Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers when Administered Concomitantly with Routine Pediatric Vaccines in the UK.

Phase 1

• Conditions: Active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W).; MedDRA version: 20.0Level: PTClassification code 10027274Term: Meningococcal infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2017-004520-30-GB
• Lead Sponsor: Sanofi Pasteur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-20
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

An individual must fulfill all of the following criteria in order to be eligible for study enrollment:

1) Aged = 56 to = 89 days on the day of the first study visit
2) Born at full term of pregnancy (= 37 weeks) and with a birth weight = 2.5 kg (or 5 lb and 8 oz)
3) 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)
4) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures

Are the trial subjects under 18? yes
Number of subjects for this age range: 700
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

An individual fulfilling any of the following criteria is to be excluded from study enrollment:

1) 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
2) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination 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
3) 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, Y, or W; or meningococcal B serogroup-containing vaccine)
4) Previous vaccination 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
5) Receipt of immune globulins, blood or blood-derived since birth
6) 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
7) History of any neurologic disorders, including any seizures and progressive neurologic disorders or encephalopathy
8) History of Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically
9) History of diphtheria, tetanus, pertussis, poliomyelitis, Hib, hepatitis B, Streptococcus pneumoniae, and/or rotavirus infection or disease
10) 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)
11) History of Guillain-Barré syndrome
12) 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
13) Hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
14) History of intussusception or uncorrected congenital malformation of the gastrointestinal tract that would predispose to intussusception
15) Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the investigator’s opinion
16) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
17) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
18) 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
19) Moderate or severe acute illness/infection (according

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine is administered concomitantly with Bexsero® in the second year of life compared to when MenACYW conjugate vaccine is given alone.;Secondary Objective: To describe the antibody geometric mean titers (GMTs) of meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine is administered concomitantly with Bexsero® in the second year of life and when MenACYW conjugate vaccine is given alone ;Primary end point(s): Antibody titers = 1:8 against meningococcal serogroups A, C, Y, and W measured by hSBA assessed 30 days after vaccination(s) at 12 to 13 months of age (Group 1 versus Group 2);Timepoint(s) of evaluation of this end point: 30 days after vaccination at 12 to 13 months of age

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): GMTs against meningococcal serogroups A, C, Y, and W measured by hSBA at baseline (pre-vaccination) and 30 days after vaccinations at 12 to 13 months of age (Group 1 versus Group 2).;Timepoint(s) of evaluation of this end point: 30 days after vaccination at 12 to 13 months of age <br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br>