Pneumococcal Vaccine Schedules (PVS)

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

ISRCTN

Registry ID

ISRCTN15056916

Enrollment

50000

Registered

2018-11-15

Start date

2019-08-22

Completion date

Unknown

Last updated

2023-12-19

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

Conditions

Streptococcus pneumoniae disease and pneumococcal colonisation Infections and Infestations Streptococcus pneumoniae infection

Interventions

13-valent pneumococcal conjugate vaccine (PCV13) will be delivered in two schedules, one with doses scheduled at ages 6, 10 and 14 weeks (3+0 schedule) and the other with doses scheduled at ages 6 wee

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Resident in the study area 2. Children aged 6 weeks to 365 days will be eligible to receive the intervention 3. Children aged 2 weeks to 59 months will be eligible for measurement of the primary endpoint and disease endpoints by disease surveillance

Exclusion criteria

Exclusion criteria: 1. Intent to move out of the study area before 4 months of age 2. Aged over 364 days 3. Contraindication to vaccination with PCV13, including severe hypersensitivity to a previous dose of PCV13

Design outcomes

Primary

Measure	Time frame
Nasopharyngeal (NP) carriage of vaccine-type (VT) pneumococci in children aged 2 weeks to 59 months with clinical pneumonia will be measured in the 2nd and 4th year of the trial. Measurement in the 4th year is the primary analysis. Measurement in the 2nd year is a secondary analysis.	—

Secondary

Measure	Time frame
1. NP carriage of non-vaccine-type (NVT) pneumococci in children aged 2 weeks to 59 months with clinical pneumonia measured in the 4th year of the trial 2. Population-based NP prevalence of VT and NVT pneumococci 3. NP prevalence of VT and NVT pneumococci in infants presenting for the first dose of PCV aged 6-12 weeks measured in the 4th year of the trial 4. Incidence of radiological pneumonia in children aged 2 weeks to 59 months will be measured by facility-based surveillance throughout the trial 5. Incidence of clinical pneumonia in children aged 2 weeks to 59 months will be measured by facility-based surveillance throughout the trial 6. Incidence of serotype-specific invasive pneumococcal disease (IPD in children aged 2 weeks to 59 months will be measured by facility-based surveillance throughout the trial 7. Incidence of hospitalisation in children aged 2 weeks to 59 months will be measured by facility-based surveillance throughout the trial 8. Mortality in children aged 2 weeks to 59 months will be measured by facility-based and demographic surveillance throughout the trial	—

Measure

Time frame

1. NP carriage of non-vaccine-type (NVT) pneumococci in children aged 2 weeks to 59 months with clinical pneumonia measured in the 4th year of the trial 2. Population-based NP prevalence of VT and NVT pneumococci 3. NP prevalence of VT and NVT pneumococci in infants presenting for the first dose of PCV aged 6-12 weeks measured in the 4th year of the trial 4. Incidence of radiological pneumonia in children aged 2 weeks to 59 months will be measured by facility-based surveillance throughout the trial 5. Incidence of clinical pneumonia in children aged 2 weeks to 59 months will be measured by facility-based surveillance throughout the trial 6. Incidence of serotype-specific invasive pneumococcal disease (IPD in children aged 2 weeks to 59 months will be measured by facility-based surveillance throughout the trial 7. Incidence of hospitalisation in children aged 2 weeks to 59 months will be measured by facility-based surveillance throughout the trial 8. Mortality in children aged 2 weeks to 59 months will be measured by facility-based and demographic surveillance throughout the trial

—

Countries

Gambia

Outcome results

None listed

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