Long-term immune response to altSonflex1-2-3 vaccine in African children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 follow-up study assessing long-term immunogenicity of the altSonflex1-2-3 vaccine in children who participated in prior dose-selection trials. No new vaccinations are given; researchers collect blood samples to measure immune markers at 1, 2, and 3 years after the last vaccine dose. The study builds on two earlier vaccination schedules to determine how durable the immune response remains over time. Participation is limited to children who completed the prior studies and are now around 12 months post-vaccination, with ongoing safety monitoring through medical history and clinical judgment. Core vaccines used as comparators in the prior studies include Menveo, Infanrix hexa, and TYPHIBEV, with the primary goal of characterizing sustained immunogenicity in an African setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• GSK Investigational Site
  Kericho, Kenya Recruiting

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.