Randomized double blind controlled, phase I clinical trial, to assess safety, reactogenicity and immunogenicity of the 638 vaccine candidate, in healthy female and male children and adolescents aged from 5 to 17 years old from Cienfuegos Province, Cuba.

Phase 1

• Conditions: Cholera infection

• Registration Number: RPCEC00000172
• Lead Sponsor: Center for Research and Production of Sera and Vaccines (Finlay Institute)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Female and male adolescents and children aged from 5 to 17 years old, located between the 10th and 90th percentile, according to the Cuban population nutritional evaluation tables.
2.Good physical and mental health criteria established by anamnesia, physical examination, and results of the hematology, hemochemistry and urine laboratory tests within reference parameters, before the beginning of the study.
3.Expressed willfulness by means of a written Informed Consent, signed either by the father, the mother or the legal tutor of the girls and boys, and by the approval of the children of 10 or more years old..

Exclusion Criteria

The participant should not be included if complies with at least one of the following criteria:
1.Transmissible or non-transmissible chronic disease referenced or detected during a clinical examination.
2.Acute illness detected in the previous week when the investigational product be fed, with or without fever.
3.Anemia with hemoglobin levels below 10 g / dl, according to the WHO criteria.
4.Axiliary temperature = 37.5°C immediately previous to the Investigational products be fed.
5.Congenital or acquired immunodeficiency.
6.To be under immunosuppressive therapy (more than 14 days before administration of the Investigational Products) or other medication that modifies the immune status, excluding topical or inhaled steroids.
7.History of therapy with immunoglobulin or blood products within 6 months prior to the administration of the vaccine candidate or placebo.
8.History of antibiotic therapy during the 28 days prior to the administration of the Investigational Products or benzathine penicillin therapy.
9.Allergy to medications under study.
10.Change in the normal stool pattern of the volunteers in the month previous to the study.
11.History of acute diarrhea event 30 days before the clinical trial starts or history of chronic diarrhea events.
12.At least one episode of abdominal pain for more than 2 weeks in the last 30 days and (or) anorexia, nausea, malaise or vomiting in the last 24 hours.
13.Antecedent of cholera disease in the last three years.
14.Previous history of immunization with vaccines against cholera.
15.V. cholerae O1 Positive stool culture.
16.Volunteers with vibriocidal antibody titer more than 20, seven days before the investigational products feeding.
17.Volunteers with IgG antibody titers by ELISA cholera antitoxin, seven days previous to the investigational products feeding.
18.History of allergic reactions to any component of the vaccine candidate, placebo or antacid as well as milk intolerance.
19.Positive pregnancy test in menstruant girls .

Study & Design

• Study Type: Interventional
• Study Design: Not specified