Fractional Dose Yellow Fever Vaccination in Gambian Infants

Phase 3

Not yet recruiting

Conditions: Yellow Fever

Registration Number: PACTR202303893454050

Lead Sponsor: ondon School of Hygiene and Tropical Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 1300

Inclusion Criteria

A prospective participant must meet all the following inclusion criteria to be eligible for enrolment (randomization and vaccination):
Participants must:
• Have voluntary written/thumb-printed informed consent provided for them by a parent
Be nine- to <12 months-of-age on the day of randomization and vaccination (i.e., enrolment). They will be eligible from the day they reach nine months of age until the day before they reach 12-months-of-age.
The identity and age of all prospective participants must be as confirmed from the Infant Welfare Card (IWC) prior to informed consent. Participants/parents will be issued with a trial photographic identification card once randomization and vaccination has taken place (V1).
• Have a parent who is judged to be able to comprehend and comply with study requirements and procedures and is willing and able to return for all scheduled follow-up visits.
• Have a parent who is willing to ensure they avoid oral consumption of herbal or other local traditional medications throughout the course of the study. Also, who is willing to ensure they avoid the use of medications (for example those available for purchase at local pharmacies) except those provided by the trial team (unless in an emergency).
• Have a readily identifiable place of residence within a reasonable travelling distance of the clinical trial site.
This aims to ensure home visits for solicited AE can be undertaken reliably and that the participant is able to present to the trial site or be reviewed at their home in the event of other unsolicited health complaints. No specific geographical limits are set with this regard. Rather such decisions will be made based on the judgement of senior members of the field team based on their detailed knowledge of local geography and transport links.
• Have a parent with a consistent means of telephone contact for the duration of trial participation.
• Have a parent who is willing to ensure the participant does not receive additional YFV

Exclusion Criteria

• Used any investigational product within the 90 days prior to study vaccination or plan to use any investigational products during the period of study participation.
• Consumed (by ingestion) any herbal or other traditional medication within 14 days of study product administration.
• History of serious reactions to any prior vaccination or known hypersensitivity to any component of the YFV and or MRV
• History of anaphylactic shock or other life-threatening allergic reactions
• Any chronic, clinically significant abnormality or illness that requires medical therapy.
• Administration of any vaccines within 28 days before trial vaccination.
• History of chronic administration of immunosuppressant or other immune modifying drugs within the 12 months prior to the administration of the study vaccine.
• History of the administration of immunoglobulins and/or any blood products or anticipation of such administration during the study period.
• History of known disturbance of coagulation or blood disorder that could cause anaemia or excess bleeding.
• Any medical or social condition that in the opinion of the study clinician may interfere with the study objectives, pose a risk to the participant or prevent the participant from completing the study follow-up.
• Employee of, or direct descendant of any person employed by the investigator or sponsor.
• Plans to travel outside the study area for an extended duration during the period of study participation.
• Any vital sign with a toxicity score of > 1
• Have HIV or have been vertically exposed to HIV based on maternal history (mothers of potential participants will not be tested for HIV as part of screening but will be specifically asked and their antenatal card reviewed when available for evidence of testing.
• Have a weight for height z-score below -3SD (severe malnutrition)
• Have been vaccinated against yellow fever, measles, or rubella.