- |||||||||| meningococcal groups ACYWX conjugate vaccine (NmCV-5) / PATH, Serum Institute of India
Journal: Meningococcal ACWYX Conjugate Vaccine in 2-to-29-Year-Olds in Mali and Gambia. (Pubmed Central) - May 28, 2023
P3
NmCV-5 also elicited immune responses to serogroup X. No safety concerns were evident. (Funded by the U.K. Foreign, Commonwealth, and Development Office and others; ClinicalTrials.gov number, NCT03964012.).
- |||||||||| meningococcal groups ACYWX conjugate vaccine (NmCV-5) / PATH, Serum Institute of India
Journal: Validation and use of a serum bactericidal antibody assay for Neisseria meningitidis serogroup X in a seroprevalence study in Niger, West Africa. (Pubmed Central) - Oct 5, 2022
The objective of the study was to provide an overview of natural immunity to serogroup X within a community in the African meningitis belt prior to the introduction of a pentavalent conjugate vaccine (NmCV-5)...The SBA assay was successfully validated for selectivity/specificity, precision/reproducibility, linearity, and stability. This study demonstrated the suitability of the serogroup X SBA assay in clinical trials for future meningococcal conjugate vaccines containing serogroup X polysaccharides.
- |||||||||| Nimenrix (MenACWY-TT) / Pfizer, meningococcal groups ACYWX conjugate vaccine (NmCV-5) / PATH, Serum Institute of India
Enrollment open: Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine (clinicaltrials.gov) - Apr 7, 2022
P3, N=1320, Recruiting,
This study demonstrated the suitability of the serogroup X SBA assay in clinical trials for future meningococcal conjugate vaccines containing serogroup X polysaccharides. Not yet recruiting --> Recruiting
- |||||||||| Tetanus Antitoxin / Serum Institute of India, meningococcal groups ACYWX conjugate vaccine (NmCV-5) / PATH, Serum Institute of India
Clinical, Journal: Evaluation of Critical Quality Attributes of a Pentavalent (A, C, Y, W, X) Meningococcal Conjugate Vaccine for Global Use. (Pubmed Central) - Aug 29, 2021
Lot-to-lot manufacturing consistency was also demonstrated in preclinical studies for polysaccharide-specific IgG and complement-dependent serum bactericidal activity for each serogroup. This study demonstrates the high quality and stability of NmCV-5, which is now undergoing Phase 3 clinical trials in Africa and India.
- |||||||||| meningococcal groups ACYWX conjugate vaccine (NmCV-5) / PATH, Serum Institute of India
Trial completion: Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5) (clinicaltrials.gov) - Jul 27, 2021
P3, N=1800, Completed,
This study demonstrates the high quality and stability of NmCV-5, which is now undergoing Phase 3 clinical trials in Africa and India. Active, not recruiting --> Completed
- |||||||||| meningococcal groups ACYWX conjugate vaccine (NmCV-5) / PATH, Serum Institute of India
Journal: Meningococcal Serogroup ACWYX Conjugate Vaccine in Malian Toddlers. (Pubmed Central) - Jun 23, 2021
P2
Adjuvanted NmCV-5 provided no discernible benefit over nonadjuvanted NmCV-5. (Funded by the U.K. Foreign, Commonwealth, and Development Office; ClinicalTrials.gov number, NCT03295318.).
- |||||||||| meningococcal groups ACYWX conjugate vaccine (NmCV-5) / PATH, Serum Institute of India
Enrollment closed, Trial completion date, Trial primary completion date: ACYWX-04: 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 (clinicaltrials.gov) - Mar 19, 2021
P2/3, N=1640, Active, not recruiting,
(Funded by the U.K. Foreign, Commonwealth, and Development Office; ClinicalTrials.gov number, NCT03295318.). Recruiting --> Active, not recruiting | Trial completion date: Jun 2022 --> Dec 2021 | Trial primary completion date: Jun 2020 --> Mar 2021
- |||||||||| MenAfriVac (meningococcal A conjugate vaccine) / Serum Institute of India, meningococcal groups ACYWX conjugate vaccine (NmCV-5) / PATH, Serum Institute of India
Journal: Serogroup A meningococcal conjugate vaccines: building sustainable and equitable vaccine strategies. (Pubmed Central) - Mar 17, 2021
The PubMed database (1996-2019) was searched for studies relating to MenA outbreaks, vaccine, and immunization strategies; and the Neisseria PubMLST database of 1755 MenA isolates (1915-2019) was reviewed.Expert opinion: Using strategies from the successful MenAfriVac campaign, expanded collaborative partnerships have been built to develop and implement (anticipated 2023) a novel, low-cost multivalent component meningococcal vaccine that includes serogroup A. This vaccine promises greater sustainability and is directed toward global control of meningococcal disease in the African meningitidis belt and beyond. The new WHO global roadmap addresses the continuing problem of bacterial meningitis, including meningococcal vaccine prevention, and provides a framework for further reducing the devastation of MenA and other acute bacterial meningitis pathogens.
- |||||||||| meningococcal groups ACYWX conjugate vaccine (NmCV-5) / PATH, Serum Institute of India
Enrollment closed: Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5) (clinicaltrials.gov) - May 21, 2020
P3, N=1800, Active, not recruiting,
The new WHO global roadmap addresses the continuing problem of bacterial meningitis, including meningococcal vaccine prevention, and provides a framework for further reducing the devastation of MenA and other acute bacterial meningitis pathogens. Recruiting --> Active, not recruiting
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