The role of under-fives in pneumococcal transmission to newborn babies within households

Not Applicable

• Conditions: Prevention of pneumococcal carriage and disease; Infections and Infestations

• Registration Number: ISRCTN10912262
• Lead Sponsor: iverpool School of Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-09
• Last Update Posted: 20 February 2023
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2588

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

Mothers:
1. <32 weeks gestation
2. Household contacts 12-59 months old (HHC)
3. 18-45 years old

HHC:
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

Infants
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

HHC:
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.
3. <2 or >4 doses of PCV

Infants:
1. Preterm birth (<37 weeks)
2. Congenital abnormalities of the upper airways

Study & Design

• Study Type: Interventional
• Study Design: Not specified