Paediatric Post Pneumococcal Conjugate Vaccine Nasopharyngeal Carriage Study
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|ClinicalTrials.gov Identifier: NCT04401488|
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : May 29, 2020
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|
|Study Type :||Observational|
|Estimated Enrollment :||4000 participants|
|Observational Model:||Ecologic or Community|
|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|
- Biological: Prevenar 7 and Prevenar 13
pneumococcal conjugate vaccines
- 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
- 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.
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
|Contact: Denise Morrisfirstname.lastname@example.org|
|Contact: Stuart Clarke||02381208895||S.C.Clarke@soton.ac.uk|
|University Hospital Southampton Foundation NHS Trust||Recruiting|
|Southampton, Hampshire, United Kingdom, SO16 6YD|
|Contact: Denise Morris 02381208895 email@example.com|
|Principal Investigator: Saul Faust|
|Principal Investigator: Stuart Clarke|