Phase III, double-blind, randomised, placebo-controlled trial to evaluate efficacy against radiological pneumonia and invasive pneumococcal disease in Gambian infants
| ISRCTN | ISRCTN46147225 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46147225 |
| Protocol serial number | RPC096 |
| Sponsor | National Institute of Allergy and Infectious Diseases - Division of Microbiology and Infectious Diseases (USA) |
| Funders | National Institutes of Health (NIH) (USA), World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland), Bill and Melinda Gates Foundation (USA), United States Agency for International Development (USAID) (USA), Medical Research Council (UK) |
- Submission date
- 10/11/2004
- Registration date
- 05/04/2005
- Last edited
- 09/11/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Felicity Cutts
Scientific
Scientific
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
| cuttsf@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase III, double-blind, randomised, placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | PVT |
| Study objectives | To assess the efficacy of a nine-valent pneumococcal conjugate vaccine in children. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pneumococcus/vaccines |
| Intervention | 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 type 18 oligosaccharide linked to the diphtheria toxoid protein CRM197, reconstituted with DPT-Hib (Tetramune™) from the same manufacturer Placebo group: Lyophilised placebo cake reconstituted with Tetramune™ |
| Intervention type | Other |
| Primary outcome measure(s) |
First episode of radiological pneumonia |
| Key secondary outcome measure(s) |
1. Clinical or severe clinical pneumonia |
| Completion date | 01/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Weeks |
| Upper age limit | 1 Year |
| Sex | All |
| Target sample size at registration | 17500 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2000 |
| Date of final enrolment | 01/01/2004 |
Locations
Countries of recruitment
- Gambia
- Switzerland
Study participating centre
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
CH 1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/03/2005 | Yes | No |
