Clinical Trial Results:
Assessment of viral shedding in children previously in receipt of multiple doses of live attenuated influenza vaccine (LAIV) compared to influenza vaccine-naïve controls
Summary
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EudraCT number |
2017-000952-24 |
Trial protocol |
GB |
Global end of trial date |
28 Feb 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Feb 2019
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First version publication date |
07 Feb 2019
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
Flu-shed
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03104790 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Public Health England
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Sponsor organisation address |
Wellington House , London , United Kingdom, SE1 8UG
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Public contact |
Elizabeth Coates
elizabeth.coates@phe.gov.uk, Public Health England
Wellington House, London SE1 8UG, +44 01980612922, elizabeth.coates@phe.gov.uk
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Scientific contact |
Elizabeth Coates
elizabeth.coates@phe.gov.uk, Public Health England
Wellington House, London SE1 8UG, +44 01980612922, elizabeth.coates@phe.gov.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Feb 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Feb 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Feb 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To measure type-specific vaccine virus shedding and immunogenicity in 2017/18 and determine if there has been any change compared to previous studies in 2016/17 (conducted by this group, Eudract 2013-003592-35 and 2016-002352‐24) following change in the A/H1N1pdm09 vaccine virus strain amongst children with the same prior vaccine history
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Protection of trial subjects |
Oral Fluids used and no blood taken or vaccines given intramuscularly so no pain
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Sep 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 362
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Worldwide total number of subjects |
362
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EEA total number of subjects |
362
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
247
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Adolescents (12-17 years) |
115
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
362 subjects received LAIV and were asked to take three nasal swabs in the ten days after vaccination to assess vaccine virus shedding | ||||||
Pre-assignment
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Screening details |
Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue). Previous systemic allergic reaction to LAIV. Previous allergic reaction to an influenza vaccine (not LAIV) is a relative contra-indication, which must be discussed with the CI to confirm patient suitability. Children/adolescents who are clinically immunode | ||||||
Period 1
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Period 1 title |
PERIOD 1 (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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ARM1 | ||||||
Arm description |
All children | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
LAIV
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation vapour, solution
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Routes of administration |
Inhalation use
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Dosage and administration details |
0.2ml
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Baseline characteristics reporting groups
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Reporting group title |
PERIOD 1
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
ARM1
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Reporting group description |
All children |
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End point title |
Proportion shedding vaccine virus for H1N1 [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
within 10 days of vaccination
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive analysis only |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Within three weeks of vaccination
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Adverse event reporting additional description |
NONE
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Assessment type |
Non-systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
All subjects
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Reporting group description |
- | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Virus Shedding study only and no adverse events were solicited |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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21 Aug 2017 |
Addition of substudy in which additional samples (nasal, blood) will be collected allowing more detailed assessment of the immune response to LAIV and how this compares with previous years |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |