Contact information
Type
Scientific
Primary contact
Dr Felicity Cutts
ORCID ID
Contact details
20
Avenue Appia
Geneva-27
CH 1211
Switzerland
cuttsf@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RPC096
Study information
Scientific title
Acronym
PVT
Study hypothesis
To assess the efficacy of a nine-valent pneumococcal conjugate vaccine in children.
Ethics approval
Not provided at time of registration
Study design
Phase III, double-blind, randomised, placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Phase III
Drug names
Primary outcome measure
First episode of radiological pneumonia
Secondary outcome measures
1. Clinical or severe clinical pneumonia
2. Invasive pneumococcal disease
3. All-cause admissions
Overall trial start date
01/08/2000
Overall trial end date
01/01/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Approx. 17500
Participant 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
Recruitment start date
01/08/2000
Recruitment end date
01/01/2004
Locations
Countries of recruitment
Gambia
Trial participating centre
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
Sponsor information
Organisation
National Institute of Allergy and Infectious Diseases - Division of Microbiology and Infectious Diseases (USA)
Sponsor details
6610 Rockledge Drive
Rm 6037
Bethesda
20892
United States of America
+1 3014022126
ehorigan@niaid.nih.gov
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
National Institutes of Health (NIH) (USA)
Alternative name(s)
The National Institutes of Health, NIH
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United States of America
Funder name
World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Bill and Melinda Gates Foundation (USA)
Alternative name(s)
बिल एंड मिलिंडा गेट्स फाउंडेशन, Bill & Melinda Gates Foundation, Gates Foundation, 比尔及梅琳达·盖茨基金会, BMGF, B&MGF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United States of America
Funder name
United States Agency for International Development (USAID) (USA)
Alternative name(s)
U.S. Agency for International Development, USAID
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United States of America
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15794968
Publication citations
-
Results
Cutts FT, Zaman SM, Enwere G, Jaffar S, Levine OS, Okoko JB, Oluwalana C, Vaughan A, Obaro SK, Leach A, McAdam KP, Biney E, Saaka M, Onwuchekwa U, Yallop F, Pierce NF, Greenwood BM, Adegbola RA, , Efficacy of nine-valent pneumococcal conjugate vaccine against pneumonia and invasive pneumococcal disease in The Gambia: randomised, double-blind, placebo-controlled trial., Lancet, 365, 9465, 1139-1146, doi: 10.1016/S0140-6736(05)71876-6.