MedTrace Logo

Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Given at 6, 7.5 and 9 Months of Age in Co-administration With Measles, Rubella and Yellow Fever (YF) Vaccines Followed by a Booster of the Malaria Vaccine.

NCT02699099 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 699

Last updated 2021-09-29

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of the SB257049 candidate malaria vaccine when co-administered with Vitamin A, measles, rubella and yellow fever vaccines to children aged 6 months at the first vaccination.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin A

Oral administration of Vitamin A (1 dose)

BIOLOGICAL

Candidate Plasmodium falciparum malaria vaccine

Intramuscular administration of SB257049 vaccine (4 doses)

BIOLOGICAL

MR-Vac

Subcutaneous injection of a combined measles and rubella vaccine (1 dose)

BIOLOGICAL

Stamaril

Intramuscular injection of a yellow fever (YF) vaccine (1 dose)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-10
Primary Completion
2018-03-14
Completion
2020-10-07

Countries

  • Ghana

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02699099 on ClinicalTrials.gov