ADITEC FLU 2 STUDY: Understanding the Genetics Basis for Immune Responses to Flu Vaccines in Children and Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 11 December 2023
• Main ID: NCT02529904
• Date of registration: 07/08/2015
• Prospective Registration: No
• Primary sponsor: University of Oxford
• Public title: ADITEC FLU 2 STUDY: Understanding the Genetics Basis for Immune Responses to Flu Vaccines in Children and Adults
• Scientific title: A Phase II, Open Label Study to Describe Immune & Transcriptional Responses to MF59 Adjuvanted Trivalent Influenza Vaccine (ATIV) in Healthy 13-24 Month Children and Adults 18-65 Years
• Date of first enrolment: August 2015
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02529904
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: Andrew J Pollard, PhD
• Affiliation: University of Oxford

Key inclusion & exclusion criteria

Inclusion Criteria:

- Children:

- The investigator believes that the parents/LAR(s) of the child can and will
comply with requirements of the protocol (e.g. completion of electronic diary,
understanding of study procedure, consent process, availability at visits) and
have internet access for the duration of the study.

- Written informed consent obtained from parent/LAR(s) of the subject

- Age from 13 months up to 24 months (excluding 24 months + 0 days and older) at
time of V1 (first immunisation visit)

- Born to two caucasian parents

- Participant is healthy as determined by medical history and clinical examination

- Have received all the vaccines specified in the UK immunisation schedule

Adults:

- Written and informed consent obtained from participant

- Age from 18 years up to 65 years (excluding 65 yrs + 0 days and older)

- Caucasian

- Participant has internet access for the duration of the study

- Participant is healthy as determined by medical history and clinical examination

Exclusion Criteria:

- Children

- 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).

- Recommended for influenza vaccine in UK (eg. Children in clinical risk groups as
specified by Public Health England)

- 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

Adults

- Use (or planned use) of any non-registered or investigational product in last 30 days

- 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

- Prior receipt of the 2015/2016 influenza vaccine

- Recommended for influenza vaccine in UK (eg. in clinical risk groups as specified by
Public Health England)

- 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

- Pregnancy



Age minimum: 13 Months
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Biological: MF59 - ATIV

Primary Outcome(s)

Relationship between early gene transcriptional responses and haemagglutination inhibition (HAI) responses [Time Frame: 113 days]

Early gene transcriptional responses to immunization with MF59-ATIV [Time Frame: 113 days]

Secondary Outcome(s)

Relationship between innate immune and gene transcriptional responses to ATIV immunization [Time Frame: 113 days]

Immunogenicity of ATIV in terms of HAI responses to each of the 3 vaccine strains [Time Frame: 113 days]

Relationship between reactogenecity of ATIV (with particular focus on early inflammatory responses and early innate immune responses and gene transcriptional patterns [Time Frame: 113 days]

Secondary ID(s)

OVG 2015/02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

VisMederi srl

Emory University