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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	PACTR
Last refreshed on:	29 May 2023
Main ID:	PACTR201507001154522
Date of registration:	01/06/2015
Prospective Registration:	Yes
Primary sponsor:	GlaxosSmithKline (GSK)
Public title:	202090 (EBOLA Z CHAD3-004)
Scientific title:	202090 (EBOLA Z CHAD3-004)
Date of first enrolment:	15/08/2015
Target sample size:	600
Recruitment status:	Pending
URL:	https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1154
Study type:	Interventional
Study design:	Parallel: different groups receive different interventions at same time during study,Randomised,Subjects will be randomised (1:1) at Day 0. In order to ensure equal distribution of the population, enrolment will be stratified by age so that an equal number of children are enrolled in each age stratum (1 to 5 years, 6 to 12 years, and 13 to 17 years of age). In addition, the randomisation will use a minimisation procedure accounting for gender and centre,Observer blind from study start to interim analysis. Single blind as interim analysis at Day 30
Phase:	Not Applicable

Countries of recruitment
Cameroon	Ghana	Mali	Nigeria	Senegal

Contacts

Name:	Sue Bailey
Address:	1011 Pretorius Ave, South Lyttleton 0157 Centurion South Africa
Telephone:	+27126712330
Email:	sue.bailey@quintiles.com
Affiliation:	Director, Clinical Operations

Name:	Patrice Golbert
Address:	Paris France
Telephone:	+33 140 215 998
Email:	Patrice.Golbert@quintiles.com
Affiliation:	Researcher

Key inclusion & exclusion criteria

Inclusion criteria: Subjects parent(s)/ legally acceptable representative(s) (LAR[s]) who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g., availability for Diary Card completion, return for follow-up visits, availability for clinical follow-up throughout the study period).
¿Written/ thumb printed informed consent obtained from the subject¿ parent(s)/ LAR(s) prior to performing any study specific procedure. In addition, written/ thumb printed informed assent should be obtained if appropriate (from all subjects aged 13 to 17 years and from younger subjects as per local requirements).
¿A male or female child aged 1 to 17 years inclusive at the time of Screening.
(Amended 06 May 2015.)
¿Subjects with a negative RDT test for Malaria within 30 days prior to randomisation into the study.
OR
Subjects with a positive RDT test for Malaria who completed antimalarial treatment at least 5 days prior to randomisation into the study.
(Amended 06 May 2015.)
¿Healthy subjects as per Investigator judgement, as established by medical history, clinical examination and haematology/ biochemistry laboratory parameters screening before entering into the study.
¿Female subjects of non-childbearing potential may be enrolled in the study.
Non-childbearing potential is defined as pre-menarche or ovariectomy.
Please refer to the glossary of terms for the definition of menarche.
¿Female subjects of childbearing potential may be enrolled in the study, if the subject:
has practiced adequate contraception for 30 days prior to the Day 0 visit, and
has a negative pregnancy test at the Day 0 visit, and has agreed to continue adequate contraception until 30 days after the Month 6 visit. Please refer to the glossary of terms for the definition of adequate contraception

Exclusion criteria: Child in care.
Please refer to the glossary of terms for the definition of child in care.
(Amended 06 May 2015.)
¿Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the Day 0 visit, or planned use during the study period.
¿Previous vaccination with an investigational EBOV or Marburg vaccine, or previous vaccination with a chimpanzee adenoviral vectored investigational vaccine.
¿Known prior EBOV or SUDV disease.
¿Travel to country affected by the EBOV epidemic or direct contact with person with EVD within 21 days prior to the Day 0 visit.
¿History of any reaction or hypersensitivity (such as anaphylaxis, urticaria [hives], respiratory difficulty, angioedema, or abdominal pain) likely to be exacerbated by any component of the study vaccine.
¿Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after each vaccination visit.
¿Acute or chronic illness determined by medical history, clinical examination and laboratory screening tests including, but not limited to:
Clinically significant immunosuppressive or immunodeficient condition (e.g., clinical acquired immune deficiency syndrome [AIDS]).
Major congenital defects.
Malnutrition (defined as weight for age Z-score less than -3, or other clinical signs of malnutrition).
Any clinically significant haematological or biochemical laboratory abnormality (see APPENDIX C for acceptable limits for eligibility determination).
¿Pregnant female.
¿Any condition that in the Investigator¿s opinion may potentially compromise subject safety or interfere with subject assessment or compliance.
(Amended 06 May 2015.)

Age minimum: 1 Year(s)
Age maximum: 17 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Ebola
EBOLA

Ebola

Intervention(s)

Ebola/Nimenrix

Nimenrix/Ebola

Primary Outcome(s)

¿Occurrence of any unsolicited AE

¿Occurrence of clinical symptoms of thrombocytopenia (AE of specific interest)

¿Occurrence of any SAE, in all subjects, in both groups

¿Occurrence of each solicited local and general AE

¿Occurrence of haematological (CBC, including differential count and platelet count) and biochemical (ALT, creatinine) laboratory abnormalities

Secondary Outcome(s)

¿ Anti-GP EBOV antibody titres, as measured by enzyme-linked immunosorbent assay (ELISA)

Secondary ID(s)

Source(s) of Monetary Support

GlaxoSmithKline (GSK)

Secondary Sponsor(s)

Ethics review