Condition category
Infections and Infestations
Date applied
10/11/2004
Date assigned
05/04/2005
Last edited
09/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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)

NIH

Funding Body Type

government organisation

Funding Body Subtype

federal/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)

Bill & Melinda Gates Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Funder name

United States Agency for International Development (USAID) (USA)

Alternative name(s)

USAID

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15794968

Publication citations

  1. 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.

Additional files

Editorial Notes