InfluenzaPhase 2NCT01682369
ADITEC FLU STUDY: Understanding the Genetic Basis for Immune Responses
A Phase 2 study testing TIV (Aggripal) and ATIV (Fluad) in people with Influenza, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Infants and young children do not respond as well as adults to the flu vaccines currently available in the UK. Fluad, is a different type of influenza vaccine that has been available in the European continent for the last decade, and contains an adjuvant known as MF59. Read more about this study
- Who is it for?
- Ages 14 to 26 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- TIV (Aggripal) and ATIV (Fluad)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to Jan 2015
- 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 14 to 26 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The investigator believes that the parents / LAR (s) of the child can and will comply with requirements of the protocol (e.g. completion of diary cards, understanding of study procedure, consent process, availability at visits)
- Written informed consent obtained from parent / LAR (s) of the subject
- Age from 14 months to 26 months (from start of 14 months up to \& excluding 27 months of age)
- Subject is healthy as determined by medical history and clinical examination
- Have received the standard UK immunisation schedule
Who cannot join
- Child in care
- Use or planned use of any non-registered or investigational product in last 30 days
- Previous influenza vaccination
- Microbiologically proven influenza illness or treatment with antiviral medications
- Confirmed or suspected egg allergy.
- Chronic serious medical conditions which may, in the opinion of the investigator, interfere with evaluation of study objectives e.g. Chronic lung disease, chronic liver/renal disease, chronic renal failure chronic heart disease, congenital genetic syndromes (e.g. Trisomy 21).
Show all 9Show fewer
- Suspected or confirmed immunosuppressive or immunodeficiency conditions (including splenic dysfunction \& HIV)
- Autoimmune conditions e.g. Type 1/2 diabetes mellitus, thyroid disease, juvenile idiopathic arthritis etc.
- Bleeding disorders
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: A Multi-centre, Phase II, Open Labelled Randomised Control Trial to Describe Immune & Transcriptomic Responses to Trivalent Inactivated Vaccine (TIV) & MF59 Adjuvanted Influenza Vaccine (ATIV) in 14 -26 Month Healthy Children
Infants and young children do not respond as well as adults to the flu vaccines currently available in the UK. Fluad, is a different type of influenza vaccine that has been available in the European continent for the last decade, and contains an adjuvant known as MF59.
This vaccine has been used extensively in adults over 65 years of age. It has been administered to over 4000 children in previous studies, which have shown that it produces an enhanced immune response in children compared with traditional vaccines, and that it is safe in this age group. It is, however, not yet licensed for use in children. The reason for this new study is to gain a better understanding of the how this vaccine is stimulating the immune system, by looking to see which parts of the genetic code are 'switched on' in response to immunisation, and to see how this differs from the response to currently used flu vaccines.
Read more
To do this the Oxford Vaccine Group will enrol children aged 14 to 26 months to receive either the influenza vaccine with the MF59 adjuvant (ATIV) or one of the influenza vaccines currently available in the UK (Agrippal/ Begripal or TIV). The study will also help to find out whether it is possible to identify patterns of genetic response which can predict responses to immunisation. Being able to do so could potentially enable more rapid development of vaccines against influenza and other diseases in the future. We will also measure how well the immune system responds to the two vaccines and look at any side effects.
The study is funded by Aditec is a collaborative research programme that aims to accelerate the development of novel and powerful immunisation technologies for the next generation of human vaccines.
- Conditions
- Influenza
- Being tested
- TIV (Aggripal), ATIV (Fluad)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIV (Aggripal)Biological
Also called Begripal
ATIV (Fluad)Biological
| Study group | Role | What they receive |
|---|---|---|
| Group 1 a - TIV | Other | V1- Day 0- Administer a dose of 0.25ml of vaccine TIV (Agrippal) + Collect blood sample (up to 6.0 ml)
V2- Day 28 (26-35)- Vaccination 2nd dose, Administer a dose of 0.25ml of vaccine TIV (Agrippal)
V3-(Day V2+1)- Collect blood sample (up to 6.0 ml)
V4- Day V2+28 (26-35)- Collect blood sample (up to 6.0 ml) Receives: Biological: TIV (Aggripal) |
| Group 1 b - TIV | Other | V1- Day 0- Administer a dose of 0.25ml of vaccine TIV (Agrippal) + Collect blood sample (up to 6.0 ml)
V2- Day 28 (26-35)- Vaccination 2nd dose, Administer a dose of 0.25ml of vaccine TIV (Agrippal)
V3-(Day V2+3)- Collect blood sample (up to 6.0 ml)
V4- Day V2+28 (26-35)- Collect blood sample (up to 6.0 ml) Receives: Biological: TIV (Aggripal) |
| Group 1 c - TIV | Other | V1- Day 0- Administer a dose of 0.25ml of vaccine TIV (Aggripal) + Collect blood sample (up to 6.0 ml)
V2- Day 28 (26-35)- Vaccination 2nd dose, Administer a dose of 0.25ml of vaccine TIV (Aggripal)
V3-(Day V2+7)- Collect blood sample (up to 6.0 ml)
V4- Day V2+28 (26-35)- Collect blood sample (up to 6.0 ml) Receives: Biological: TIV (Aggripal) |
| Group 2 a - ATIV | Other | V1- Day 0- Administer a dose of 0.25ml of vaccine ATIV (Fluad) + Collect blood sample (up to 6.0 ml)
V2- Day 28 (26-35)- Vaccination 2nd dose, Administer a dose of 0.25ml of vaccine ATIV (Fluad)
V3- V3(Day V2+1)- Collect blood sample (up to 6.0 ml)
V4- V4 Day V2+28 (26-35)- Collect blood sample (up to 6.0 ml) Receives: Biological: ATIV (Fluad) |
| Group 2 b - ATIV | Other | V1- Day 0- Administer a dose of 0.25ml of vaccine ATIV (Fluad) + Collect blood sample (up to 6.0 ml)
V2- Day 28 (26-35)- Vaccination 2nd dose, Administer a dose of 0.25ml of vaccine ATIV (Fluad)
V3- V3(Day V2+3)- Collect blood sample (up to 6.0 ml)
V4- V4 Day V2+28 (26-35)- Collect blood sample (up to 6.0 ml) Receives: Biological: ATIV (Fluad) |
| Group 2 c - ATIV | Other | V1- Day 0- Administer a dose of 0.25ml of vaccine ATIV (Fluad) + Collect blood sample (up to 6.0 ml)
V2- Day 28 (26-35)- Vaccination 2nd dose, Administer a dose of 0.25ml of vaccine ATIV (Fluad)
V3- V3(Day V2+7)- Collect blood sample (up to 6.0 ml)
V4- V4 Day V2+28 (26-35)- Collect blood sample (up to 6.0 ml) Receives: Biological: ATIV (Fluad) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive analyses of gene expression profiles of participants following immunisation with TIV or ATIV in relation to baseline profiles.
To describe gene expression profiles of participants following immunisation with TIV or ATIV in relation to baseline profiles.
Measured: 56 days
Secondary outcomes (5)
To describe the immunogenicity of TIV & ATIV in terms of haemagglutination-Inhibition test (HAI) against each of the three vaccine strains (A/H1N1, A/H3N2, B), four weeks after completion of vaccination.
Measured: 56 days
To evaluate the reactogenicity & safety of ATIV in terms of local & systemic reactions following vaccination.
Measured: 56 days
To study T&B cell responses following immunisation with each vaccine.
Measured: 56 days
To explore the relationship between gene expression and the T cell, B cell and HIA response to immunisation with TIV and ATIV.
Measured: 56 days
To explore the relationship between gene expression and the reactogenicity of TIV and ATIV.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2013
- Study completionJan 2015
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew J Pollard, PhD, Principal investigator, Oxford Vaccine GroupMatthew Snape, PhD, Principal investigator, Oxford Vaccine Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682369
- Sponsor's protocol ID
- OVG 2012/04
- Other IDs
- 2012-002443-26
- Status last verified
- Sep 2017
- First submitted
- 6 Sep 2012
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nakaya HI, Clutterbuck E, Kazmin D, Wang L, Cortese M, Bosinger SE, Patel NB, Zak DE, Aderem A, Dong T, Del Giudice G, Rappuoli R, Cerundolo V, Pollard AJ, Pulendran B, Siegrist CA. Systems biology of immunity to MF59-adjuvanted versus nonadjuvanted trivalent seasonal influenza vaccines in early childhood. Proc Natl Acad Sci U S A. 2016 Feb 16;113(7):1853-8. doi: 10.1073/pnas.1519690113. Epub 2016 Jan 11.
PubMed 26755593
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Phase II, Open Labelled Randomised Control Trial to Describe Immune & Transcriptomic Responses to Trivalent Inactivated Vaccine (TIV) & MF59 Adjuvanted Influenza Vaccine (ATIV) in 14 -26 Month Healthy Children
- ClinicalTrials.gov ID
- NCT01682369
- Acronym / sponsor ID
- OVG 2012/04
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Sep 2012 (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.
Infants and young children do not respond as well as adults to the flu vaccines currently available in the UK. Fluad, is a different type of influenza vaccine that has been available in the European continent for the last decade, and contains an adjuvant known as MF59.
This vaccine has been used extensively in adults over 65 years of age. It has been administered to over 4000 children in previous studies, which have shown that it produces an enhanced immune response in children compared with traditional vaccines, and that it is safe in this age group. It is, however, not yet licensed for use in children. The reason for this new study is to gain a better understanding of the how this vaccine is stimulating the immune system, by looking to see which parts of the genetic code are 'switched on' in response to immunisation, and to see how this differs from the response to currently used flu vaccines.
To do this the Oxford Vaccine Group will enrol children aged 14 to 26 months to receive either the influenza vaccine with the MF59 adjuvant (ATIV) or one of the influenza vaccines currently available in the UK (Agrippal/ Begripal or TIV). The study will also help to find out whether it is possible to identify patterns of genetic response which can predict responses to immunisation. Being able to do so could potentially enable more rapid development of vaccines against influenza and other diseases in the future. We will also measure how well the immune system responds to the two vaccines and look at any side effects.
The study is funded by Aditec is a collaborative research programme that aims to accelerate the development of novel and powerful immunisation technologies for the next generation of human vaccines.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 a - TIV | Other | Biological: TIV (Aggripal)V1- Day 0- Administer a dose of 0.25ml of vaccine TIV (Agrippal) + Collect blood sample (up to 6.0 ml) V2- Day 28 (26-35)- Vaccination 2nd dose, Administer a dose of 0.25ml of vaccine TIV (Agrippal) V3-(Day V2+1)- Collect blood sample (up to 6.0 ml) V4- Day V2+28 (26-35)- Collect blood sample (up to 6.0 ml) |
| Group 1 b - TIV | Other | Biological: TIV (Aggripal)V1- Day 0- Administer a dose of 0.25ml of vaccine TIV (Agrippal) + Collect blood sample (up to 6.0 ml) V2- Day 28 (26-35)- Vaccination 2nd dose, Administer a dose of 0.25ml of vaccine TIV (Agrippal) V3-(Day V2+3)- Collect blood sample (up to 6.0 ml) V4- Day V2+28 (26-35)- Collect blood sample (up to 6.0 ml) |
| Group 1 c - TIV | Other | Biological: TIV (Aggripal)V1- Day 0- Administer a dose of 0.25ml of vaccine TIV (Aggripal) + Collect blood sample (up to 6.0 ml) V2- Day 28 (26-35)- Vaccination 2nd dose, Administer a dose of 0.25ml of vaccine TIV (Aggripal) V3-(Day V2+7)- Collect blood sample (up to 6.0 ml) V4- Day V2+28 (26-35)- Collect blood sample (up to 6.0 ml) |
| Group 2 a - ATIV | Other | Biological: ATIV (Fluad)V1- Day 0- Administer a dose of 0.25ml of vaccine ATIV (Fluad) + Collect blood sample (up to 6.0 ml) V2- Day 28 (26-35)- Vaccination 2nd dose, Administer a dose of 0.25ml of vaccine ATIV (Fluad) V3- V3(Day V2+1)- Collect blood sample (up to 6.0 ml) V4- V4 Day V2+28 (26-35)- Collect blood sample (up to 6.0 ml) |
| Group 2 b - ATIV | Other | Biological: ATIV (Fluad)V1- Day 0- Administer a dose of 0.25ml of vaccine ATIV (Fluad) + Collect blood sample (up to 6.0 ml) V2- Day 28 (26-35)- Vaccination 2nd dose, Administer a dose of 0.25ml of vaccine ATIV (Fluad) V3- V3(Day V2+3)- Collect blood sample (up to 6.0 ml) V4- V4 Day V2+28 (26-35)- Collect blood sample (up to 6.0 ml) |
| Group 2 c - ATIV | Other | Biological: ATIV (Fluad)V1- Day 0- Administer a dose of 0.25ml of vaccine ATIV (Fluad) + Collect blood sample (up to 6.0 ml) V2- Day 28 (26-35)- Vaccination 2nd dose, Administer a dose of 0.25ml of vaccine ATIV (Fluad) V3- V3(Day V2+7)- Collect blood sample (up to 6.0 ml) V4- V4 Day V2+28 (26-35)- Collect blood sample (up to 6.0 ml) |
Who may qualify
- Ages
- 14 to 26 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The investigator believes that the parents / LAR (s) of the child can and will comply with requirements of the protocol (e.g. completion of diary cards, understanding of study procedure, consent process, availability at visits)
- Written informed consent obtained from parent / LAR (s) of the subject
- Age from 14 months to 26 months (from start of 14 months up to \& excluding 27 months of age)
- Subject is healthy as determined by medical history and clinical examination
- Have received the standard UK immunisation schedule
Key exclusion criteria (9 listed)
- Child in care
- Use or planned use of any non-registered or investigational product in last 30 days
- Previous influenza vaccination
- Microbiologically proven influenza illness or treatment with antiviral medications
- Confirmed or suspected egg allergy.
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 |
|---|---|---|
| TIV (Aggripal)Also: Begripal | Biological | Group 1 a - TIV, Group 1 b - TIV, Group 1 c - TIV |
| ATIV (Fluad) | Biological | Group 2 a - ATIV, Group 2 b - ATIV, Group 2 c - ATIV |
Primary outcome
Descriptive analyses of gene expression profiles of participants following immunisation with TIV or ATIV in relation to baseline profiles.
Time frame: 56 days
To describe gene expression profiles of participants following immunisation with TIV or ATIV in relation to baseline profiles.
5 secondary outcomes
To describe the immunogenicity of TIV & ATIV in terms of haemagglutination-Inhibition test (HAI) against each of the three vaccine strains (A/H1N1, A/H3N2, B), four weeks after completion of vaccination.
Time frame: 56 days
To evaluate the reactogenicity & safety of ATIV in terms of local & systemic reactions following vaccination.
Time frame: 56 days
To study T&B cell responses following immunisation with each vaccine.
Time frame: 56 days
To explore the relationship between gene expression and the T cell, B cell and HIA response to immunisation with TIV and ATIV.
Time frame: 56 days
To explore the relationship between gene expression and the reactogenicity of TIV and ATIV.
Time frame: 56 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 2 Oct 2017.
- Background: PubMed 26755593Nakaya HI, Clutterbuck E, Kazmin D, Wang L, Cortese M, Bosinger SE, Patel NB, Zak DE, Aderem A, Dong T, Del Giudice G, Rappuoli R, Cerundolo V, Pollard AJ, Pulendran B, Siegrist CA. Systems biology of immunity to MF59-adjuvanted versus nonadjuvanted trivalent seasonal influenza vaccines in early childhood. Proc Natl Acad Sci U S A. 2016 Feb 16;113(7):1853-8. doi: 10.1073/pnas.1519690113. Epub 2016 Jan 11.
- OVG websiteLink provided by the sponsor.
Related trials for Influenza
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Not yet recruitingPhase 1
Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
ARDS, Covid19
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
RecruitingPhase 4
Impact of Egg-Based and Cell-Based Vaccine Platforms on Immune Responses to Repeated Influenza Vaccination
Immunology
RecruitingEarly Phase 1
Intradermal Influenza Vaccination
Vaccine Reaction
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 J Pollard, PhD principal investigator
Oxford Vaccine Group
Matthew Snape, PhD principal investigator
Oxford Vaccine Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TIV (Aggripal) and ATIV (Fluad) in people with Influenza, run by University of Oxford 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 5 inclusion and 9 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 2 Oct 2017. 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 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?
Descriptive analyses of gene expression profiles of participants following immunisation with TIV or ATIV in relation to baseline profiles. (time frame: 56 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 NCT01682369, 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 2 Oct 2017.