Immune Response to a Delayed Second Dose of Oral Cholera Vaccine (NCT05453253) | Clinical Trial Compass
UnknownPhase 4
Immune Response to a Delayed Second Dose of Oral Cholera Vaccine
Guinea456 participantsStarted 2022-07-20
Plain-language summary
Immune response to a delayed second dose of oral cholera vaccine
A randomized, controlled, non-inferiority immunogenicity trial in Conakry, The Republic of Guinea
Who can participate
Age range1 Year – 40 Years
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:
* Any healthy individual ≥ 1 year-old and younger than 40 years old , eligible for OCV vaccination (not suffering from a medical condition that contraindicates vaccination, i.e. any acute illness, including acute gastrointestinal illness or acute febrile illness).
* Living in the study area with no plan to move away over the study period (up to 18 months).
* Who provided written informed consent or whose representative (mother, father or main caretaker) provided written informed consent in case of individuals younger than 18 years. A written assent will also be obtained from adolescents (10-17 years)
* An individual who (or whose mother, father or main caretaker) is, based on the judgment of the investigator, capable of complying with the study requirements.
Exclusion Criteria:
* Known history of hypersensitivity reactions to other vaccines.
* Individual acutely ill or with signs of infection at the time of enrolment (e.g. fever \> 38⁰C)
* Gastrointestinal symptoms including nausea, vomiting, diarrhea, or decreased appetite within 24 hours prior to study initiation .
* Diarrhea, administration of antidiarrheal drugs or antibiotics to treat diarrhea or abdominal pain either lasting 2 weeks or longer within 6 months prior to study initiation, or occurring during the week before study initiation.
* Other vaccination within 1 week prior to study initiation or planned vaccination during the following month after vaccine intake .
* Participation in another tr…
What they're measuring
1
Serum vibriocidal antibody specific to V. cholerae O1, Inaba, Ogawa and O139 strains
Timeframe: 14 days after the administration of the second vaccine dose