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Trial record 4 of 28 for:    pandemrix AND influenza vaccine

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 ™). (LAIV Immuno)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02143882
Recruitment Status : Completed
First Posted : May 21, 2014
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
Institute of Child Health
Information provided by (Responsible Party):
Prof. Elizabeth Miller, Public Health England

Tracking Information
First Submitted Date  ICMJE May 13, 2014
First Posted Date  ICMJE May 21, 2014
Last Update Posted Date January 16, 2018
Study Start Date  ICMJE September 2014
Actual Primary Completion Date March 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
Immune responses to LAIV [ Time Frame: three subsequent years, all children ]
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 .
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02143882 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
  • Incidence of influenza [ Time Frame: all children, three subsequent years ]
    To document the incidence of laboratory confirmed influenza and other respiratory viruses in the naïve and Pandemrix™ primed children over the three seasons.
  • safety and tolerability of LAIV [ Time Frame: all children, three years of participation ]
    To compare the safety and tolerability of annual doses of LAIV in naïve compared to Panemrix™ vaccinated children in terms of local and systemic reactions following vaccination as recorded in a health diary for the week following vaccination as well as any serious adverse events identified throughout the study period.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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 ™).
Official Title  ICMJE 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 ™).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 ™).
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.
Detailed Description

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. The programme will begin in the influenza season, from September 2013, with children aged 24 years of age, and older children being included from the influenza season of 2014. Therefore 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.

The study will specifically recruit children in previous receipt of Pandemrix, a pandemic influenza vaccine, and those naïve to pandemic influenza vaccination, which will allow the comparison of responses to LAIV between these groups.

The sample size required to answer the primary objective of the study is 200 evaluable children per group. As the study will be conducted over three years the recruitment target will be 500 children across the two groups to allow for the expected attrition of numbers over time.

The investigators will also be assessing how well the vaccines are tolerated and each participant will therefore be asked to complete a health diary for the week following vaccination. They will be asked to record any symptoms, which the investigators will elicit in line with the information in the Summary of Product Characteristics (SPC) as well as any illnesses or visits to their GP or hospital.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Live Attenuated Influenza Vaccine
Intervention  ICMJE Drug: Fluenz
Live attenuated influenza vaccine
Study Arms  ICMJE Experimental: LAIV
All children will receive LAIV, currently available as the marketed product Fluenz
Intervention: Drug: Fluenz
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2017)
300
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2014)
500
Actual Study Completion Date  ICMJE March 31, 2017
Actual Primary Completion Date March 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Absolute exclusion criteria. The participant may not enter the study if ANY of the following apply:

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.

Study specific exclusions:

  • 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).
  • Any other significant condition or circumstance which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. *Temporary Exclusion Criteria

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02143882
Other Study ID Numbers  ICMJE LAIV Immuno
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prof. Elizabeth Miller, Public Health England
Study Sponsor  ICMJE Public Health England
Collaborators  ICMJE Institute of Child Health
Investigators  ICMJE
Principal Investigator: Elizabeth Miller, MD Public Health England
PRS Account Public Health England
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP