Clinical Trials Logo
  1. Home
  2. Meningococcal Infections
  3. NCT03476135

Immunogenicity and Safety of a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine in Children

Meningococcal Infections Clinical Trial

Official title:
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered as a Booster Dose in Children Vaccinated 3 Years Earlier as Toddlers

Clinical Trial Summary

This was an open-label, multi-center study to describe the immune persistence of the priming dose and describe the immunogenicity and safety of a booster dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) conjugate vaccine in children in Finland who had been vaccinated 3 years earlier as toddlers with either MenACYW conjugate vaccine or Nimenrix® as part of the MET54 study (NCT03205358). The objectives were: - To describe the antibody persistence of meningococcal serogroups A, C, Y, and W before a booster dose in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers. - To describe the antibody responses to meningococcal serogroups A, C, Y, and W 30 days after a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers. - To describe the antibody responses against tetanus toxoid 30 days after a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers. - To describe the safety profile of a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.

Clinical Trial Description

Healthy children who were vaccinated 3 years earlier at 12 to 23 months of age in study MET54 (NCT03205358) were eligible for enrollment. All participants received a single booster dose of MenACYW conjugate vaccine on Day 0. Immunogenicity was assessed at pre-vaccination and 30 days after vaccination. Safety was assessed throughout the study period, and included solicited injection site and systemic reactions (Day 0 to Day 7 post-vaccination); unsolicited adverse events up to Day 30 (Visit 2), and serious adverse events occurring throughout the trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03476135
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date February 27, 2018
Completion date September 10, 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT00774384 - Regulation of Mucosal Immune Response to Systemic MenB Vaccine Phase 2
Completed NCT00450632 - Creation of a Biotheque of Patients of Seine-Maritime With Meningococcal Infection N/A
Completed NCT00874549 - Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years Phase 1/Phase 2
Completed NCT00850603 - Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune® Phase 4
Completed NCT02591290 - Immunogenicity and Safety of Two-Dose Series of Menactra® in Japanese Healthy Adult Subjects Phase 4
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.
Completed NCT01482052 - Safety Study of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningitis Phase 1
Completed NCT01239043 - Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination Phase 2
Completed NCT01732627 - Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older Phase 2
Not yet recruiting NCT05212935 - A Surveillance Study on Timing and Coverage Of Rotavirus and MenB Vaccine Co-administration in Campania Region, Italy
Completed NCT00474487 - A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults Phase 3
Completed NCT02041663 - Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis N/A
Completed NCT03205358 - Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers Phase 2
Completed NCT00616421 - Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children Phase 3
Completed NCT00450437 - A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults Phase 3
Completed NCT03798574 - The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults
Completed NCT02640404 - Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Healthy Subjects in Vietnam Phase 2
Recruiting NCT05981599 - Epidemiological, Clinical and Biological Caracteristics of Patients Presenting With Invasive Meningococcal Disease
Completed NCT02500511 - Persistence of Protective Antibody Titers 12-24 Months After NmVac4-A/C/Y/W-135-DT Vaccination: Follow Up Study N/A
Completed NCT02199691 - Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents Phase 2