Evidence map›Paper›PMID 41604139›Full record

ArticleInfectious diseases and therapy2026

Immunogenicity and Safety of Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Potential Hajj/Umrah Pilgrims Aged ≥ 56 Years: A Phase III, Open-Label Study.

Ghassan S Dbaibo, Ismail Balik, İrem Akdemir, Turan Buzgan, Rahmet Guner, Celina F Boutros, Stephanie Damaj, Zeinab El Zein, Sarah Merhi, Kawthar Faour and 4 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Infectious diseases and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03869866 (Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Potential Pilgrims Aged 56 Years and Older), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03869866 phase3completednot on this map

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Potential Pilgrims Aged 56 Years and Older

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2019 to 2022Enrolled290ConditionsHealthy Volunteers (Meningococcal Infection)ArmsMeningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Ghassan S DbaiboCenter for Infectious Diseases Research (CIDR) and WHO Collaborating Center for Reference and Research On Bacterial Pathogens, American University of Beirut, Beirut, Lebanon.
Ismail BalikInfectious Disease and Clinical Microbiology Department, Ankara Universitesi Medical School, Ankara, Türkiye.
İrem AkdemirInfectious Disease and Clinical Microbiology Department, Ankara Universitesi Medical School, Ankara, Türkiye.
Turan BuzganAnkara Bilkent City Hospital, Department of Infectious Diseases and Clinical Microbiology, Ankara Yildirim Beyazit University, Ankara, Türkiye.
Rahmet GunerAnkara Bilkent City Hospital, Department of Infectious Diseases and Clinical Microbiology, Ankara Yildirim Beyazit University, Ankara, Türkiye.
Celina F BoutrosCenter for Infectious Diseases Research (CIDR) and WHO Collaborating Center for Reference and Research On Bacterial Pathogens, American University of Beirut, Beirut, Lebanon.
Stephanie DamajCenter for Infectious Diseases Research (CIDR) and WHO Collaborating Center for Reference and Research On Bacterial Pathogens, American University of Beirut, Beirut, Lebanon.
Zeinab El ZeinCenter for Infectious Diseases Research (CIDR) and WHO Collaborating Center for Reference and Research On Bacterial Pathogens, American University of Beirut, Beirut, Lebanon.
Sarah MerhiCenter for Infectious Diseases Research (CIDR) and WHO Collaborating Center for Reference and Research On Bacterial Pathogens, American University of Beirut, Beirut, Lebanon.
Kawthar FaourDepartment of Pediatrics, CMU Health, Saginaw, MI, USA.
Nadim TfailyCenter for Infectious Diseases Research (CIDR) and WHO Collaborating Center for Reference and Research On Bacterial Pathogens, American University of Beirut, Beirut, Lebanon.
Sarah KhafajaCenter for Infectious Diseases Research (CIDR) and WHO Collaborating Center for Reference and Research On Bacterial Pathogens, American University of Beirut, Beirut, Lebanon.
Alp DoguMedical Affairs Department, Sanofi Vaccines, Level 3, One JLT Building, Jumeirah Lake Towers, P.O. Box 53899, Dubai, UAE. Alp.Dogu@sanofi.com.
Mehmet CeyhanHacettepe University School of Medicine, Ankara, Türkiye.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionInvasive meningococcal disease poses a substantial disease burden worldwide, including older adults (aged ≥ 56 years) along with higher case fatality rates. MenACYW-TT, a quadrivalent meningococcal tetanus toxoid-conjugate vaccine, is indicated worldwide in individuals ≥ 56 years of age and is the only licensed vaccine in the USA for this age group. The annual Hajj pilgrimage is considered an epidemiologic event with approximately two million pilgrims per year; hence, immunization with a quadrivalent meningococcal vaccine is mandatory for visitors traveling to Saudi Arabia for Umrah and Hajj. We evaluated the immunogenicity and safety of a single dose of MenACYW-TT in prospective Hajj/Umrah pilgrims aged ≥ 56 years in Turkiye and Lebanon.

methodsIn this open-label phase III study (NCT03869866), conducted in Turkiye and Lebanon, healthy adults aged ≥ 56 years received a single dose of the MenACYW-TT vaccine. Serum bactericidal assays were performed using human (hSBA) and rabbit (rSBA) complements to measure antibody titers against all four serogroups at baseline (D0) and 30 days post vaccination (D30). Safety data were collected up to 30 days (+ 14 days) post vaccination.

resultsA total of 290 individuals were enrolled in the study. On D30, vaccine seroprotection rates (hSBA titers ≥ 1:8) for serogroups A, C, Y, and W were 82.8%, 92.5%, 92.1%, and 83.5%, respectively, and rSBA titers (≥ 1:128) were 83.4%, 90.0%, 94.3%, and 88.9%, respectively. hSBA geometric mean titers (GMTs) were 32 [95% confidence interval (CI) 26.3-39.1], 132 (102-169), 126 (99.3-161), and 56.4 (43.8-72.6) for serogroups A, C, Y, and W, respectively. On D30, seroresponse rates in the per-protocol analysis set (PPAS) were 48-71.0%. Safety concerns and any serious adverse events related to the study vaccine were not observed.

conclusionsMenACYW-TT vaccine induced a robust immune response against all serogroups (per seroprotection rates and GMTs). A single dose of the vaccine demonstrated acceptable safety profile in potential pilgrims aged ≥ 56 years.

trial registrationClinicalTrials.gov, NCT03869866. A Graphical Abstract is available for this article.

Indexed as

Hajj/Umrah pilgrimsImmunogenicityInvasive meningococcal diseaseMenACYW-TTOlder adultsSafetyVaccine

Identifiers

PMID41604139
PMCPMC12924817

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.