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A phase II, double-blind, randomised, controlled, dose ranging study to evaluate the safety, immunogenicity, dose response and schedule response of a meningococcal A conjugate vaccine administered concomitantly with local expanded program on immunisation (EPI) vaccines in healthy infants
ISRCTN ISRCTN82484612
DOI 10.1186/ISRCTN82484612
ClinicalTrials.gov identifier
EudraCT number
Public title A phase II, double-blind, randomised, controlled, dose ranging study to evaluate the safety, immunogenicity, dose response and schedule response of a meningococcal A conjugate vaccine administered concomitantly with local expanded program on immunisation (EPI) vaccines in healthy infants
Scientific title
Acronym N/A
Serial number at source RPC258
Study hypothesis The present study is primarily a dose-ranging study intended to evaluate the safety and immunogenicity of three different dosages of the meningococcal A conjugate (PsA-TT) vaccine administered in a two-dose schedule at 14 weeks and 9 months concomitantly with expanded program on immunisation (EPI) vaccine schedule currently used in Ghana that includes three doses of oral poliomyelitis vaccine (OPV) and diphtheria, tetanus, pertussis, haemophilus influenzae type B and hepatitis B virus (DTPHibHBV) vaccine administered at 6, 10 and 14 weeks of age and one dose of yellow fever vaccine and measles vaccine administered at 9 months of age.
Lay summary
Ethics approval Ethics approval received from:
1. Western Institutional Review Board (WIRB) on the 30th November 2007 (Protocol ID: 20072007; WIRB study no.: 1095050)
2. Ghana Health Service Ethical Review Committee (GHS-ERC) on the 12th June 2008 (ref: GHS-ERC 01/1/08)
3. Navrongo Health Research Centre Institutional Review Board (NHRC IRB) on the 7th July 2008 (ref: NHRCIRB070)
4. Food and Drugs Board (FDB) (Ghana) on the 25th July 2008 (ref: FDB/CT/803)
Study design Phase II, double-blind, randomised, dose-ranging controlled clinical study
Countries of recruitment Ghana
Disease/condition/study domain Bacterial meningitis
Participants - inclusion criteria A subject will be eligible for inclusion if ALL of the following apply at the time of enrolment:
1. Aged 14 to 18 weeks of age (both sexes included)
2. Written informed consent obtained from the mother, father, or guardian of the child
3. Free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator
4. Mother, father, or guardian capable and willing to bring their child or to receive home visits for their child for all follow-up visits
5. Residence in the study area
6. Fully vaccinated according to the local EPI schedule (Bacillus Calmette-Guerin [BCG] and OPV at birth, two doses of diphtheria, tetanus, whole cell pertussis, haemophilus influenzae type B and hepatitis B virus [DTwPHibHBV] and OPV at 6 and 10 weeks of age)
Participants - exclusion criteria 1. Previous vaccination against serogroup A Neisseria meningitidis
2. Known exposure to serogroup A N. meningitidis since birth
3. History of allergic disease or known hypersensitivity to any component of the study vaccines
4. History of serious adverse reactions following administration of vaccines included in the local program of immunisation
5. Administration of any vaccine other than EPI vaccines within 30 days prior to administration of study vaccines or planned vaccination during the first four weeks after the study vaccination
6. Use of any investigational or non-registered drug since birth
7. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
8. Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying agents since birth (including systemic or inhaled corticosteroids, this means prednisone, or equivalent, greater than 0.5 mg/kg/day; topical steroids are allowed)
9. A family history of congenital or hereditary immunodeficiency
10. History of meningitis or seizures or any neurological disorder
11. Major congenital defects or serious chronic illness, including malnutrition (as per investigator's judgment). Minimum weight should be of 4 kg at the time of enrolment in the study (at 14 - 18 weeks of age).
12. Acute disease at the time of enrolment (acute disease is defined as the presence of a moderate or severe illness with or without fever) is a temporary exclusion
13. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination or laboratory tests, which in the opinion of the investigator, might interfere with the study objectives
14. Any condition or criteria that in the opinion of the investigator might compromise the well being of the subject or the compliance with study procedures or interfere with the outcome of the study
15. Non-residence in the study area or intent to move out within 2 years
Anticipated start date 18/08/2008
Anticipated end date 31/12/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 1200
Interventions Group 1: EPI vaccines concomitantly with two doses of the study vaccine (PsA-TT) in infancy at 14 weeks and 9 months of age
Group 2: EPI vaccines concomitantly with one single dose of the study vaccine (PsA-TT) in infancy at 9 months of age
Group 3: EPI vaccines concomitantly with one single dose of the study vaccine (PsA-TT) in the first year of life at 12 months of age
Group 4: EPI vaccines only

Contact details for Principal Investigator:
Dr Abraham Hodgson
Navrongo Health Research Center
PO Box 114
Navrongo
Ghana
Tel: +233 742 22380
Fax: +233 742 22320
Email: ahodgson@navrongo.imicom.net

Details of joint sponsor:
Program for Appropriate Technology in Health (PATH) (USA)
1455 NW Leary Way
Seattle
WA 98107
USA
Tel: +1 206 285 3500
Fax: +1 206 285 6619
info@path.org
http://www.path.org
Primary outcome measure(s) To compare the immunogenicity at 28 days after vaccination of range dosages of the PsA-TT vaccine, when administered to infants in a two-dose schedule at 14 weeks and 9 months of age concomitantly with EPI vaccines.
Secondary outcome measure(s) 1. To evaluate the safety of range dosages of the PsA-TT vaccine, when administered to healthy infants in a two-dose schedule at 14 weeks and 9 months of age concomitantly with EPI vaccines (i.e. diphtheria, tetanus, whole cell pertussis, hepatitis B, Hib, and oral poliomyelitis at 14 weeks; measles and yellow fever at 9 months)
2. To evaluate the immunogenicity of the EPI vaccines in all vaccines groups, when administered alone or concomitantly with the PsA-TT vaccine at 14 weeks, 9 months, and 12 months of age
3. To evaluate the immunogenicity at 28 days, at 12 and 24 months (i.e. at 24 and 36 months of age) after a single dose of the PsA-TT vaccine administered at 12 months of age concomitantly with EPI vaccines
Sources of funding Bill and Melinda Gates Foundation (USA)
Trial website
Publications
Contact name Dr  Marie-Pierre  Preziosi
  Address Initiative for Vaccine Research
World Health Organization (WHO)
20 Avenue Appia
  City/town Geneva-27
  Zip/Postcode CH-1211
  Country Switzerland
  Tel +41 (0)22 791 3744
  Fax +41 (0)22 791 4860
  Email preziosim@who.int
Sponsor Serum Institute of India Limited (SIIL) (India)
  Address 212/2, Hadapsar
  City/town Pune
  Zip/Postcode 411 028
  Country India
  Tel +91 (0)20 699 3900
  Fax +91 (0)20 699 3945
  Email contact@seruminstitute.com
  Sponsor website: http://www.seruminstitute.com
Date applied 06/08/2008
Last edited 06/08/2008
Date ISRCTN assigned 06/08/2008
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