Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
ConditionDiarrhoea
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age26-55
SponsorGlaxoSmithKline
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AltSonflex1-2-3
- Menveo
- Infanrix hexa
- TYPHIBEV
Treatment groups
528 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov