STELLAR - STudying Early Life Live Attenuated influenza virus immune Responses
- Conditions
- This study is to evaluate nasal mucosal and systemic immune response in children given a live-attenuated intra-nasal influenza vaccineNot Applicable
- Registration Number
- ISRCTN87260269
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 40
1. Children aged between 2 and 5 years old eligible for yearly LAIV vaccination in the UK, in good health
2. Parents/legal guardian(s) have capacity to give informed consent
3. Parents/legal guardian(s) are willing and able to comply with all study procedures
4. Parents/legal guardian(s) who are over 18 years of age and are able and willing to provide written informed consent for their child’s participation in the study
Children may not participate in the study if any of the following apply:
1. Are enrolled in another clinical trial unless observational or follow-up phase (or at the discretion of the lead clinician)
2. Are taking daily medications that may affect the immune system
3. Are currently taking a steroid therapy (inhaled, nasal, oral or intravenous), or have been on these medications in the previous 6 months
4. Are confirmed or suspected to have any disease or syndrome associated with altered immunity or immunodeficiency
5. Have household contacts with a severe immunodeficiency (for example, someone who has had a recent bone marrow transplant)
6. Have already had an influenza vaccine in the current influenza season
7. Have a history of hypersensitivity to any of the following constituents – Sucrose, Dipotassium phosphate, Potassium dihydrogen phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate, gentamicin
8. Have a history of an allergic reaction to a nasal spray flu vaccine in the past
9. Are on or have a condition that needs salicylate therapy
10. Have unrepaired craniofacial malformations
11. Have a history of Guillain-Barré syndrome or Leigh syndrome
12. The nasal spray vaccine contains small traces of gelatine derived from pigs (porcine gelatine). If the use of porcine gelatine in medical products is unacceptable, they will excluded.
13. The influenza strains for the nasal spray vaccine are cultured in chicken eggs. This does not increase the risk of anaphylaxis in children with egg allergy, but if the use of chicken eggs is unacceptable, they will be excluded.
14. Are a child of a study site staff member
15. Any other issue, in the opinion of the study staff, may:
15.1. Put the children or their contact at risk because of participation in the study, or
15.2. Adversely affect the interpretation of the study results
Temporary Exclusion Criteria
Children are temporarily excluded from participating if they:
1. Are currently experiencing an exacerbation of asthma or wheeze symptoms when due the LAIV, including the increased use of relieving inhalers in the preceding 72 hours
2. Have received any other vaccine within 14 days prior to the study vaccine
3. Have scheduled elective surgery, planned admission or other procedures requiring general anaesthesia within the study period
4. Have a febrile illness (axillary temperature =38.0°C) within the previous 72 hours of the scheduled vaccination
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Viral load of LAIV from the nose and in saliva will be assessed by RT-qPCR using nasosorption and saliva sampling on days 0, 1, 2, 3, 4, 6, 9, 14, 21 and 28 of the study.
- Secondary Outcome Measures
Name Time Method 1. Measurement of antibody levels against the Influenza virus strains contained in LAIV by ELISA or comparable technical approaches on days 0, 1, 2, 3, 4, 6, 9, 14, 21 and 28 of the study<br>2. Detection of pneumococcus, most common respiratory viruses and other respiratory bacteria will be assessed by microfluidic qPCR on days 0, 1, 2, 3, 4, 6, 9, 14, 21 and 28 of the study<br>3. Measurement of antibody levels against the Influenza virus strains contained in LAIV by ELISA or comparable technical approaches by blood test at day 0 and day 28 post-vaccination