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CompletedNCT04143061MET55Updated Feb 3, 2025Results posted

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, Children, and Toddlers in India and Healthy Adolescents and Children in the Republic of South Africa

A Phase 3 interventional study of Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine and Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine in Meningococcal Immunization and Healthy Volunteers, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 17 sites in 2 countries. Open to participants aged 12 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.

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

Phase
Phase 3
Study type
Interventional
Enrollment
1,328
Allocation
Randomized
Ages
12 Months and older
Sex
All
01

Study summary

This will be a Phase III, modified double-blind (open-label for toddlers in India), randomized, parallel-group, active-controlled, step-wise, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adults, adolescents, children, and toddlers in India and a modified double-blind, randomized, parallel-group, active-controlled, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adolescents and children in RSA.

Read the detailed description

Study duration per participant is approximately 31 to 45 days

02

Conditions studied

  • Meningococcal Immunization
  • Healthy Volunteers
03

In context

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
12 Months and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age in the defined range on the day of inclusion: For Adults: Aged ≥ 18 years on the day of inclusion For Children and Adolescents: Aged 2 to 17 years on the day of inclusion For Toddlers: Aged 12 to 23 months† on the day of inclusion
  • Z-score of ≥ -2 standard deviations (SD) on the Weight-for-height table of the World Health Organization (WHO) Child Growth Standards: For toddlers and children: Toddlers aged 12 to 23 months and Children aged 2 to 5 years had a Z-score of ≥ -2 SD on the Weight-for-height table of the WHO Child Growth Standards
  • Informed consent obtained For adults: Informed consent form has been signed and dated by the subject and by an independent witness, if required by local regulations For toddlers, children, and adolescents: Assent form has been signed and dated by the subject (for subjects 7 to 17 years of age), and informed consent form has been signed and dated by the parent(s) or legally acceptable representative and by an independent witness, if required by local regulations
  • Were able to attend all scheduled visits and to comply with all trial procedures For adults: Were able to attend all scheduled visits and to comply with all trial procedures For toddlers, children, and adolescents: Participants and parent / legally acceptable representative were able to attend all scheduled visits and to comply with all trial procedures
  • For Toddlers: All toddlers were due to receive an age-recommended RPV on D0

Exclusion criteria

Exclusion Criteria:

  • Participant was pregnant, or lactating, or of childbearing potential and was not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile
  • Participation at the time of study enrollment (or in the 4 weeks preceding the 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 (28 days) preceding the IMP or planned receipt of any vaccine in the 4 weeks following vaccination except for oral poliovirus vaccine (OPV) in India, received during national immunization days. In India, OPV might have been received with a gap of at least 2 weeks before the IMP. This exception included monovalent and bivalent OPV.
  • Previous vaccination against meningococcal disease with either the IMP 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)
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
  • At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects traveling to countries with high endemic or epidemic disease)
  • Known systemic hypersensitivity to latex or to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
  • Verbal report of thrombocytopenia, as reported by the subject or the subject's parent / legally acceptable representative, contraindicating intramuscular vaccination in the Investigator's opinion
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion
  • Personal history of Guillain-Barré syndrome
  • Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within 10 years of the proposed study vaccination
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Current alcohol abuse or drug addiction
  • 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 have interfered with the evaluation of the study objectives.
  • Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination, febrile illness (temperature ≥ 38.0°C), persistent diarrhea, vomiting. A prospective subject was not included in the study until the condition has been resolved or the febrile event has been subsided
  • Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
  • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,328 participants (actual)

Study arms

  • Experimental
    Group 1

    MenACYW conjugate vaccine, 1 vaccination, adults in India aged 18 to 55 years

    Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine

  • Active comparator
    Group 2

    Menactra® conjugate vaccine, 1 vaccination, adults in India aged 18 to 55 years

    Biological: Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine

  • Experimental
    Group 3

    MenACYW conjugate vaccine, 1 vaccination, adults in India aged ≥ 56 years

    Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine

  • Active comparator
    Group 4

    Quadri Meningo™, 1 vaccination, adults in India aged ≥ 56 years

    Biological: Meningococcal polysaccharide (serogroups A, C, Y and W-135) vaccine

  • Experimental
    Group 5

    MenACYW conjugate vaccine, 1 vaccination, children and adolescents in India aged 2 to 17 years

    Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine

  • Active comparator
    Group 6

    Menactra®, 1 vaccination, children and adolescents in India aged 2 to 17 years

    Biological: Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine

  • Experimental
    Group 7

    MenACYW conjugate vaccine, 1 vaccination, children and adolescents in RSA aged 2 to 17 years

    Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine

  • Active comparator
    Group 8

    Menactra®, 1 vaccination, children and adolescents in RSA aged 2 to 17 years

    Biological: Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine

Interventions

  • BiologicalMeningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine

    Pharmaceutical form: solution for injection; Route of administration: intramuscular, 0.5 mL

    Also known as: MenACYW conjugate vaccine

  • BiologicalMeningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine

    Pharmaceutical form: sterile aqueous solution; Route of administration: intramuscular, 0.5 mL

    Also known as: Menactra®

  • BiologicalMeningococcal polysaccharide (serogroups A, C, Y and W-135) vaccine

    Pharmaceutical form: reconstituted solution for injection; Route of administration: intramuscular, 0.5 mL

    Also known as: Quadri Meningo™

06

What researchers measure

Primary outcomes

  1. Group 5 + 7 and Group 6 + 8: Percentage of Participants Who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W

    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Percentages are rounded off to the tenth decimal place. As pre-specified in protocol, the endpoint was assessed in children and adolescents aged 2 to 17 years in India and RSA as combined groups: Group 5 + Group 7 and Group 6 + Group 8 as they received the same dose of MenACYW conjugate vaccine and Menactra® respectively.

    Time frame: Day 30 (30 days post-vaccination on Day 0)

Secondary outcomes

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

    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and serum bactericidal assay using baby rabbit complement (rSBA).

    Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

  2. Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W

    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. Percentages are rounded off to the tenth decimal place. Percentage of participants who achieved antibody titers ≥1:4 and ≥1:8 by hSBA and ≥1:8 and ≥1:128 by rSBA are reported.

    Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

  3. Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W

    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA.

    Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

  4. Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W

    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. Percentages are rounded off to the tenth decimal place. Percentage of participants who achieved antibody titers ≥1:4 and ≥1:8 by hSBA and ≥1:8 and ≥1:128 by rSBA are reported.

    Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

  5. Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W

    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. As pre-specified in protocol, the endpoint was assessed in children and adolescents aged 2 to 17 years in India and RSA as combined groups: Group 5 + Group 7 and Group 6 + Group 8 as they received the same dose of MenACYW conjugate vaccine and Menactra® respectively.

    Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

  6. Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W

    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA.

    Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

  7. Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W

    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. Percentages are rounded off to the tenth decimal place. Percentage of participants who achieved antibody titers ≥1:4 and ≥1:8 by hSBA and ≥1:8 and ≥1:128 by rSBA are reported.

    Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

  8. Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W

    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA.

    Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

  9. Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W

    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. Percentages are rounded off to the tenth decimal place. Percentage of participants who achieved antibody titers ≥1:4 and ≥1:8 by hSBA and ≥1:8 and ≥1:128 by rSBA are reported.

    Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

07

Results

Posted Feb 3, 2025

Participant flow

This study was conducted at 17 investigational sites: 10 centers in India and 7 centers in the Republic of South Africa (RSA) between 30 December 2019 and 28 January 2023.

Participant flow — Overall Study
MilestoneGroup 1: MenACYW Conjugate VaccineGroup 2: Menactra®Group 3: MenACYW Conjugate VaccineGroup 4: Quadri Meningo™/Locally Available Licensed Meningococcal VaccineGroup 5: MenACYW Conjugate VaccineGroup 6: Menactra®Group 7: MenACYW Conjugate VaccineGroup 8: Menactra®
Started98100100100232233233232
Completed96100100100224229226220
Not completed200084712
Withdrew: Protocol deviation00000055
Withdrew: Withdrawal by subject20000100
Withdrew: Withdrawal by parent/guardian00008327

Outcome measures

PrimaryGroup 5 + 7 and Group 6 + 8: Percentage of Participants Who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Percentages are rounded off to the tenth decimal place. As pre-specified in protocol, the endpoint was assessed in children and adolescents aged 2 to 17 years in India and RSA as combined groups: Group 5 + Group 7 and Group 6 + Group 8 as they received the same dose of MenACYW conjugate vaccine and Menactra® respectively.

Time frame:
Day 30 (30 days post-vaccination on Day 0)
Reported as:
Number · percentage of participants
Group 5 + 7 and Group 6 + 8: Percentage of Participants Who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W
percentage of participantsGroup 5 + Group 7: MenACYW Conjugate VaccineGroup 6 + Group 8: Menactra®
Serogroup A89.6 (86.4 to 92.3)83.1 (79.2 to 86.4)
Serogroup C99.3 (98.0 to 99.9)77.7 (73.5 to 81.4)
Serogroup Y96.6 (94.5 to 98.1)85.6 (81.9 to 88.7)
Serogroup W98.7 (97.1 to 99.5)87.6 (84.2 to 90.6)
Statistical analysis
  • Group 5 + Group 7: MenACYW Conjugate Vaccine vs Group 6 + Group 8: Menactra® · Difference in percentage of participants: 6.55 · 95% CI 2.03 to 11.08
  • Group 5 + Group 7: MenACYW Conjugate Vaccine vs Group 6 + Group 8: Menactra® · Difference in percentage of participants: 21.67 · 95% CI 17.82 to 25.80
  • Group 5 + Group 7: MenACYW Conjugate Vaccine vs Group 6 + Group 8: Menactra® · Difference in percentage of participants: 11.08 · 95% CI 7.43 to 14.89
  • Group 5 + Group 7: MenACYW Conjugate Vaccine vs Group 6 + Group 8: Menactra® · Difference in percentage of participants: 11.01 · 95% CI 7.86 to 14.47
SecondaryGroup 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and serum bactericidal assay using baby rabbit complement (rSBA).

Time frame:
Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Reported as:
Geometric mean · titer
Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W
titerGroup 1: MenACYW Conjugate VaccineGroup 2: Menactra®
hSBA: Serogroup A: Day 07.28 (6.03 to 8.78)9.60 (7.68 to 12.0)
hSBA: Serogroup A: Day 3052.8 (34.7 to 80.3)39.2 (27.8 to 55.3)
hSBA: Serogroup C: Day 06.20 (4.99 to 7.70)7.05 (5.53 to 8.99)
hSBA: Serogroup C: Day 30551 (365 to 831)107 (68.8 to 165)
hSBA: Serogroup Y: Day 05.24 (3.86 to 7.11)4.03 (3.09 to 5.25)
hSBA: Serogroup Y: Day 30119 (80.2 to 177)47.4 (30.7 to 73.1)
hSBA: Serogroup W: Day 04.18 (3.39 to 5.15)4.17 (3.39 to 5.14)
hSBA: Serogroup W: Day 30106 (72.8 to 153)63.1 (44.7 to 89.1)
rSBA: Serogroup A: Day 0194 (81.3 to 463)64.0 (25.9 to 158)
rSBA: Serogroup A: Day 3010644 (7745 to 14629)4467 (3428 to 5820)
rSBA: Serogroup C: Day 05.88 (3.51 to 9.86)4.88 (3.00 to 7.93)
rSBA: Serogroup C: Day 3012227 (7923 to 18868)1149 (612 to 2158)
rSBA: Serogroup Y: Day 09.36 (4.33 to 20.2)9.40 (4.12 to 21.5)
rSBA: Serogroup Y: Day 305934 (3758 to 9372)3534 (2545 to 4909)
rSBA: Serogroup W: Day 015.5 (6.49 to 37.1)7.56 (3.49 to 16.4)
rSBA: Serogroup W: Day 3016638 (10325 to 26812)7732 (4098 to 14589)
SecondaryGroup 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. Percentages are rounded off to the tenth decimal place. Percentage of participants who achieved antibody titers ≥1:4 and ≥1:8 by hSBA and ≥1:8 and ≥1:128 by rSBA are reported.

Time frame:
Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Reported as:
Number · percentage of participants
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W
percentage of participantsGroup 1: MenACYW Conjugate VaccineGroup 2: Menactra®
hSBA: Serogroup A: Day 0: ≥1:481.1 (71.7 to 88.4)87.9 (79.8 to 93.6)
hSBA: Serogroup A: Day 0: ≥1:861.1 (50.5 to 70.9)72.7 (62.9 to 81.2)
hSBA: Serogroup A: Day 30: ≥1:487.2 (78.8 to 93.2)93.9 (87.3 to 97.7)
hSBA: Serogroup A: Day 30: ≥1:876.6 (66.7 to 84.7)87.9 (79.8 to 93.6)
hSBA: Serogroup C: Day 0: ≥1:469.5 (59.2 to 78.5)69.7 (59.6 to 78.5)
hSBA: Serogroup C: Day 0: ≥1:847.4 (37.0 to 57.9)50.5 (40.3 to 60.7)
hSBA: Serogroup C: Day 30: ≥1:498.9 (94.3 to 100)93.9 (87.3 to 97.7)
hSBA: Serogroup C: Day 30: ≥1:896.8 (91.0 to 99.3)88.9 (81.0 to 94.3)
hSBA: Serogroup Y: Day 0: ≥1:438.9 (29.1 to 49.5)30.3 (21.5 to 40.4)
hSBA: Serogroup Y: Day 0: ≥1:829.5 (20.6 to 39.7)24.2 (16.2 to 33.9)
hSBA: Serogroup Y: Day 30: ≥1:493.7 (86.8 to 97.6)82.8 (73.9 to 89.7)
hSBA: Serogroup Y: Day 30: ≥1:892.6 (85.4 to 97.0)76.8 (67.2 to 84.7)
hSBA: Serogroup W: Day 0: ≥1:444.2 (34.0 to 54.8)44.4 (34.5 to 54.8)
hSBA: Serogroup W: Day 0: ≥1:829.5 (20.6 to 39.7)29.3 (20.6 to 39.3)
hSBA: Serogroup W: Day 30: ≥1:496.8 (91.0 to 99.3)96.0 (90.0 to 98.9)
hSBA: Serogroup W: Day 30: ≥1:893.6 (86.6 to 97.6)90.9 (83.4 to 95.8)
rSBA: Serogroup A: Day 0: ≥1:875.6 (60.5 to 87.1)61.7 (46.4 to 75.5)
rSBA: Serogroup A: Day 0: ≥1:12862.2 (46.5 to 76.2)48.9 (34.1 to 63.9)
rSBA: Serogroup A: Day 30: ≥1:8100 (92.1 to 100)100 (92.6 to 100)
rSBA: Serogroup A: Day 30: ≥1:128100 (92.1 to 100)100 (92.6 to 100)
rSBA: Serogroup C: Day 0: ≥1:828.9 (16.4 to 44.3)24.5 (13.3 to 38.9)
rSBA: Serogroup C: Day 0: ≥1:12811.1 (3.7 to 24.1)10.2 (3.4 to 22.2)
rSBA: Serogroup C: Day 30: ≥1:8100 (92.1 to 100)95.8 (85.7 to 99.5)
rSBA: Serogroup C: Day 30: ≥1:128100 (92.1 to 100)89.6 (77.3 to 96.5)
rSBA: Serogroup Y: Day 0: ≥1:829.5 (16.8 to 45.2)25.6 (13.5 to 41.2)
rSBA: Serogroup Y: Day 0: ≥1:12825.0 (13.2 to 40.3)23.3 (11.8 to 38.6)
rSBA: Serogroup Y: Day 30: ≥1:897.7 (87.7 to 99.9)100 (92.5 to 100)
rSBA: Serogroup Y: Day 30: ≥1:12897.7 (87.7 to 99.9)100 (92.5 to 100)
rSBA: Serogroup W: Day 0: ≥1:835.6 (21.9 to 51.2)20.4 (10.2 to 34.3)
rSBA: Serogroup W: Day 0: ≥1:12831.1 (18.2 to 46.6)20.4 (10.2 to 34.3)
rSBA: Serogroup W: Day 30: ≥1:8100 (92.1 to 100)97.9 (88.9 to 99.9)
rSBA: Serogroup W: Day 30: ≥1:128100 (92.1 to 100)97.9 (88.9 to 99.9)
SecondaryGroup 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA.

Time frame:
Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Reported as:
Geometric mean · titer
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W
titerGroup 3: MenACYW Conjugate VaccineGroup 4: Quadri Meningo™/Locally Available Licensed Meningococcal Vaccine
hSBA: Serogroup A: Day 015.3 (12.2 to 19.3)12.5 (10.2 to 15.4)
hSBA: Serogroup A: Day 3056.6 (38.2 to 83.9)36.2 (26.8 to 48.8)
hSBA: Serogroup C: Day 08.00 (6.18 to 10.4)8.00 (6.13 to 10.4)
hSBA: Serogroup C: Day 30393 (255 to 606)159 (102 to 248)
hSBA: Serogroup Y: Day 06.36 (4.57 to 8.86)6.97 (5.03 to 9.68)
hSBA: Serogroup Y: Day 30197 (127 to 303)55.4 (35.5 to 86.4)
hSBA: Serogroup W: Day 04.42 (3.53 to 5.54)5.66 (4.40 to 7.27)
hSBA: Serogroup W: Day 3090.8 (60.4 to 137)34.6 (23.5 to 51.2)
rSBA: Serogroup A: Day 083.0 (37.0 to 186)46.3 (20.1 to 106)
rSBA: Serogroup A: Day 305834 (3730 to 9124)4677 (2935 to 7455)
rSBA: Serogroup C: Day 06.47 (3.69 to 11.3)5.53 (3.06 to 9.99)
rSBA: Serogroup C: Day 309304 (5532 to 15649)3283 (1680 to 6415)
rSBA: Serogroup Y: Day 06.86 (3.33 to 14.1)8.24 (3.94 to 17.3)
rSBA: Serogroup Y: Day 304274 (2640 to 6917)1119 (529 to 2366)
rSBA: Serogroup W: Day 011.6 (5.55 to 24.4)12.4 (5.04 to 30.4)
rSBA: Serogroup W: Day 306626 (3243 to 13539)2304 (925 to 5739)
SecondaryGroup 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. Percentages are rounded off to the tenth decimal place. Percentage of participants who achieved antibody titers ≥1:4 and ≥1:8 by hSBA and ≥1:8 and ≥1:128 by rSBA are reported.

Time frame:
Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Reported as:
Number · percentage of participants
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W
percentage of participantsGroup 3: MenACYW Conjugate VaccineGroup 4: Quadri Meningo™/Locally Available Licensed Meningococcal Vaccine
hSBA: Serogroup A: Day 0: ≥1:494.8 (88.4 to 98.3)93.8 (86.9 to 97.7)
hSBA: Serogroup A: Day 0: ≥1:882.5 (73.4 to 89.4)77.1 (67.4 to 85.0)
hSBA: Serogroup A: Day 30: ≥1:489.6 (81.7 to 94.9)96.9 (91.1 to 99.4)
hSBA: Serogroup A: Day 30: ≥1:882.3 (73.2 to 89.3)86.5 (78.0 to 92.6)
hSBA: Serogroup C: Day 0: ≥1:471.1 (61.0 to 79.9)75.0 (65.1 to 83.3)
hSBA: Serogroup C: Day 0: ≥1:853.6 (43.2 to 63.8)50.0 (39.6 to 60.4)
hSBA: Serogroup C: Day 30: ≥1:497.9 (92.7 to 99.7)92.7 (85.6 to 97.0)
hSBA: Serogroup C: Day 30: ≥1:895.9 (89.8 to 98.9)89.6 (81.7 to 94.9)
hSBA: Serogroup Y: Day 0: ≥1:445.4 (35.2 to 55.8)51.0 (40.6 to 61.4)
hSBA: Serogroup Y: Day 0: ≥1:836.1 (26.6 to 46.5)40.6 (30.7 to 51.1)
hSBA: Serogroup Y: Day 30: ≥1:493.8 (87.0 to 97.7)83.3 (74.4 to 90.2)
hSBA: Serogroup Y: Day 30: ≥1:893.8 (87.0 to 97.7)79.2 (69.7 to 86.8)
hSBA: Serogroup W: Day 0: ≥1:445.4 (35.2 to 55.8)54.2 (43.7 to 64.4)
hSBA: Serogroup W: Day 0: ≥1:830.9 (21.9 to 41.1)38.5 (28.8 to 49.0)
hSBA: Serogroup W: Day 30: ≥1:491.8 (84.4 to 96.4)90.6 (82.9 to 95.6)
hSBA: Serogroup W: Day 30: ≥1:889.7 (81.9 to 94.9)79.2 (69.7 to 86.8)
rSBA: Serogroup A: Day 0: ≥1:868.8 (53.7 to 81.3)55.3 (40.1 to 69.8)
rSBA: Serogroup A: Day 0: ≥1:12856.3 (41.2 to 70.5)46.8 (32.1 to 61.9)
rSBA: Serogroup A: Day 30: ≥1:898.0 (89.1 to 99.9)100 (92.5 to 100)
rSBA: Serogroup A: Day 30: ≥1:12898.0 (89.1 to 99.9)97.9 (88.7 to 99.9)
rSBA: Serogroup C: Day 0: ≥1:830.6 (18.3 to 45.4)21.3 (10.7 to 35.7)
rSBA: Serogroup C: Day 0: ≥1:12816.3 (7.3 to 29.7)10.6 (3.5 to 23.1)
rSBA: Serogroup C: Day 30: ≥1:898.0 (89.1 to 99.9)93.6 (82.5 to 98.7)
rSBA: Serogroup C: Day 30: ≥1:12898.0 (89.1 to 99.9)93.6 (82.5 to 98.7)
rSBA: Serogroup Y: Day 0: ≥1:820.0 (9.6 to 34.6)26.1 (14.3 to 41.1)
rSBA: Serogroup Y: Day 0: ≥1:12820.0 (9.6 to 34.6)21.7 (10.9 to 36.4)
rSBA: Serogroup Y: Day 30: ≥1:898.0 (89.1 to 99.9)89.4 (76.9 to 96.5)
rSBA: Serogroup Y: Day 30: ≥1:12898.0 (89.1 to 99.9)89.4 (76.9 to 96.5)
rSBA: Serogroup W: Day 0: ≥1:833.3 (20.4 to 48.4)30.4 (17.7 to 45.8)
rSBA: Serogroup W: Day 0: ≥1:12831.3 (18.7 to 46.3)28.3 (16.0 to 43.5)
rSBA: Serogroup W: Day 30: ≥1:895.9 (86.0 to 99.5)89.4 (76.9 to 96.5)
rSBA: Serogroup W: Day 30: ≥1:12893.9 (83.1 to 98.7)87.2 (74.3 to 95.2)
SecondaryGroup 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. As pre-specified in protocol, the endpoint was assessed in children and adolescents aged 2 to 17 years in India and RSA as combined groups: Group 5 + Group 7 and Group 6 + Group 8 as they received the same dose of MenACYW conjugate vaccine and Menactra® respectively.

Time frame:
Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Reported as:
Geometric mean · titer
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W
titerGroup 5 + Group 7: MenACYW Conjugate VaccineGroup 6 + Group 8: Menactra®
hSBA: Serogroup A: Day 07.40 (6.79 to 8.07)7.21 (6.66 to 7.80)
hSBA: Serogroup A: Day 3056.1 (48.5 to 65.0)36.3 (31.0 to 42.5)
hSBA: Serogroup C: Day 03.97 (3.63 to 4.34)3.78 (3.46 to 4.13)
hSBA: Serogroup C: Day 30600 (521 to 692)47.3 (38.3 to 58.4)
hSBA: Serogroup Y: Day 03.50 (3.13 to 3.91)3.50 (3.14 to 3.91)
hSBA: Serogroup Y: Day 30167 (145 to 191)46.2 (39.3 to 54.3)
hSBA: Serogroup W: Day 04.31 (3.88 to 4.78)4.04 (3.65 to 4.48)
hSBA: Serogroup W: Day 30121 (106 to 137)35.4 (30.4 to 41.1)
rSBA: Serogroup A: Day 0308 (199 to 478)387 (260 to 577)
rSBA: Serogroup A: Day 3010561 (9223 to 12094)8313 (7275 to 9499)
rSBA: Serogroup C: Day 03.56 (2.91 to 4.36)3.73 (3.02 to 4.62)
rSBA: Serogroup C: Day 3014430 (11923 to 17463)1199 (869 to 1655)
rSBA: Serogroup Y: Day 017.3 (11.5 to 26.2)21.9 (14.4 to 33.4)
rSBA: Serogroup Y: Day 3015404 (13409 to 17696)5966 (4850 to 7339)
rSBA: Serogroup W: Day 07.01 (5.00 to 9.83)7.46 (5.36 to 10.4)
rSBA: Serogroup W: Day 3019644 (16338 to 23618)6598 (5160 to 8437)
SecondaryGroup 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA.

Time frame:
Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Reported as:
Geometric mean · titer
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W
titerGroup 5: MenACYW Conjugate VaccineGroup 6: Menactra®
hSBA: Serogroup A: Day 07.33 (6.50 to 8.26)7.71 (6.94 to 8.58)
hSBA: Serogroup A: Day 3070.3 (56.5 to 87.6)40.9 (32.8 to 51.1)
hSBA: Serogroup C: Day 03.36 (3.00 to 3.76)3.17 (2.84 to 3.55)
hSBA: Serogroup C: Day 30595 (494 to 716)38.3 (28.4 to 51.6)
hSBA: Serogroup Y: Day 03.32 (2.84 to 3.88)3.12 (2.70 to 3.60)
hSBA: Serogroup Y: Day 30119 (97.4 to 145)27.1 (21.7 to 33.8)
hSBA: Serogroup W: Day 03.23 (2.86 to 3.65)2.85 (2.56 to 3.17)
hSBA: Serogroup W: Day 3092.8 (78.7 to 109)24.3 (19.8 to 29.7)
rSBA: Serogroup A: Day 0159 (81.9 to 310)337 (188 to 605)
rSBA: Serogroup A: Day 3011462 (9425 to 13938)6877 (5755 to 8217)
rSBA: Serogroup C: Day 03.09 (2.39 to 4.01)2.98 (2.40 to 3.70)
rSBA: Serogroup C: Day 3011139 (8843 to 14030)659 (413 to 1052)
rSBA: Serogroup Y: Day 011.4 (6.25 to 20.6)18.8 (10.4 to 33.7)
rSBA: Serogroup Y: Day 3015696 (12565 to 19609)4522 (3316 to 6168)
rSBA: Serogroup W: Day 06.62 (4.10 to 10.7)7.78 (4.78 to 12.7)
rSBA: Serogroup W: Day 3019037 (14748 to 24572)4332 (2969 to 6320)
SecondaryGroup 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. Percentages are rounded off to the tenth decimal place. Percentage of participants who achieved antibody titers ≥1:4 and ≥1:8 by hSBA and ≥1:8 and ≥1:128 by rSBA are reported.

Time frame:
Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Reported as:
Number · percentage of participants
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W
percentage of participantsGroup 5: MenACYW Conjugate VaccineGroup 6: Menactra®
hSBA: Serogroup A: Day 0: ≥1:485.1 (79.8 to 89.5)91.2 (86.8 to 94.6)
hSBA: Serogroup A: Day 0: ≥1:860.8 (54.1 to 67.3)63.6 (57.0 to 69.8)
hSBA: Serogroup A: Day 30: ≥1:492.3 (87.9 to 95.4)94.7 (91.0 to 97.3)
hSBA: Serogroup A: Day 30: ≥1:889.5 (84.7 to 93.3)83.8 (78.3 to 88.3)
hSBA: Serogroup C: Day 0: ≥1:437.8 (31.4 to 44.6)30.7 (24.8 to 37.1)
hSBA: Serogroup C: Day 0: ≥1:819.8 (14.8 to 25.7)18.4 (13.6 to 24.1)
hSBA: Serogroup C: Day 30: ≥1:499.5 (97.5 to 100)82.9 (77.4 to 87.5)
hSBA: Serogroup C: Day 30: ≥1:899.5 (97.5 to 100)72.8 (66.5 to 78.5)
hSBA: Serogroup Y: Day 0: ≥1:421.2 (16.0 to 27.1)18.9 (14.0 to 24.6)
hSBA: Serogroup Y: Day 0: ≥1:816.2 (11.6 to 21.7)13.6 (9.4 to 18.7)
hSBA: Serogroup Y: Day 30: ≥1:494.1 (90.2 to 96.8)83.8 (78.3 to 88.3)
hSBA: Serogroup Y: Day 30: ≥1:893.7 (89.6 to 96.5)76.8 (70.7 to 82.1)
hSBA: Serogroup W: Day 0: ≥1:427.9 (22.1 to 34.3)20.2 (15.2 to 26.0)
hSBA: Serogroup W: Day 0: ≥1:818.9 (14.0 to 24.7)13.6 (9.4 to 18.7)
hSBA: Serogroup W: Day 30: ≥1:499.1 (96.8 to 99.9)86.8 (81.8 to 90.9)
hSBA: Serogroup W: Day 30: ≥1:898.2 (95.5 to 99.5)82.0 (76.4 to 86.8)
rSBA: Serogroup A: Day 0: ≥1:866.3 (55.7 to 75.8)76.5 (66.9 to 84.5)
rSBA: Serogroup A: Day 0: ≥1:12862.0 (51.2 to 71.9)73.5 (63.6 to 81.9)
rSBA: Serogroup A: Day 30: ≥1:8100 (96.3 to 100)100 (96.3 to 100)
rSBA: Serogroup A: Day 30: ≥1:128100 (96.3 to 100)100 (96.3 to 100)
rSBA: Serogroup C: Day 0: ≥1:811.3 (5.8 to 19.4)13.1 (7.2 to 21.4)
rSBA: Serogroup C: Day 0: ≥1:1285.2 (1.7 to 11.6)4.0 (1.1 to 10.0)
rSBA: Serogroup C: Day 30: ≥1:8100 (96.3 to 100)90.9 (83.4 to 95.8)
rSBA: Serogroup C: Day 30: ≥1:128100 (96.3 to 100)85.9 (77.4 to 92.0)
rSBA: Serogroup Y: Day 0: ≥1:828.7 (19.5 to 39.4)40.7 (30.5 to 51.5)
rSBA: Serogroup Y: Day 0: ≥1:12828.7 (19.5 to 39.4)38.5 (28.4 to 49.2)
rSBA: Serogroup Y: Day 30: ≥1:8100 (96.3 to 100)98.0 (92.8 to 99.8)
rSBA: Serogroup Y: Day 30: ≥1:128100 (96.3 to 100)98.0 (92.8 to 99.8)
rSBA: Serogroup W: Day 0: ≥1:821.1 (13.4 to 30.6)24.5 (16.4 to 34.2)
rSBA: Serogroup W: Day 0: ≥1:12821.1 (13.4 to 30.6)24.5 (16.4 to 34.2)
rSBA: Serogroup W: Day 30: ≥1:8100 (96.3 to 100)98.0 (92.9 to 99.8)
rSBA: Serogroup W: Day 30: ≥1:128100 (96.3 to 100)97.0 (91.4 to 99.4)
SecondaryGroup 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA.

Time frame:
Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Reported as:
Geometric mean · titer
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W
titerGroup 7: MenACYW Conjugate VaccineGroup 8: Menactra®
hSBA: Serogroup A: Day 07.47 (6.59 to 8.47)6.71 (5.97 to 7.55)
hSBA: Serogroup A: Day 3044.9 (37.1 to 54.4)31.9 (25.5 to 40.0)
hSBA: Serogroup C: Day 04.69 (4.10 to 5.36)4.55 (3.97 to 5.20)
hSBA: Serogroup C: Day 30606 (488 to 751)59.2 (44.0 to 79.7)
hSBA: Serogroup Y: Day 03.69 (3.13 to 4.34)3.96 (3.35 to 4.69)
hSBA: Serogroup Y: Day 30233 (195 to 279)81.5 (66.0 to 101)
hSBA: Serogroup W: Day 05.74 (4.89 to 6.74)5.85 (4.97 to 6.88)
hSBA: Serogroup W: Day 30157 (129 to 191)52.5 (42.3 to 65.2)
rSBA: Serogroup A: Day 0589 (338 to 1026)450 (260 to 778)
rSBA: Serogroup A: Day 309706 (8032 to 11729)10242 (8432 to 12440)
rSBA: Serogroup C: Day 04.12 (3.00 to 5.66)4.77 (3.28 to 6.93)
rSBA: Serogroup C: Day 3018848 (13953 to 25460)2317 (1544 to 3476)
rSBA: Serogroup Y: Day 025.6 (14.6 to 45.2)25.7 (13.9 to 47.3)
rSBA: Serogroup Y: Day 3015108 (12775 to 17865)8067 (6207 to 10483)
rSBA: Serogroup W: Day 07.43 (4.57 to 12.1)7.14 (4.55 to 11.2)
rSBA: Serogroup W: Day 3020290 (15479 to 26598)10481 (7890 to 13924)
SecondaryGroup 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. Percentages are rounded off to the tenth decimal place. Percentage of participants who achieved antibody titers ≥1:4 and ≥1:8 by hSBA and ≥1:8 and ≥1:128 by rSBA are reported.

Time frame:
Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Reported as:
Number · percentage of participants
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W
percentage of participantsGroup 7: MenACYW Conjugate VaccineGroup 8: Menactra®
hSBA: Serogroup A: Day 0: ≥1:488.8 (83.9 to 92.6)86.6 (81.4 to 90.9)
hSBA: Serogroup A: Day 0: ≥1:861.0 (54.2 to 67.4)57.6 (50.7 to 64.3)
hSBA: Serogroup A: Day 30: ≥1:496.9 (93.6 to 98.7)93.5 (89.3 to 96.4)
hSBA: Serogroup A: Day 30: ≥1:889.7 (84.9 to 93.3)82.3 (76.6 to 87.2)
hSBA: Serogroup C: Day 0: ≥1:458.3 (51.5 to 64.8)57.1 (50.3 to 63.8)
hSBA: Serogroup C: Day 0: ≥1:832.3 (26.2 to 38.9)30.4 (24.4 to 37.0)
hSBA: Serogroup C: Day 30: ≥1:499.6 (97.5 to 100)93.0 (88.8 to 96.0)
hSBA: Serogroup C: Day 30: ≥1:899.1 (96.8 to 99.9)82.8 (77.1 to 87.6)
hSBA: Serogroup Y: Day 0: ≥1:428.1 (22.2 to 34.5)32.3 (26.1 to 38.9)
hSBA: Serogroup Y: Day 0: ≥1:821.3 (16.1 to 27.3)25.3 (19.7 to 31.7)
hSBA: Serogroup Y: Day 30: ≥1:499.6 (97.5 to 100)95.8 (92.2 to 98.1)
hSBA: Serogroup Y: Day 30: ≥1:899.6 (97.5 to 100)94.9 (91.0 to 97.4)
hSBA: Serogroup W: Day 0: ≥1:453.4 (46.6 to 60.1)55.3 (48.4 to 62.0)
hSBA: Serogroup W: Day 0: ≥1:842.2 (35.6 to 48.9)41.0 (34.4 to 47.9)
hSBA: Serogroup W: Day 30: ≥1:499.1 (96.8 to 99.9)94.9 (91.1 to 97.4)
hSBA: Serogroup W: Day 30: ≥1:899.1 (96.8 to 99.9)93.5 (89.4 to 96.4)
rSBA: Serogroup A: Day 0: ≥1:884.0 (75.0 to 90.8)83.5 (74.3 to 90.5)
rSBA: Serogroup A: Day 0: ≥1:12881.9 (72.6 to 89.1)80.2 (70.6 to 87.8)
rSBA: Serogroup A: Day 30: ≥1:8100 (96.2 to 100)100 (96.0 to 100)
rSBA: Serogroup A: Day 30: ≥1:128100 (96.2 to 100)100 (96.0 to 100)
rSBA: Serogroup C: Day 0: ≥1:819.1 (11.8 to 28.6)19.8 (12.2 to 29.4)
rSBA: Serogroup C: Day 0: ≥1:1286.4 (2.4 to 13.4)9.9 (4.6 to 17.9)
rSBA: Serogroup C: Day 30: ≥1:8100 (96.2 to 100)98.9 (94.0 to 100)
rSBA: Serogroup C: Day 30: ≥1:128100 (96.2 to 100)96.7 (90.6 to 99.3)
rSBA: Serogroup Y: Day 0: ≥1:847.9 (37.5 to 58.4)46.2 (35.6 to 56.9)
rSBA: Serogroup Y: Day 0: ≥1:12846.8 (36.4 to 57.4)40.7 (30.5 to 51.5)
rSBA: Serogroup Y: Day 30: ≥1:8100 (96.2 to 100)98.9 (94.0 to 100)
rSBA: Serogroup Y: Day 30: ≥1:128100 (96.2 to 100)98.9 (94.0 to 100)
rSBA: Serogroup W: Day 0: ≥1:824.5 (16.2 to 34.4)26.4 (17.7 to 36.7)
rSBA: Serogroup W: Day 0: ≥1:12822.3 (14.4 to 32.1)23.1 (14.9 to 33.1)
rSBA: Serogroup W: Day 30: ≥1:8100 (96.2 to 100)100 (96.0 to 100)
rSBA: Serogroup W: Day 30: ≥1:128100 (96.2 to 100)100 (96.0 to 100)

Adverse events

Collected over From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: MenACYW Conjugate Vaccine0/98 (0%)1/98 (1%)32/98 (32.7%)
Group 2: Menactra®0/100 (0%)0/100 (0%)26/100 (26%)
Group 3: MenACYW Conjugate Vaccine0/100 (0%)0/100 (0%)18/100 (18%)
Group 4: Quadri Meningo™/Locally Available Licensed Meningococcal Vaccine0/100 (0%)0/100 (0%)21/100 (21%)
Group 5: MenACYW Conjugate Vaccine0/232 (0%)1/232 (0.4%)81/232 (34.9%)
Group 6: Menactra®0/232 (0%)0/232 (0%)43/232 (18.5%)
Group 7: MenACYW Conjugate Vaccine0/229 (0%)0/229 (0%)115/229 (50.2%)
Group 8: Menactra®0/227 (0%)0/227 (0%)128/227 (56.4%)
Most frequent serious events
Most frequent serious events
EventGroup 1: MenACYW Conjugate VaccineGroup 2: Menactra®Group 3: MenACYW Conjugate VaccineGroup 4: Quadri Meningo™/Locally Available Licensed Meningococcal VaccineGroup 5: MenACYW Conjugate VaccineGroup 6: Menactra®Group 7: MenACYW Conjugate VaccineGroup 8: Menactra®
Covid-19Infections and infestations1/980/1000/1000/1000/2320/2320/2290/227
Dengue FeverInfections and infestations0/980/1000/1000/1001/2320/2320/2290/227
Most frequent other events
Most frequent other events
EventGroup 1: MenACYW Conjugate VaccineGroup 2: Menactra®Group 3: MenACYW Conjugate VaccineGroup 4: Quadri Meningo™/Locally Available Licensed Meningococcal VaccineGroup 5: MenACYW Conjugate VaccineGroup 6: Menactra®Group 7: MenACYW Conjugate VaccineGroup 8: Menactra®
Injection Site PainGeneral disorders27/9824/1009/10014/10052/23229/23285/22982/227
HeadacheNervous system disorders6/986/1003/1003/10013/2323/23256/22957/227
MyalgiaMusculoskeletal and connective tissue disorders5/986/1002/1000/1007/2323/23246/22949/227
MalaiseGeneral disorders6/985/1001/1001/10011/2324/23245/22944/227
Injection Site SwellingGeneral disorders1/980/1000/1002/1001/2321/23225/22937/227
PyrexiaGeneral disorders5/982/1004/1004/10037/23216/2328/2298/227
Injection Site ErythemaGeneral disorders1/980/1000/1001/1001/2320/23228/22927/227

Baseline characteristics

Randomized study participants included all enrolled participants for whom an injection group had been allocated and who had any available data in case report form.

Age, Continuous
Age, Continuous(years)Group 1: MenACYW Conjugate VaccineGroup 2: Menactra®Group 3: MenACYW Conjugate VaccineGroup 4: Quadri Meningo™/Locally Available Licensed Meningococcal VaccineGroup 5: MenACYW Conjugate VaccineGroup 6: Menactra®Group 7: MenACYW Conjugate VaccineGroup 8: Menactra®Total
Mean36.7 ± 9.2134.8 ± 9.0561.7 ± 6.0961.1 ± 5.619.39 ± 4.199.34 ± 4.109.45 ± 4.019.19 ± 4.1921.1 ± 20.1
Sex: Female, Male
Sex: Female, Male(Participants)Group 1: MenACYW Conjugate VaccineGroup 2: Menactra®Group 3: MenACYW Conjugate VaccineGroup 4: Quadri Meningo™/Locally Available Licensed Meningococcal VaccineGroup 5: MenACYW Conjugate VaccineGroup 6: Menactra®Group 7: MenACYW Conjugate VaccineGroup 8: Menactra®Total
Female30312431101118123110568
Male68697669131115110122760
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Group 1: MenACYW Conjugate VaccineGroup 2: Menactra®Group 3: MenACYW Conjugate VaccineGroup 4: Quadri Meningo™/Locally Available Licensed Meningococcal VaccineGroup 5: MenACYW Conjugate VaccineGroup 6: Menactra®Group 7: MenACYW Conjugate VaccineGroup 8: Menactra®Total
Asian9810010010023223300863
Black or African American000000142139281
White00000091019
Not Reported000000639
Unknown0000006915
Mixed Origin0000007071141
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Study locations

17 sites
  • Investigational Site Number : 3560002
    Bangalore, 560054, India
  • Investigational Site Number : 3560016
    Belgaum, 590002, India
  • Investigational Site Number : 3560007
    Chennai, 603203, India
  • Investigational Site Number : 3560004
    Hyderabad, 500018, India
  • Investigational Site Number : 3560011
    Kolkata, 700017, India
  • Investigational Site Number : 3560012
    Mysore, 570004, India
  • Investigational Site Number : 3560015
    Odisha, 751003, India
  • Investigational Site Number : 3560003
    Pune, 411011, India
  • Investigational Site Number : 3560008
    Pune, 411043, India
  • Investigational Site Number : 3560010
    Punjab, 141008, India
  • Investigational Site Number : 7100004
    Bertsham, 2013, South Africa
  • Investigational Site Number : 7100007
    Bloemfontein, 9301, South Africa
  • Investigational Site Number : 7100005
    Cape Town, 7505, South Africa
  • Investigational Site Number : 7100002
    Cape Town, 7937, South Africa
  • Investigational Site Number : 7100001
    Middelburg, 1055, South Africa
  • Investigational Site Number : 7100006
    Pretoria, 0002, South Africa
  • Investigational Site Number : 7100003
    Soweto, 1818, South Africa
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References and documents

Study documents

  • Study protocol · Jun 11, 2019
  • Statistical analysis plan · Nov 23, 2023

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

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Updates

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

Key details

Study ID
NCT04143061
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Responsible party
Sponsor
First posted
Oct 29, 2019
Start date
Dec 30, 2019
Primary completion
Jan 28, 2023
Completion
Jan 28, 2023
Results posted
Feb 3, 2025
Last update
Feb 3, 2025

Study contacts

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

Oversight

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

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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