Evidence map›Paper›PMID 33814028›Full record

Trial reportEpidemiology and infection2021

Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine administered concomitantly with other paediatric vaccines in toddlers: a phase III randomised study.

M S Dhingra, L Namazova-Baranova, J L Arredondo-Garcia, K-H Kim, K Limkittikul, W Jantarabenjakul, O Perminova, I A R Kobashi, C-W Bae, J Ojeda and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Epidemiology and infection, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03205371 (Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Other Pediatric Vaccines in Healthy Toddlers), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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.

NCT03205371 phase3completednot on this map

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Other Pediatric Vaccines in Healthy Toddlers

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2016 to 2018Enrolled1,183ConditionsMeningitis, MeningococcalArmsMenACYW conjugate vaccine, MMR, Varicella, DTaP-IPV-HB-Hib, PCV13
3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

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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

16 authors.

M S DhingraGlobal Clinical Sciences, Sanofi Pasteur, Swiftwater, PA, USA.ORCID 0000-0002-2507-7165
L Namazova-BaranovaInstitute of Pediatrics, Central Clinical Hospital of the Russian Academy of Science, Moscow, Russia.
J L Arredondo-GarciaInstituto Nacional de Pediatría Clinical Research Unit, Mexico City, Mexico.
K-H KimDepartment of Pediatrics, Ewha Woman's University College of Medicine, Seoul, South Korea.
K LimkittikulFaculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
W JantarabenjakulDepartment of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
O PerminovaCity Children Clinical Outpatient Hospital #5, Perm, Russia.
I A R KobashiCentro de Investigación Clínica del Pacífico, Guerrero, Mexico.
C-W BaeKyung Hee University Hospital at Gangdong, Seoul, Korea.
J OjedaGlobal Clinical Sciences, Sanofi Pasteur, Mexico City, Mexico.
J ParkGlobal Clinical Sciences, Sanofi Pasteur, Singapore, Singapore.
D ChansinghakulGlobal Clinical Sciences, Sanofi Pasteur, Bangkok, Thailand.
S B'ChirGlobal Biostatistical Sciences, Sanofi Pasteur, Marcy l'Etoile, France.
D NeveuGlobal Pharmacovigilance, Sanofi Pasteur, Swiftwater, PA, USA.
M BonaparteGlobal Clinical Immunology, Sanofi Pasteur, Swiftwater, PA, USA.
E JordanovGlobal Clinical Sciences, Sanofi Pasteur, Swiftwater, PA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Invasive meningococcal disease has high morbidity and mortality, with infants and young children among those at greatest risk. This phase III, open-label, randomised study in toddlers aged 12-23 months evaluated the immunogenicity and safety of meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT), a tetanus toxoid conjugated vaccine against meningococcal serogroups A, C, W and Y, when coadministered with paediatric vaccines (measles, mumps and rubella [MMR]; varicella [V]; 6-in-1 combination vaccine against diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b [DTaP-IPV-HepB-Hib] and pneumococcal conjugate vaccine [PCV13])(NCT03205371). Immunogenicity to each meningococcal serogroup was assessed by serum bactericidal antibody assay using human complement (hSBA). Vaccine safety profiles were described up to 30 days post-vaccination. A total of 1183 participants were enrolled. The proportion with seroprotection (hSBA ≥1:8) to each meningococcal serogroup at Day 30 was comparable between the MenACYW-TT and MenACYW-TT + MMR + V groups (≥92 and ≥96%, respectively), between the MenACYW-TT and MenACYW-TT + DTaP-IPV-HepB-Hib groups (≥90% for both) and between the MenACYW-TT and MenACYW-TT + PCV13 groups (≥91 and ≥84%, respectively). The safety profiles of MenACYW-TT, and MMR + V, DTaP-IPV-HepB-Hib, and PCV13, with or without MenACYW-TT, were generally comparable. Coadministration of MenACYW-TT with paediatric vaccines in toddlers had no clinically relevant effect on the immunogenicity and safety of any of the vaccines.

Indexed as

Antibodies, BacterialAntibodies, ViralChickenpox VaccineDiphtheria-Tetanus-Pertussis VaccineFemaleHaemophilus VaccinesHepatitis B VaccinesHumansImmunogenicity, VaccineInfantMaleMeasles-Mumps-Rubella VaccineMeningococcal InfectionsMeningococcal VaccinesNeisseria meningitidisPneumococcal Vaccines13-valent pneumococcal vaccineAntibodies, BacterialAntibodies, ViralChickenpox Vaccinediphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccineDiphtheria-Tetanus-Pertussis VaccineHaemophilus VaccinesHepatitis B VaccinesMeasles-Mumps-Rubella VaccineMeningococcal VaccinesPneumococcal VaccinesPoliovirus Vaccine, Inactivatedtetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccineVaccines, CombinedCoadministrationMenACYW-TTpaediatric vaccinestoddlers

Identifiers

PMID33814028
PMCPMC8080229

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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.