ISRCTN10912262
Active, not recruiting
未知
A pneumococcal conjugate vaccine (PCV) probe study to define the role of under-fives in within-household transmission of Streptococcus pneumoniae to infants in high disease burden settings (PNEUMOCOCOON)
iverpool School of Tropical Medicine0 sites2,588 target enrollmentFebruary 9, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- iverpool School of Tropical Medicine
- Enrollment
- 2588
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All participants:
- •1\. Adult participants (\>18 years old) with written informed consent and children with parental/legal guardian’s written informed consent
- •2\. Residence in Blantyre District
- •1\. \<32 weeks gestation
- •2\. Household contacts 12\-59 months old (HHC)
- •3\. 18\-45 years old
- •1\. 12\-59 months old at time of entry into the study
- •2\. Record of PCV13 infant immunisation
- •3\. Lives in the same household as study mothers
- •1\. \<14 days old at recruitment
Exclusion Criteria
- •Mothers and household contacts 12\-59 months old (HHC):
- •1\. Ongoing antibiotic treatment
- •2\. Ongoing TB treatment including isoniazid prophylaxis
- •3\. Immunosuppressive illnesses e.g., HIV infection
- •4\. Immunosuppressive treatment e.g., steroids
- •5\. Women with prior PCV vaccination
- •6\. Women with the following comorbidities: a hypertensive disorder (including pre\-eclampsia and eclampsia), diabetes (including gestational diabetes), a previous history of preterm delivery, incompetent cervix/cervical cerclage placement, or multiple gestations (twins or more babies)
- •7\. Residence in a PAVE 2\+1 catchment area
- •1\. Previous severe adverse reaction to PCV13 or the pentavalent vaccine
- •2\. Known hypersensitivity to any components of the Prevnar 13 or the pentavalent combination vaccine, or a severe reaction to a previous dose of either vaccines or any of their constituents.
Outcomes
Primary Outcomes
Not specified
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