Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children (H06_04TP)

GlaxoSmithKline (GSK)

Status and phase: Not yet enrolling; Phase 2

Conditions: Diarrhoea

Treatments: Biological: Menveo; Biological: Infanrix hexa; Biological: AltSonflex1-2-3; Biological: TYPHIBEV

Study type: Interventional

Funder types: Industry

Identifiers

NCT07320716

223136

Details and patient eligibility

About

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.

Enrollment: 528 estimated patients

Sex: All

Ages: 26 to 55 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children who, as infants, previously participated in two completed studies (H06_01TP or H06_02TP) and were vaccinated with 3 or 2 doses of altSonflex1-2-3 or control vaccines, respectively, completed all previous vaccinations and are 12±1 months after the last altSonflex1-2-3 vaccination.
• Individuals in good health as determined by medical history since last study visit and clinical judgment of the investigator.

Exclusion criteria

• Serious and significant progressive, unstable, or uncontrolled clinical condition(s).
• Any confirmed or suspected immunosuppressive or immunodeficient condition.
• Clinical condition(s) representing a contraindication to blood draws.
• Any behavioural or cognitive impairment or psychiatric disease.
• Acute disease and/or fever at the time of enrollment.
• Individuals with known or suspected HIV infection or HIV-related disease, with history of an autoimmune disorder or any other known or suspected impairment/alteration of the immune system, or under immunosuppressive therapy.
• Receipt of immunoglobulins and/or any blood products or plasma derivatives, during the period starting 3 months before each study visit.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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528 participants in 4 patient groups

H06_01TP Study_Infants_Selected dose

Experimental group

Description:

Infants who received 3 doses of the altSonflex1-2-3 vaccine on Day 1, Day 85, and Day 253 in the H06\_01TP parent study.

Treatment:

Biological: AltSonflex1-2-3

H06_01TP Study_ ST2_Infants_Control

Active Comparator group

Description:

Infants who received 2 doses of the Menveo vaccine on Day 1 and Day 85, and 1 dose of the Infanrix hexa vaccine on Day 281 in the H06\_01TP parent study.

Treatment:

Biological: Infanrix hexa

Biological: Menveo

H06_02TP Study_Infants_Selected dose

Experimental group

Description:

Infants who received 2 doses of the altSonflex1-2-3 vaccine on Day 1 and Day 169 in the H06\_02TP parent study.

Treatment:

Biological: AltSonflex1-2-3

H06_02TP Study_ Infants_Control

Active Comparator group

Description:

Infants who received 1 dose of the TYPHIBEV vaccine on Day 1 and 1 dose of the Infanrix hexa vaccine on Day 169 in the H06\_02TP parent study.

Treatment:

Biological: TYPHIBEV

Biological: Infanrix hexa