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Clinical Trials/EUCTR2014-004634-26-GB
EUCTR2014-004634-26-GB
Active, not recruiting
Phase 1

The Effect of Live Attenuated Influenza Vaccine (LAIV) on Experimental Human Pneumococcal Colonisation (EHPC) Study - LAIV and EHPC

Royal Liverpool University Hospital0 sites335 target enrollmentApril 28, 2015
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ConditionsPneumococcal colonisation post inoculationMedDRA version: 18.1 Level: PT Classification code 10059429 Term: Influenza immunisation System Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Body processes [G] - Microbiological Phenomena [G06]
DrugsFluenz Tetra/ FluMistFluarix Tetra

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Pneumococcal colonisation post inoculation
Sponsor
Royal Liverpool University Hospital
Enrollment
335
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 28, 2015
End Date
April 30, 2017
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • •have capacity to give informed consent
  • •aged 18\-50 yrs \- ages chosen to minimise the risk of pneumococcal infection
  • •speak fluent English\- to ensure a comprehensive understanding of the research project and their proposed involvement, in order to minimise any communication issues to maximise participant safety.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 314
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range 0

Exclusion Criteria

  • •Not currently involved in another study unless observational or in follow\-up phase (non\-interventional)
  • •Not received any influenza vaccine over the last 2 years
  • •No egg allergy (as per influenza vaccines patient leaflet)
  • •No previous significant adverse reaction to any vaccination/immunisation
  • •No close contact with at risk individuals (children under 5years, immunosuppressed adults, elderly, chronic ill health) – to minimise risk of pneumococcal transmission and transmission of virus for those receiving the LAIV
  • •Not current regular smoker (smokes daily)
  • •No significant smoking history \[defined as someone who has previously smoked more than 20 cigarettes per day for 10 years or the equivalent (\>10 pack yrs)] – to minimise risk of bronchoscopy or pneumococcal disease
  • •No asthma (on regular medication) or respiratory disease – to minimise risk of bronchoscopy or pneumococcal disease
  • •Not pregnant \- to minimise the risk of pneumococcal disease
  • •Women of child\-bearing potential (WOCBP) who are not deemed to have sufficient, effective birth control in place for 1 month prior to vaccination and 1 month after the final vaccination

Outcomes

Primary Outcomes

Not specified

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