Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom

Last updated: October 10, 2023
Sponsor: Sanofi Pasteur, a Sanofi Company
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine

Human rotavirus RIX4414 strain vaccine

Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine

Clinical Study ID

NCT03632720
MET52
U1111-1183-6530
2017-004520-30
  • Ages 56-89
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The primary objective of the study was to demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, W, and Y (MenACYW) in terms of serum bactericidal assay using human complement (hSBA) vaccine seroprotection (antibody titer greater than or equal to [>=] 1:8) when MenACYW Conjugate vaccine was administered concomitantly with Bexsero® in the second year of life compared to when MenACYW Conjugate vaccine was given alone.

The secondary objectives were to compare the hSBA antibody response in terms of geometric mean titers (GMTs) against meningococcal serogroups A, C, W, and Y when MenACYW Conjugate vaccine was administered concomitantly with Bexsero® or when MenACYW Conjugate vaccine was given alone in the second year of life; to describe the hSBA and serum bactericidal assay using baby rabbit complement (rSBA) antibody responses against meningococcal serogroups A, C, W, and Y before and after the 1st dose of MenACYW Conjugate vaccine administered at 3 months of age, before and after the 2nd dose of MenACYW Conjugate vaccine administered at 12 to 13 months of age for Group 1 and Group 2; to describe the hSBA and rSBA antibody persistence against meningococcal serogroups A, C, W, and Y after the 1st dose of MenACYW Conjugate vaccine administered at 3 months of age for Group 1 and Group 2.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged >= 56 to less than or equal to (<=) 89 days on the day of the first study visit.
  • Born at full term of pregnancy (>= 37 weeks) and with a birth weight >= 2.5 kilogram (kg) (or 5 lb and 8 oz).
  • Informed consent form had been signed and dated by the parent(s) or other legallyacceptable representative (and by an independent witness if required by localregulations).
  • Participant and parent/legally acceptable representative were able to attend allscheduled visits and to comply with all trial procedures.

Exclusion

Exclusion Criteria:

-- Participation at the time of study enrollment (or in the 4 weeks preceding the firsttrial vaccination) or planned participation during the present trial period in anotherclinical trial investigating a vaccine, drug, medical device, or medical procedure.

  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (at Visit
  1. or planned receipt of any vaccine in the 4 weeks before and/or following any trialvaccination except for influenza vaccination, which may be received at a gap of atleast 2 weeks before or 2 weeks after any study vaccines. This exception includesmonovalent pandemic influenza vaccines and multivalent influenza vaccines.
  • Previous vaccination against meningococcal disease with either the trial vaccine oranother vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcalvaccine containing serogroups A, C, W, or Y; or meningococcal B serogroup-containingvaccine).
  • Previous vaccination (before Visit 1) with any pneumococcal, diphtheria, tetanus,pertussis, hepatitis B, Haemophilus influenzae type b (Hib), poliovirus, and/orrotavirus vaccines. Receipt of BCG vaccine at birth was acceptable.
  • Receipt of immune globulins, blood or blood-derived since birth.
  • Known or suspected congenital or acquired immunodeficiency, including Severe CombinedImmunodeficiency disorder (SCID); or receipt of immunosuppressive therapy, such asanti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroidtherapy (prednisone or equivalent for more than 2 consecutive weeks) since birth.
  • History of any neurologic disorders, including any seizures and progressive neurologicdisorders or encephalopathy.
  • History of Neisseria meningitidis infection, confirmed either clinically,serologically, or microbiologically.
  • History of diphtheria, tetanus, pertussis, poliomyelitis, Hib, hepatitis B,Streptococcus pneumoniae, and/or rotavirus infection or disease.
  • At high risk for meningococcal infection during the trial (specifically, but notlimited to, participants with persistent complement deficiency, with anatomic orfunctional asplenia, or participants travelling to countries with high endemic orepidemic disease).
  • History of Guillain-Barré syndrome.
  • Known systemic hypersensitivity to any of the vaccine components, or history of alife-threatening reaction to the vaccines used in the trial or to a vaccine containingany of the same substances including neomycin, kanamycin, polymyxin, formaldehyde, andlatex.
  • Hereditary problems of fructose intolerance, glucose-galactose malabsorption orsucrase-isomaltase insufficiency.
  • History of intussusception or uncorrected congenital malformation of thegastrointestinal tract that would predispose to intussusception.
  • Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in theinvestigator's opinion.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,contraindicating intramuscular vaccination.
  • Chronic illness that, in the opinion of the investigator, was at a stage where itmight interfere with trial conduct or completion.
  • Any condition which, in the opinion of the investigator, might interfere with theevaluation of the study objectives, including planning to leave the area of the studysite before the end of the study.
  • Moderate or severe acute illness/infection (according to investigator judgment), orfebrile illness (temperature >= 38.0°C), or diarrhea or vomiting on the day ofvaccination. A prospective participant should not be included in the study until thecondition had resolved or the febrile event has subsided.
  • Identified as a natural or adopted child of the Investigator or employee with directinvolvement in the proposed study.

Study Design

Total Participants: 788
Treatment Group(s): 6
Primary Treatment: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine
Phase: 3
Study Start date:
October 10, 2018
Estimated Completion Date:
December 05, 2022

Study Description

Study duration per participant was approximately 11 to 12 months.

Connect with a study center

  • Investigational Site Number :8260024

    Newquay, Cornwall TR7 1RU
    United Kingdom

    Site Not Available

  • Investigational Site Number :8260009

    Penzance, Cornwall TR19 7HX
    United Kingdom

    Site Not Available

  • Investigational Site Number :8260013

    Torpoint, Cornwall PL11 2TB
    United Kingdom

    Site Not Available

  • Investigational Site Number :8260010

    Exeter, Devon EX2 5DW
    United Kingdom

    Site Not Available

  • Investigational Site Number :8260017

    Poole, Dorset BH15 2HX
    United Kingdom

    Site Not Available

  • Investigational Site Number :8260018

    Gloucester, Gloucestershire GL1 3NN
    United Kingdom

    Site Not Available

  • Investigational Site Number :8260001

    Bristol, BS2 8AE
    United Kingdom

    Site Not Available

  • Investigational Site Number :8260011

    Ivybridge, PL21 OAJ
    United Kingdom

    Site Not Available

  • Investigational Site Number :8260002

    London, SW 17 ORE
    United Kingdom

    Site Not Available

  • Investigational Site Number :8260004

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Investigational Site Number 8260016

    Portsmouth, PO6 3LY
    United Kingdom

    Site Not Available

  • Investigational Site Number :8260003

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Investigational Site Number :8260006

    Taunton, TA1 5DA
    United Kingdom

    Site Not Available

  • UK

    UK,
    United Kingdom

    Site Not Available

  • Investigational Site Number :8260021

    Waterlooville, PO8 8DL
    United Kingdom

    Site Not Available

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