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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)

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ClinicalTrials.gov Identifier: NCT03632720
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : November 29, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief 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

Condition or disease Intervention/treatment Phase
Healthy Volunteers (Meningococcal Infection) Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine Biological: Meningococcal group B vaccine Biological: Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine Biological: Human rotavirus RIX4414 strain vaccine Biological: Pneumococcal 13-valent polysaccharide conjugate vaccine Phase 3

Detailed Description:
Study duration per participant will be approximately 11 to 12 months

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : November 19, 2022
Estimated Study Completion Date : November 19, 2022


Arm Intervention/treatment
Experimental: Group 1
MenACYW conjugate vaccine at 3 months and at 12 to 13 months of age; meningococcal Group B vaccine at 2, 4, and 12 to 13 months of age; routine pediatric vaccines
Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine
Pharmaceutical form: solution for injection; route of administration: intramuscular, 0.5 mL
Other Name: MenACYW conjugate vaccine

Biological: Meningococcal group B vaccine
Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL
Other Name: Bexsero®

Biological: 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
Other Name: Infanrix hexa®

Biological: Human rotavirus RIX4414 strain vaccine
Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL
Other Name: Rotarix®

Biological: Pneumococcal 13-valent polysaccharide conjugate vaccine
Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL
Other Name: Prevenar 13®

Experimental: Group 2
MenACYW conjugate vaccine at 3 months and at 12 to 13 months of age; meningococcal Group B vaccine at 2 and 4 months of age; routine pediatric vaccines
Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine
Pharmaceutical form: solution for injection; route of administration: intramuscular, 0.5 mL
Other Name: MenACYW conjugate vaccine

Biological: Meningococcal group B vaccine
Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL
Other Name: Bexsero®

Biological: 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
Other Name: Infanrix hexa®

Biological: Human rotavirus RIX4414 strain vaccine
Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL
Other Name: Rotarix®

Biological: Pneumococcal 13-valent polysaccharide conjugate vaccine
Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL
Other Name: Prevenar 13®

Active Comparator: Group 3
Meningococcal Group B vaccine at 2, 4, and 12 to 13 months of age; routine pediatric vaccines
Biological: Meningococcal group B vaccine
Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL
Other Name: Bexsero®

Biological: 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
Other Name: Infanrix hexa®

Biological: Human rotavirus RIX4414 strain vaccine
Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL
Other Name: Rotarix®

Biological: Pneumococcal 13-valent polysaccharide conjugate vaccine
Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL
Other Name: Prevenar 13®




Primary Outcome Measures :
  1. Percentage of participants achieving antibody titers against meningococcal serogroups A, C, Y, and W ≥ predefined threshold [ Time Frame: Day 31 ]
    Antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W


Secondary Outcome Measures :
  1. Geometric Mean Titers (GMTs) of antibodies against meningococcal serogroups A, C, Y, and W in Group 1 and Group 2 [ Time Frame: 30 days after vaccination with MenACYW conjugate vaccine concomitantly with Bexsero® (Group 1) or alone at 12 to 13 months of age (Group 2) ]
    Antibody titers (hSBA) are expressed as GMTs

  2. GMTs of antibodies (hSBA and rSBA) against meningococcal serogroups A, C, Y, and W [ Time Frame: Before and 30 days after the first dose of MenACYW conjugate vaccine administered at 3 months of age, before and 30 days after the second dose of MenACYW conjugate vaccine administered at 12 to 13 months of age ]
    Antibody titers (hSBA and rSBA) are expressed as GMTs

  3. hSBA antibody titer above predefined threshold in participants [ Time Frame: Before and 30 days after the first dose of MenACYW conjugate vaccine administered at 3 months of age, before and 30 days after the second dose of MenACYW conjugate vaccine administered at 12 to 13 months of age ]
    hSBA antibody titer ≥ 1:4 and titers ≥ 1:8

  4. rSBA antibody titer above predefined threshold in participants [ Time Frame: Before and 30 days after the first dose of MenACYW conjugate vaccine administered at 3 months of age, before and 30 days after the second dose of MenACYW conjugate vaccine administered at 12 to 13 months of age ]
    rSBA antibody titer ≥ 1:8 and titers ≥ 1:128

  5. Antibody titer above predefined threshold in participants [ Time Frame: Before and 30 days after the first dose of MenACYW conjugate vaccine administered at 3 months of age, before and 30 days after the second dose of MenACYW conjugate vaccine administered at 12 to 13 months of age ]
    Antibody titer ≥ 4-fold rise from pre-vaccination to post-vaccination

  6. Percentage of participants with hSBA and rSBA vaccine seroresponse [ Time Frame: Before and 30 days after the first dose of MenACYW conjugate vaccine administered at 3 months of age, before and 30 days after the second dose of MenACYW conjugate vaccine administered at 12 to 13 months of age ]

    hSBA vaccine seroresponse for serogroups A, C, W, and Y defined as:

    • if pre-vaccination titer < 1:8, post-vaccination titer must be ≥ 1:16
    • if pre-vaccination titer ≥ 1:8, post-vaccination titer must be ≥ 4-fold greater than the pre-vaccination titer rSBA vaccine seroresponse for serogroups A, C, W, and Y defined as:
    • if pre-vaccination titer < 1:8, post-vaccination titer must be ≥ 1:32
    • if pre-vaccination titer ≥ 1:8, post-vaccination titer must be ≥ 4-foldgreater than the pre-vaccination titer

  7. GMTs of antibodies (hSBA and rSBA) against meningococcal serogroups A, C, Y, and W [ Time Frame: 30 days after the first dose of MenACYW conjugate vaccine administered at 3 months of age, and before the second dose of MenACYW conjugate vaccine administered at 12 to 13 months of age ]
    Antibody titers (hSBA and rSBA) are expressed as GMTs

  8. hSBA antibody titer above predefined threshold in participants [ Time Frame: 30 days after the first dose of MenACYW conjugate vaccine administered at 3 months of age, and before the second dose of MenACYW conjugate vaccine administered at 12 to 13 months of age ]
    hSBA antibody titer ≥ 1:4 and titers ≥ 1:8

  9. rSBA antibody titer above predefined threshold in participants [ Time Frame: 30 days after the first dose of MenACYW conjugate vaccine administered at 3 months of age, and before the second dose of MenACYW conjugate vaccine administered at 12 to 13 months of age ]
    rSBA antibody titer ≥ 1:8 and titers ≥ 1:128

  10. Solicited injection site reactions and systemic reactions [ Time Frame: 7 days after each vaccination ]
    Injection site reactions: pain, erythema, and swelling; Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability



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Ages Eligible for Study:   56 Days to 89 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03632720


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
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United Kingdom
Investigational Site Number :8260024 Recruiting
Newquay, Cornwall, United Kingdom, TR7 1RU
Investigational Site Number :8260009 Recruiting
Penzance, Cornwall, United Kingdom, TR19 7HX
Investigational Site Number :8260013 Recruiting
Torpoint, Cornwall, United Kingdom, PL11 2TB
Investigational Site Number :8260010 Recruiting
Exeter, Devon, United Kingdom, EX2 5DW
Investigational Site Number :8260017 Recruiting
Poole, Dorset, United Kingdom, BH15 2HX
Investigational Site Number :8260018 Recruiting
Gloucester, Gloucestershire, United Kingdom, GL1 3NN
Investigational Site Number :8260001 Recruiting
Bristol, United Kingdom, BS2 8AE
Investigational Site Number :8260011 Recruiting
Ivybridge, United Kingdom, PL21 OAJ
Investigational Site Number :8260002 Recruiting
London, United Kingdom, SW 17 ORE
Investigational Site Number :8260003 Recruiting
Southampton, United Kingdom, SO16 6YD
Investigational Site Number :8260006 Recruiting
Taunton, United Kingdom, TA1 5DA
Investigational Site Number :8260021 Recruiting
Waterlooville, United Kingdom, PO8 8DL
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT03632720    
Other Study ID Numbers: MET52
2017-004520-30 ( EudraCT Number )
U1111-1183-6530 ( Registry Identifier: ICTRP )
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: November 29, 2021
Last Verified: November 25, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs