Evaluating the effectiveness of the 10-valent pneumococcal conjugate vaccine in preventing invasive pneumococcal disease among Vietnamese children under 5 years of age
- Conditions
- Invasive pneumococcal diseasePCV10, invasive pneumococcal disease, vaccine effectiveness
- Registration Number
- TCTR20201206002
- Lead Sponsor
- Pasteur Institute in Ho Chi Minh City
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1000
Case-patients: A 2-59 month-old child with clinically suspected invasive disease (including meningitis and respiratory infections with bacteremia or sepsis) will be eligible if all the following criteria are met:
- Pneumococcus is isolated from his/her normal sterile body fluid (i.e., blood and CSF) taken as part of routine therapeutic practice.
- A case-patient who the investigator believes that his/her parent(s) or Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol
- Written informed consent obtained from the subject/from his/her parent(s) or LAR.
Controls: At recruitment, controls are healthy children who are individually matched to case-patients by age intervals (2-<12, 12-<24, and 24-59 months) and commune where case-patients live before hospital admission. The age of a case-patient will be determined based on the culture-positive date. The age of a control will be determined at the time when the enrollment takes place.
A child who meet one of the following criteria: (1) his/her parent (s) or LAR are unable or refuse to consent; (2) he/she have neither birth certificates nor hospital birth registries; (3) he/she have no immunization records; (4) he/she has participated in a PCV trial.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VE of PCV10 against IPD caused by 10 PCV10-serotypes among children recommended to receiving PCV10 30/06/2024 Matched case-control study
- Secondary Outcome Measures
Name Time Method Vaccine effectiveness of PCV10 against overall IPD among children receiving PCV10 30/06/2024 Matched case-control study ,VE of PCV10 against IPD caused by 10 PCV10 serotypes among subgroups of children receiving PCV10 30/06/2024 Matched case-control study ,Risk of IPD caused by non-PCV10 serotypes among children recommended to receiving PCV10 30/06/2024 Matched case-control study ,Risk factors among children recommended to receiving PCV10 30/06/2024 Matched case-control study