search
Back to results

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)

Primary Purpose

Healthy Volunteers (Meningococcal Infection)

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine
Meningococcal group B vaccine
Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine
Human rotavirus RIX4414 strain vaccine
Pneumococcal 13-valent polysaccharide conjugate vaccine
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy Volunteers (Meningococcal Infection)

Eligibility Criteria

56 Days - 89 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Investigational Site Number :8260024
  • Investigational Site Number :8260009
  • Investigational Site Number :8260013
  • Investigational Site Number :8260010
  • Investigational Site Number :8260017
  • Investigational Site Number :8260018
  • Investigational Site Number :8260001
  • Investigational Site Number :8260011
  • Investigational Site Number :8260002
  • Investigational Site Number :8260004
  • Investigational Site Number :8260003
  • Investigational Site Number :8260006
  • Investigational Site Number :8260021

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

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

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

Meningococcal Group B vaccine at 2, 4, and 12 to 13 months of age; routine pediatric vaccines

Outcomes

Primary Outcome Measures

Percentage of participants achieving antibody titers against meningococcal serogroups A, C, Y, and W ≥ predefined threshold
Antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W

Secondary Outcome Measures

Geometric Mean Titers (GMTs) of antibodies against meningococcal serogroups A, C, Y, and W in Group 1 and Group 2
Antibody titers (hSBA) are expressed as GMTs
GMTs of antibodies (hSBA and rSBA) against meningococcal serogroups A, C, Y, and W
Antibody titers (hSBA and rSBA) are expressed as GMTs
hSBA antibody titer above predefined threshold in participants
hSBA antibody titer ≥ 1:4 and titers ≥ 1:8
rSBA antibody titer above predefined threshold in participants
rSBA antibody titer ≥ 1:8 and titers ≥ 1:128
Antibody titer above predefined threshold in participants
Antibody titer ≥ 4-fold rise from pre-vaccination to post-vaccination
Percentage of participants with hSBA and rSBA vaccine seroresponse
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
GMTs of antibodies (hSBA and rSBA) against meningococcal serogroups A, C, Y, and W
Antibody titers (hSBA and rSBA) are expressed as GMTs
hSBA antibody titer above predefined threshold in participants
hSBA antibody titer ≥ 1:4 and titers ≥ 1:8
rSBA antibody titer above predefined threshold in participants
rSBA antibody titer ≥ 1:8 and titers ≥ 1:128
Solicited injection site reactions and systemic reactions
Injection site reactions: pain, erythema, and swelling; Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability

Full Information

First Posted
August 3, 2018
Last Updated
June 8, 2023
Sponsor
Sanofi Pasteur, a Sanofi Company
search

1. Study Identification

Unique Protocol Identification Number
NCT03632720
Brief Title
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom
Acronym
MET52
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
December 5, 2022 (Actual)
Study Completion Date
December 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers (Meningococcal Infection)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
788 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
Meningococcal Group B vaccine at 2, 4, and 12 to 13 months of age; routine pediatric vaccines
Intervention Type
Biological
Intervention Name(s)
Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine
Other Intervention Name(s)
MenACYW conjugate vaccine
Intervention Description
Pharmaceutical form: solution for injection; route of administration: intramuscular, 0.5 mL
Intervention Type
Biological
Intervention Name(s)
Meningococcal group B vaccine
Other Intervention Name(s)
Bexsero®
Intervention Description
Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL
Intervention Type
Biological
Intervention Name(s)
Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine
Other Intervention Name(s)
Infanrix hexa®
Intervention Description
Pharmaceutical form: powder and suspension for suspension injection; route of administration: deep intramuscular, 0.5 mL
Intervention Type
Biological
Intervention Name(s)
Human rotavirus RIX4414 strain vaccine
Other Intervention Name(s)
Rotarix®
Intervention Description
Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL
Intervention Type
Biological
Intervention Name(s)
Pneumococcal 13-valent polysaccharide conjugate vaccine
Other Intervention Name(s)
Prevenar 13®
Intervention Description
Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL
Primary Outcome Measure Information:
Title
Percentage of participants achieving antibody titers against meningococcal serogroups A, C, Y, and W ≥ predefined threshold
Description
Antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W
Time Frame
Day 31
Secondary Outcome Measure Information:
Title
Geometric Mean Titers (GMTs) of antibodies against meningococcal serogroups A, C, Y, and W in Group 1 and Group 2
Description
Antibody titers (hSBA) are expressed as GMTs
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)
Title
GMTs of antibodies (hSBA and rSBA) against meningococcal serogroups A, C, Y, and W
Description
Antibody titers (hSBA and rSBA) are expressed as GMTs
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
Title
hSBA antibody titer above predefined threshold in participants
Description
hSBA antibody titer ≥ 1:4 and titers ≥ 1:8
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
Title
rSBA antibody titer above predefined threshold in participants
Description
rSBA antibody titer ≥ 1:8 and titers ≥ 1:128
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
Title
Antibody titer above predefined threshold in participants
Description
Antibody titer ≥ 4-fold rise from pre-vaccination to post-vaccination
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
Title
Percentage of participants with hSBA and rSBA vaccine seroresponse
Description
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
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
Title
GMTs of antibodies (hSBA and rSBA) against meningococcal serogroups A, C, Y, and W
Description
Antibody titers (hSBA and rSBA) are expressed as GMTs
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
Title
hSBA antibody titer above predefined threshold in participants
Description
hSBA antibody titer ≥ 1:4 and titers ≥ 1:8
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
Title
rSBA antibody titer above predefined threshold in participants
Description
rSBA antibody titer ≥ 1:8 and titers ≥ 1:128
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
Title
Solicited injection site reactions and systemic reactions
Description
Injection site reactions: pain, erythema, and swelling; Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability
Time Frame
7 days after each vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
56 Days
Maximum Age & Unit of Time
89 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number :8260024
City
Newquay
State/Province
Cornwall
ZIP/Postal Code
TR7 1RU
Country
United Kingdom
Facility Name
Investigational Site Number :8260009
City
Penzance
State/Province
Cornwall
ZIP/Postal Code
TR19 7HX
Country
United Kingdom
Facility Name
Investigational Site Number :8260013
City
Torpoint
State/Province
Cornwall
ZIP/Postal Code
PL11 2TB
Country
United Kingdom
Facility Name
Investigational Site Number :8260010
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Investigational Site Number :8260017
City
Poole
State/Province
Dorset
ZIP/Postal Code
BH15 2HX
Country
United Kingdom
Facility Name
Investigational Site Number :8260018
City
Gloucester
State/Province
Gloucestershire
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
Investigational Site Number :8260001
City
Bristol
ZIP/Postal Code
BS2 8AE
Country
United Kingdom
Facility Name
Investigational Site Number :8260011
City
Ivybridge
ZIP/Postal Code
PL21 OAJ
Country
United Kingdom
Facility Name
Investigational Site Number :8260002
City
London
ZIP/Postal Code
SW 17 ORE
Country
United Kingdom
Facility Name
Investigational Site Number :8260004
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Investigational Site Number :8260003
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Investigational Site Number :8260006
City
Taunton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
Investigational Site Number :8260021
City
Waterlooville
ZIP/Postal Code
PO8 8DL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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://vivli.org

Learn more about this trial

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom

We'll reach out to this number within 24 hrs