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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002443-26 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| 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) |
|
| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIV (Aggripal) | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 56 days | |
| To evaluate the reactogenicity & safety of ATIV in terms of local & systemic reactions following vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew J Pollard, PhD | Oxford Vaccine Group | Principal Investigator |
| Matthew Snape, PhD | Oxford Vaccine Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Vaccinology & Tropical Medicine (CCVTM) | Oxford | Oxfordshire | OX3 7LE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26755593 | Background | 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. |
| Label | URL |
|---|---|
| OVG website | View source |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| 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) |
|
| 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) |
|
| ATIV (Fluad) | Biological |
|
| 56 days |
| To study T&B cell responses following immunisation with each vaccine. | 56 days |
| To explore the relationship between gene expression and the T cell, B cell and HIA response to immunisation with TIV and ATIV. | 56 days |
| To explore the relationship between gene expression and the reactogenicity of TIV and ATIV. | 56 days |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |