NCT03276962

Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age

Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or With-out Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,500 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 5 Months – 17 Months
• Healthy volunteers: Accepted

Summary

The study intends to establish proof of concept for a fractional dose schedule under conditions of natural exposure in children 5-17 months old at first vaccination. The study also aims to establish the role of third dose spacing in a fractional dose schedule, describe the effect of an earlier full fourth dose at Month 14 and describe the effect of multiple fractional or full yearly doses.

Detailed description

The current study intends to establish proof of concept (POC) for a fractional dose schedule under conditions of natural exposure. The study will be conducted in children 5-17 months old at first vaccination living in areas of mid to high malaria transmission, in line with the age group recommended by the World Health Organization (WHO) for the implementation of the RTS,S/AS01E vaccine. Results from this study will be critical in informing future possibilities for the development of vaccine-based strategies which, in combination with other interventions, may contribute to the malaria elimination agenda.

Conditions

• Malaria

Interventions

Type	Name	Description
BIOLOGICAL	RTS,S/AS01E (Full dose)	Participants will receive intramuscular injection of RTS,S/AS01E (full dose: 0.5 ml).
BIOLOGICAL	RTS,S/AS01E (1/5th dose)	Participants will receive intramuscular injection of RTS,S/AS01E (1/5th dose: 0.1 ml).
BIOLOGICAL	Rabies vaccine	Participants will receive intramuscular injection of rabies vaccine (0.1 ml).

Timeline

• Start date: 2017-09-28
• Primary completion: 2019-11-04
• Completion: 2022-11-14
• First posted: 2017-09-08
• Last updated: 2024-05-21
• Results posted: 2024-05-21

Locations

2 sites across 2 countries: Ghana, Kenya