Live Attenuated Influenza VaccinePhase 4LAIV ImmunoNCT02143882

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 4 study testing Fluenz in people with Live Attenuated Influenza Vaccine, run by Public Health England at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 5 to 10 yearsHealthy volunteers can take part
Conditions the study is for: Live Attenuated Influenza Vaccine
What is being tested?: Fluenz
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 2 sitesUnited Kingdom
Study dates: Sep 2014to 31 Mar 2017
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 10 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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:

Show all 16Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

Gloucestershire
Gloucestershire, Gloucestershire
Hertfordshire
Hertfordshire, Hertfordshire

Other trials in United Kingdom

About this study

Official title: 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 ™).

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.

Read the 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.

Conditions: Live Attenuated Influenza Vaccine
Being tested: Fluenz
Keywords: Live attenuated influenza vaccine, fluenz, pandemrix, pandemic influenza vaccine, immunogenicity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FluenzDrug
Live attenuated influenza vaccine

Study groups in NCT02143882
Study group	Role	What they receive
LAIV	Experimental	All children will receive LAIV, currently available as the marketed product Fluenz Receives: Drug: Fluenz

What is being measured

The primary outcome is the main question the study is designed to answer.

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 .
Measured: three subsequent years, all children

Secondary outcomes (2)

Incidence of influenza
To document the incidence of laboratory confirmed influenza and other respiratory viruses in the naïve and Pandemrix™ primed children over the three seasons.
Measured: all children, three subsequent years
safety and tolerability of LAIV
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.
Measured: all children, three years of participation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201431 Mar 2017

First posted21 May 2014 (estimated)
Study startSep 2014
Primary completion31 Mar 2017
Study completion31 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Live Attenuated Influenza VaccineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02143882
Sponsor's protocol ID: LAIV Immuno
Acronym: LAIV Immuno
Status last verified: Jan 2018
First submitted: 13 May 2014
Last updated: 16 Jan 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 31642899

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingEarly Phase 1
Vaccine Pandemic Preparedness Through Airway Immunology Characterization
Influenza, Human
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How Healthy Adults Respond to the Nasal Flu Vaccine
Mucosal Immune Response to Influenza Vaccination
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All Live Attenuated Influenza Vaccine trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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 ™).
ClinicalTrials.gov ID: NCT02143882
Acronym / sponsor ID: LAIV Immuno / LAIV Immuno
Conditions: Live Attenuated Influenza Vaccine
Keywords: Live attenuated influenza vaccine, fluenz, pandemrix, pandemic influenza vaccine, immunogenicity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Public Health EnglandOther government
Collaborators: Institute of Child Health
Study start: Sep 2014
Primary completion: 31 Mar 2017 (actual)
Study completion: 31 Mar 2017 (actual)
First posted: 21 May 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LAIV	Experimental	Drug: FluenzAll children will receive LAIV, currently available as the marketed product Fluenz

Who may qualify

Ages: 5 to 10 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Parent/legal guardian gives written informed consent for participation of their child in the study.

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FluenzLive attenuated influenza vaccine	Drug	LAIV

Primary outcome

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 .

2 secondary outcomes

Incidence of influenza
Time frame: all children, three subsequent years
safety and tolerability of LAIV
Time frame: all children, three years of participation

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
Derived from this study: PubMed 31642899Jackson 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.
PHE websiteLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Live Attenuated Influenza Vaccine

Active, not recruitingEarly Phase 1
Vaccine Pandemic Preparedness Through Airway Immunology Characterization
Influenza, Human
Not yet recruitingPhase 4
How Healthy Adults Respond to the Nasal Flu Vaccine
Mucosal Immune Response to Influenza Vaccination
Not yet recruitingPhase 4
Intranasal LAIV Mucosal Immunity Examination
Impact of Vaccination
Enrolling by invitationPhase 4
A Study on Mucosal Specific IgA Immunokinetics After Administration of Nasal Spray Live Attenuated Influenza Vaccine
Influenza
Recruiting
GEneRating Mucosal Immunity After INfluenzA Infection and Vaccination in Lung and Lymphoid TissuE
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elizabeth Miller, MD principal investigator

Public Health England

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluenz in people with Live Attenuated Influenza Vaccine, run by Public Health England at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immune responses to LAIV (time frame: three subsequent years, all children). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02143882, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.