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Pneumococcal Vaccine Schedules

A cluster-randomised, non-inferiority trial of the impact of a two-dose compared to a three-dose schedule of pneumococcal conjugate vaccine in rural Gambia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202105646878477
Enrollment
40000
Registered
2021-05-06
Start date
2018-11-01
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pneumococci

Interventions

Sponsors

London School of Hygiene and Tropical Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Resident in the study area

Exclusion criteria

Exclusion criteria: Intent to move out of the study area before 4 months of age. Age greater than 9 months Completed PCV schedule Contraindication to PCV13 – severe hypersensitivity to a previous dose of PCV13

Design outcomes

Primary

MeasureTime frame
Nasopharyngeal (NP) carriage of vaccine-type (VT) pneumococci in children aged 2 weeks - 59 months with clinical pneumonia.

Secondary

MeasureTime frame
.NP carriage of non-vaccine-type (NVT) pneumococci in children aged 2 weeks - 59 months with clinical pneumonia. • Population-based NP prevalence of VT and NVT pneumococci with measurement of interpersonal contact patterns. • NP prevalence of VT and NVT pneumococci in infants presenting for the first dose of PCV aged 6 – 12 weeks. • Incidence of radiological pneumonia in children aged 2 weeks - 59 months. • Incidence of clinical pneumonia in children aged 2 weeks - 59 months. • Incidence of clinical pneumonia with NP carriage of VT pneumococci in children aged 2 weeks – 59 months • Incidence of serotype-specific IPD in children aged 2 weeks - 59 months. • Incidence of hospitalisation in children aged 2 weeks – 59 months. • Mortality in children aged 2 weeks - 59 months.

Countries

Gambia

Contacts

Public ContactJama Jack

Head of Communications MRCG at LSHTM

jjack@mrc.gm002204495442

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026