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CompletedNCT03547271Updated Mar 3, 2025Results posted

Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe

A Phase 3 interventional study of MenACYW conjugate vaccine and Meningococcal group A, C, W-135, and Y conjugate vaccine in Meningococcal Infections, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 33 sites in 7 countries. Open to participants aged 42 Days to 89 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-03.

Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
1,660
Allocation
Randomized
Ages
42 Days to 89 Days
Sex
All
01

Study summary

Primary objective:

This study aimed to demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of MenACYW conjugate vaccine compared to a 3-dose series of a licensed meningococcal vaccine when each vaccine was given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b [DTaP-IPV-HB-Hib vaccine]) to infants and toddlers 6 weeks to 18 months old

Secondary objectives:

This study aimed to demonstrate the non-inferiority of the antibody (Ab) response against meningococcal serogroups A, C, Y, and W following the administration of 2 doses in infancy of MenACYW conjugate vaccine compared to 2 doses of a licensed meningococcal vaccine when each vaccine was given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and DTaP-IPV-HB-Hib vaccine) to infants and toddlers 6 weeks to 18 months old.

  • This study aimed to describe the Ab responses against meningococcal groups A, C, Y, and W and the antigens of the routine pediatric vaccines administered in the study.
02

Conditions studied

  • Meningococcal Infections

Keywords

  • Meningococcal meningitis
  • MenACYW conjugate vaccine
  • Quadrivalent meningococcal vaccine
03

In context

Meningococcal Infections

219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.

This study's enrollment of 1,660 is above the median of 450 across 190 interventional studies indexed under Meningococcal Infections.

Browse Meningococcal Infections studies →

Lead sponsor

Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
42 Days to 89 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Aged ≥ 42 to ≤ 89 days on the day of the first study visit
  • Healthy infants as determined by medical history, physical examination and judgment of the Investigator
  • Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
  • Subject and parent/legally acceptable representative were able to attend all scheduled visits and to comply with all study procedures
  • Covered by health insurance according to local regulations

Exclusion criteria

Exclusion Criteria:

  • Participated at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
  • Received any vaccine in the 4 weeks preceding the first study vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any study vaccination except for influenza vaccination and rotavirus vaccination, which may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccines. This exception included monovalent pandemic influenza vaccines and multivalent influenza vaccines. This exclusion criterion did not apply to subjects in Finland, Sweden or Poland who planned to receive the licensed rotavirus vaccine concomitantly with study vaccines at study vaccination visits V1 and V2.
  • Received or planned to receipt during the study period vaccination against meningococcal disease with either the study 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)
  • Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type B (Hib), poliovirus, Streptococcus pneumoniae, measles, mumps, or rubella. Previous vaccination against hepatitis B when administered to risk groups, as per local recommendation.
  • Received immune globulins, blood or blood-derived products since birth
  • Known or suspected congenital or acquired immunodeficiency; or received 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
  • Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated
  • Individuals that had blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
  • Individuals that had active tuberculosis
  • History of Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically
  • History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, measles, mumps, rubella, and of Haemophilus influenzae type b, and / or Streptococcus pneumoniae infection or disease
  • Individuals that were at high risk for meningococcal infection during the study (specifically, but not limited to, subjects that had persistent complement deficiency, with anatomic or functional asplenia, or subjects traveling to countries with high endemic or epidemic disease)
  • Individuals that had underlying conditions predisposing them to invasive pneumococcal disease (specifically, but not limited to, subjects with sickle cell disease or human immunodeficiency virus [HIV] infection)
  • History of any neurologic disorders, including seizures and progressive neurologic disorders
  • History of Guillain-Barré syndrome
  • Known systemic hypersensitivity to any of the vaccine components, or history of a severe allergic reaction (e.g., anaphylaxis) to the vaccine(s) used in the study or to a vaccine containing any of the same substances including neomycin, streptomycin, polymyxin B, glutaraldehyde, formaldehyde, and gelatin
  • Reported of thrombocytopenia, contraindicating intramuscular vaccination in the investigator's opinion
  • Bleeding disorder, or received of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the investigator's opinion
  • Chronic illness (including, but not limited to, cardiac disorders, congenital heart disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and known congenital or genetic diseases) that, in the opinion of the investigator, were at a stage where it could interfere with study conduct or completion
  • Any condition which, in the opinion of the investigator, could interfere with the evaluation of the study objectives, including planned to leave the area of the study site before the end of the study
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective subject could not be included in the study until the condition was resolved or the febrile event was subsided.
  • Received oral or injectable antibiotic therapy within 72 hours prior to the first blood draw Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
  • Infants born preterm (by less than 37 weeks of gestation) required specific immunization schedule for routine childhood vaccines and/or specific care at the time of vaccination, as per national recommendations
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,660 participants (actual)

Study arms

  • Experimental
    Group 1: MenACYW

    Participants received 3 doses of meningococcal polysaccharide (serogroups A, C, Y and W) tetanus toxoid \[MenACYW conjugate vaccine\] 0.5 milliliter (mL) as an intramuscular (IM) injection at dose 1: 2 months of age (MoA), dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and haemophilus influenzae type b conjugate vaccine \[DTaP-IPV-HB-Hib\], the pneumococcal vaccine (pneumococcal conjugate vaccine \[10-valent, adsorbed\] {PCV10} were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the measles, mumps, rubella (MMR) vaccine was administered at 12 to 18 MoA.

    Biological: MenACYW conjugate vaccine · Biological: DTaP-IPV-HB-Hib vaccine · Biological: Pneumococcal vaccine (10-valent) · Biological: MMR vaccine

  • Active comparator
    Group 2: Nimenrix

    Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.

    Biological: Meningococcal group A, C, W-135, and Y conjugate vaccine · Biological: DTaP-IPV-HB-Hib vaccine · Biological: Pneumococcal vaccine (10-valent) · Biological: MMR vaccine

  • Experimental
    Group 3: MenACYW

    Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the pneumococcal conjugate vaccine (13-valent, adsorbed) \[PCV13\] were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.

    Biological: MenACYW conjugate vaccine · Biological: DTaP-IPV-HB-Hib vaccine · Biological: Pneumococcal vaccine (13-valent) · Biological: MMR vaccine

  • Experimental
    Group 4: MenACYW

    Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.

    Biological: MenACYW conjugate vaccine · Biological: DTaP-IPV-HB-Hib vaccine · Biological: Pneumococcal vaccine (13-valent) · Biological: MMR vaccine

Interventions

  • BiologicalMenACYW conjugate vaccine

    Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine, 0.5 mL, intramuscular

    Also known as: MenQuadfi®

  • BiologicalMeningococcal group A, C, W-135, and Y conjugate vaccine

    Meningococcal group A, C, W-135, and Y conjugate vaccine, 0.5 mL, intramuscular

    Also known as: Nimenrix®

  • BiologicalDTaP-IPV-HB-Hib vaccine

    Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine

    Also known as: Hexyon®/Hexacima®

  • BiologicalPneumococcal vaccine (13-valent)

    Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

    Also known as: Prevenar 13®

  • BiologicalPneumococcal vaccine (10-valent)

    Pneumococcal polysaccharide conjugate vaccine (10-valent, adsorbed)

    Also known as: Synflorix®

  • BiologicalMMR vaccine

    Measles, mumps, and rubella vaccine

    Also known as: M-M-RVAXPRO®

06

What researchers measure

Primary outcomes

  1. Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y

    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the serum bactericidal assay using human complement (hSBA).

    Time frame: At 30 days post Dose 3 [12 to 18 months of age (MoA)]

Secondary outcomes

  1. Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y

    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place.

    Time frame: At 30 days post Dose 2 (4 MoA)

  2. Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y

    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA.

    Time frame: Group 3: Day 0 before Dose 1 (2 MoA) and Dose 3 (12 to 18 MoA) and Day 30 Post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: Day 0 before Dose 1 (2 MoA) and Dose 4 (12 to 18 MoA) and Day 30 Post Dose 3 (6 MoA) and Dose 4 (12 to 18 MoA)

  3. Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8

    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place.

    Time frame: Day 0 Before Dose 1 (2 MoA) and Day 30 Post Dose 2 (4 MoA); Day 0 Before Dose 3 (12 to 18 MoA) and Day 30 Post Dose 3 (12 to 18 MoA)

  4. Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8

    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place.

    Time frame: Group 3: Day 0 before Dose 1 (2 MoA) and Dose 3 (12 to 18 MoA) and Day 30 Post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: Day 0 before Dose 1 (2 MoA) and Dose 4 (12 to 18 MoA) and Day 30 Post Dose 3 (6 MoA) and Dose 4 (12 to 18 MoA)

  5. Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse

    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse was defined for a participant with a pre vaccination titer \<1:8, the post-vaccination titer must be \>=1:16 and for a participant with a pre vaccination titer \>=1:8, the post-vaccination titer must be at least 4-fold greater than the pre vaccination titer. Percentages are rounded off to the tenth decimal place.

    Time frame: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA)

  6. Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse

    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse was defined for a participant with a pre vaccination titer \<1:8, the post-vaccination titer must be \>=1:16 and for a participant with a pre vaccination titer \>=1:8, the post-vaccination titer must be at least 4-fold greater than the pre vaccination titer. Percentages are rounded off to the tenth decimal place.

    Time frame: Group 3: Day 30 Post Dose 2 (4 MoA), Day 30 Post Dose 3 (12 to 18 MoA); Group 4: D30 Post Dose 3 (6 MoA), Day 30 Post Dose 4 (12 to 18 MoA)

  7. Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies

    GMCs of anti-pertussis antibodies (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\]) were measured by electrochemiluminescent (ECL) assay.

    Time frame: Groups 1, 2 and 3: Day 0 before Dose 1 (2 MoA); Group 4: Day 0 before Dose 4 (12 to 18 MoA)

  8. Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines

    GMCs of hexavalent vaccines were measured as: anti-diphtheria, anti-tetanus, anti-pertussis antibodies (PT, FHA) by ECL assay, anti-hepatitis antibodies (anti-Hepatitis B surface antigen \[HBsAg\]) by the commercially available VITROS ECi/ECiQ, anti-poliovirus types 1, 2, and 3 by neutralization assay and anti-Haemophilus influenzae type b (anti-polyribosylribitol phosphate \[PRP\]) by Farr-type radioimmunoassay (RIA).

    Time frame: Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)

  9. Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP)

    GMCs of anti-diphtheria, anti-tetanus, anti-poliovirus types 1, 2, and 3, anti-haemophilus influenzae type b (anti-PRP) vaccines were measured as: anti-diphtheria, anti-tetanus by ECL assay, anti-poliovirus types 1, 2, and 3 by neutralization assay and anti-Haemophilus influenzae type b (anti-PRP) by Farr-type RIA. Response rate was defined as percentage of participants who achieved: anti diphtheria and anti-tetanus antibody concentrations \>=0.01 international units (IU)/milliliter (mL), \>=0.1 IU/mL and \>=1.0 IU/mL; anti-poliovirus types 1, 2, and 3 antibody titers \>=1:8; anti-PRP antibody concentrations \>=0.15 microgram (mcg)/mL and \>=1 mcg/mL. Percentages are rounded off to the tenth decimal place.

    Time frame: Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)

  10. Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies

    GMCs of anti-pertussis antibodies (PT, FHA) were measured by ECL assay. The pertussis vaccine seroresponse for anti-PT and anti-FHA was defined as: For groups 1, 2, and 3, 30 days after dose 2 in infancy as if the pre-primary vaccination concentration is \<4 × lower limit of quantification (LLOQ), post-primary vaccination concentration \>=4 × LLOQ, if the pre-primary vaccination concentration is \>=4 ×LLOQ, post-primary vaccination concentration \>=pre-primary vaccination concentration; and for Groups 1, 2, and 3, before and 30 days after the dose 3 and for group 4, before and 30 days after the dose 4 as if the pre-booster vaccination concentration is \<4 × LLOQ, post-booster vaccination concentration \>=4 × pre-booster concentration, if the pre-booster vaccination concentration is \>=4 × LLOQ, post-booster vaccination concentration \>=2 × pre-booster concentration. Percentages are rounded off to the tenth decimal place.

    Time frame: Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)

  11. Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL

    GMCs of anti-hepatitis antibodies (anti-HBsAg) was measured by the commercially available VITROS ECi/ECiQ. Response rate for anti-HBsAg was defined as percentage of participants who achieved anti-HBsAg antibody concentrations \>=10 mIU/mL and \>=100 mIU/mL. Percentages are rounded off to the tenth decimal place.

    Time frame: Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)

  12. Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine

    GMCs of anti-pneumococcal antibodies was assessed by pneumococcal capsular polysaccharide (PnPS) Immunoglobulin G (IgG) ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) antibodies in human serum.

    Time frame: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA)

  13. Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine

    GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) antibodies in human serum.

    Time frame: Group 3: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)

  14. Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine

    GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) antibodies in human serum. Percentages are rounded off to the tenth decimal place.

    Time frame: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA)

  15. Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine

    GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) antibodies in human serum. Percentages are rounded off to the tenth decimal place.

    Time frame: Group 3: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)

  16. Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies

    GMCs of anti-measles and anti-rubella antibodies were measured by bulk IgG enzyme immunoassay (EIA) and anti-mumps antibodies were assessed by enzyme-linked immunosorbent assay (ELISA).

    Time frame: Groups 1, 2 and 3: At 30 days post Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)

  17. Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies

    GMCs of anti-measles and anti-rubella antibodies were measured by bulk IgG EIA and anti-mumps antibodies were assessed by ELISA. Vaccine response against anti-measles, anti-mumps, anti-rubella antibodies were defined as percentage of participants with anti-measles, anti-mumps, anti-rubella antibody concentration that met the respective mentioned criterion: measles: \>=255 mIU/mL; mumps: \>=10 mumps antibody units/mL and rubella: \>=10 IU/mL. Percentages are rounded off to the tenth decimal place.

    Time frame: Groups 1, 2 and 3: At 30 days post Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)

07

Results

Posted Jan 22, 2025

Participant flow

This study was conducted at 33 investigational sites in 7 countries between 14 December 2018 to 24 May 2023.

Participant flow — Overall Study
MilestoneGroup 1: MenACYWGroup 2: NimenrixGroup 3: MenACYWGroup 4: MenACYW
Started714726112108
Safety analysis set (safas)696706112108
Completed681691106104
Not completed333564
Withdrew: Adverse event1100
Withdrew: Protocol deviation5730
Withdrew: Withdrawal by parent/guardian242424
Withdrew: Lost to follow-up3310

Outcome measures

PrimaryGroups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y

Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the serum bactericidal assay using human complement (hSBA).

Time frame:
At 30 days post Dose 3 [12 to 18 months of age (MoA)]
Reported as:
Geometric mean · Titer
Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y
TiterGroup 1: MenACYWGroup 2: Nimenrix
Serogroup A131 (113 to 151)189 (165 to 218)
Serogroup C565 (505 to 632)120 (106 to 135)
Serogroup W423 (382 to 468)275 (247 to 305)
Serogroup Y285 (260 to 313)160 (145 to 177)
Statistical analysis
  • Group 1: MenACYW vs Group 2: Nimenrix · Gmt ratio: 0.690 · 95% CI 0.565 to 0.84295% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.
  • Group 1: MenACYW vs Group 2: Nimenrix · Gmt ratio: 4.73 · 95% CI 4.00 to 5.5895% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.
  • Group 1: MenACYW vs Group 2: Nimenrix · Slope: 1.54 · 95% CI 1.33 to 1.7895% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.
  • Group 1: MenACYW vs Group 2: Nimenrix · Gmt ratio: 1.78 · 95% CI 1.55 to 2.0495% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.
SecondaryGroups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y

Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place.

Time frame:
At 30 days post Dose 2 (4 MoA)
Reported as:
Number · Percentage of participants
Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y
Percentage of participantsGroup 1: MenACYWGroup 2: Nimenrix
Serogroup A63.6 (59.2 to 67.8)75.8 (71.8 to 79.5)
Serogroup C98.8 (97.5 to 99.6)91.9 (89.3 to 94.1)
Serogroup W96.5 (94.6 to 97.9)94.5 (92.1 to 96.3)
Serogroup Y96.5 (94.5 to 97.9)93.5 (91.0 to 95.5)
Statistical analysis
  • Group 1: MenACYW vs Group 2: Nimenrix · Difference in percentage of participants: -12.20 · 95% CI -17.74 to -6.5695% CI of the difference was calculated from the Wilson score method without continuity correction.
  • Group 1: MenACYW vs Group 2: Nimenrix · Difference in percentage of participants: 6.89 · 95% CI 4.44 to 9.6295% CI of the difference was calculated from the Wilson score method without continuity correction.
  • Group 1: MenACYW vs Group 2: Nimenrix · Difference in percentage of participants: 2.07 · 95% CI -0.49 to 4.7095% CI of the difference was calculated from the Wilson score method without continuity correction
  • Group 1: MenACYW vs Group 2: Nimenrix · Difference in percentage of participants: 3.01 · 95% CI 0.34 to 5.7795% CI of the difference was calculated from the Wilson score method without continuity correction.
SecondaryGroups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y

Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA.

Time frame:
Group 3: Day 0 before Dose 1 (2 MoA) and Dose 3 (12 to 18 MoA) and Day 30 Post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: Day 0 before Dose 1 (2 MoA) and Dose 4 (12 to 18 MoA) and Day 30 Post Dose 3 (6 MoA) and Dose 4 (12 to 18 MoA)
Reported as:
Geometric mean · Titer
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y
TiterGroup 3: MenACYWGroup 4: MenACYW
PPAS1: Serogroup A: Day 0 before dose 13.00 (2.58 to 3.49)2.86 (2.49 to 3.28)
PPAS1: Serogroup A: Day 30 post dose 214.8 (10.6 to 20.8)—
PPAS1: Serogroup A: Day 30 post dose 3—23.0 (17.1 to 30.9)
PPAS1: Serogroup C: Day 0 before dose 13.91 (3.16 to 4.84)3.88 (3.25 to 4.62)
PPAS1: Serogroup C: Day 30 post dose 2309 (235 to 407)—
PPAS1: Serogroup C: Day 30 post dose 3—481 (376 to 616)
PPAS1: Serogroup W: Day 0 before dose 12.67 (2.40 to 2.96)3.08 (2.63 to 3.60)
PPAS1: Serogroup W: Day 30 post dose 2102 (79.7 to 131)—
PPAS1: Serogroup W: Day 30 post dose 3—196 (156 to 245)
PPAS1: Serogroup Y: Day 0 before dose 12.85 (2.45 to 3.32)2.76 (2.36 to 3.23)
PPAS1: Serogroup Y: Day 30 post dose 273.4 (57.7 to 93.5)—
PPAS1: Serogroup Y: Day 30 post dose 3—150 (116 to 195)
PPAS2: Serogroup A: Day 0 before dose 35.18 (4.22 to 6.37)—
PPAS2: Serogroup A: Day 30 post dose 3104 (67.9 to 161)—
PPAS2: Serogroup A: Day 0 before dose 4—8.13 (6.33 to 10.4)
PPAS2: Serogroup A: Day 30 post dose 4—62.0 (39.9 to 96.4)
PPAS2: Serogroup C: Day 0 before dose 326.2 (18.7 to 36.8)—
PPAS2: Serogroup C: Day 30 post dose 3819 (622 to 1078)—
PPAS2: Serogroup C: Day 0 before dose 4—56.9 (42.4 to 76.4)
PPAS2: Serogroup C: Day 30 post dose 4—791 (608 to 1029)
PPAS2: Serogroup W: Day 0 before dose 339.1 (29.6 to 51.8)—
PPAS2: Serogroup W: Day 30 post dose 31049 (782 to 1406)—
PPAS2: Serogroup W: Day 0 before dose 4—92.6 (74.3 to 115)
PPAS2: Serogroup W: Day 30 post dose 4—1024 (806 to 1301)
PPAS2: Serogroup Y: Day 0 before dose 333.0 (25.0 to 43.5)—
PPAS2: Serogroup Y: Day 30 post dose 3589 (470 to 737)—
PPAS2: Serogroup Y: Day 0 before dose 4—85.8 (68.2 to 108)
PPAS2: Serogroup Y: Day 30 post dose 4—632 (512 to 780)
SecondaryGroups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8

Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place.

Time frame:
Day 0 Before Dose 1 (2 MoA) and Day 30 Post Dose 2 (4 MoA); Day 0 Before Dose 3 (12 to 18 MoA) and Day 30 Post Dose 3 (12 to 18 MoA)
Reported as:
Number · Percentage of participants
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8
Percentage of participantsGroup 1: MenACYWGroup 2: Nimenrix
PPAS1: Serogroup A: >=1:4: Day 0 before dose 131.1 (27.1 to 35.3)28.3 (24.5 to 32.4)
PPAS1: Serogroup A: >=1:8: Day 0 before dose 15.6 (3.8 to 7.9)6.4 (4.4 to 8.8)
PPAS1: Serogroup A: >=1:4: Day 30 post dose 277.2 (73.3 to 80.7)88.0 (84.8 to 90.7)
PPAS1: Serogroup A: >=1:8: Day 30 post dose 263.6 (59.2 to 67.8)75.8 (71.8 to 79.5)
PPAS1: Serogroup C: >=1:4: Day 0 before dose 114.3 (11.4 to 17.6)14.9 (11.9 to 18.3)
PPAS1: Serogroup C: >=1:8: Day 0 before dose 15.2 (3.5 to 7.5)5.2 (3.5 to 7.5)
PPAS1: Serogroup C: >=1:4: Day 30 post dose 299.0 (97.7 to 99.7)96.4 (94.4 to 97.8)
PPAS1: Serogroup C: >=1:8: Day 30 post dose 298.8 (97.5 to 99.6)91.9 (89.3 to 94.1)
PPAS1: Serogroup W: >=1:4: Day 0 before dose 111.7 (9.1 to 14.8)11.0 (8.4 to 14.0)
PPAS1: Serogroup W: >=1:8: Day 0 before dose 13.7 (2.2 to 5.6)3.5 (2.1 to 5.4)
PPAS1: Serogroup W: >=1:4: Day 30 post dose 298.6 (97.2 to 99.5)98.3 (96.8 to 99.2)
PPAS1: Serogroup W: >=1:8: Day 30 post dose 296.5 (94.6 to 97.9)94.5 (92.1 to 96.3)
PPAS1: Serogroup Y: >=1:4: Day 0 before dose 110.0 (7.6 to 12.9)9.8 (7.4 to 12.7)
PPAS1: Serogroup Y: >=1:8: Day 0 before dose 16.4 (4.4 to 8.8)5.6 (3.8 to 7.9)
PPAS1: Serogroup Y: >=1:4: Day 30 post dose 298.3 (96.7 to 99.2)97.3 (95.5 to 98.5)
PPAS1: Serogroup Y: >=1:8: Day 30 post dose 296.5 (94.5 to 97.9)93.5 (91.0 to 95.5)
PPAS2: Serogroup A: >=1:4: Day 0 before dose 369.1 (65.0 to 73.0)73.7 (69.9 to 77.3)
PPAS2: Serogroup A: >=1:8: Day 0 before dose 333.7 (29.7 to 37.9)46.2 (42.0 to 50.4)
PPAS2: Serogroup A: >=1:4: Day 30 post dose 398.2 (96.6 to 99.1)98.1 (96.6 to 99.0)
PPAS2: Serogroup A: >=1:8: Day 30 post dose 394.7 (92.4 to 96.4)96.5 (94.6 to 97.8)
PPAS2: Serogroup C: >=1:4: Day 0 before dose 392.5 (89.9 to 94.5)62.1 (57.9 to 66.1)
PPAS2: Serogroup C: >=1:8: Day 0 before dose 388.1 (85.1 to 90.7)41.6 (37.5 to 45.8)
PPAS2: Serogroup C: >=1:4: Day 30 post dose 399.8 (99.0 to 100)98.1 (96.6 to 99.0)
PPAS2: Serogroup C: >=1:8: Day 30 post dose 399.6 (98.7 to 100)95.5 (93.5 to 97.0)
PPAS2: Serogroup W: >=1:4: Day 0 before dose 396.7 (94.8 to 98.0)91.2 (88.5 to 93.4)
PPAS2: Serogroup W: >=1:8: Day 0 before dose 389.1 (86.2 to 91.6)77.6 (73.9 to 81.0)
PPAS2: Serogroup W: >=1:4: Day 30 post dose 3100 (99.3 to 100)100 (99.4 to 100)
PPAS2: Serogroup W: >=1:8: Day 30 post dose 399.8 (99.0 to 100)99.5 (98.5 to 99.9)
PPAS2: Serogroup Y: >=1:4: Day 0 before dose 395.8 (93.7 to 97.3)85.7 (82.5 to 88.4)
PPAS2: Serogroup Y: >=1:8: Day 0 before dose 387.9 (84.9 to 90.5)69.6 (65.6 to 73.3)
PPAS2: Serogroup Y: >=1:4: Day 30 post dose 3100 (99.3 to 100)100 (99.4 to 100)
PPAS2: Serogroup Y: >=1:8: Day 30 post dose 3100 (99.3 to 100)99.8 (99.0 to 100)
SecondaryGroups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8

Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place.

Time frame:
Group 3: Day 0 before Dose 1 (2 MoA) and Dose 3 (12 to 18 MoA) and Day 30 Post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: Day 0 before Dose 1 (2 MoA) and Dose 4 (12 to 18 MoA) and Day 30 Post Dose 3 (6 MoA) and Dose 4 (12 to 18 MoA)
Reported as:
Number · Percentage of participants
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8
Percentage of participantsGroup 3: MenACYWGroup 4: MenACYW
PPAS1: Serogroup A: >=1:4: Day 0 before dose 133.0 (23.6 to 43.4)32.6 (23.0 to 43.3)
PPAS1: Serogroup A: >=1:8: Day 0 before dose 114.9 (8.4 to 23.7)11.2 (5.5 to 19.7)
PPAS1: Serogroup A: >=1:4: Day 30 post dose 279.1 (69.3 to 86.9)—
PPAS1: Serogroup A: >=1:8: Day 30 post dose 263.7 (53.0 to 73.6)—
PPAS1: Serogroup A: >=1:4: Day 30 post dose 3—92.0 (84.3 to 96.7)
PPAS1: Serogroup A: >=1:8: Day 30 post dose 3—81.8 (72.2 to 89.2)
PPAS1: Serogroup C: >=1:4: Day 0 before dose 143.6 (33.4 to 54.2)48.9 (38.2 to 59.7)
PPAS1: Serogroup C: >=1:8: Day 0 before dose 126.6 (18.0 to 36.7)32.2 (22.8 to 42.9)
PPAS1: Serogroup C: >=1:4: Day 30 post dose 298.9 (94.3 to 100)—
PPAS1: Serogroup C: >=1:8: Day 30 post dose 298.9 (94.3 to 100)—
PPAS1: Serogroup C: >=1:4: Day 30 post dose 3—98.9 (94.0 to 100)
PPAS1: Serogroup C: >=1:8: Day 30 post dose 3—98.9 (94.0 to 100)
PPAS1: Serogroup W: >=1:4: Day 0 before dose 128.7 (19.9 to 39.0)35.6 (25.7 to 46.3)
PPAS1: Serogroup W: >=1:8: Day 0 before dose 110.6 (5.2 to 18.7)16.7 (9.6 to 26.0)
PPAS1: Serogroup W: >=1:4: Day 30 post dose 299.0 (94.3 to 100)—
PPAS1: Serogroup W: >=1:8: Day 30 post dose 296.9 (91.1 to 99.4)—
PPAS1: Serogroup W: >=1:4: Day 30 post dose 3—98.9 (94.0 to 100)
PPAS1: Serogroup W: >=1:8: Day 30 post dose 3—98.9 (94.0 to 100)
PPAS1: Serogroup Y: >=1:4: Day 0 before dose 126.6 (18.0 to 36.7)22.2 (14.1 to 32.2)
PPAS1: Serogroup Y: >=1:8: Day 0 before dose 112.8 (6.8 to 21.2)12.2 (6.3 to 20.8)
PPAS1: Serogroup Y: >=1:4: Day 30 post dose 299.0 (94.3 to 100)—
PPAS1: Serogroup Y: >=1:8: Day 30 post dose 295.8 (89.7 to 98.9)—
PPAS1: Serogroup Y: >=1:4: Day 30 post dose 3—98.9 (94.0 to 100)
PPAS1: Serogroup Y: >=1:8: Day 30 post dose 3—98.9 (94.0 to 100)
PPAS2: Serogroup A: >=1:4: Day 0 before dose 365.9 (55.3 to 75.5)—
PPAS2: Serogroup A: >=1:8: Day 0 before dose 337.4 (27.4 to 48.1)—
PPAS2: Serogroup A: >=1:4: Day 30 post dose 392.4 (84.9 to 96.9)—
PPAS2: Serogroup A: >=1:8: Day 30 post dose 389.1 (80.9 to 94.7)—
PPAS2: Serogroup A: >=1:4: Day 0 before dose 4—80.9 (71.2 to 88.5)
PPAS2: Serogroup A: >=1:8: Day 0 before dose 4—52.8 (41.9 to 63.5)
PPAS2: Serogroup A: >=1:4: Day 30 post dose 4—82.0 (72.5 to 89.4)
PPAS2: Serogroup A: >=1:8: Day 30 post dose 4—82.0 (72.5 to 89.4)
PPAS2: Serogroup C: >=1:4: Day 0 before dose 387.2 (78.8 to 93.2)—
PPAS2: Serogroup C: >=1:8: Day 0 before dose 379.8 (70.2 to 87.4)—
PPAS2: Serogroup C: >=1:4: Day 30 post dose 3100 (96.1 to 100)—
PPAS2: Serogroup C: >=1:8: Day 30 post dose 3100 (96.1 to 100)—
PPAS2: Serogroup C: >=1:4: Day 0 before dose 4—97.8 (92.1 to 99.7)
PPAS2: Serogroup C: >=1:8: Day 0 before dose 4—92.1 (84.5 to 96.8)
PPAS2: Serogroup C: >=1:4: Day 30 post dose 4—100 (95.8 to 100)
PPAS2: Serogroup C: >=1:8: Day 30 post dose 4—100 (95.8 to 100)
PPAS2: Serogroup W: >=1:4: Day 0 before dose 396.8 (90.9 to 99.3)—
PPAS2: Serogroup W: >=1:8: Day 0 before dose 392.5 (85.1 to 96.9)—
PPAS2: Serogroup W: >=1:4: Day 30 post dose 3100 (95.8 to 100)—
PPAS2: Serogroup W: >=1:8: Day 30 post dose 3100 (95.8 to 100)—
PPAS2: Serogroup W: >=1:4: Day 0 before dose 4—100 (96.0 to 100)
PPAS2: Serogroup W: >=1:8: Day 0 before dose 4—100 (96.0 to 100)
PPAS2: Serogroup W: >=1:4: Day 30 post dose 4—100 (95.8 to 100)
PPAS2: Serogroup W: >=1:8: Day 30 post dose 4—100 (95.8 to 100)
PPAS2: Serogroup Y: >=1:4: Day 0 before dose 394.7 (88.0 to 98.3)—
PPAS2: Serogroup Y: >=1:8: Day 0 before dose 389.4 (81.3 to 94.8)—
PPAS2: Serogroup Y: >=1:4: Day 30 post dose 3100 (96.2 to 100)—
PPAS2: Serogroup Y: >=1:8: Day 30 post dose 3100 (96.2 to 100)—
PPAS2: Serogroup Y: >=1:4: Day 0 before dose 4—100 (96.0 to 100)
PPAS2: Serogroup Y: >=1:8: Day 0 before dose 4—100 (96.0 to 100)
PPAS2: Serogroup Y: >=1:4: Day 30 post dose 4—100 (95.9 to 100)
PPAS2: Serogroup Y: >=1:8: Day 30 post dose 4—100 (95.9 to 100)
SecondaryGroups 1 and 2: Percentage of Participants With Vaccine Seroresponse

Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse was defined for a participant with a pre vaccination titer \<1:8, the post-vaccination titer must be \>=1:16 and for a participant with a pre vaccination titer \>=1:8, the post-vaccination titer must be at least 4-fold greater than the pre vaccination titer. Percentages are rounded off to the tenth decimal place.

Time frame:
Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA)
Reported as:
Number · Percentage of participants
Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse
Percentage of participantsGroup 1: MenACYWGroup 2: Nimenrix
PPAS1: Serogroup A: Day 30 post dose 246.7 (42.3 to 51.2)60.9 (56.5 to 65.2)
PPAS1: Serogroup C: Day 30 post dose 297.4 (95.7 to 98.6)86.8 (83.5 to 89.6)
PPAS1: Serogroup W: Day 30 post dose 292.6 (90.0 to 94.7)88.4 (85.4 to 91.1)
PPAS1: Serogroup Y: Day 30 post dose 287.1 (83.9 to 89.9)81.4 (77.8 to 84.7)
PPAS2: Serogroup A: Day 30 post dose 390.6 (87.8 to 92.9)91.7 (89.1 to 93.8)
PPAS2: Serogroup C: Day 30 post dose 398.7 (97.4 to 99.5)91.3 (88.7 to 93.5)
PPAS2: Serogroup W: Day 30 post dose 399.4 (98.4 to 99.9)98.4 (97.0 to 99.3)
PPAS2: Serogroup Y: Day 30 post dose 398.7 (97.4 to 99.5)96.9 (95.1 to 98.1)
SecondaryGroups 3 and 4: Percentage of Participants With Vaccine Seroresponse

Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse was defined for a participant with a pre vaccination titer \<1:8, the post-vaccination titer must be \>=1:16 and for a participant with a pre vaccination titer \>=1:8, the post-vaccination titer must be at least 4-fold greater than the pre vaccination titer. Percentages are rounded off to the tenth decimal place.

Time frame:
Group 3: Day 30 Post Dose 2 (4 MoA), Day 30 Post Dose 3 (12 to 18 MoA); Group 4: D30 Post Dose 3 (6 MoA), Day 30 Post Dose 4 (12 to 18 MoA)
Reported as:
Number · Percentage of participants
Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse
Percentage of participantsGroup 3: MenACYWGroup 4: MenACYW
PPAS1: Serogroup A: Day 30 post dose 251.7 (40.8 to 62.4)—
PPAS1: Serogroup A: Day 30 post dose 3—65.5 (54.6 to 75.4)
PPAS1: Serogroup C: Day 30 post dose 292.5 (85.1 to 96.9)—
PPAS1: Serogroup C: Day 30 post dose 3—96.7 (90.6 to 99.3)
PPAS1: Serogroup W: Day 30 post dose 294.7 (88.0 to 98.3)—
PPAS1: Serogroup W: Day 30 post dose 3—95.6 (89.0 to 98.8)
PPAS1: Serogroup Y: Day 30 post dose 289.4 (81.3 to 94.8)—
PPAS1: Serogroup Y: Day 30 post dose 3—94.4 (87.5 to 98.2)
PPAS2: Serogroup A: Day 30 post dose 377.8 (67.8 to 85.9)—
PPAS2: Serogroup A: Day 30 post dose 4—63.6 (52.7 to 73.6)
PPAS2: Serogroup C: Day 30 post dose 397.8 (92.4 to 99.7)—
PPAS2: Serogroup C: Day 30 post dose 4—95.3 (88.5 to 98.7)
PPAS2: Serogroup W: Day 30 post dose 397.7 (91.9 to 99.7)—
PPAS2: Serogroup W: Day 30 post dose 4—89.5 (81.1 to 95.1)
PPAS2: Serogroup Y: Day 30 post dose 391.5 (83.9 to 96.3)—
PPAS2: Serogroup Y: Day 30 post dose 4—80.9 (71.2 to 88.5)
SecondaryGeometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies

GMCs of anti-pertussis antibodies (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\]) were measured by electrochemiluminescent (ECL) assay.

Time frame:
Groups 1, 2 and 3: Day 0 before Dose 1 (2 MoA); Group 4: Day 0 before Dose 4 (12 to 18 MoA)
Reported as:
Geometric mean · Titer
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies
TiterGroup 1: MenACYWGroup 2: NimenrixGroup 3: MenACYWGroup 4: MenACYW
PPAS1: Anti-PT: Day 0 before dose 12.97 (2.68 to 3.29)2.61 (2.38 to 2.87)11.0 (8.74 to 14.0)—
PPAS1: Anti-FHA: Day 0 before dose 110.8 (9.73 to 12.1)10.1 (9.10 to 11.2)55.6 (42.4 to 73.0)—
PPAS2: Anti-PT: Day 0 before dose 4———10.7 (8.82 to 13.1)
PPAS2: Anti-FHA: Day 0 before dose 4———30.3 (25.0 to 36.7)
SecondaryGeometric Mean Concentrations (GMCs) of Hexavalent Vaccines

GMCs of hexavalent vaccines were measured as: anti-diphtheria, anti-tetanus, anti-pertussis antibodies (PT, FHA) by ECL assay, anti-hepatitis antibodies (anti-Hepatitis B surface antigen \[HBsAg\]) by the commercially available VITROS ECi/ECiQ, anti-poliovirus types 1, 2, and 3 by neutralization assay and anti-Haemophilus influenzae type b (anti-polyribosylribitol phosphate \[PRP\]) by Farr-type radioimmunoassay (RIA).

Time frame:
Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)
Reported as:
Geometric mean · Titer
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines
TiterGroup 1: MenACYWGroup 2: NimenrixGroup 3: MenACYWGroup 4: MenACYW
PPAS1: Anti-diphtheria: Day 30 after dose 20.523 (0.474 to 0.578)0.489 (0.443 to 0.541)0.563 (0.458 to 0.691)—
PPAS1: Anti-tetanus: Day 30 after dose 21.10 (1.02 to 1.18)1.13 (1.05 to 1.22)0.931 (0.788 to 1.10)—
PPAS1: Anti-PT: Day 30 after dose 264.9 (61.4 to 68.7)68.1 (64.5 to 72.0)50.0 (43.2 to 58.0)—
PPAS1: Anti-FHA: Day 30 after dose 292.4 (87.3 to 97.8)96.6 (90.8 to 103)125 (109 to 144)—
PPAS1: Anti-HBsAg: Day 30 after dose 2369 (323 to 421)345 (303 to 393)218 (147 to 322)—
PPAS1: Anti-polio 1: Day 30 after dose 247.1 (40.1 to 55.3)43.5 (37.0 to 51.2)362 (260 to 504)—
PPAS1: Anti-polio 2: Day 30 after dose 2139 (117 to 167)143 (120 to 171)618 (429 to 890)—
PPAS1: Anti-polio 3: Day 30 after dose 2133 (112 to 157)145 (123 to 172)584 (419 to 814)—
PPAS1: Anti-PRP: Day 30 after dose 20.376 (0.326 to 0.435)0.435 (0.379 to 0.499)0.725 (0.492 to 1.07)—
PPAS2: Anti-diphtheria: Day 0 before dose 30.086 (0.079 to 0.095)0.080 (0.073 to 0.087)0.094 (0.076 to 0.116)—
PPAS2: Anti-diphtheria: Day 30 after dose 31.82 (1.69 to 1.96)1.69 (1.57 to 1.81)2.71 (2.36 to 3.11)—
PPAS2: Anti-diphtheria: Day 30 after dose 4———3.26 (2.88 to 3.69)
PPAS2: Anti-tetanus: Day 0 before dose 30.362 (0.336 to 0.391)0.424 (0.397 to 0.453)0.218 (0.180 to 0.264)—
PPAS2: Anti-tetanus: Day 30 after dose 36.71 (6.33 to 7.12)8.59 (8.13 to 9.08)6.02 (5.06 to 7.16)—
PPAS2: Anti-tetanus: Day 30 after dose 4———7.00 (5.99 to 8.18)
PPAS2: Anti-PT: Day 0 before dose 314.8 (13.8 to 15.8)14.6 (13.7 to 15.6)10.4 (8.99 to 12.0)—
PPAS2: Anti-PT: Day 30 after dose 3111 (105 to 118)109 (104 to 115)79.2 (66.2 to 94.6)—
PPAS2: Anti-PT: Day 30 after dose 4———80.9 (68.2 to 95.9)
PPAS2: Anti-FHA: Day 0 before dose 338.4 (35.8 to 41.2)38.1 (35.5 to 40.8)30.6 (26.0 to 36.0)—
PPAS2: Anti-FHA: Day 30 after dose 3177 (167 to 187)184 (173 to 195)168 (142 to 200)—
PPAS2: Anti-FHA: Day 30 after dose 4———181 (151 to 217)
PPAS2: Anti-HBsAg: Day 0 before dose 353.0 (45.5 to 61.8)48.8 (42.1 to 56.5)26.0 (17.6 to 38.2)—
PPAS2: Anti-HBsAg: Day 30 after dose 32273 (1927 to 2681)2158 (1852 to 2515)1117 (666 to 1872)—
PPAS2: Anti-HBsAg: Day 30 after dose 4———1144 (648 to 2020)
PPAS2: Anti-polio 1: Day 0 before dose 314.5 (12.7 to 16.5)13.6 (12.0 to 15.4)55.2 (40.8 to 74.6)—
PPAS2: Anti-polio 1: Day 30 after dose 31099 (980 to 1233)994 (883 to 1119)1538 (1212 to 1952)—
PPAS2: Anti-polio 1: Day 30 after dose 4———1625 (1291 to 2047)
PPAS2: Anti-polio 2: Day 0 before dose 333.2 (28.7 to 38.4)33.1 (28.8 to 37.9)85.3 (63.9 to 114)—
PPAS2: Anti-polio 2: Day 30 after dose 32214 (1982 to 2472)2146 (1937 to 2379)3549 (2846 to 4425)—
PPAS2: Anti-polio 2: Day 30 after dose 4———3858 (3001 to 4960)
PPAS2: Anti-polio 3: Day 0 before dose 319.7 (17.1 to 22.6)18.4 (16.0 to 21.1)37.7 (27.6 to 51.5)—
PPAS2: Anti-polio 3: Day 30 after dose 31595 (1393 to 1827)1533 (1361 to 1728)2431 (1897 to 3115)—
PPAS2: Anti-polio 3: Day 30 after dose 4———3397 (2567 to 4495)
PPAS2: Anti-PRP: Day 0 before dose 30.201 (0.176 to 0.230)0.224 (0.197 to 0.255)0.244 (0.174 to 0.343)—
PPAS2: Anti-PRP: Day 30 after dose 39.42 (8.31 to 10.7)11.5 (10.3 to 12.9)16.1 (11.9 to 21.6)—
PPAS2: Anti-PRP: Day 30 after dose 4———16.1 (12.1 to 21.6)
SecondaryPercentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP)

GMCs of anti-diphtheria, anti-tetanus, anti-poliovirus types 1, 2, and 3, anti-haemophilus influenzae type b (anti-PRP) vaccines were measured as: anti-diphtheria, anti-tetanus by ECL assay, anti-poliovirus types 1, 2, and 3 by neutralization assay and anti-Haemophilus influenzae type b (anti-PRP) by Farr-type RIA. Response rate was defined as percentage of participants who achieved: anti diphtheria and anti-tetanus antibody concentrations \>=0.01 international units (IU)/milliliter (mL), \>=0.1 IU/mL and \>=1.0 IU/mL; anti-poliovirus types 1, 2, and 3 antibody titers \>=1:8; anti-PRP antibody concentrations \>=0.15 microgram (mcg)/mL and \>=1 mcg/mL. Percentages are rounded off to the tenth decimal place.

Time frame:
Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)
Reported as:
Number · Percentage of participants
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP)
Percentage of participantsGroup 1: MenACYWGroup 2: NimenrixGroup 3: MenACYWGroup 4: MenACYW
PPAS1: Anti-diphtheria: >=0.01 IU/mL: Day 30 post dose 2100 (99.3 to 100)99.8 (98.9 to 100)100 (96.1 to 100)—
PPAS1: Anti-diphtheria: >=0.1 IU/mL: Day 30 post dose 290.5 (87.6 to 92.9)89.6 (86.7 to 92.1)94.6 (87.9 to 98.2)—
PPAS1: Anti-diphtheria: >=1.0 IU/mL: Day 30 post dose 232.7 (28.6 to 36.9)32.5 (28.5 to 36.7)33.3 (23.9 to 43.9)—
PPAS1: Anti-tetanus: >=0.01 IU/mL: Day 30 post dose 2100 (99.3 to 100)100 (99.3 to 100)100 (96.1 to 100)—
PPAS1: Anti-tetanus: >=0.1 IU/mL: Day 30 post dose 2100 (99.3 to 100)99.8 (98.9 to 100)100 (96.1 to 100)—
PPAS1: Anti-tetanus: >=1.0 IU/mL: Day 30 post dose 253.3 (48.9 to 57.7)56.3 (52.0 to 60.7)44.1 (33.8 to 54.8)—
PPAS1: Anti-polio 1: >=1:8: Day 30 post dose 287.0 (83.7 to 89.9)83.2 (79.6 to 86.4)98.8 (93.5 to 100)—
PPAS1: Anti-polio 2:>=1:8: Day 30 post dose 297.5 (95.7 to 98.7)98.6 (97.0 to 99.4)100 (95.4 to 100)—
PPAS1: Anti-polio 3:>=1:8: Day 30 post dose 295.9 (93.7 to 97.5)96.1 (94.0 to 97.7)98.8 (93.4 to 100)—
PPAS1: Anti-PRP: >=0.15 mcg/mL: Day 30 post dose 271.8 (67.7 to 75.6)74.9 (70.9 to 78.5)78.1 (68.5 to 85.9)—
PPAS1: Anti-PRP: >=1 mcg/mL: Day 30 post dose 224.2 (20.5 to 28.1)27.3 (23.5 to 31.3)39.6 (29.7 to 50.1)—
PPAS2: Anti-diphtheria: >=0.01 IU/mL: Day 0 before dose 398.2 (96.6 to 99.1)98.6 (97.2 to 99.4)97.8 (92.3 to 99.7)—
PPAS2: Anti-diphtheria: >=0.01 IU/mL: Day 30 after dose 3100 (99.3 to 100)100 (99.4 to 100)100 (96.1 to 100)—
PPAS2: Anti-diphtheria: >=0.01 IU/mL: Day 30 after dose 4———100 (95.9 to 100)
PPAS2: Anti-diphtheria: >=0.1 IU/mL: Day 0 before dose 348.2 (43.9 to 52.5)41.3 (37.2 to 45.5)47.3 (36.7 to 58.0)—
PPAS2: Anti-diphtheria: >=0.1 IU/mL: Day 30 after dose 399.6 (98.7 to 100)99.8 (99.0 to 100)100 (96.1 to 100)—
PPAS2: Anti-diphtheria: >=0.1 IU/mL: Day 30 after dose 4———100 (95.9 to 100)
PPAS2: Anti-diphtheria: >=1.0 IU/mL: Day 0 before dose 31.1 (0.4 to 2.4)0.7 (0.2 to 1.8)0 (0 to 4.0)—
PPAS2: Anti-diphtheria: >=1.0 IU/mL: Day 30 after dose 375.5 (71.7 to 79.0)72.4 (68.6 to 76.1)92.4 (84.9 to 96.9)—
PPAS2: Anti-diphtheria: >=1.0 IU/mL: Day 30 after dose 4———100 (95.9 to 100)
PPAS2: Anti-tetanus: >=0.01 IU/mL: Day 0 before dose 3100 (99.3 to 100)100 (99.4 to 100)100 (96.1 to 100)—
PPAS2: Anti-tetanus: >=0.01 IU/mL: Day 30 after dose 3100 (99.3 to 100)100 (99.4 to 100)100 (96.1 to 100)—
PPAS2: Anti-tetanus: >=0.01 IU/mL: Day 30 after dose 4———100 (95.9 to 100)
PPAS2: Anti- tetanus: >=0.1 IU/mL: Day 0 before dose 394.1 (91.8 to 95.9)97.4 (95.7 to 98.5)83.7 (74.5 to 90.6)—
PPAS2: Anti-tetanus: >=0.1 IU/mL: Day 30 after dose 3100 (99.3 to 100)100 (99.4 to 100)100 (96.1 to 100)—
PPAS2: Anti-tetanus: >=0.1 IU/mL: Day 30 after dose 4———100 (95.9 to 100)
PPAS2: Anti-tetanus: >=1.0 IU/mL: Day 0 before dose 310.7 (8.2 to 13.6)14.7 (11.9 to 17.9)6.5 (2.4 to 13.7)—
PPAS2: Anti-tetanus: >=1.0 IU/mL: Day 30 after dose 399.6 (98.7 to 100)99.7 (98.8 to 100)96.7 (90.8 to 99.3)—
PPAS2: Anti-tetanus: >=1.0 IU/mL: Day 30 after dose 4———98.9 (93.9 to 100)
PPAS2: Anti-polio 1: >=1:8: Day 0 before dose 364.4 (60.2 to 68.5)63.7 (59.5 to 67.7)93.3 (85.9 to 97.5)—
PPAS2: Anti-polio 1: >=1:8: Day 30 after dose 399.8 (99.0 to 100)98.9 (97.7 to 99.6)100 (95.8 to 100)—
PPAS2: Anti-polio 1: >=1:8: Day 30 after dose 4———100 (95.8 to 100)
PPAS2: Anti-polio 2: >=1:8: Day 0 before dose 379.5 (75.8 to 82.9)80.9 (77.4 to 84.1)95.5 (88.8 to 98.7)—
PPAS2: Anti-polio 2: >=1:8: Day 30 after dose 3100 (99.3 to 100)100 (99.3 to 100)100 (95.8 to 100)—
PPAS2: Anti-polio 2: >=1:8: Day 30 after dose 4———100 (95.8 to 100)
PPAS2: Anti-polio 3: >=1:8: Day 0 before dose 368.6 (64.5 to 72.6)65.7 (61.6 to 69.6)84.3 (75.0 to 91.1)—
PPAS2: Anti-polio 3: >=1:8: Day 30 after dose 399.2 (98.1 to 99.8)99.8 (99.0 to 100)100 (95.8 to 100)—
PPAS2: Anti-polio 3: >=1:8: Day 30 after dose 4———100 (95.8 to 100)
PPAS2: Anti-PRP: >=0.15 mcg/mL: Day 0 before dose 356.5 (52.2 to 60.7)60.4 (56.3 to 64.5)60.2 (49.5 to 70.2)—
PPAS2: Anti-PRP: >=0.15 mcg/mL: Day 30 after dose 398.2 (96.7 to 99.1)98.8 (97.5 to 99.5)100 (96.0 to 100)—
PPAS2: Anti-PRP: >=0.15 mcg/mL: Day 30 after dose 4———100 (96.0 to 100)
PPAS2: Anti-PRP: >=1 mcg/mL: Day 0 before dose 313.9 (11.1 to 17.1)14.9 (12.1 to 18.1)15.1 (8.5 to 24.0)—
PPAS2: Anti-PRP: >=1 mcg/mL: Day 30 after dose 391.5 (88.9 to 93.7)94.9 (92.7 to 96.5)97.8 (92.3 to 99.7)—
PPAS2: Anti-PRP: >=1 mcg/mL: Day 30 after dose 4———96.7 (90.6 to 99.3)
SecondaryPercentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies

GMCs of anti-pertussis antibodies (PT, FHA) were measured by ECL assay. The pertussis vaccine seroresponse for anti-PT and anti-FHA was defined as: For groups 1, 2, and 3, 30 days after dose 2 in infancy as if the pre-primary vaccination concentration is \<4 × lower limit of quantification (LLOQ), post-primary vaccination concentration \>=4 × LLOQ, if the pre-primary vaccination concentration is \>=4 ×LLOQ, post-primary vaccination concentration \>=pre-primary vaccination concentration; and for Groups 1, 2, and 3, before and 30 days after the dose 3 and for group 4, before and 30 days after the dose 4 as if the pre-booster vaccination concentration is \<4 × LLOQ, post-booster vaccination concentration \>=4 × pre-booster concentration, if the pre-booster vaccination concentration is \>=4 × LLOQ, post-booster vaccination concentration \>=2 × pre-booster concentration. Percentages are rounded off to the tenth decimal place.

Time frame:
Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)
Reported as:
Number · Percentage of participants
Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies
Percentage of participantsGroup 1: MenACYWGroup 2: NimenrixGroup 3: MenACYWGroup 4: MenACYW
PPAS1: Anti-PT: Day 30 post dose 294.5 (92.2 to 96.3)97.9 (96.2 to 98.9)82.6 (73.3 to 89.7)—
PPAS1: Anti-FHA: Day 30 post dose 289.6 (86.7 to 92.1)91.5 (88.8 to 93.8)62.0 (51.2 to 71.9)—
PPAS2: Anti-PT: Day 30 post dose 397.0 (95.2 to 98.3)97.0 (95.2 to 98.2)93.3 (86.1 to 97.5)—
PPAS2: Anti-PT: Day 30 post dose 4———88.8 (80.3 to 94.5)
PPAS2: Anti-FHA: Day 30 post dose 389.1 (86.2 to 91.6)90.1 (87.3 to 92.4)92.2 (84.6 to 96.8)—
PPAS2: Anti-FHA: Day 30 post dose 4———91.0 (83.1 to 96.0)
SecondaryPercentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL

GMCs of anti-hepatitis antibodies (anti-HBsAg) was measured by the commercially available VITROS ECi/ECiQ. Response rate for anti-HBsAg was defined as percentage of participants who achieved anti-HBsAg antibody concentrations \>=10 mIU/mL and \>=100 mIU/mL. Percentages are rounded off to the tenth decimal place.

Time frame:
Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)
Reported as:
Number · Percentage of participants
Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL
Percentage of participantsGroup 1: MenACYWGroup 2: NimenrixGroup 3: MenACYWGroup 4: MenACYW
PPAS1: Anti-HBsAg: >=10 mIU/mL: Day 30 post dose 296.4 (94.4 to 97.9)97.8 (96.2 to 98.9)92.4 (84.9 to 96.9)—
PPAS1: Anti-HBsAg: >=100 mIU/mL: Day 30 post dose 285.7 (82.4 to 88.7)81.8 (78.1 to 85.0)72.8 (62.6 to 81.6)—
PPAS2: Anti-HBsAg: >=10 mIU/mL: Day 0 before dose 381.5 (77.9 to 84.7)79.5 (75.9 to 82.7)65.9 (55.3 to 75.5)—
PPAS2: Anti-HBsAg: >=10 mIU/mL: Day 30 after dose 398.0 (96.4 to 99.0)98.6 (97.3 to 99.4)94.4 (87.5 to 98.2)—
PPAS2: Anti-HBsAg: >=10 mIU/mL: Day 0 before dose 4———64.4 (53.7 to 74.3)
PPAS2: Anti-HBsAg: >=10 mIU/mL: Day 30 after dose 4———91.9 (83.9 to 96.7)
PPAS2: Anti-HBsAg: >=100 mIU/mL: Day 0 before dose 338.7 (34.5 to 43.0)35.4 (31.5 to 39.5)26.4 (17.7 to 36.7)—
PPAS2: Anti-HBsAg: >=100 mIU/mL: Day 30 after dose 393.4 (91.0 to 95.3)93.5 (91.2 to 95.4)80.0 (70.2 to 87.7)—
PPAS2: Anti-HBsAg: >=100 mIU/mL: Day 0 before dose 4———27.8 (18.9 to 38.2)
PPAS2: Anti-HBsAg: >=100 mIU/mL: Day 30 after dose 4———83.7 (74.2 to 90.8)
SecondaryGroups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine

GMCs of anti-pneumococcal antibodies was assessed by pneumococcal capsular polysaccharide (PnPS) Immunoglobulin G (IgG) ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) antibodies in human serum.

Time frame:
At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA)
Reported as:
Geometric mean · Titer
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine
TiterGroup 1: MenACYWGroup 2: Nimenrix
PPAS1: Serogroup 11.68 (1.52 to 1.84)1.71 (1.56 to 1.87)
PPAS1: Serogroup 41.97 (1.83 to 2.12)2.06 (1.91 to 2.23)
PPAS1: Serogroup 51.08 (0.991 to 1.17)1.10 (1.01 to 1.19)
PPAS1: Serogroup 6B0.600 (0.534 to 0.675)0.660 (0.586 to 0.742)
PPAS1: Serogroup 7F2.03 (1.89 to 2.17)2.20 (2.05 to 2.37)
PPAS1: Serogroup 9V1.67 (1.54 to 1.81)1.81 (1.67 to 1.96)
PPAS1: Serogroup 145.92 (5.41 to 6.48)5.97 (5.44 to 6.55)
PPAS1: Serogroup 18C0.680 (0.618 to 0.748)0.796 (0.722 to 0.879)
PPAS1: Serogroup 19F1.59 (1.39 to 1.82)1.45 (1.26 to 1.66)
PPAS1: Serogroup 23F0.830 (0.746 to 0.924)0.869 (0.785 to 0.961)
PPAS2: Serogroup 14.71 (4.32 to 5.13)4.54 (4.18 to 4.94)
PPAS2: Serogroup 43.61 (3.37 to 3.86)3.19 (2.99 to 3.41)
PPAS2: Serogroup 52.21 (2.05 to 2.39)2.05 (1.90 to 2.20)
PPAS2: Serogroup 6B4.21 (3.89 to 4.55)4.36 (4.04 to 4.71)
PPAS2: Serogroup 7F2.91 (2.73 to 3.10)2.89 (2.70 to 3.10)
PPAS2: Serogroup 9V4.08 (3.80 to 4.38)4.17 (3.89 to 4.47)
PPAS2: Serogroup 149.07 (8.44 to 9.75)7.89 (7.25 to 8.59)
PPAS2: Serogroup 18C2.12 (1.99 to 2.26)2.17 (2.03 to 2.33)
PPAS2: Serogroup 19F9.03 (8.32 to 9.81)8.41 (7.76 to 9.12)
PPAS2: Serogroup 23F2.24 (2.10 to 2.40)2.04 (1.90 to 2.18)
SecondaryGroups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine

GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) antibodies in human serum.

Time frame:
Group 3: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)
Reported as:
Geometric mean · Titer
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine
TiterGroup 3: MenACYWGroup 4: MenACYW
PPAS1: Serogroup 1: 30 days post dose 21.47 (1.16 to 1.87)—
PPAS1: Serogroup 3: 30 days post dose 20.658 (0.554 to 0.781)—
PPAS1: Serogroup 4: 30 days post dose 21.73 (1.42 to 2.12)—
PPAS1: Serogroup 5: 30 days post dose 20.803 (0.617 to 1.04)—
PPAS1: Serogroup 6A: 30 days post dose 21.65 (1.24 to 2.19)—
PPAS1: Serogroup 6B: 30 days post dose 20.275 (0.205 to 0.368)—
PPAS1: Serogroup 7F: 30 days post dose 23.04 (2.59 to 3.57)—
PPAS1: Serogroup 9V: 30 days post dose 21.25 (0.987 to 1.59)—
PPAS1: Serogroup 14: 30 days post dose 25.88 (4.31 to 8.01)—
PPAS1: Serogroup 18C: 30 days post dose 21.65 (1.30 to 2.10)—
PPAS1: Serogroup 19A: 30 days post dose 22.17 (1.67 to 2.80)—
PPAS1: Serogroup 19F: 30 days post dose 25.73 (4.64 to 7.08)—
PPAS1: Serogroup 23F: 30 days post dose 20.722 (0.552 to 0.945)—
PPAS2: Serogroup 1: 30 days post dose 35.32 (4.41 to 6.42)—
PPAS2: Serogroup 1: 30 days post dose 4—5.47 (4.66 to 6.42)
PPAS2: Serogroup 3: 30 days post dose 31.13 (0.945 to 1.35)—
PPAS2: Serogroup 3: 30 days post dose 4—1.21 (0.982 to 1.50)
PPAS2: Serogroup 4: 30 days post dose 33.99 (3.43 to 4.64)—
PPAS2: Serogroup 4: 30 days post dose 4—3.97 (3.35 to 4.70)
PPAS2: Serogroup 5: 30 days post dose 33.33 (2.75 to 4.03)—
PPAS2: Serogroup 5: 30 days post dose 4—3.95 (3.36 to 4.65)
PPAS2: Serogroup 6A: 30 days post dose 312.9 (10.9 to 15.4)—
PPAS2: Serogroup 6A: 30 days post dose 4—14.3 (12.2 to 16.8)
PPAS2: Serogroup 6B: 30 days post dose 37.01 (5.38 to 9.13)—
PPAS2: Serogroup 6B: 30 days post dose 4—9.41 (7.86 to 11.3)
PPAS2: Serogroup 7F: 30 days post dose 35.36 (4.56 to 6.29)—
PPAS2: Serogroup 7F: 30 days post dose 4—4.92 (4.20 to 5.76)
PPAS2: Serogroup 9V: 30 days post dose 35.12 (4.26 to 6.17)—
PPAS2: Serogroup 9V: 30 days post dose 4—5.40 (4.65 to 6.26)
PPAS2: Serogroup 14: 30 days post dose 314.8 (12.2 to 18.1)—
PPAS2: Serogroup 14: 30 days post dose 4—14.7 (12.1 to 17.9)
PPAS2: Serogroup 18C: 30 days post dose 33.18 (2.70 to 3.76)—
PPAS2: Serogroup 18C: 30 days post dose 4—3.48 (3.00 to 4.03)
PPAS2: Serogroup 19A: 30 days post dose 38.82 (7.25 to 10.7)—
PPAS2: Serogroup 19A: 30 days post dose 4—10.9 (9.26 to 12.9)
PPAS2: Serogroup 19F: 30 days post dose 312.1 (9.91 to 14.7)—
PPAS2: Serogroup 19F: 30 days post dose 4—12.2 (10.5 to 14.2)
PPAS2: Serogroup 23F: 30 days post dose 33.70 (3.01 to 4.55)—
PPAS2: Serogroup 23F: 30 days post dose 4—4.06 (3.45 to 4.76)
SecondaryGroups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine

GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) antibodies in human serum. Percentages are rounded off to the tenth decimal place.

Time frame:
At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA)
Reported as:
Number · Percentage of participants
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine
Percentage of participantsGroup 1: MenACYWGroup 2: Nimenrix
PPAS1: Serogroup 192.7 (90.0 to 94.8)93.6 (91.1 to 95.5)
PPAS1: Serogroup 496.8 (94.9 to 98.2)96.7 (94.7 to 98.1)
PPAS1: Serogroup 588.5 (85.4 to 91.2)90.6 (87.8 to 93.0)
PPAS1: Serogroup 6B67.1 (62.8 to 71.2)69.9 (65.7 to 73.8)
PPAS1: Serogroup 7F98.8 (97.4 to 99.6)98.2 (96.7 to 99.2)
PPAS1: Serogroup 9V94.6 (92.3 to 96.4)95.1 (92.9 to 96.8)
PPAS1: Serogroup 1497.8 (96.1 to 98.9)98.2 (96.7 to 99.2)
PPAS1: Serogroup 18C72.5 (68.4 to 76.3)77.3 (73.5 to 80.9)
PPAS1: Serogroup 19F82.2 (78.6 to 85.4)79.3 (75.5 to 82.7)
PPAS1: Serogroup 23F77.8 (73.9 to 81.4)80.3 (76.6 to 83.6)
PPAS2: Serogroup 199.8 (99.0 to 100)99.8 (99.0 to 100)
PPAS2: Serogroup 499.8 (99.0 to 100)99.6 (98.7 to 100)
PPAS2: Serogroup 598.2 (96.6 to 99.1)97.7 (96.1 to 98.8)
PPAS2: Serogroup 6B98.9 (97.6 to 99.6)99.5 (98.5 to 99.9)
PPAS2: Serogroup 7F99.6 (98.7 to 100)99.3 (98.2 to 99.8)
PPAS2: Serogroup 9V99.8 (99.0 to 100)99.8 (99.0 to 100)
PPAS2: Serogroup 14100 (99.3 to 100)99.3 (98.2 to 99.8)
PPAS2: Serogroup 18C99.1 (97.9 to 99.7)98.6 (97.2 to 99.4)
PPAS2: Serogroup 19F99.3 (98.1 to 99.8)99.3 (98.2 to 99.8)
PPAS2: Serogroup 23F98.5 (97.1 to 99.4)97.2 (95.5 to 98.4)
SecondaryGroups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine

GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) antibodies in human serum. Percentages are rounded off to the tenth decimal place.

Time frame:
Group 3: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)
Reported as:
Number · Percentage of participants
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine
Percentage of participantsGroup 3: MenACYWGroup 4: MenACYW
PPAS1: Serogroup 1: 30 days post dose 289.9 (81.7 to 95.3)—
PPAS1: Serogroup 3: 30 days post dose 282.0 (72.5 to 89.4)—
PPAS1: Serogroup 4: 30 days post dose 296.6 (90.5 to 99.3)—
PPAS1: Serogroup 5: 30 days post dose 276.4 (66.2 to 84.8)—
PPAS1: Serogroup 6A: 30 days post dose 288.8 (80.3 to 94.5)—
PPAS1: Serogroup 6B: 30 days post dose 240.4 (30.2 to 51.4)—
PPAS1: Serogroup 7F: 30 days post dose 297.8 (92.1 to 99.7)—
PPAS1: Serogroup 9V: 30 days post dose 288.8 (80.3 to 94.5)—
PPAS1: Serogroup 14: 30 days post dose 296.6 (90.5 to 99.3)—
PPAS1: Serogroup 18C: 30 days post dose 291.0 (83.1 to 96.0)—
PPAS1: Serogroup 19A:30 days post dose 293.3 (85.9 to 97.5)—
PPAS1: Serogroup 19F: 30 days post dose 298.9 (93.9 to 100)—
PPAS1: Serogroup 23F: 30 days post dose 271.9 (61.4 to 80.9)—
PPAS2: Serogroup 1: 30 days post dose 3100 (96.0 to 100)—
PPAS2: Serogroup 1: 30 days post dose 4—100 (95.9 to 100)
PPAS2: Serogroup 3: 30 days post dose 397.8 (92.3 to 99.7)—
PPAS2: Serogroup 3: 30 days post dose 4—92.1 (84.5 to 96.8)
PPAS2: Serogroup 4: 30 days post dose 3100 (96.0 to 100)—
PPAS2: Serogroup 4: 30 days post dose 4—100 (95.9 to 100)
PPAS2: Serogroup 5: 30 days post dose 398.9 (94.0 to 100)—
PPAS2: Serogroup 5: 30 days post dose 4—100 (95.9 to 100)
PPAS2: Serogroup 6A: 30 days post dose 3100 (96.0 to 100)—
PPAS2: Serogroup 6A: 30 days post dose 4—100 (95.9 to 100)
PPAS2: Serogroup 6B: 30 days post dose 398.9 (94.0 to 100)—
PPAS2: Serogroup 6B: 30 days post dose 4—100 (95.9 to 100)
PPAS2: Serogroup 7F: 30 days post dose 3100 (96.0 to 100)—
PPAS2: Serogroup 7F: 30 days post dose 4—100 (95.9 to 100)
PPAS2: Serogroup 9V: 30 days post dose 3100 (96.0 to 100)—
PPAS2: Serogroup 9V: 30 days post dose 4—100 (95.9 to 100)
PPAS2: Serogroup 14: 30 days post dose 3100 (96.0 to 100)—
PPAS2: Serogroup 14: 30 days post dose 4—100 (95.9 to 100)
PPAS2: Serogroup 18C: 30 days post dose 3100 (96.0 to 100)—
PPAS2: Serogroup 18C: 30 days post dose 4—100 (95.9 to 100)
PPAS2: Serogroup 19A: 30 days post dose 3100 (96.0 to 100)—
PPAS2: Serogroup 19A: 30 days post dose 4—100 (95.9 to 100)
PPAS2: Serogroup 19F: 30 days post dose 3100 (96.0 to 100)—
PPAS2: Serogroup 19F: 30 days post dose 4—100 (95.9 to 100)
PPAS2: Serogroup 23F: 30 days post dose 3100 (96.0 to 100)—
PPAS2: Serogroup 23F: 30 days post dose 4—100 (95.9 to 100)
SecondaryGeometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies

GMCs of anti-measles and anti-rubella antibodies were measured by bulk IgG enzyme immunoassay (EIA) and anti-mumps antibodies were assessed by enzyme-linked immunosorbent assay (ELISA).

Time frame:
Groups 1, 2 and 3: At 30 days post Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)
Reported as:
Geometric mean · Titer
Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies
TiterGroup 1: MenACYWGroup 2: NimenrixGroup 3: MenACYWGroup 4: MenACYW
Anti-measles: 30 days post dose 32780 (2581 to 2995)2919 (2739 to 3110)3457 (2972 to 4021)—
Anti-measles: 30 days post dose 4———3933 (3241 to 4773)
Anti-mumps: 30 days post dose 383.3 (77.5 to 89.6)86.1 (80.5 to 92.1)105 (90.4 to 121)—
Anti-mumps: 30 days post dose 4———121 (105 to 141)
Anti-rubella: 30 days post dose 356.8 (53.2 to 60.6)56.0 (52.5 to 59.8)72.8 (62.7 to 84.6)—
Anti-rubella: 30 days post dose 4———74.4 (63.7 to 86.7)
SecondaryPercentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies

GMCs of anti-measles and anti-rubella antibodies were measured by bulk IgG EIA and anti-mumps antibodies were assessed by ELISA. Vaccine response against anti-measles, anti-mumps, anti-rubella antibodies were defined as percentage of participants with anti-measles, anti-mumps, anti-rubella antibody concentration that met the respective mentioned criterion: measles: \>=255 mIU/mL; mumps: \>=10 mumps antibody units/mL and rubella: \>=10 IU/mL. Percentages are rounded off to the tenth decimal place.

Time frame:
Groups 1, 2 and 3: At 30 days post Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)
Reported as:
Number · Percentage of participants
Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies
Percentage of participantsGroup 1: MenACYWGroup 2: NimenrixGroup 3: MenACYWGroup 4: MenACYW
Anti-measles: 30 days post dose 398.3 (96.8 to 99.2)99.1 (97.9 to 99.7)100 (96.2 to 100)—
Anti-measles: 30 days post dose 4———97.8 (92.2 to 99.7)
Anti-mumps: 30 days post dose 398.7 (97.3 to 99.5)98.7 (97.4 to 99.5)100 (96.2 to 100)—
Anti-mumps: 30 days post dose 4———100 (96.0 to 100)
Anti-rubella: 30 days post dose 398.7 (97.3 to 99.5)97.3 (95.6 to 98.5)98.9 (94.2 to 100)—
Anti-rubella: 30 days post dose 4———100 (96.0 to 100)

Adverse events

Collected over Adverse events (AEs), serious adverse events (SAEs) and all-cause mortality (deaths) were collected from the study vaccine administration (Day 0) until 30 days after the last vaccination (Visit 5 [13 to 19 MoA] for Groups 1, 2, and 3 and Visit 6 [13 to 19 MoA] for Group 4), up to 14 to 20 MoA.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: MenACYW0/696 (0%)51/696 (7.3%)678/696 (97.4%)
Group 2: Nimenrix0/706 (0%)57/706 (8.1%)680/706 (96.3%)
Group 3: MenACYW0/112 (0%)8/112 (7.1%)107/112 (95.5%)
Group 4: MenACYW0/108 (0%)3/108 (2.8%)103/108 (95.4%)
Most frequent serious events
Showing 10 of 84
Most frequent serious events
EventGroup 1: MenACYWGroup 2: NimenrixGroup 3: MenACYWGroup 4: MenACYW
PneumoniaInfections and infestations1/6965/7062/1122/108
Respiratory Syncytial Virus BronchiolitisInfections and infestations0/6961/7061/1122/108
BronchiolitisInfections and infestations2/6962/7062/1120/108
Lymphatic MalformationCongenital, familial and genetic disorders0/6960/7060/1121/108
Craniocerebral InjuryInjury, poisoning and procedural complications0/6960/7060/1121/108
ThrombocytopeniaBlood and lymphatic system disorders0/6960/7061/1120/108
Escherichia Urinary Tract InfectionInfections and infestations0/6960/7061/1120/108
Respiratory Syncytial Virus InfectionInfections and infestations1/6960/7061/1120/108
Upper Respiratory Tract InfectionInfections and infestations2/6960/7061/1120/108
Clinically Isolated SyndromeNervous system disorders0/6960/7061/1120/108
Most frequent other events
Showing 10 of 27
Most frequent other events
EventGroup 1: MenACYWGroup 2: NimenrixGroup 3: MenACYWGroup 4: MenACYW
IrritabilityPsychiatric disorders600/696608/70691/11286/108
CryingGeneral disorders579/696579/70674/11275/108
Injection Site PainGeneral disorders562/696566/70688/11276/108
SomnolenceNervous system disorders529/696545/70667/11275/108
Injection Site ErythemaGeneral disorders537/696520/70661/11258/108
Injection Site SwellingGeneral disorders422/696417/70641/11247/108
Decreased AppetiteMetabolism and nutrition disorders389/696372/70660/11258/108
PyrexiaGeneral disorders375/696345/70646/11242/108
VomitingGastrointestinal disorders196/696197/70625/11227/108
Respiratory Tract Infection ViralInfections and infestations0/6961/70618/11222/108

Baseline characteristics

All randomized participants included study participants for whom an injection group had been allocated.

Age, Continuous
Age, Continuous(Days)Group 1: MenACYWGroup 2: NimenrixGroup 3: MenACYWGroup 4: MenACYWTotal
Mean72.6 ± 12.272.4 ± 12.162.5 ± 7.1263.3 ± 7.9371.2 ± 12.1
Sex: Female, Male
Sex: Female, Male(Participants)Group 1: MenACYWGroup 2: NimenrixGroup 3: MenACYWGroup 4: MenACYWTotal
Female3553784558836
Male3593486750824
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Group 1: MenACYWGroup 2: NimenrixGroup 3: MenACYWGroup 4: MenACYWTotal
American Indian or Alaska Native00101
Asian21429
Black or African American00134
Native Hawaiian or Other Pacific Islander01001
White6936991061011599
Not Reported13160130
Unknown23005
Multiple origin460111
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Study locations

33 sites
  • Investigational Site Number : 2031006
    Chlumec Nad Cidlinou, 503 51, Czechia
  • Investigational Site Number : 2031013
    Domazlice, 34401, Czechia
  • Investigational Site Number : 2031010
    Jindrichuv Hradec, 377 01, Czechia
  • Investigational Site Number : 2031012
    Jindrichuv Hradec, 377 01, Czechia
  • Investigational Site Number : 2031008
    Ostrava-hrabuvka, 700 30, Czechia
  • Investigational Site Number : 2031003
    Ostrava, 702 00, Czechia
  • Investigational Site Number : 2031009
    Pardubice, 530 09, Czechia
  • Investigational Site Number : 2031005
    Pardubice, 530 12, Czechia
  • Investigational Site Number : 2031007
    Smirice, 503 03, Czechia
  • Investigational Site Number : 2462007
    Espoo, 02230, Finland
  • Investigational Site Number : 2462003
    Helsinki, 00100, Finland
  • Investigational Site Number : 2462004
    Helsinki, 00930, Finland
  • Investigational Site Number : 2462001
    Järvenpää, 04400, Finland
  • Investigational Site Number : 2462006
    Kokkola, 67100, Finland
  • Investigational Site Number : 2462005
    Oulu, 90220, Finland
  • Investigational Site Number : 2462002
    Pori, 28100, Finland
  • Investigational Site Number : 2462009
    Seinajoki, 60100, Finland
  • Investigational Site Number : 2462010
    Tampere, 33100, Finland
  • Investigational Site Number : 2462008
    Turku, 20520, Finland
  • Investigational Site Number : 3803002
    Milano, 20122, Italy
  • Investigational Site Number : 6167004
    Trzebnica, Dolnoslaskie 55-100, Poland
  • Investigational Site Number : 6167002
    Bydgoszcz, Kujawsko-pomorskie 85-090, Poland
  • Investigational Site Number : 6167003
    Siemianowice Slaskie, 41-103, Poland
  • Investigational Site Number : 6167006
    Torun, 87-100, Poland
  • Investigational Site Number : 6424003
    Brasov, 500063, Romania
  • Investigational Site Number : 6424001
    Bucaresti, 21105, Romania
  • Investigational Site Number : 6424002
    Calarasi, 910160, Romania
  • Investigational Site Number : 6424006
    Caracal, 235200, Romania
  • Investigational Site Number : 7245003
    Madrid, Madrid, Comunidad De 28007, Spain
  • Investigational Site Number : 7245002
    Madrid, 28046, Spain
  • Investigational Site Number : 7245001
    Santiago de Compostela, 15706, Spain
  • Investigational Site Number : 7245006
    Sevilla, 41014, Spain
  • Investigational Site Number : 7526001
    Umea, 901 87, Sweden
09

References and documents

Study documents

  • Study protocol · Feb 3, 2022
  • Statistical analysis plan · Apr 26, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03547271
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Responsible party
Sponsor
First posted
Jun 6, 2018
Start date
Dec 14, 2018
Primary completion
May 17, 2023
Completion
May 24, 2023
Results posted
Jan 22, 2025
Last update
Mar 3, 2025

Study contacts

Clinical Sciences & Operations
study director · Sanofi Pasteur, a Sanofi Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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