None listed
Conditions
Interventions
Group 1 Type of group
The dengue vaccine group will receive a 5555 formula (~ 5 log10 CCID50 of serotypes 1, 2,3, 4) of the sanofi pasteur dengue vaccine in the first, second and third vaccinations.
Group name:Group 2 Type of group
The control group will receive a placebo (NaCl containing human serum albumin) in the first and second vaccination, and the pneumococcal polysaccharide vaccine (Pneumo23) in the third vaccination.
Sponsors
SANOFI PASTEUR S.A.,
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: • Age from 2 to 11 years to the day of inclusion (Preselection) • Subject with good health, according to medical history, physical examination and laboratory parameters (Preselection + VOl) • Assent form signed by the subject (subjects> 8 years of age) and Informed Consent Form signed by the parents or other legal representative (and by an independent witness if the father or mother is illiterate) (Preselection) • Possibility of the subject and the parents / legal representative to attend all the scheduled visits and to comply with all the study procedures (Preselection + VOI) • For subjects able to conceive (girls who have already had their menarche), prevent pregnancy (use of effective contraception or abstinence) for at least 4 weeks before the first vaccination and at least 4 weeks after the last vaccination (Preselection + VOI). • Documented application of the yellow fever vaccine at least one month before the first vaccination (Preselection)
Exclusion criteria
Exclusion criteria: • Personal or family history of thymus pathology (thymoma), thymectomy or myasthenia (Preselection). • For subjects with capacity to conceive (girls who have already had their menarche), known pregnancy (Pre-selection) • For subjects with the ability to conceive (girls who have already had their menarche), known pregnancy or positive pregnancy test in the sample of blood drawn in the preselection (VOI) • Participation in another clinical study that investigates a vaccine, a medication, a medical device or a medical procedure in the 4 weeks prior to the first vaccination of the study (Preselection + VOI). • Participation planned in another clinical study during the present study (Preselection). • Congenital or acquired immunodeficiency known or suspected, immunosuppressive therapies such as anticancer chemotherapy or radiotherapy within the previous 6 months, or long-term systemic corticosteroid therapy (Preselection). • Known systemic hypersensitivity to any of the components of the vaccines, or a history of life-threatening reactions to the study vaccines or to a vaccine containing the same substances (Preselection). • Systemic hypersensitivity to the vaccine against yellow fever or a history of life-threatening reactions to the yellow fever vaccine (Preselection). • Chronic disease in a stage that could interfere with the completion or completion of the study, in the opinion of the researcher (Preselection). • Abuse of alcohol or addiction to drugs, current or past, that could interfere with the ability of the subject to comply with the procedures of the study (Preselection). • Administration of blood or blood products in the last 3 months that may interfere with the evaluation of the immune response (Preselection). • Administration of any vaccine in the 4 weeks prior to the first vaccination of the study (Pre-selection). • Planned administration of any vaccine in the 4 weeks after the first vaccination of the study (Preselection + VOI). • Seropositivity to human immunodeficiency virus, hepatitis B antigen or hepatitis C in the blood sample taken at the preselection (VOI). • Clinically significant laboratory abnormalities (as determined by the investigator) in the blood sample drawn in the preselection (VOI). • Knowledge of previous vaccination with the vaccine against pneumococcal polysaccharide (Preselection)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Neutralizing antibody levels will be measured against each of the four strains of serotypes of the parental dengue virus in the serum collected from all subjects before and 28 days after each vaccination (Dengue microneutralization test). Measure:humoral immune response Timepoints:before and 28 days after each vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Neutralizing antibodies against YF in the blood samples taken at the pre-selection visit and 28 days after the first vaccination: Neutralization test by plate reduction (PRNT). Neutralizing antibody levels will be measured by a microneutralization assay performed by GCI, sanofi pasteur, Swiftwater, USA. Measure:Serology of yellow fever Timepoints:at the pre-selection visit and 28 days after the first vaccination ; Outcome name:If temperature> 38 ° C is registered for> 48 hours, the subject and his parents will go to the study center. Tests will be conducted to identify any potential case of dengue. Measure:symptomatic cases of dengue Timepoints:28 days ; Outcome name:If temperature> 38 ° C is registered for> 48 hours within 28 days after each vaccination, the occurrence and level of virus of the vaccine against dengue in serum will be measured by quantitative RT-PCR analysis; A plaque assay may be performed on YF RT-PCR positive samples. In addition, the biological parameters of the subject will be evaluated (biochemistry and hematology) Measure:Detection of the viremia of the vaccine against dengue Timepoints:28 days | — |
Countries
Peru
Contacts
Public ContactClaudio Franco Lanata
IQVIA RDS Peru S.R.L
Outcome results
None listed