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)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers (Meningococcal Infection)
• Intervention / Treatment: 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; Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine

Detailed Description

Study duration per participant was approximately 11 to 12 months.

• Study Type: Interventional
• Enrollment (Actual): 788
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom, BS2 8AE
    • Investigational Site Number :8260001
  • Ivybridge, United Kingdom, PL21 OAJ
    • Investigational Site Number :8260011
  • London, United Kingdom, SW 17 ORE
    • Investigational Site Number :8260002
  • Manchester, United Kingdom, M13 9WL
    • Investigational Site Number :8260004
  • Southampton, United Kingdom, SO16 6YD
    • Investigational Site Number :8260003
  • Taunton, United Kingdom, TA1 5DA
    • Investigational Site Number :8260006
  • Waterlooville, United Kingdom, PO8 8DL
    • Investigational Site Number :8260021
  • Cornwall
    • Newquay, Cornwall, United Kingdom, TR7 1RU
      • Investigational Site Number :8260024
    • Penzance, Cornwall, United Kingdom, TR19 7HX
      • Investigational Site Number :8260009
    • Torpoint, Cornwall, United Kingdom, PL11 2TB
      • Investigational Site Number :8260013
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Investigational Site Number :8260010
  • Dorset
    • Poole, Dorset, United Kingdom, BH15 2HX
      • Investigational Site Number :8260017
  • Gloucestershire
    • Gloucester, Gloucestershire, United Kingdom, GL1 3NN
      • Investigational Site Number :8260018

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: Meningococcal group B vaccine; Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL; Other Names: 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 Names: Infanrix hexa®; Biological: Human rotavirus RIX4414 strain vaccine; Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL; Other Names: Rotarix®; Biological: Pneumococcal 13-valent polysaccharide conjugate vaccine; Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL; Other Names: Prevenar 13®; 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 Names: MenACYW Conjugate vaccine
Experimental: 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.	Biological: Meningococcal group B vaccine; Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL; Other Names: 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 Names: Infanrix hexa®; Biological: Human rotavirus RIX4414 strain vaccine; Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL; Other Names: Rotarix®; Biological: Pneumococcal 13-valent polysaccharide conjugate vaccine; Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL; Other Names: Prevenar 13®; 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 Names: MenACYW Conjugate vaccine
Active Comparator: 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.	Biological: Meningococcal group B vaccine; Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL; Other Names: 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 Names: Infanrix hexa®; Biological: Human rotavirus RIX4414 strain vaccine; Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL; Other Names: Rotarix®; Biological: Pneumococcal 13-valent polysaccharide conjugate vaccine; Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL; Other Names: Prevenar 13®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3	GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.	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	GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Infancy was defined as up to 4 months of age. Titers were expressed in terms of 1/dilution. Data for this outcome measure was not planned to be collected and analyzed for Group 3.	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	GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Infancy was defined as up to 4 months of age. Titers were expressed in terms of 1/dilution. Data for this outcome measure was not planned to be collected and analyzed for Group 3.	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	GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Infancy was defined as up to 4 months of age. Titers were expressed in terms of 1/dilution.	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	GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.	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 rSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1	GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by serum bactericidal assay using baby rabbit complement (rSBA). Infancy was defined as up to 4 months of age. Titers were expressed in terms of 1/dilution.	Before vaccination at the age of 3 months
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1	GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by rSBA. Infancy was defined as up to 4 months of age. Titers were expressed in terms of 1/dilution.	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 rSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3	GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution.	Before vaccination at the age of 12 to 13 months
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3	GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution.	30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers >=1.4 and >=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.	Before vaccination at the age of 3 months
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers >=1.4 and >=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.	30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers >=1.4 and >=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.	Before vaccination at the age of 12 to 13 months
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Percentage of participants with antibody titers >=1.4 and >=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.	30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers >=1.8 and >=1:128 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.	Before vaccination at the age of 3 months
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers >=1.8 and >=1:128 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.	30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers >=1.8 and >=1:128 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.	Before vaccination at the age of 12 to 13 months
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Percentage of participants with antibody titers >=1.8 and >=1:128 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.	30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With >= 4-Fold Rise in hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 3 months) to pre-dose titer at the age of 3 months. Infancy was defined as up to 4 months of age.	Before vaccination at the age of 3 months, 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)
Percentage of Participants With >= 4-Fold Rise in hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 12 to 13 months) to pre-dose titer before vaccination at the age of 3 months.	Before vaccination at the age of 3 months, 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With >= 4-Fold Rise in hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 12 to 13 months) to pre-dose titer before vaccination at the age of 12 to 13 months.	Before vaccination at the age of 12 to 13 months, 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With >= 4-Fold Rise in rSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 3 months) to pre-dose titer at the age of 3 months. Infancy was defined as up to 4 months of age.	Before vaccination at the age of 3 months, 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)
Percentage of Participants With >= 4-Fold Rise in rSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 12 to 13 months) to pre-dose titer before vaccination at the age of 3 months.	Before vaccination at the age of 3 months, 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With >= 4-Fold Rise in rSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 12 to 13 months) to pre-dose titer before vaccination at the age of 12 to 13 months.	Before vaccination at the age of 12 to 13 months, 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1	The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titer >=1:16 for participants with pre-vaccination hSBA titer <1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers >=1:8. Infancy was defined as up to 4 months of age.	Before vaccination at the age of 3 months up to 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3	The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titer >=1:16 for participants with pre-vaccination hSBA titer <1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers >=1:8.	Before vaccination at the age of 3 months up to 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3	The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titer >=1:16 for participants with pre-vaccination hSBA titer <1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers >=1:8.	Before vaccination at the age of 12 to 13 months up to 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1	The rSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination rSBA titer >=1:32 for participants with pre-vaccination rSBA titer <1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers >=1:8. Infancy was defined as up to 4 months of age.	Before vaccination at the age of 3 months up to 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3	The rSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination rSBA titer >=1:32 for participants with pre-vaccination rSBA titer <1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers >=1:8.	Before vaccination at the age of 3 months up to 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3	The rSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination rSBA titer >=1:32 for participants with pre-vaccination rSBA titer <1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers >=1:8.	Before vaccination at the age of 12 to 13 months up to 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Percentage of participants with hSBA antibody titers distribution <1:4, >=1:4, >=1:8, >=1:16; >=1:32; >=1:64, >=1:128, >=1:256; >=1:512; >=1:1024 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.	Before vaccination at the age of 3 months
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with hSBA antibody titers distribution <1:4, >=1:4, >=1:8, >=1:16; >=1:32; >=1:64, >=1:128, >=1:256; >=1:512; >=1:1024 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.	30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with hSBA antibody titers distribution <1:4, >=1:4, >=1:8, >=1:16; >=1:32; >=1:64, >=1:128, >=1:256; >=1:512; >=1:1024; >=1:2048; >=1:4096; >=1:8192; >=1:16384; >=1:32768; >=1:65536 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.	Before vaccination at the age of 12 to 13 months
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Percentage of participants with hSBA antibody titers distribution <1:4, >=1:4, >=1:8, >=1:16; >=1:32; >=1:64, >=1:128, >=1:256; >=1:512; >=1:1024; >=1:2048; >=1:4096; >=1:8192; >=1:16384; >=1:32768; >=1:65536 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.	30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with rSBA antibody titers distribution <1:4, >=1:4, >=1:8, >=1:16; >=1:32; >=1:64, >=1:128, >=1:256; >=1:512; >=1:1024; >=1:2048; >=1:4096; >=1:8192 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.	Before vaccination at the age of 3 months
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with rSBA antibody titers distribution <1:4, >=1:4, >=1:8, >=1:16; >=1:32; >=1:64, >=1:128, >=1:256; >=1:512; >=1:1024; >=1:2048; >=1:4096; >=1:8192 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.	30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with rSBA antibody titers distribution <1:4, >=1:4, >=1:8, >=1:16; >=1:32; >=1:64, >=1:128, >=1:256; >=1:512; >=1:1024; >=1:2048; >=1:4096; >=1:8192; >=1:16384; >=1:32768 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.	Before vaccination at the age of 12 to 13 months
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Percentage of participants with rSBA antibody titers distribution <1:4, >=1:4, >=1:8, >=1:16; >=1:32; >=1:64, >=1:128, >=1:256; >=1:512; >=1:1024; >=1:2048; >=1:4096; >=1:8192; >=1:16384; >=1:32768 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.	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: Group 1 and 2 - PPAS2	GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.	30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months) and before vaccination at the age of 12-13 months
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W - PPAS2	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Percentage of participants with hSBA antibody titers >=1.4 and >=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.	30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months) and before vaccination at the age of 12-13 months
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2	GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution.	30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months) and before vaccination at the age of 12-13 months
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W - PPAS2	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Percentage of participants with rSBA antibody titers >=1:8 and >=1:128 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.	30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months) and before vaccination at the age of 12-13 months
Number of Participants With Solicited Injection Site Reactions After Any Vaccination	A solicited reaction (SR) was defined as an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and case report form (CRF) and considered as related to vaccination. Solicited injection site reactions included injection site tenderness, injection site erythema, and injection site swelling and were planned to be collected and reported for each vaccine separately; and not planned to be collected for Rotavirus vaccine as the vaccine was administered orally, and no injection site reactions were expected to occur. Reported AEs for each arm were presented as pre-specified in the study protocol. Here, '0' in number analyzed field for MenACYW categories signifies that no participant was evaluable because in Group 3 MenACYW vaccine was not administered.	Within 7 days post any vaccination
Number of Participants With Solicited Systemic Reactions After Any Vaccination	A SR was an expected AR (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability. Reported AEs for each arm were presented as pre-specified in the study protocol.	Within 7 days after any vaccination

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): December 5, 2022
• Study Completion (Actual): December 5, 2022

Study Registration Dates

• First Submitted: August 3, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: MET52; 2017-004520-30 (EudraCT Number); U1111-1183-6530 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• 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