Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom
NCT ID: NCT03632720
Last Updated: 2023-11-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
788 participants
INTERVENTIONAL
2018-10-10
2022-12-05
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine
Pharmaceutical form: solution for injection; route of administration: intramuscular, 0.5 mL
Meningococcal group B vaccine
Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL
Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine
Pharmaceutical form: powder and suspension for suspension injection; route of administration: deep intramuscular, 0.5 mL
Human rotavirus RIX4414 strain vaccine
Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL
Pneumococcal 13-valent polysaccharide conjugate vaccine
Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine
Pharmaceutical form: solution for injection; route of administration: intramuscular, 0.5 mL
Meningococcal group B vaccine
Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL
Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine
Pharmaceutical form: powder and suspension for suspension injection; route of administration: deep intramuscular, 0.5 mL
Human rotavirus RIX4414 strain vaccine
Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL
Pneumococcal 13-valent polysaccharide conjugate vaccine
Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
Meningococcal group B vaccine
Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL
Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine
Pharmaceutical form: powder and suspension for suspension injection; route of administration: deep intramuscular, 0.5 mL
Human rotavirus RIX4414 strain vaccine
Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL
Pneumococcal 13-valent polysaccharide conjugate vaccine
Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL
Interventions
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Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine
Pharmaceutical form: solution for injection; route of administration: intramuscular, 0.5 mL
Meningococcal group B vaccine
Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL
Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine
Pharmaceutical form: powder and suspension for suspension injection; route of administration: deep intramuscular, 0.5 mL
Human rotavirus RIX4414 strain vaccine
Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL
Pneumococcal 13-valent polysaccharide conjugate vaccine
Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
56 Days
89 Days
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number :8260024
Newquay, Cornwall, United Kingdom
Investigational Site Number :8260009
Penzance, Cornwall, United Kingdom
Investigational Site Number :8260013
Torpoint, Cornwall, United Kingdom
Investigational Site Number :8260010
Exeter, Devon, United Kingdom
Investigational Site Number :8260017
Poole, Dorset, United Kingdom
Investigational Site Number :8260018
Gloucester, Gloucestershire, United Kingdom
Investigational Site Number :8260001
Bristol, , United Kingdom
Investigational Site Number :8260011
Ivybridge, , United Kingdom
Investigational Site Number :8260002
London, , United Kingdom
Investigational Site Number :8260004
Manchester, , United Kingdom
Investigational Site Number :8260003
Southampton, , United Kingdom
Investigational Site Number :8260006
Taunton, , United Kingdom
Investigational Site Number :8260021
Waterlooville, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-004520-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1183-6530
Identifier Type: REGISTRY
Identifier Source: secondary_id
MET52
Identifier Type: -
Identifier Source: org_study_id
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