Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Using a 1+1 Schedule in a National Immunization Schedule Having a Meningococcal Group B Vaccine as Standard of Care
3 other identifiers
interventional
788
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2018
Typical duration for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedStudy Start
First participant enrolled
October 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2022
CompletedResults Posted
Study results publicly available
November 7, 2023
CompletedNovember 7, 2023
October 1, 2023
4.2 years
August 3, 2018
October 10, 2023
October 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA After Vaccination: Groups 1 and 2 - PPAS3
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Percentage of participants with antibody titers \>=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Secondary Outcomes (43)
Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Before vaccination at the age of 3 months
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Before vaccination at the age of 12 to 13 months
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
- +38 more secondary outcomes
Study Arms (3)
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
EXPERIMENTALParticipants 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.
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
EXPERIMENTALParticipants 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.
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
ACTIVE COMPARATORParticipants 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.
Interventions
Pharmaceutical form: solution for injection; route of administration: intramuscular, 0.5 mL
Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL
Pharmaceutical form: powder and suspension for suspension injection; route of administration: deep intramuscular, 0.5 mL
Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL
Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \-- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Investigational Site Number :8260024
Newquay, Cornwall, TR7 1RU, United Kingdom
Investigational Site Number :8260009
Penzance, Cornwall, TR19 7HX, United Kingdom
Investigational Site Number :8260013
Torpoint, Cornwall, PL11 2TB, United Kingdom
Investigational Site Number :8260010
Exeter, Devon, EX2 5DW, United Kingdom
Investigational Site Number :8260017
Poole, Dorset, BH15 2HX, United Kingdom
Investigational Site Number :8260018
Gloucester, Gloucestershire, GL1 3NN, United Kingdom
Investigational Site Number :8260001
Bristol, BS2 8AE, United Kingdom
Investigational Site Number :8260011
Ivybridge, PL21 OAJ, United Kingdom
Investigational Site Number :8260002
London, SW 17 ORE, United Kingdom
Investigational Site Number :8260004
Manchester, M13 9WL, United Kingdom
Investigational Site Number :8260003
Southampton, SO16 6YD, United Kingdom
Investigational Site Number :8260006
Taunton, TA1 5DA, United Kingdom
Investigational Site Number :8260021
Waterlooville, PO8 8DL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi Pasteur
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2018
First Posted
August 15, 2018
Study Start
October 10, 2018
Primary Completion
December 5, 2022
Study Completion
December 5, 2022
Last Updated
November 7, 2023
Results First Posted
November 7, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org