Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom (MET52)

  • STATUS
    Recruiting
  • End date
    Jan 20, 2023
  • participants needed
    800
  • sponsor
    Sanofi Pasteur, a Sanofi Company
Updated on 13 May 2022
Accepts healthy volunteers

Summary

The primary objective of the study is to demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, W, and Y in terms of hSBA vaccine seroprotection (antibody titer ≥ 1:8) when MenACYW conjugate vaccine is administered concomitantly with Bexsero® in the second year of life compared to when MenACYW conjugate vaccine is given alone The secondary objective is 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 is administered concomitantly with Bexsero® or when MenACYW conjugate vaccine is given alone in the second year of life; to describe the hSBA and 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

Description

Study duration per participant will be approximately 11 to 12 months

Details
Condition Healthy Volunteers (Meningococcal Infection)
Treatment Meningococcal group B vaccine, Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine, Human rotavirus RIX4414 strain vaccine, Pneumococcal 13-valent polysaccharide conjugate vaccine, Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine
Clinical Study IdentifierNCT03632720
SponsorSanofi Pasteur, a Sanofi Company
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged ≥ 56 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 kg (or 5 lb and 8 oz)
Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)
Participant and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria

- Participation at the time of study enrollment (or in the 4 weeks preceding the first
trial vaccination) or planned participation during the present trial period in another
clinical 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
) or planned receipt of any vaccine in the 4 weeks before and/or following any trial
vaccination except for influenza vaccination, which may be received at a gap of at
least 2 weeks before or 2 weeks after any study vaccines. This exception includes
monovalent pandemic influenza vaccines and multivalent influenza vaccines
Previous vaccination against meningococcal disease with either the trial vaccine or
another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal
vaccine containing serogroups A, C, W, or Y; or meningococcal B serogroup-containing
vaccine)
Previous vaccination (before Visit 1) with any pneumococcal, diphtheria, tetanus
pertussis, hepatitis B, Haemophilus influenzae type b (Hib), poliovirus, and/or
rotavirus vaccines. Receipt of BCG vaccine at birth is acceptable
Receipt of immune globulins, blood or blood-derived since birth
Known or suspected congenital or acquired immunodeficiency, including Severe Combined
Immunodeficiency disorder (SCID); or receipt of immunosuppressive therapy, such as
anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid
therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth
History of any neurologic disorders, including any seizures and progressive neurologic
disorders 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 not
limited to, subjects with persistent complement deficiency, with anatomic or
functional asplenia, or subjects travelling to countries with high endemic or epidemic
disease)
History of Guillain-Barré syndrome
Known systemic hypersensitivity to any of the vaccine components, or history of a
life-threatening reaction to the vaccines used in the trial or to a vaccine containing
any of the same substances including neomycin, kanamycin, polymyxin, formaldehyde, and
latex
Hereditary problems of fructose intolerance, glucose-galactose malabsorption or
sucrase-isomaltase insufficiency
History of intussusception or uncorrected congenital malformation of the
gastrointestinal tract that would predispose to intussusception
Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the
investigator'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, is at a stage where it might
interfere with trial conduct or completion
Any condition which, in the opinion of the investigator, might interfere with the
evaluation of the study objectives, including planning to leave the area of the study
site before the end of the study
Moderate or severe acute illness/infection (according to investigator judgment), or
febrile illness (temperature ≥ 38.0°C), or diarrhea or vomiting on the day of
vaccination. A prospective subject should not be included in the study until the
condition has resolved or the febrile event has subsided
Identified as a natural or adopted child of the Investigator or employee with direct
involvement in the proposed study
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