Ignite Creation Date:
2024-05-06 @ 8:56 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02858570
Status:
UNKNOWN
Last Update Posted:
2018-10-10
First Post:
2016-07-26
Brief Title:
Conjugate Vaccine Against Meningococcus C a Brazilian Project
Sponsor:
The Immunobiological Technology Institute Bio-Manguinhos Oswaldo Cruz Foundation Fiocruz
Organization:
The Immunobiological Technology Institute Bio-Manguinhos Oswaldo Cruz Foundation Fiocruz
Study Overview
Official Title:
Immunogenicity Reactogenicity and Safety Assessment of the Meningococcal Serogroup C Vaccine Produced by Bio-Manguinhos FIOCRUZ in Infants Children and Adolescents
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
TYPE DESIGN STUDY Clinical trial phase II III randomized double-blind national multi-center with a total of 1644 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 childs 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
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 childs 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
Detailed Description:
Status Not yet recruiting participants are not yet being recruited
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None