Meningococcal Disease, Meningococcal Meningitis Meningococcal Infections Meningococcal Meningitis
Conditions
Interventions
Group 1 (Experimental): A single dose of 0.5 mL of the MPV ACW135 vaccine by subcutaneous route
Group 2 (Control): A single dose of 0.5 mL of the MENCEVAX ACW vaccine by subcutaneous route
Meningococcal Vaccines
Meningococcal vaccine
Sponsors
Finlay Institute, Center for Research, and Productions of Serum and Vaccines.
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adult of both sexes, with ages between 18-35 years old. 2. Good state of physical and mental health established by medical opinion by means of anamnesis and physical exam, before beginning the study. 3. Voluntary nature expressed by means of written informed consent.
Exclusion criteria
Exclusion criteria: 1. Presence of acute disease (with or without fever) previous to the moment of their incorporation to the study. 2. Axilar temperature equal to or higher than 37.5 Celcius degrees immediately before the administration of the treatment. 3. Any suspicious or confirmed condition of immunodeficiency including positive diagnostic of HIV. 4. To have suffered meningococcal disease. 5. Therapy history with immunoglobulin during the 30 previous days to the administration of the vaccines included in the study 6. To be under immunosuppressive treatment (more than 14 days) or another type of medication that modifies the immunologic state, excluding the topical steroids or by inhalation. 7. Administration of a vaccine not planned in the Protocol, 30 days before the beginning of the study. 8. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Serious Adverse Events (SAEs) related to the vaccine (anaphylactic reaction, temperature higher than 40oC, hypotension, bronchospasm, glottis edema, convulsions). Measuring time: 1, 2, 3, 4, 5, 6, 7, 15 28 days after vaccination. Reactogenicity: Local Adverse Events (Pain in the injection site, redness in the injection site, induration in the injection site). Measuring time: Day 1,2,3,4,5,6,7, 15 and 28 after vaccination General Adverse Events (Fever, Malaise, Headache and somnolence). Measuring time: Day 1, 2, 3, 4, 5, 6, 7, 15 and 28 after vaccination. Description of the unexpected adverse events (Adverse Event name). Measuring time: 7, 15 and 28 days after the vaccination. Intensity of adverse events (Mild, moderate, or severe). Measuring time: Day 1, 2, 3, 4, 5, 6, 7, 15 and 28 after vaccination. Adverse events with causality relationship (related, unrelated). Measuring time: Day 1, 2, 3, 4, 5, 6, 7, 15 and 28 after vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity - Seroprotection (Bactericidal antibody titers = 1:8). Measuring time: at baseline and 28 days after vaccination. - Bactericidal antibody seroconversion (Increase of at least 4 times the bactericidal antibodies titers). Measuring time: at baseline and 28 days after vaccination. - Bactericidal Antibodies Geometric mean titers in serum samples. Measuring time: at baseline and 28 days after vaccination. | — |
Countries
Cuba
Contacts
Public ContactBelkis Barrera-Suarez
Polyclinic Ernesto Che Guevara, University of Computer Sciences
Outcome results
None listed