Condition category
Nervous System Diseases
Date applied
06/08/2008
Date assigned
06/08/2008
Last edited
06/08/2008
Prospective/Retrospective
Prospectively 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 Marie-Pierre Preziosi

ORCID ID

Contact details

Initiative for Vaccine Research
World Health Organization (WHO)
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 3744
preziosim@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RPC258

Study information

Scientific title

Acronym

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Bacterial meningitis

Intervention

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

Intervention type

Drug

Phase

Phase II

Drug names

Meningococcal A conjugate (PsA-TT) vaccine, oral poliomyelitis vaccine (OPV), diphtheria, tetanus, pertussis, haemophilus influenzae type B and hepatitis B virus (DTPHibHBV) vaccine, yellow fever vaccine, measles vaccine

Primary outcome measures

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 measures

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

Overall trial start date

18/08/2008

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1200

Participant 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

Recruitment start date

18/08/2008

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Ghana

Trial participating centre

Initiative for Vaccine Research
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

Serum Institute of India Limited (SIIL) (India)

Sponsor details

212/2
Hadapsar
Pune
411 028
India
+91 (0)20 699 3900
contact@seruminstitute.com

Sponsor type

Research organisation

Website

http://www.seruminstitute.com

Funders

Funder type

Charity

Funder name

Bill and Melinda Gates Foundation (USA)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

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

Publication citations

Additional files

Editorial Notes