Phase III, double-blind, randomised, placebo-controlled trial to evaluate efficacy against radiological pneumonia and invasive pneumococcal disease in Gambian infants

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN46147225

Enrollment

17500

Registered

2005-04-05

Start date

2000-08-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Pneumococcus/vaccines Infections and Infestations Vaccination

Interventions

Treatment group: Nine-valent pneumococcal/polysaccharide protein conjugate vaccine which contains 2 µg of type 1, 4, 5, 9V, 14, 19F, 23F polysaccharides, 4 µg of type 6B polysaccharide and 2 µg of typ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Infants aged at least 6 weeks and less than one year 2. Resident in study area 3. Written informed consent obtained from mother

Exclusion criteria

Exclusion criteria: 1. Aged less than 6 weeks or more than 1 year 2. Not resident in study area 3. Planning to move out of study area within 4 months 4. Previous receipt of Diphtheria, Pertussis, Tetanus (DPT)-Haemophilus influenzae type b (Hib) vaccine 5. Uncertain prior vaccination record 6. Serious chronic illness 7. Inclusion in previous vaccine trial 8. Failure of family to give consent

Design outcomes

Primary

Measure	Time frame
First episode of radiological pneumonia	—

Secondary

Measure	Time frame
1. Clinical or severe clinical pneumonia 2. Invasive pneumococcal disease 3. All-cause admissions	—

Countries

Gambia

Outcome results

None listed

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