Serogroup C Meningococcal Meningitis Clinical Trial
Official title:
Immunogenicity, Reactogenicity and Safety Assessment of the Meningococcal Serogroup C Vaccine Produced by Bio-Manguinhos / FIOCRUZ in Infants, Children and Adolescents
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 in areas covered by the municipal units health participants) that fit in the study
eligibility criteria.
NUMBER OF CENTRES: Two Clinical sites.
STUDY DURATION: Estimate of 19 months.
INTERVENTION / TREATMENT: Two intervention groups (MenCC-BIO Vaccine and Comparator) in three
age groups, with specific vaccination schedules. For the age groups I and II are applied 2
doses ideal interval of 6 months between them. In stratum III, are recommended 3 doses of the
vaccine, at ages 3, 5 and 12 months of age, according to calendar of the National
Immunization Program.
OUTCOMES PRIMARY:
Immunogenicity:
Proportion of seroconversion defined by the seronegative status change (titles of
bactericidal antibodies in children rabbit complement than 1: 8) to seropositive (titers of
bactericidal antibodies in larger rabbit complement or equal to 1: 8) or increase 4 times of
post vaccinal compared to pre-vacianais after the full vaccination schedule by age stratum.
Geometric mean antibody titers (TGM) pre- and post-vaccination, for each vaccine group, and
the ratio of these securities after the full vaccination schedule by age stratum.
Safety and reactogenicity: Frequency and intensity of adverse events solicited and
unsolicited, which occurred 30 days after vaccination.
SECONDARY OUTCOME : cell detection B (CD19 +) memory phenotype (CD27 + IgD +, CD27 + IgD) in
a subgroup of patients in the age stratum I (11-19 years old). ADDITIONAL INFORMATION age
escalation, with interim analysis of inter-layer security and approval by the Security
Independent Monitoring Committee of progression to the next lower age stratum.
Status: Not yet recruiting: participants are not yet being recruited. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04061382 -
Sero-epidemiological Survey of England in 2019/2020 - COVID-19
|