Paediatric Post Pneumococcal Conjugate Vaccine Nasopharyngeal Carriage Study

NCT04401488 | Unknown FDA Drug

• 1 other identifier: RHM CHI0678
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

S. Pneumoniae; Pneumococcal Conjugate Vaccine

Outcome Measures

Primary Outcomes (1)

• Collection of pneumococci

  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

  By the end of the study (31/03/2027)

Secondary Outcomes (1)

• Understand changes in the molecular epidemiology of pneumococci

  By the end of the study (31/03/2027)

Interventions

Prevenar 7 and Prevenar 13 BIOLOGICAL

pneumococcal conjugate vaccines

Eligibility Criteria

• Age: Up to 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 4 years and under.

You may qualify if:

• 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.

You may not qualify if:

• One child per family
• Children with obstructed nasal passages

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Solent NHS Trust: collaborator

Study Sites (1)

University Hospital Southampton Foundation NHS Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

MeSH Terms

Interventions

13-valent pneumococcal vaccine

Central Study Contacts

Denise Morris

CONTACT

02381208895; d.e.morris@soaoton.ac.uk

Stuart Clarke

CONTACT

02381208895; S.C.Clarke@soton.ac.uk

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 26, 2020
• Study Start: October 1, 2014
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)