Clinical Trials Logo
  1. Home
  2. Meningococcal Meningitis
  3. NCT03964012

Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5)

Meningococcal Meningitis Clinical Trial

Official title:
Phase 3, Observer-blind, Randomized, Active Controlled Trial to Assess the Safety of an Investigational Meningococcal Serogroups ACYWX Conjugate Vaccine (NmCV-5) and Compare Its Immunogenicity to a Licensed Meningococcal Serogroups ACYW Conjugate Vaccine (Menactra®), in Healthy Subjects 2 to 29 Years of Age

Clinical Trial Summary

This observer-blind, randomized, active controlled trial will be conducted among 2-29 year olds in two sites (Mali and The Gambia). The objectives of the study are to assess and compare the immunogenicity and safety of NmCV-5 with that of Menactra. A total of 1800 eligible participants (who or their parents/guardians have given written informed consent) will be randomised 2:1 (NmCV-5: Menactra) in each of the three age strata 18-29 years, 11-17 years & 2-10 years (400 NmCV-5 recipients & 200 Menactra recipients in each age strata). Each subject will receive a single dose of study vaccine and will be followed up for 6 months post vaccination during which solicited reactions (for seven days), unsolicited AEs (28 days) and SAEs (until the end of study i.e. 168 days after vaccination) will be collected. A blood sample will be collected at baseline (pre-vaccination) and at day 28 post-vaccination for immunogenicity assessment by a Serum Bactericidal Activity assay using rabbit complement (rSBA).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03964012
Study type Interventional
Source Serum Institute of India Pvt. Ltd.
Contact
Status Completed
Phase Phase 3
Start date August 20, 2019
Completion date March 4, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT01434680 - Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers Phase 2
Completed NCT01424644 - A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents Phase 4
Completed NCT00384397 - A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers Phase 3
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 NCT00874549 - Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years Phase 1/Phase 2
Completed NCT00355121 - Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL® Phase 2
Completed NCT02591290 - Immunogenicity and Safety of Two-Dose Series of Menactra® in Japanese Healthy Adult Subjects Phase 4
Completed NCT01717638 - Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1 Phase 3
Completed NCT01482052 - Safety Study of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningitis Phase 1
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 NCT01239043 - Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination Phase 2
Completed NCT00994695 - Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Vaccine Phase 2
Completed NCT01732627 - Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older Phase 2
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
Completed NCT00474487 - A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults Phase 3
Completed NCT00483574 - Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers Phase 3
Completed NCT03205358 - Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers Phase 2
Not yet recruiting NCT06226714 - A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 18-59 Year Olds Phase 3
Completed NCT00667602 - Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers Phase 3