Invasive pneumococcal disease PCV10, invasive pneumococcal disease, vaccine effectiveness
Conditions
Interventions
A 2-
59 month-
old child with clinically suspected invasive disease (including meningitis and respiratory infections with bacteremia or sepsis) with all the following criteria:
• Pneumococcus is isolated from his/
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 obtaine
patients by age intervals (2-
<12,
12-
<24,
and 24-
59 months) and commune where case-
patients live before hospital admission.
Prevention,Prevention
Sponsors
Pasteur Institute in Ho Chi Minh City
Eligibility
Sex/Gender
All
Age
2 Months to 59 Months
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VE of PCV10 against IPD caused by 10 PCV10-serotypes among children recommended to receiving PCV10 30/06/2024 Matched case-control study | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Vietnam
Contacts
Public ContactThuong Nguyen
Pasteur Institute in Ho Chi Minh city
Outcome results
None listed