Frequently Asked Questions
Who is the Sponsor?
Who is the Vaccine Manufacturer?
Aventis Pasteur, Lyon, France
Where are the Trial Centres?
48 Barangay Health Stations in 6 municipalities of Province of Bohol (Baclayon, Balilihan, Cortes, Dauis, Panglao and Tagbilaran), The Philippines
Are there any Trial hospitals?
4 hospitals from the municipality of Tagbilaran will be involved in the case detection: the Bohol Regional Hospital (BRH) and 3 private hospitals, i.e. the Borja Family Clinic, the Medical Mission Group of Hospitals and the Community Hospital. Additionally to these hospitals, the four other private hospitals of Tagbilaran will be involved in the Serious Adverse Event surveillance.
What is the planned trial period?
June 2000 - June 2005
What is the primary objective?
To determine the protective efficacy of the eleven-valent pneumococcal conjugate vaccine compared to the placebo, against community acquired X-ray positive pneumonia.
What is the trial design?
Effectiveness trial Double blind, randomized, placebo-controlled, multicenter
How many children will be enrolled?
Total 12190 children
Are any other vaccines given?
Bacillus Calmette Guerin vaccine (BCG)
Plasma derived Hepatitis B vaccine
Diphtheria-Tetanus-Pertussis // PRP-T vaccine
Oral polio vaccine
Live measles vaccine
What is the vaccination schedule?
one dose at 6, 10, and 14 weeks
What is the follow-up duration?
until 2 years of age or until the end of the trial (June 2005)
This trial is conducted in accordance with the latest South Africa revision of the Declaration of Helsinki http://www.wma.net/e/policy/17c.pdf, International Conference on Harmonisation (ICH) guidelines for Good Clinical Practice (GCP) http://www.ifpma.org/ich1.asp and local regulatory requirements. The protocol and its amendments are approved by an Ethical Review Board (ERB) and an Institutional Review (IRB) Board.
See also http://www.who.int/medicines/library/par/ggcp/GGCP.asp for further information on Good Clinical Practice