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
Secondary identifying numbers	RPC096

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Felicity Cutts
Scientific

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Email	cuttsf@who.int

Study design	Phase III, double-blind, randomised, placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
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	First episode of radiological pneumonia
Secondary outcome measures	1. Clinical or severe clinical pneumonia 2. Invasive pneumococcal disease 3. All-cause admissions
Overall study start date	01/08/2000
Completion date	01/01/2004

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Weeks
Upper age limit	1 Year
Sex	Both
Target number of participants	Approx. 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

20, Avenue Appia

Geneva-27
CH 1211
Switzerland

National Institute of Allergy and Infectious Diseases - Division of Microbiology and Infectious Diseases (USA)
Government

6610 Rockledge Drive, Rm 6037
Bethesda
20892
United States of America

Research organisation

National Institutes of Health (NIH) (USA)
Government organisation / National government

Alternative name(s): Institutos Nacionales de la Salud, US National Institutes of Health, NIH
Location: United States of America

World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)

No information available

Bill and Melinda Gates Foundation (USA)
Government organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Bill & Melinda Gates Foundation, Gates Foundation, BMGF, B&MGF, GF
Location: United States of America

United States Agency for International Development (USAID) (USA)
Government organisation / National government

Alternative name(s): U.S. Agency for International Development, Agency for International Development, USAID
Location: United States of America

Medical Research Council (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/03/2005		Yes	No