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NOT YET RECRUITING
NCT07320716
PHASE2

Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The current study is a follow-up to 2 previous parent studies, a dose-selection study with 3 different dose-levels of the altSonflex1-2-3 vaccine in a schedule of 3 vaccinations (H06\_01TP study \[NCT05073003, 212149\]) and a study with an alternate 2 vaccination schedule H06\_02TP study \[NCT06663436, 219449\]). The current study aims to assess the longevity of the immune response to the selected dose of the altSonflex1-2-3 vaccine 1, 2, and 3 years after the last vaccination in African children. The study involves no new vaccinations but will collect immunogenicity blood samples from participants.

Official title: A Phase 2, Open-Label, Single-Center, Long-Term Immunogenicity Follow-Up Study of the GVGH altSonflex1-2-3 Shigella Vaccine 1, 2 and 3 Years After Vaccination in African Children

Key Details

Gender

All

Age Range

26 Months - 55 Months

Study Type

INTERVENTIONAL

Enrollment

528

Start Date

2026-01-02

Completion Date

2028-10-31

Last Updated

2026-01-06

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

AltSonflex1-2-3

No intervention is administered in this extension study. The selected dose of altSonflex1-2-3 vaccine was administered intramuscularly in the participants' thigh during the H06\_01TP (212149) parent study on Day 1, Day 85, and Day 253; or on Day 1 and Day 169 during the H06\_02TP (219449) study.

BIOLOGICAL

Menveo

No intervention is administered in this extension study. The Menveo vaccine was administered intramuscularly in the participants' thigh on Day 1 and Day 85 during the H06\_01TP (212149) parent study.

BIOLOGICAL

Infanrix hexa

No intervention is administered in this extension study. The Infanrix hexa vaccine was administered intramuscularly in the participants' thigh on Day 281 during the H06\_01TP (212149) study; or on Day 169 during the H06\_02TP (219449) parent study.

BIOLOGICAL

TYPHIBEV

No intervention is administered in this extension study. The TYPHIBEV vaccine was administered intramuscularly in the participants' thigh on Day 1 during the H06\_02TP (219449) parent study.