Last update 27 Dec 2024
Meningococcal group A, C, W-135 and Y conjugate vaccine(Novartis Pharma AG)
Last update 27 Dec 2024
Overview
Basic Info
Drug Type Prophylactic vaccine, Conjugated vaccine |
Synonyms MCV4 vaccine (Novartis), MenACWY-CRM, Meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine (Novartis) + [5] |
Target- |
Mechanism Immunostimulants |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (19 Feb 2010), |
Regulation- |
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Related
44
Clinical Trials associated with Meningococcal group A, C, W-135 and Y conjugate vaccine(Novartis Pharma AG)Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV: A Single Center, Non-blinded, Randomized Clinical Trial
A Phase IIIB, Randomized, Observer-blind, Multicenter Study to Assess the Safety and Immunogenicity of GSK's Meningococcal Group B Vaccine When Administered Concomitantly With GSK's Meningococcal MenACWY Conjugate Vaccine to Healthy Subjects of 16-18 Years of Age
A Phase I/II Study to Determine Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19 in UK Healthy Adult Volunteers
100 Clinical Results associated with Meningococcal group A, C, W-135 and Y conjugate vaccine(Novartis Pharma AG)
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100 Translational Medicine associated with Meningococcal group A, C, W-135 and Y conjugate vaccine(Novartis Pharma AG)
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100 Patents (Medical) associated with Meningococcal group A, C, W-135 and Y conjugate vaccine(Novartis Pharma AG)
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165
Literatures (Medical) associated with Meningococcal group A, C, W-135 and Y conjugate vaccine(Novartis Pharma AG)01 Jan 2025VACCINE
Randomized trial showing persistence of hSBA titers elicited by a pentavalent meningococcal MenABCWY vaccine for up to 4 years following a primary series and safety and immunogenicity of a booster dose
Article
Author: Maguire, Jason D ; Maansson, Roger ; O'Neill, Robert ; Drazan, Daniel ; Peyrani, Paula ; Maguire, Jason D. ; Zolotas, Lefteris ; Beeslaar, Johannes ; Gruber, William C ; Gruber, William C. ; Jodar, Luis ; Moughan, Beth ; Anderson, Annaliesa S. ; Peterson, James ; Anderson, Annaliesa S
BACKGROUND:
Vaccination against 5 prominent meningococcal serogroups (A/B/C/W/Y) is necessary for broad disease protection. We report immunopersistence through 4 years after a 2-dose (6-month interval) pentavalent MenABCWY primary vaccine series and safety and immunogenicity of a booster administered 4 years after primary vaccination.
METHODS:
This randomized, active-controlled, observer-blinded study was conducted in the United States and Europe. In stage 1, healthy MenACWY vaccine-naive or -experienced 10- to 25-year-olds were randomized 1:2 to receive MenABCWY and placebo or MenB-fHbp and MenACWY-CRM. Eligible participants were randomly selected to participate in stage 2, which was an open-label immunopersistence and booster extension. Immunogenicity was assessed through serum bactericidal antibody using human complement (hSBA) assays with serogroups A/C/W/Y (MenA/C/W/Y) and 4 primary serogroup B (MenB) test strains. Immunogenicity endpoints included hSBA seroprotection rates through 48 months after primary vaccination and 1 month after the booster. Safety endpoints included booster reactogenicity events and adverse events (AEs).
RESULTS:
Of 1379 eligible participants, 353 entered stage 2; 242 completed the 48-month blood draw after primary vaccination and 240 completed the booster vaccination phase. MenA/C/W/Y seroprotection rates remained high for 4 years following a 2-dose MenABCWY primary series (MenACWY-naive, 62.0 %-100.0 %; MenACWY-experienced, 98.7 %-100.0 %) and trended higher than those after a single MenACWY-CRM dose (MenACWY-naive, 38.1 %-95.2 %; MenACWY-experienced, 89.7 %-100.0 %). Corresponding seroprotection rates against MenB remained stable and generally higher than baseline (MenABCWY, 18.2 %-36.6 %; MenB-fHbp, 16.2 %-31.9 % across strains). Following a booster, seroprotection rates against all 5 serogroups were ≥ 93.8 % across groups. Most booster dose reactogenicity events were mild or moderate in severity, and AEs were infrequent.
CONCLUSIONS:
Immune responses remained high for MenA/C/W/Y and above baseline for MenB through 4 years after the MenABCWY primary series, with robust responses for all 5 serogroups observed following a booster. The MenABCWY booster had an acceptable safety and tolerability profile consistent with the primary series. NCT03135834.
01 Dec 2024LANCET INFECTIOUS DISEASES
Breadth of immune response, immunogenicity, reactogenicity, and safety for a pentavalent meningococcal ABCWY vaccine in healthy adolescents and young adults: results from a phase 3, randomised, controlled observer-blinded trial
Article
Author: Langley, Joanne ; Carter, Robert ; Simon, William ; Jeanfreau, Robert ; Ackerman, Ronald ; Pelayo, Enrique ; Willemsen, Arnold ; Ukkonen, Benita ; Freeman, George ; Trapani, Mauro ; Staben, Jonathan ; Chakerian, Maia ; Vale, Noah ; Rämet, Mika ; Dionne, Marc ; Lattanzi, Maria ; de Looze, Ferdinandus ; Cetin, Benhur Sirvan ; Zemanek, Josef ; Paavola, Pauliina ; Vachon, Marie-Louise ; Athan, Eugene ; Dzongowski, Peter ; Surber, Joseph ; Beran, Jiří ; Cetin, Benhur ; Osowa, Alexander ; Farjo, Rand ; Dinleyici, Ener Cagri ; Silas, Peter ; Ayesu, Kwabena ; Byars, William ; Spaziererova, Martina ; Koski, Susanna ; Tipton, Mary ; Dalebout, Marije ; Lechevin, Isabelle ; Meisalu, Sandra ; Adamovska, Renata ; Bhusal, Chiranjiwi ; Ince, Tolga ; Rouhbakhsh, Rambod ; Tapiero, Bruce ; Raulier, Stefanie ; Laajalahti, Outi ; Finn, Daniel ; Bernard, David ; Grubb, Paul ; Gottfredson, Ryan ; Pavlasek, Miroslav ; Morelle, Danielle ; Jones, Jake ; Kokko, Satu ; Richmond, Peter ; Kiiroja, Kaia ; Toneatto, Daniela ; Dražan, Daniel ; Patel, Minesh ; Rok, Walter ; Bloch, Mark ; Seppä, Ilkka ; Sanchez, Yamirka ; Schear, Martin ; Gupta, Anil ; Tiong, Florence ; Sadarangani, Manish ; Mehta, Hemalini ; Scott, John ; Nolan, Terry ; Richmond, Peter C ; Kellner, James ; Wauters, Dominique ; Ulukol, Betul ; Langley, Joanne M
BACKGROUND:
A multicomponent meningococcal serogroups ABCWY vaccine (MenABCWY) could provide broad protection against disease-causing meningococcal strains and simplify the immunisation schedule. The aim of this trial was to confirm the effect of the licensed meningococcal serogroup B (MenB) vaccine, 4CMenB, against diverse MenB strains, and to assess the breadth of immune response against a panel of 110 MenB strains for MenABCWY containing the antigenic components of 4CMenB and licensed serogroups ACWY vaccine, MenACWY-CRM, the non-inferiority of the immune response with MenABCWY versus 4CMenB and MenACWY-CRM, safety, and MenABCWY lot-to-lot consistency.
METHODS:
We conducted a phase 3 randomised, controlled, observer-blinded trial of healthy adolescents and young adults (age 10-25 years) across 114 centres in Australia, Canada, Czechia, Estonia, Finland, Türkiye, and the USA. Exclusion criteria included previous vaccination with a MenB vaccine or (within the last 4 years) MenACWY vaccine. Participants were randomly allocated (5:5:3:3:3:1 ratio) via a central randomisation system using a minimisation procedure to receive 4CMenB at months 0, 2, and 6 (referred to as 4CMenB 0-2-6 hereafter); or 4CMenB at months 0 and 6 (referred to as 4CMenB 0-6 hereafter); or MenABCWY (three groups, each receiving one production lot of the MenACWY-CRM component) at months 0 and 6; or MenACWY-CRM at month 0. Demonstration in the per-protocol set of the consistency of three MenACWY-CRM component lots of the MenABCWY vaccine was a primary objective (demonstrated with two-sided 95% CIs for the ratio of human serum bactericidal antibody [hSBA] geometric mean titres against each serogroup within predefined criteria [0·5-2·0]). The primary endpoints (breadth of immune response) for the MenB component of MenABCWY and 4CMenB were measured using the endogenous complement hSBA (enc-hSBA) assay against a panel of 110 diverse MenB invasive disease strains. For each serum sample, 35 strains from the 110 MenB strain panel were randomly selected for testing. The 4CMenB breadth of immune response data have been published separately. For MenABCWY, breadth of immune response was assessed in two analyses: a test-based analysis of the percentage of samples (tests) without bactericidal serum activity against MenB strains 1 month after two MenABCWY doses versus the percentage after one MenACWY-CRM dose in the per-protocol set, and a responder-based analysis of the percentage of participants (responders) whose sera killed 70% or more strains at 1 month after two MenABCWY doses in the full analysis set. A lower limit of two-sided 95% CI above 65% would demonstrate breadth of immune response. Other primary outcomes included non-inferiority (5% margin) of two MenABCWY doses versus two 4CMenB doses by enc-hSBA assay in the per-protocol set, non-inferiority (10% margin) of two MenABCWY doses versus one MenACWY-CRM dose in MenACWY vaccine-naive participants by traditional hSBA assay in the per-protocol set, and safety in all vaccinated participants. This trial is registered with ClinicalTrials.gov, NCT04502693, and is complete.
FINDINGS:
Between Aug 14, 2020, and Sept 3, 2021, 3651 participants were enrolled and randomly allocated (900 in the 4CMenB 0-2-6 group and 908 in the 4CMenB 0-6 group, 1666 in the three MenABCWY groups combined, and 177 in the MenACWY-CRM group). All primary objectives for MenABCWY were met. Consistency of immune responses against the three production lots of the MenACWY component of MenABCWY was demonstrated since two-sided 95% CIs for the ratios of hSBA geometric mean titres against serogroups A, C, W, and Y for each pair of lots were within the predefined equivalence criteria. The lot data were pooled for the remainder of MenABCWY endpoints. By enc-hSBA assay, breadth of immune response against the MenB strain panel was 77·9% (95% CI 76·6 to 79·2) in the test-based analysis and 84·1% (81·4 to 86·5; 687 of 817 participants) in the responder-based analysis. Non-inferiority of MenABCWY to 4CMenB was demonstrated by enc-hSBA assay: the difference in percentage of samples with bactericidal serum activity between the MenABCWY group (82·5% [95% CI 82·1 to 83·0]; 21 222 of 25 715) and 4CMenB 0-2 group (83·1% [82·7 to 83·6]; 22 921 of 27 569) was -0·61% (-1·25 to 0·03). Non-inferiority of two-dose MenABCWY to one-dose MenACWY-CRM was demonstrated by traditional hSBA assay, with differences between the MenABCWY group and MenACWY group in percentages of participants with a four-fold rise in hSBA titres of 11·3% (5·9 to 19·0) for serogroup A, 47·2% (38·1 to 56·3) for serogroup C, 35·3% (26·9 to 44·5) for serogroup W, and 27·0% (19·4 to 35·8) for serogroup Y. MenABCWY reactogenicity was mostly of mild or moderate severity and transient, with similar frequencies of adverse events in the MenABCWY and 4CMenB groups and no safety concerns were identified.
INTERPRETATION:
This study demonstrates breadth of immune response against a panel of 110 MenB strains for the MenB component of the investigational MenABCWY vaccine, when administered as a 0-6 months schedule to the target population of adolescents and young adults, with predefined criteria for success met for both breadth of immune response endpoints and for non-inferiority versus 4CMenB. This investigational vaccine could provide broad meningococcal serogroup coverage in a simplified immunisation schedule, thus aiding the public health attempt in preventing invasive meningococcal disease due to five Neisseria meningitidis serogroups in adolescents and young adults.
FUNDING:
GSK.
01 Nov 2024LANCET INFECTIOUS DISEASES
Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine versus a quadrivalent meningococcal conjugate vaccine in adults in India: an observer-blind, randomised, active-controlled, phase 2/3 study
Article
Author: Mallya, Asha ; Panigrahi, Sandeep Kumar ; Parulekar, Varsha ; Gogtay, Nithya J ; Munshi, Renuka ; Venkatarao, Epari ; Patil, Rakesh ; Sahoo, Jyotiranjan ; Kawade, Anand ; Dharmadhikari, Abhijeet ; S, Ravish H ; Kulkarni, Prasad S ; Raut, Abhishek ; Singh, Kiranjit ; Gagnon, Luc ; Kumari, Nitu ; Dhere, Rajeev M ; Raj, Jeffrey P ; Poonawalla, Cyrus S ; Garg, B S ; Chaudhari, Vijaya L ; Gairola, Sunil ; Kale, Sameer ; Pisal, Sambhaji S ; Bavdekar, Ashish ; Kapse, Dhananjay ; Vengadakrishnan, K ; Maliye, Chetna ; Kohli, Sunil ; Gensale, Tania ; Saxena, Unnati ; Surendran, Jithin
BACKGROUND:
Meningococcal disease remains an important public health problem globally. We assessed the non-inferiority and the lot-to-lot consistency of a pentavalent meningococcal ACYWX conjugate vaccine (NmCV-5; Serum Institute of India, Pune, India) versus a quadrivalent meningococcal ACWY conjugate vaccine (MenACWY-D) in healthy adults.
METHODS:
In this observer-blind, randomised, active-controlled, phase 2/3 study, healthy adults aged 18-85 years were recruited from nine hospitals across seven cities in India. Participants were grouped by age (age 18-29, 30-60, and 61-85 years), and within each age group they were randomly assigned (3:1) to receive either NmCV-5 or MenACWY-D (Sanofi Pasteur). In the age 18-29 years group, participants were additionally randomly assigned (1:1:1:1) to either lot A, lot B, or lot C of NmCV-5 or MenACWY-D. Block randomisation was used (block sizes of 4, 8, and 12). Study participants and study personnel were masked to treatment assignment. Participants received either a 0·5 mL dose of NmCV-5, containing 5 μg each of conjugated A, C, W, Y, and X polysaccharides, or 0·5 mL MenACWY-D, containing 4 μg of each of conjugated A, C, W, and Y polysaccharides. Vaccinations were administered intramuscularly in the deltoid muscle. The primary outcomes were seroresponse (non-inferiority margin of -10%) and geometric mean titres (GMTs; non-inferiority margin of 0·5) in all participants, and lot-to-lot consistency of NmCV-5 (in participants aged 18-29 years; consistency was shown if the geometric mean ratio [GMR] 95% CIs were within the limit interval of 0·5 to 2). For non-inferiority, serogroup X immune response in the NmCV-5 group was compared with the lowest immune response among serogroups A, C, W, and Y in the MenACWY-D group. Immunogenicity was assessed with a serum bactericidal activity assay that used baby rabbit serum as the complement (rSBA) on days 1 and 29 in the modified per-protocol population (including all participants who were randomly assigned, received vaccine, had a post-vaccination rSBA measurement up to 121 days after vaccination, and no major protocol violations). Solicited events were collected for 7 days and serious adverse events were collected for 180 days, and assessed in the safety population (all participants who received vaccination). This study is registered with ClinicalTrials.gov, NCT04358731, and CTRI, CTRI/2019/12/022436, and is now complete.
FINDINGS:
Between Dec 27, 2019, and Sept 19, 2020, 1712 individuals were screened, of whom 1640 were randomly assigned and received NmCV-5 (n=1233) or MenACWY-D (n=407; mean age 26·4 years [SD 12·2], 551 [33·6%] of 1640 were female, and 1089 [66·4%] were male). 1441 participants were aged 18-29 years (362 received lot A, 360 received lot B, and 361 received lot C of NmCV-5 and 357 received MenACWY-D, with one participant mis-randomised by age group and excluded from lot-to-lot consistency analysis). Non-inferiority of NmCV-5 against MenACWY-D was met in terms of seroresponse rates and GMT ratios for all five serogroups. The seroresponse rates were 84·3% (97·5% CI 81·7 to 86·7; serogroup A) or higher in the NmCV-5 group and 54·5% (48·5 to 60·3; serogroup A) or higher in the MenACWY-D group, with the difference in the seroresponse rate between vaccine groups ranging from 0·2 (97·5% CI -2·2 to 2·6) for serogroup W to 29·8 (24·4 to 35·2) for serogroup A. GMTs on day 29 were 7016·9 (97·5% CI 6475·7 to 7603·4; serogroup Y) or higher in the NmCV-5 group and 3646·8 (3188·2 to 4171·5; serogroup Y) or higher in the MenACWY-D group, with GMT ratios between vaccine groups for serogroups A, C, Y, and W ranging from 1·9 (97·5% CI 1·5-2·3) for serogroup W to 2·5 (2·2-2·8) for serogroup A. NmCV-5 induced robust immune responses against serogroup X. Lot-to-lot consistency of NmCV-5 was found for all five serogroups, with 95% CIs for the GMT ratio for each pair of lots being between 0·5 and 2: the lowest lower bound and the highest upper bound of the 95% CI for the GMR between NmCV-5 lot A and lot B were 0·6 and 1·4, between lot A and lot C were 0·7 and 1·6, and between lot B and lot C were 0·8 and 1·6, respectively, for any of the five serogroups. At least one solicited adverse event was reported by 527 (42·7%) of 1233 participants in the NmCV-5 group and 142 (34·9%) of 407 in the MenACWY-D group. No serious adverse events occurred that were determined to be causally related to vaccination.
INTERPRETATION:
NmCV-5 was non-inferior to MenACWY-D in terms of seroresponse and GMTs, was safe, and demonstrated lot-to-lot consistency. NmCV-5 is prequalified by WHO and was rolled out in the African meningitis belt in April, 2024.
FUNDING:
Serum Institute of India.
22
News (Medical) associated with Meningococcal group A, C, W-135 and Y conjugate vaccine(Novartis Pharma AG)29 Nov 2024
Clinical ResultDrug ApprovalPhase 2VaccinePhase 3
03 Oct 2024
Clinical ResultVaccineDrug ApprovalPhase 3Phase 2
24 Sep 2024
100 Deals associated with Meningococcal group A, C, W-135 and Y conjugate vaccine(Novartis Pharma AG)
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
R&D Status
Approved
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Meningitis | KR | 02 Mar 2015 | |
| Meningitis | CH | 02 Mar 2015 | |
| Meningococcal Infections | US | 19 Feb 2010 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Encephalitis, Japanese | Phase 3 | CZ | 01 Nov 2011 | |
| Encephalitis, Japanese | Phase 3 | DE | 01 Nov 2011 | |
| Rabies | Phase 3 | CZ | 01 Nov 2011 | |
| Rabies | Phase 3 | DE | 01 Nov 2011 | |
| Typhoid Fever | Phase 3 | CZ | 01 Nov 2011 | |
| Typhoid Fever | Phase 3 | DE | 01 Nov 2011 | |
| Yellow Fever | Phase 3 | CZ | 01 Nov 2011 | |
| Yellow Fever | Phase 3 | DE | 01 Nov 2011 | |
| Meningitis, Bacterial | Phase 3 | CN | 01 Aug 2011 | |
| Meningitis, Meningococcal | Phase 3 | AR | 01 May 2007 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
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Phase 4 | 1,021 | (rMenB+OMV NZ Group) | txwtdpohln(tomuhucizs) = iumstuuasf neevfkfakx (uvpdafywrh, ajhfbxpfyj - dsvmsbgpdb) View more | - | 17 Jul 2023 | ||
(MenACWY 1 Group) | txwtdpohln(tomuhucizs) = vgzcnhfkjl neevfkfakx (uvpdafywrh, oxoglxdyes - aiaogbshhl) View more | ||||||
Phase 2 | 996 | (GSK3536820A ACWY_Liq Group) | ouanotyize(turjzkdpcf) = qufiikezsg yuebpbkkbv (yfsfiyxjwi, yenvwslmzx - lklvdnnrez) View more | - | 09 Feb 2021 | ||
Licensed GSK MenACWY vaccine (Menveo) (ACWY Group) | ouanotyize(turjzkdpcf) = etncbycbds yuebpbkkbv (yfsfiyxjwi, nmjonyavhh - kfcqzcwzqw) View more | ||||||
Phase 4 | 128 | nscynoswar(dvkowkamhm) = ybamdzdrwi caoxejvgww (ovpkhatcmq, gfqhqjrzgm - xkkgzzmrxa) View more | - | 01 Apr 2019 | |||
Phase 2 | 600 | dadwuwawmu(tbnvxiwdjp) = mbogjnreuf yklsycbnfz (mcuvecmmuj, ktjcqivkqm - mxwkelolzf) View more | - | 03 May 2018 | |||
dadwuwawmu(tbnvxiwdjp) = rmsjqbeeed yklsycbnfz (mcuvecmmuj, mtxqprobux - rruqowywfx) View more | |||||||
Phase 2 | 202 | (MenACWY-CRM (12 to 15 Months Old)) | vozqhqrumc(lpdxufouqx) = xswnwjegai diprtjpqvc (xsmfogbohf, jhinnzsewc - xxopsbmqay) View more | - | 04 Nov 2015 | ||
(MenACWY-TT (12 to 15 Months Old)) | vozqhqrumc(lpdxufouqx) = rcdvngmwvm diprtjpqvc (xsmfogbohf, vjhprkoywx - bmtcwjtkpe) View more | ||||||
Phase 3 | 751 | (MenACWY4) | bjirnnblim(hygnnllfzr) = wosjguriqx ppdwcbubqi (igpjksujbo, wbubnfynta - plnwlvflsx) View more | - | 02 Oct 2014 | ||
(MenACWY3) | oowbsceyka(hnfpfmgnjl) = kkfyfjoihr slvvyejfxc (khpmnpkjel, vzodsdjsdq - tmnqnuqzpz) View more | ||||||
Phase 4 | 465 | (MenACWY-CRM_2 (≥7-≤10 Years)) | eapryuedlm(uyzanthshy) = xhpaoshnzm hcqtdheqsb (lydxmdlblu, bdbknbbgsk - vxriegyfle) View more | - | 15 Aug 2014 | ||
(MenACWY-CRM_1 (≥7-≤10 Years)) | eapryuedlm(uyzanthshy) = usuvpiuhso hcqtdheqsb (lydxmdlblu, ugiurpilja - bjwrrqregm) View more | ||||||
Phase 2 | 216 | (MenACWY-CRM and Routine Vaccines (Group 1)) | liaswefvkn(hkqjvkqkih) = zccvqjsgfe xuxzdcnhdd (gscysyhbzc, rkynrqhcqy - hzgjoquhgv) View more | - | 15 Aug 2014 | ||
(MenACWY-CRM and Routine Vaccines (Group 2)) | liaswefvkn(hkqjvkqkih) = asqmmheznu xuxzdcnhdd (gscysyhbzc, nbojogdwrp - mgrqoqilnq) View more | ||||||
Phase 3 | 1,072 | saline placebo+Meningococcal ACWY conjugate vaccine (MenACWY-CRM) | ofyfwclyuv(aoxvbhrofh) = fftirevkmz hienscokao (jkoiphwnmo, pyjafaxjuy - zbcduvjkce) View more | - | 18 Jun 2014 | ||
Phase 3 | 433 | (ACWY - 4) | mpnowtuiko(pdarawwfeh) = rnitporxhu lvwihyrxwg (icdscwmuge, djngodqdje - crqnxdwprp) View more | - | 14 May 2014 | ||
(ACWY - 2) | mpnowtuiko(pdarawwfeh) = xnnxiahijr lvwihyrxwg (icdscwmuge, rwghpoojos - rkisdhhnoz) View more |
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