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Paediatric Post Pneumococcal Conjugate Vaccine Nasopharyngeal Carriage Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04401488
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : May 29, 2020
Sponsor:
Collaborator:
Solent NHS Trust
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

Brief Summary:

The investigators intend to investigate the carriage of pneumococci and other respiratory microbes since the introduction of pneumococcal conjugate vaccines (Prevenar 7 and Prevenar 13). The principal aim is to gain a collection of samples that can be used to help investigate any changes that might occur in the epidemiology of microbes that are carried in the upper respiratory tract and which may cause respiratory disease, sepsis or meningitis after the introduction of Prevenar.

Nasopharyngeal and nasal swabs will be taken from up to 2,000 children aged 4 years and under in each year of the study. Swabs will be processed using traditional microbiology and molecular diagnostic techniques and isolated microbes such as S. pneumoniae further characterised using molecular methods. The investigators will also ask parents to complete a short questionnaire requesting: basic demographic data; vaccine history; recent illness; overseas travel and antibiotic usage.

The study will contribute to the success of the introduction of pneumococcal conjugate vaccines and will play a central role in maintaining confidence. The study will also help provide information for future vaccine policy as further vaccines are developed against microbes which cause respiratory disease, sepsis and meningitis.


Condition or disease Intervention/treatment
S. Pneumoniae Pneumococcal Conjugate Vaccine Biological: Prevenar 7 and Prevenar 13

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Paediatric Post Pneumococcal Conjugate Vaccine Nasopharyngeal Carriage Study
Actual Study Start Date : October 1, 2014
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: Prevenar 7 and Prevenar 13
    pneumococcal conjugate vaccines


Primary Outcome Measures :
  1. Collection of pneumococci [ Time Frame: By the end of the study (31/03/2027) ]
    To gain a collection of pneumococci and other microbes of related importance that can be used to help investigate any changes that occur in the epidemiology of pneumococcal disease since the introduction of Prevenar 13


Secondary Outcome Measures :
  1. Understand changes in the molecular epidemiology of pneumococci [ Time Frame: By the end of the study (31/03/2027) ]
    To use all isolated strains to help understand changes in the molecular epidemiology of pneumococci, and other relevant microbe species of the upper respiratory tract.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children aged 4 years and under.
Criteria

Inclusion Criteria:

  • All children aged 4 years or under, attending the recruitment sites during the recruitment period will be invited to participate through their parents or legal guardian.

Exclusion Criteria:

  • One child per family
  • Children with obstructed nasal passages

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04401488


Contacts
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Contact: Denise Morris 02381208895 d.e.morris@soaoton.ac.uk
Contact: Stuart Clarke 02381208895 S.C.Clarke@soton.ac.uk

Locations
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United Kingdom
University Hospital Southampton Foundation NHS Trust Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Denise Morris    02381208895    d.e.morris@soton.ac.uk   
Principal Investigator: Saul Faust         
Principal Investigator: Stuart Clarke         
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
Solent NHS Trust
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Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04401488    
Other Study ID Numbers: RHM CHI0678
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs