FindTrial
Sign In

RANDOMIZED, DOUBLE-BLIND, PIVOTAL STUDY OF PHASE III OF THE IMMUNOGENICITY, SECURITY AND COMPARATIVE TOLERANCE OF TWO VACCINES 17D AGAINST YELLOW FEVER (ARILVAX TM AND YF-VAX TM) IN INFANTS AND HEALTHY CHILDREN IN PERU

RANDOMIZED STUDY, DOUBLE-BLIND, PIVOTAL OF PHASE III OF THE IMMUNOGENICITY, SECURITY AND COMPARATIVE TOLERANCE OF TWO VACCINES 17D AGAINST YELLOW FEVER (ARILVAX TM AND YF-VAX TM) IN INFANTS AND HEALTHY CHILDREN IN PERU

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-036-02
Enrollment
Unknown
Registered
2002-05-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

group 1 Type of group
In patients with an age range of 9 months to 5 years, ARILVAX will be administered in doses of more than 3.7 PUF in 0.5 mL. Group name:group 4 Type of group
In patients of an age range of 5 years to 10 years, YF-VAX will be administered in doses of more than 5.04 PUF in 0.5 mL

Sponsors

INSTITUTO DE INVESTIGACION DE ENFERMEDADES TROPICALES DE LA MARINA DE LOS E.E.U.U (NMRCD),
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: * Age> 9 months to 10 years, also in good general health, with no medical history. * Absence of moderate or severe malnutrition according to the nomogram specific for each sex that the Ministry of Health of Peru offers to all the children.

Exclusion criteria

Exclusion criteria: *History of infection or previous vaccination against yellow fever. *History of hypersensitivity to egg ingestion or reaction. allergic to vaccines prepared in cell cultures of eggs embryonated chicken (for example, the flu, measles). *History of past treatment of leukemia, lymphoma or other malignancies.

Design outcomes

Primary

MeasureTime frame
Outcome name:seroconversion after vaccination Measure:proportion of subjects in the combined age range (9 months to 10 years of age inclusive) in each treatment group who seroconvert after vaccination. Timepoints:3 month—

Secondary

MeasureTime frame
Outcome name:Neutralization index expressed in the form of log10 Measure:The measurement of the secondary end point is the geometric mean of the neutralizing antibody titer Timepoints:31 day ; Outcome name:Neutralization index expressed in the form of log10 Measure:The measurement of the secondary end point is the geometric mean of the neutralizing antibody titer Timepoints:31 day—

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)