Health Trials

A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months

ConditionMalaria
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age5-60
SponsorGlaxoSmithKline

About this trial

The purpose of this study is to evaluate the safety and immunogenicity of reduced antigen doses and alternative vaccination regimes for RTS,S/AS01E in healthy children aged 5-60 months in a malaria-endemic area.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy male or female participants aged 5 to 60 months at the time of the first vaccination, who have previously completed the World Health Organization (WHO) Expanded Programme on Immunization (EPI) vaccinations or for younger infants have received all required vaccinations at point of recruitment according to the schedule for the country where the study is conducted.

Participants' parent(s)/Legally Acceptable Representative(s) (LAR), in the opinion of the investigator, can and will comply with the requirements of the protocol (eg, completion of the diaries, returning for follow-up visits).

Written or witnessed/thumb-printed informed consent obtained from the participant's parent(s)/LAR prior to performance of any study-specific procedure.

Healthy, as established by medical history and clinical examination.

Disqualifiers

Progressive, unstable, or uncontrolled clinical conditions.

History (known or suspected) of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.

Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

Clinical conditions representing a contraindication to IM vaccination or blood draws.

Trial design

Design model

Parallel

Treatments tested in this trial

  • RTS,S/AS01E vaccine

    Biological/Vaccine

    RTS,S/AS01E vaccine will be administered intramuscularly.

Treatment groups

238 Participants
are divided into 3 treatment groups
Group A: Groups 1 to 3Experimental treatment 1 intervention
Group B: Groups 4 and 5Experimental treatment 1 intervention
Group C: Groups 6 and 7Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Geometric Mean Concentrations (GMCs) of anti-NANP immunoglobulin G (IgG) antibodies

Time frame
12 months post-Dose 3 (Month 14 for Groups 1 to 3 and Month 19 for Groups 4 and 5 and Groups 6 and 7)

Secondary outcomes

1

Area under the curve (AUC) of anti-NANP IgG antibodies

Time frame
At Month 7 and 19
2

GMC of anti-NANP IgG antibodies

Time frame
At Month 0, 1, 2, 3, 7, 8, 14, and 19
3

Number of participants with a greater than or equal to (>=) 2-fold and a (>=) 4-fold increase from pre-Dose 1 in IgG antibody concentration

Time frame
At Month 0, 1, 2, 3, 7, 8, 14, and 19
4

Number of participants with solicited administration site events

Solicited administration site events include pain, redness, and swelling at administration site.

Time frame
Up to 7 days after each vaccine administration (vaccine administered on Day 1, Month 1, Month 2, and Month 7)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov
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