Meningococcal Disease Clinical Trial
Official title:
A Phase 3, Open Label, Multi-Center, Extension Study to Assess Antibody Persistence and Response to a Third or Fifth Dose of Novartis Meningococcal B Recombinant Vaccine in 4-Year-Old Children Who Previously Participated in Study V72P12E1
It is a Phase 3 extension of study V72P12E1 (NCT00944034). The main aim of the second
extension study is to explore the bactericidal antibody persistence in 4-year-old children
after a fourth dose boost of rMenB+OMV NZ or after a two-dose catch-up schedule of rMenB+OMV
NZ administered to toddlers as part of their respective vaccination courses in study
V72P12E1.
In addition, this study will characterize the antibody response to a fifth dose boost in all
children who received a three-dose primary series of rMenB+OMV NZ at 2, 3, 4 months of age
(in parent study V72P12, NCT00721396), and only in a subset of children who received a
three-dose primary series of rMenB+OMV NZ at 2, 4, 6 months of age (in parent study V72P12).
Antibody response will also be characterized to a third dose boost of rMenB+OMV NZ
administered at approximately 4 years of age in all children who received a two catch-up
doses of rMenB+OMV NZ as toddlers in study V72P12E1.
Finally, the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ administered 2
months apart to healthy naïve children at 4 years of age will be assessed.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02223637 -
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
|
||
Completed |
NCT01452464 -
Safety of MenACWY-CRM Vaccination in Adolescents
|
N/A | |
Completed |
NCT01434680 -
Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers
|
Phase 2 | |
Completed |
NCT01452438 -
Safety Surveillance of MenACWY-CRM Vaccine in Children
|
N/A | |
Completed |
NCT02173704 -
Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants of 2 Months of Age and Older, in Taiwan.
|
Phase 3 | |
Completed |
NCT01682876 -
Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.
|
Phase 3 | |
Recruiting |
NCT04023929 -
Sources of COmplement in Meningococcal and Pertussis Serum Bactericidal Antibody Assays
|
||
Completed |
NCT01453348 -
Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine
|
Phase 3 | |
Completed |
NCT01214837 -
Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life
|
Phase 3 | |
Completed |
NCT03378258 -
Petechiae In Children (PIC) Study: Defining A Clinical Decision Rule for The Management Of Fever and Non-Blanching Rashes In Children Including The Role Of Point Of Care Testing For Procalcitonin & Neisseria Meningitidis DNA.
|
||
Recruiting |
NCT04239430 -
Propositive (Protecting Positive People From Meningococcal Infection) Follow-up Study
|
||
Completed |
NCT01994629 -
Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers
|
Phase 2 | |
Completed |
NCT01973218 -
Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.
|
Phase 3 | |
Completed |
NCT01725217 -
Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in Russia
|
Phase 3 | |
Completed |
NCT01466387 -
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults
|
Phase 3 | |
Completed |
NCT01000311 -
A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months
|
Phase 3 | |
Completed |
NCT02141516 -
Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects
|
Phase 3 | |
Completed |
NCT02140762 -
Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
|
Phase 2 | |
Completed |
NCT01823536 -
Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose
|
Phase 4 | |
Completed |
NCT01478347 -
A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults
|
Phase 3 |