Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Immunogenicity, Reactogenicity and Safety Assessment of the Meningococcal Serogroup C Vaccine Produced by Bio-Manguinhos / FIOCRUZ in Infants, Children and Adolescents
Brief Summary:
TYPE / DESIGN STUDY: Clinical trial phase II / III, randomized, double-blind, national multi-center, with a total of 1,644 research participants stratified into 3 groups according to age for starting of the primary vaccination schedule (Stratum I - 11 to 19 years, Stratum II - 1 to 10 years; Stratum III - less than 1 year old).
BACKGROUND / STUDY CASE: Clinical trial phase II / III, which purpose is to evaluate immunogenicity, safety and reactogenicity of the vaccine against meningococcus C, conjugated to tetanus toxoid, developed by Bio-Manguinhos / FIOCRUZ (MenCC-Bio). The hypothesis of the study is that MenCC-BIO vaccine is safe and not inferior in terms of immunogenicity to the comparator vaccine currently available for the National Immunization Program in the child's immunization schedule. Thus, MenCC-Bio vaccine may meet the need for expansion of the target age group of vaccination in routine public health services and will be available to the National Immunization Program as a strategy to ensure sustainability and self-sufficiency to vaccination policy.
OBJECTIVES PRIMARY: To assess the immunogenicity of MenCC Bio-vaccine in patients from 3 months to 19 years of age, in relation to the vaccine against meningococcus C currently provided by the National Immunization Program. To evaluate the safety and reactogenicity of MenCC Bio-vaccine in patients from 3 months to 19 years old.
SECONDARY OBJECTIVES: Evaluate the cellular immune component to meningococcal C conjugate vaccine in a subset of survey participants, aged 11 to 19 years.
STUDY POPULATION: Individuals of both sexes, healthy, aged between 3 months and 19 years, attending the campus of Fiocruz / Rio de Janeiro, or municipal health units in Rio de Janeiro (living