A Phase III/IV Open-label Study of the Immunogenicity and Safety of a Single Dose of a Live Attenuated Influenza Vaccine (LAIV) (FluenzTM) for Each of Three Successive Years in Children naïve to, or in Previous Receipt of the AS03B Adjuvanted H1N1 (2009) Influenza Vaccine (Pandemrix ™).

NCT02143882 | Completed Phase 4

• 1 other identifier: LAIV Immuno
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

The Department of Health has recently announced the implementation of annual vaccination for all those aged 18 years and under, with live attenuated influenza vaccine (LAIV), which is delivered as a nasal spray. This study seeks primarily to measure antibody responses to the LAIV vaccination over three subsequent years and will involve six blood samples, six dried blood spots (taken from the end of the blood sample needle) and six oral fluid samples - before and three weeks after each vaccination each year. These samples will allow us to assess how the immune system responds to the vaccinations in terms of the antibodies that are present.

Conditions

Live Attenuated Influenza Vaccine

Keywords

Live attenuated influenza vaccine; fluenz; pandemrix; pandemic influenza vaccine; immunogenicity

Outcome Measures

Primary Outcomes (1)

• Immune responses to LAIV

  To compare the immune response to homologous and heterologous strains before and after to annual doses of LAIV over three consecutive years in children aged 49(+364days) years at enrollment in naïve children vs those in previous receipt of the AS03B adjuvanted pandemic influenza vaccine to homologous vaccine strains .

  three subsequent years, all children

Secondary Outcomes (2)

• Incidence of influenza

  all children, three subsequent years

• safety and tolerability of LAIV

  all children, three years of participation

Study Arms (1)

LAIV

EXPERIMENTAL

All children will receive LAIV, currently available as the marketed product Fluenz

Drug: Fluenz

Interventions

Fluenz DRUG

Live attenuated influenza vaccine

LAIV

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parent/legal guardian gives written informed consent for participation of their child in the study.
• Male or female aged 4 years (+364 days) to 8 years (+364 days) on the day of consent.
• Documented prior receipt of Pandemrix, or no evidence in the medical notes of never having had pandemic influenza vaccine.

You may not qualify if:

• From Fluenz Summary of Product Characteristics (SPC):
• Hypersensitivity to the active substances, to any of the excipients (e.g. gelatin; see appendix 1), to gentamicin (a possible trace residue), to eggs or to egg proteins (e.g. ovalbumin).
• Children and adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and highdose corticosteroids. FLUENZ is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled corticosteroids or lowdose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.
• Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wildtype influenza infection.
• Any contraindication to vaccination as specified in the "Green Book"Immunisation against Infectious Disease, HMSO.
• known bleeding diathesis (or any condition that may be associated with a prolonged bleeding time).
• From the SPC:
• The concurrent use of FLUENZ with antiviral agents that are active against influenza A and/or B viruses has not been evaluated. However, based upon the potential for influenza antiviral agents to reduce the effectiveness of FLUENZ, it is recommended not to administer the vaccine until 48 hours after the cessation of influenza antiviral therapy.
• Administration of influenza antiviral agents within two weeks of vaccination may affect the response of the vaccine.
• Because of this information in the SPC, should any child be given these medications the administration of LAIV would be delayed as specified.
• Study specific:
• Fever (sublingual temperature ≥ 38°C)
• Received any blood or blood products within the past 12 weeks.

Sponsors & Collaborators

• Public Health England: lead
• Institute of Child Health: collaborator

Study Sites (2)

Gloucestershire

Gloucestershire, Gloucestershire, United Kingdom

Location

Hertfordshire

Hertfordshire, Hertfordshire, United Kingdom

Location

Related Publications (1)

• Jackson D, Pitcher M, Hudson C, Andrews N, Southern J, Ellis J, Hoschler K, Pebody R, Turner PJ, Miller E, Zambon M. Viral Shedding in Recipients of Live Attenuated Influenza Vaccine in the 2016-2017 and 2017-2018 Influenza Seasons in the United Kingdom. Clin Infect Dis. 2020 Jun 10;70(12):2505-2513. doi: 10.1093/cid/ciz719.

  PMID: 31642899 DERIVED

Related Links

• PHE website

Study Officials

• Elizabeth Miller, MD

  Public Health England

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Epidemiologist

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 21, 2014
• Study Start: September 1, 2014
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: January 16, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)