Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom
Investigating the Safety and Immune Response of a Meningococcal Vaccine in Young Children
Study Overview
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.
Study Details
Study duration per participant was approximately 11 to 12 months.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy Volunteers (Meningococcal Infection)
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Age: 56 days - 89 days
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Gender: All
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 legally acceptable representative (and by an independent witness if required by local regulations).
- Participant and parent/legally acceptable representative were 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
1) 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 was 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, participants with persistent complement deficiency, with anatomic or
functional asplenia, or participants 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, was 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 participant should not be included in the study until the
condition had 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.
This study investigates the safety and immune response of a quadrivalent meningococcal conjugate vaccine in infants and toddlers.
The purpose of this study is to evaluate how well the vaccine works when given with other routine vaccines. It looks at the immune response to the vaccine and its safety in young children.
- Who can participate: Children aged 56 to 89 days who were born full-term and have a birth weight of at least 2.5 kg can participate. Parents must consent and be able to attend all visits.
- Study details: Participants will receive the investigational vaccine along with routine vaccines. A placebo may be used for comparison.
- Study timelines: The study will last 11 to 12 months.
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