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

NCT07036159 | Recruiting Phase 2

• 2 other identifiers: 2232472024-000563-20
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Malaria

Keywords

Parasitic disease; Plasmodium falciparum; Malaria; Safety; Immunogenicity; Healthy children

Outcome Measures

Primary Outcomes (1)

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

  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 (13)

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

  At Month 7 and 19

• GMC of anti-NANP IgG antibodies

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

• 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

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

• Number of participants with solicited administration site events

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

• Number of participants with solicited systemic events

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

Study Arms (3)

Groups 1 to 3

EXPERIMENTAL

Participants receive 3 doses of RTS,S/AS01E vaccine on Day 1, Month 1, and Month 2.

Biological: RTS,S/AS01E vaccine

Groups 4 and 5

EXPERIMENTAL

Participants receive 3 doses of RTS,S/AS01E vaccine on Day 1, Month 1, and Month 7.

Biological: RTS,S/AS01E vaccine

Groups 6 and 7

EXPERIMENTAL

Participants receive 3 doses of RTS,S/AS01E vaccine on Day 1, Month 2, and Month 7.

Biological: RTS,S/AS01E vaccine

Interventions

RTS,S/AS01E vaccine BIOLOGICAL

RTS,S/AS01E vaccine will be administered intramuscularly.

Also known as: Mosquirix

Groups 1 to 3; Groups 4 and 5; Groups 6 and 7

Eligibility Criteria

• Age: 5 Months - 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Negative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV).
• With hemoglobin levels \>8 g/dL.
• Born after a gestation period of ≥37 weeks.

You may not qualify if:

• 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.
• Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study.
• Recurrent history of or uncontrolled neurological disorders or seizures.
• Undernutrition, defined as WHO Z-score less than -2 standard deviation.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant as a result of participation in the study, for example, any major congenital defects.
• Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination and medical history.
• Administration of long-acting immune-modifying drugs (eg, infliximab) during the study period starting 3 months before the first dose of study vaccine or planned administration during the study period.
• Prior receipt of a malaria vaccine (registered or experimental).
• Use of any investigational or non-registered product (drug, vaccine, or medical device)\* other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -30 to Day 1), or planned use during the study period.
• Planned administration of a vaccine not foreseen by the study protocol or the country EPI in the period starting 14 days before each dose and ending 28 days after the last dose of study vaccine administration\*, with the exception of flu vaccines and vaccines administered as part of a public health vaccination campaign\*.
• \*If emergency mass vaccination for an unforeseen public health threat (eg, a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced, provided the vaccination is used according to the local governmental recommendations and the Sponsor is notified.
• Administration of immunoglobulins and/or any blood products or plasma derivatives, or bone marrow transplantation, during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Kigali, Rwanda

RECRUITING

GSK Investigational Site

Kigali, Rwanda

RECRUITING

MeSH Terms

Conditions

Malaria; Parasitic Diseases; Malaria, Falciparum

Interventions

RTS,S-AS01E vaccine; RTS malaria vaccine

Condition Hierarchy (Ancestors)

Protozoan Infections; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Julien M Nyombayire, MD, MSc

  Center for Family Health Research

  PRINCIPAL INVESTIGATOR

• Mossi Nzeyimana, MD

  Rinda Ubuzima Gatenga Medicalized Health Center University of Rwanda

  PRINCIPAL INVESTIGATOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: August 6, 2025
• Primary Completion (Estimated): April 23, 2027
• Study Completion (Estimated): April 23, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

RW (2)