of the study by methods including print and electronic media, posters and direct mail out via the child health computer departments. The study visits themselves will be conducted in locations such as hospital outpatients, GP surgeries, or schools. General practitioners will be informed of the study and all immunisations administered during the study, as will the relevant child health computer department.
Participants will be randomised on 1:1 basis to receive 2 doses of either of the H1N1 influenza vaccines being studied. These vaccines will be given 2-3 weeks apart and the blood tests will be taken at baseline and around 3 weeks after completion of the 2 dose immunisation course. If at the start of the trial there is clinical data or a recommendation from JCVI that supports the use of a half dose of either vaccine in children under 3 years of age, this will be used for this age group and the ethics committee will be informed of this change.
Participants' families will be given diary cards to record local and systemic reactions to the vaccines administered, as well as recording daily temperatures for the 7 days after receipt of the vaccines. They will be telephoned 5-7 days after each vaccination to determine if there have been any SAEs since vaccination and to remind them to mail their completed diary cards to the HPA. Participants' families will also receive a memory card on which to record any visits to a doctor or emergency department from the 8th day after vaccine administration to the next study visit and any adverse events recorded in the diary card that are ongoing after day 7.
There will be 4 groups of children in the study:
Group A1: Children aged 6 months to less than 3 years of age will receive 2 doses of the Baxter H1N1 vaccine, 2-3 weeks apart. A blood sample will be taken at baseline and around 3 weeks after the second vaccine dose.
Group B1: Children aged 6 months to less than 3 years of age will receive 2 doses of the GSK H1N1 vaccine, 2-3 weeks apart. A blood sample will be taken at baseline and around 3 weeks after the second vaccine dose.
Group A2: Children aged greater than 3 years of age to 12 years of age will receive 2 doses of the Baxter H1N1 vaccine, 2-3 weeks apart. A blood sample will be taken at baseline and around 3 weeks after the second vaccine dose.
Group B2: Children aged greater than 3 years of age to 12 years of age will receive 2 doses of the GSK H1N1 vaccine, 2-3 weeks apart. A blood sample will be taken at baseline and around 3 weeks after the second vaccine dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Groups A1 and A2 | Experimental | Biological: Baxter Novel Influenza A H1N1 Whole Virus VaccineBaxter vaccine |
| Groups B1 and B2 | Experimental | Biological: GlaxoSmithKline Novel Influenza A H1N1 Split Virion VaccineGSK vaccine |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- baby or child aged between 6 months to 12 years of age (i.e., to day before 13th birthday)
- for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained
- available for all the visits scheduled in the study
- willingness to complete all study procedures
Key exclusion criteria (11 listed)
- History of any vaccine against novel influenza A strain H1N1 (based on verbal confirmation from parent/guardian)
- Previous laboratory confirmed case of novel influenza A strain H1N1 or treatment with oseltamivir or zanamivir for novel influenza A strain H1N1 (n.b. a child commenced on treatment with oseltamivir or zanamivir for novel influenza A strain H1N1 whose treatment was stopped following negative microbiological tests for H1N1 on nasal swabs would be allowed to enrol in the study]
- History of severe allergic reaction after previous vaccinations or hypersensitivity to any H1N1 vaccine component
- Current egg allergy
- Known or suspected impairment/alteration of the immune system
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 |
|---|---|---|
| Baxter Novel Influenza A H1N1 Whole Virus VaccineAlso: CelvapanTwo 0.5 ml doses of vaccine given within 3 weeks interval | Biological | Groups A1 and A2 |
| GlaxoSmithKline Novel Influenza A H1N1 Split Virion VaccineAlso: PandemrixTwo 0.25 ml doses of vaccine given within 3 weeks interval | Biological | Groups B1 and B2 |
Primary outcome
Percentage of subjects with a 4 fold rise in MN titre between the pre-vaccination sample and sample taken 3 weeks after the second dose
Time frame: 3 weeks after second vaccine dose
Percentage of participants experiencing each of fever (≥ 38°C per axilla), local tenderness, local swelling or local erythema within the 7 days following each immunisation with the study vaccines
Time frame: Within the 7 days following each immunisation with the study vaccines
8 secondary outcomes
Percentage of subjects with an HAI titre ≥ 1 in 32
Time frame: 3 weeks after the second dose
Percentage of subjects with a 4 fold rise in HAI titre between the pre-vaccination sample and sample taken 3 weeks after the second dose
Time frame: 3 weeks after the second dose
The geometric mean fold rises in HAI titres from baseline to after three weeks after 2 doses of the Baxter H1N1 vaccine and the GSK H1N1 vaccine.
Time frame: 3 weeks after the second dose
The geometric mean fold rises in MN titres from baseline to three weeks after 2 doses of the Baxter H1N1 vaccine and the GSK H1N1 vaccine.
Time frame: 3 weeks after the second dose
The geometric mean HAI and MN titres three weeks after 2 doses of the Baxter H1N1 vaccine and the GSK H1N1 vaccine.
Time frame: 3 weeks after the second dose
Percentage of participants experiencing each of: reduced feeding, reduced activity, irritability, persistent crying, vomiting or diarrhoea, receiving medication for pain or temperature (6 month to 5 year olds).
Time frame: Up to 3 weeks after the second dose
Percentage of participants experiencing each of: malaise, headache, nausea/ vomiting, diarrhoea, reduced appetite, muscle pain or joint pain, receiving analgesic/ antipyretic medication (5 to 12 year olds).
Time frame: Up to 3 weeks after the second dose
The effect of genetic polymorphisms on the immunogenicity and reactogenicity of the H1N1 vaccines.
Time frame: Up to 3 weeks after the second dose
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 9 May 2013.
- Background: PubMed 21875635Andrews NJ, Walker WT, Finn A, Heath PT, Collinson AC, Pollard AJ, Snape MD, Faust SN, Waight PA, Hoschler K, Sheasby L, Waddington C, Kerridge S, Chalk J, Reiner A, John T, Fletcher M, Allen R, Fineman N, Wilkins S, Casey M, Michaelis L, Oeser C, Okike I, Ladhani S, Miller E. Predictors of immune response and reactogenicity to AS03B-adjuvanted split virion and non-adjuvanted whole virion H1N1 (2009) pandemic influenza vaccines. Vaccine. 2011 Oct 19;29(45):7913-9. doi: 10.1016/j.vaccine.2011.08.076. Epub 2011 Aug 27.
- Background: PubMed 20508026Waddington CS, Walker WT, Oeser C, Reiner A, John T, Wilkins S, Casey M, Eccleston PE, Allen RJ, Okike I, Ladhani S, Sheasby E, Hoschler K, Andrews N, Waight P, Collinson AC, Heath PT, Finn A, Faust SN, Snape MD, Miller E, Pollard AJ. Safety and immunogenicity of AS03B adjuvanted split virion versus non-adjuvanted whole virion H1N1 influenza vaccine in UK children aged 6 months-12 years: open label, randomised, parallel group, multicentre study. BMJ. 2010 May 27;340:c2649. doi: 10.1136/bmj.c2649.
- Background: PubMed 20923610Waddington C, Andrews N, Hoschler K, Walker W, Oeser C, Reiner A, John T, Wilkins S, Casey M, Eccleston P, Allen R, Okike I, Ladhani S, Sheasby E, Waight P, Collinson A, Heath P, Finn A, Faust S, Snape M, Miller E, Pollard A. Open-label, randomised, parallel-group, multicentre study to evaluate the safety, tolerability and immunogenicity of an AS03(B)/oil-in-water emulsion-adjuvanted (AS03(B)) split-virion versus non-adjuvanted whole-virion H1N1 influenza vaccine in UK children 6 months to 12 years of age. Health Technol Assess. 2010 Oct;14(46):1-130. doi: 10.3310/hta14460-01.
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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.
Andrew Pollard, MRCP, PhD study director
Oxford Vaccine Group, University of Oxford
Liz Miller, FRCPath, DSc principal investigator
Public Health England
Paul Heath, FRCPCH principal investigator
St Georges Vaccine Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baxter Novel Influenza A H1N1 Whole Virus Vaccine and GlaxoSmithKline Novel Influenza A H1N1 Split Virion Vaccine in people with Influenza, run by University of Oxford at 5 sites 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 4 inclusion and 11 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 9 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of subjects with a 4 fold rise in MN titre between the pre-vaccination sample and sample taken 3 weeks after the second dose (time frame: 3 weeks after second vaccine dose). 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 NCT00980850, which also lists 3 linked publications.
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 9 May 2013.