Study to Expand Safety and Immunogenicity Data With Shigella Bioconjugate Vaccine (Shigella4V2) i… (NCT06523231) | Clinical Trial Compass
CompletedPhase 2
Study to Expand Safety and Immunogenicity Data With Shigella Bioconjugate Vaccine (Shigella4V2) in 9-month-old Infants.
Kenya110 participantsStarted 2025-04-07
Plain-language summary
In this study, the second-generation tetravalent bioconjugate candidate vaccine Shigella4V2 will be tested to confirm data on its safety and immunogenicity in infants and to identify the best dose of Shigella4V2 in 9-month-old infants.
Who can participate
Age range8 Months – 10 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female or male aged 9 months (± 1 month) old at the time of the first vaccination.
* Born full-term (i.e., after a gestation period of 37 to less than 42 full weeks).
* Healthy by medical history, laboratory findings and physical examination before entering into the study (Participants with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
* Seronegative for HIV, hepatitis B and C (as per screening laboratory tests)
* Resident of Siaya County during the whole trial period.
* Previously completed routine primary vaccinations (6,10 and 14 weeks or thereabouts) to the best knowledge of the participant's parent/guardian. This information will be abstracted from the maternal and child health booklet. All the participant's parent/guardian will be requested to carry this booklet whenever they visit the clinic.
* Signed/thumb printed informed consent, in accordance with local practice, provided by participants' parents or guardian who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Demonstrated comprehension (by the parent/guardian) of the protocol procedures through passing a written/verbal comprehension test with a score of 80% or higher (at least 10 out of 12 questions).
Exclusion Criteria:
* Any clinically significant deviation from the normal range in biochemistry or hematological blood tests.
* Suspected or known…
What they're measuring
1
Safety - Solicited Local and Systemic Adverse Events (AEs)
Timeframe: During 7 days following each vaccination
2
Safety - Unsolicited Adverse Events (AEs)
Timeframe: During 28 days following each vaccination
3
Safety - Serious Adverse Events (SAEs)
Timeframe: Throughout the study, up to 9 months
4
Immunology - change in serum immunoglobulin G (IgG)
Timeframe: From first vaccination until 1 month following the second vaccination