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Meningococcal Infections clinical trials

View clinical trials related to Meningococcal Infections.

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NCT ID: NCT06228586 Completed - Healthy Volunteers Clinical Trials

Study on a MenACYW Conjugate Vaccine Administered as a Single Dose in Participants Aged 12 Months and Older in Vietnam

Start date: January 18, 2024
Phase: Phase 3
Study type: Interventional

The MEQ00074 study is a Phase III, open-label, single-center study aimed at describing the immunogenicity and safety of a single dose of investigational quadrivalent Meningococcal Polysaccharide (serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine (MenACYW conjugate vaccine) in participants aged 12 months and older in Vietnam. The primary objectives of the study are: - To describe the antibody responses to meningococcal serogroups A, C, W, and Y before and 30 days after the administration of a single dose of MenACYW conjugate vaccine - To describe the safety profile of a single dose of MenACYW conjugate vaccine The duration of each participant's participation will be approximately 30 to 44 days.

NCT ID: NCT05739292 Completed - Clinical trials for Infection, Meningococcal

Safety and Immunogenicity of Pentavalent Meningococcal Conjugate Vaccine (EuNmCV-5) in Healthy Adults Aged 19 to 55 Years Old

Start date: February 28, 2023
Phase: Phase 1
Study type: Interventional

Phase I study to evaluate safety and immunogenicity in healthy adult subjects following a single dose administration of Meningococcal (Group A, C, W-135, X, and Y)-CRM197 Conjugate vaccine

NCT ID: NCT04794881 Completed - Meningitis Clinical Trials

Repeat Lumbar Puncture at 24 Versus 48 Hours After Traumatic Lumbar Puncture in Neonates

Start date: March 18, 2019
Phase: N/A
Study type: Interventional

Visibly traumatic as well as microtraumatic lumbar punctures (LP) are very common in the neonatal period. The presence of blood makes it difficult to interpret cerebro-spinal fluid (CSF) findings. Clinicians often perform a repeat LP in the hope that some of the red blood cells would have cleared by then, allowing a better interpretation of the CSF findings. There is no published information whether a repeat LP provides any added information to the original traumatic LP, and if so what is the best time to repeat an LP after a traumatic LP. In this randomised controlled trial (RCT), we plan to randomly allocate neonates following a visibly traumatic LP to either undergo a repeat LP at 24 hours or 48 hours later to determine which LP gives more accurate results.

NCT ID: NCT04714229 Completed - Clinical trials for Infection, Meningococcal

Safety and Immunogenicity of Meningococcal Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old

Start date: September 1, 2020
Phase: Phase 1
Study type: Interventional

Phase I study to evaluate safety and immunogenicity in healthy adult subjects following a single dose administration of Meningococcal (Group A, C, W-135, and Y)-CRM197 Conjugate vaccine

NCT ID: NCT04502693 Completed - Clinical trials for Infections, Meningococcal

Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults

Start date: August 14, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the effectiveness of 2 doses or 3 doses of GSK's licenced meningococcal group B Bexsero (rMenB+OMV NZ) vaccine and of 2 doses of GSK's investigational combined meningococcal (MenABCWY) vaccine (GSK3536819A) in healthy adolescents and young adults. The immunogenicity and safety were evaluated in the study.

NCT ID: NCT04358731 Completed - Clinical trials for Vaccine for Meningococcal Disease

Study to Evaluate the Lot to Lot Consistency of SIIPL Meningococcal ACYWX Conjugate Vaccine and to Compare Its Safety and Immunogenicity With That of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Individuals 18-85 Years of Age

ACYWX-04
Start date: December 27, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This is a Phase 2/3, randomized, observer blind, multi-centre, controlled study to evaluate the safety, immune response and consistency of immune response of three consecutively manufactured lots of NmCV-5 in healthy individuals between the ages of 18 to 85 years (both inclusive). The immune response of NmCV-5 will also be statistically compared against a licensed conjugate vaccine against ACYW (Menactra). A total of 1640 subjects 18 to 85 years of age will be accrued contemporaneously across three age groups - 18 to 29 years, 30 to 60 years, and 61 to 85 years. Within each age group subjects will be randomly assigned in a 3:1 ratio to receive either NmCV-5 or Menactra. The NmCV-5 subjects in 18-29 year age group will be further randomized 1:1:1 into three different lots (Lot A, B & C) of NmCV-5. All the randomized subjects will receive a single dose of 0.5 ml of NmCV-5 or Menactra on Day 1. Post vaccination site visits are planned on Days 8, 29 and 180 and a telephonic call at Day 85.

NCT ID: NCT04236960 Completed - Clinical trials for Meningococcal Infections

Safety Evaluation of Meningococcal Group ACYW135 Conjugate Vaccine in 2-month to 55 Years Old Population.

Start date: July 17, 2018
Phase: Phase 1
Study type: Interventional

A single-center and open-labeled Phase I study, designed to evaluate the safety by observing the occurrence of adverse events and change of hematology, liver and renal function after vaccination of a meningococcal group A, C, Y, and W135 conjugate vaccine in healthy population aged 2 months to 55 years old.

NCT ID: NCT04143061 Completed - Clinical trials for Healthy Volunteers (Meningococcal Infection)

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, Children, and Toddlers in India and Healthy Adolescents and Children in the Republic of South Africa

MET55
Start date: December 30, 2019
Phase: Phase 3
Study type: Interventional

This will be a Phase III, modified double-blind (open-label for toddlers in India), randomized, parallel-group, active-controlled, step-wise, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adults, adolescents, children, and toddlers in India and a modified double-blind, randomized, parallel-group, active-controlled, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adolescents and children in the Republic of South Africa (RSA).

NCT ID: NCT04142242 Completed - Clinical trials for Meningococcal Infection (Healthy Volunteers)

Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine in Older Adults Who Received a Primary Vaccination (3 or More Years Earlier) in Study MET49

Start date: October 4, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate sufficiency of the vaccine seroresponse to meningococcal serogroups A, C, W, and Y following administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine to Group 1 participants (who received primary vaccination with Menomune vaccine greater than or equal to [>= 3] years earlier at >= 56 years of age in Study MET49). Secondary Objectives: Secondary Objective 1 - To demonstrate sufficiency of the vaccine seroresponse to meningococcal serogroups A, C, W, and Y following administration of a single dose of MenACYW Conjugate vaccine to Group 2 participants (who received primary vaccination with MenACYW Conjugate vaccine >= 3 years earlier at >= 56 years of age in Study MET49). Secondary Objective 2 - To describe vaccine seroresponse rates with respect to serogroups A, C, W, and Y in serum specimens collected 6 days (window, 5-7) post-vaccination in approximately 60 participants from Group 1 (Menomune-primed) and approximately 60 participants from Group 2 (MenACYW Conjugate vaccine-primed). Secondary Objective 3 - To describe antibody persistence >= 3 years after primary vaccination with Menomune vaccine or MenACYW Conjugate vaccine for participants from all groups.

NCT ID: NCT03900091 Completed - Meningitis Clinical Trials

Paediatric Infections Point-Of-Care

PI-POC
Start date: April 1, 2019
Phase:
Study type: Observational

This study aims to identify the aetiology of childhood meningitis in Southwestern Uganda and develop and evaluate new methods for point-of-care diagnosis of childhood meningitis in a low-income setting. A prospective observational study including 600 children aged 0-12 years will be conducted during 1 year in Mbarara, Uganda. We estimate to recruit about 300 children with suspected meningitis (cases), and 300 with non-severe infection age-matched as controls.