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Completed

NCT Number: NCT01682369

ADITEC FLU STUDY: Understanding the Genetic Basis for Immune Responses

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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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

14 month–26 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).
  • 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

Treatment and study plan

TIV (Aggripal)

Biological

Other names: Begripal

ATIV (Fluad)

Biological

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. To evaluate the reactogenicity & safety of ATIV in terms of local & systemic reactions following vaccination.

    Time frame: 56 days

  3. To study T&B cell responses following immunisation with each vaccine.

    Time frame: 56 days

  4. 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

  5. To explore the relationship between gene expression and the reactogenicity of TIV and ATIV.

    Time frame: 56 days

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Sep 10, 2012
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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