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CompletedNCT03077438Updated Mar 28, 2022Results posted

Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Children Aged 2 to 9 Years

A Phase 3 interventional study of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate and Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine in Meningitis, Meningococcal Meningitis and Meningococcal Infections, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 36 sites in 2 countries. Open to participants aged 2 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-28.

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

Phase
Phase 3
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
2 Years to 9 Years
Sex
All
01

Study summary

The purpose of the study was to evaluate the immunogenicity and describe the safety of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) vaccine in children 2 to 9 years of age in the United States (US) and Puerto Rico.

Primary objective:

  • To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine compared to that observed following the administration of a single dose of MENVEO® in children aged 2 to 9 years.

Secondary objectives:

  • To compare the serum bactericidal assay using human complement (hSBA) antibody geometric mean titers (GMTs) of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine to those observed following the administration of MENVEO® in children 2 to 9 years of age.
  • To evaluate the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine and those observed following the administration of MENVEO® in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively.
  • To evaluate the hSBA vaccine seroresponse to meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) post-vaccination in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively.

Observational objective:

  • To describe the safety profile of MenACYW Conjugate vaccine and that of the licensed MENVEO®.
Read the detailed description

Healthy children were randomized and received a single dose of either MenACYW Conjugate vaccine or MENVEO®. They were assessed for immunogenicity at baseline (pre-vaccination) and at 30-44 days post-vaccination. Safety information were collected post-vaccination and throughout the entire study.

02

Conditions studied

  • Meningitis
  • Meningococcal Meningitis
  • Meningococcal Infections

Keywords

  • Meningitis
  • Meningococcal Meningitis
  • MenACYW Conjugate vaccine
  • MENVEO®
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 1,000 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
2 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Aged 2 to 9 years on the day of inclusion.
  • Assent form had been signed and dated by the participant (as required by local regulations) and informed consent form had been signed and dated by parent(s) or guardian.
  • Participant and parent/guardian were able to attend all scheduled visits and complied with all trial procedures.

Exclusion criteria

Exclusion Criteria:

  • Participant was pregnant, or lactating, or of childbearing potential and 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.
  • Participation 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 trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which might be received at least 2 weeks before or after the study investigational vaccines. This exception included monovalent, multivalent, live, and attenuated influenza vaccines.
  • Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie., mono- or polyvalent, polysaccharide, or Conjugate meningococcal vaccine containing serogroups A, C, Y, 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, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease).
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
  • Verbal report of thrombocytopenia, contraindicating intramuscular vaccination by the Investigator's judgment.
  • 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.
  • Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion.
  • Moderate or severe acute illness/infection (according to Investigator's judgment) on the day of vaccination or febrile illness (temperature ≥100.4°F). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.
  • Receipt of 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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,000 participants (actual)

Study arms

  • Experimental
    Group 1: MenACYW Conjugate Vaccine

    Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MenACYW Conjugate vaccine on Day 0.

    Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate

  • Active comparator
    Group 2: MENVEO® Vaccine

    Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MENVEO® Conjugate vaccine on Day 0.

    Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine

Interventions

  • BiologicalMeningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate

    0.5 milliliter (mL), Intramuscular

    Also known as: MenACYW Conjugate vaccine

  • BiologicalMeningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine

    0.5 mL, Intramuscular

    Also known as: MENVEO®

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine

    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titers less than (\<) 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.

    Time frame: Day 30 (post-vaccination)

Secondary outcomes

  1. Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age

    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.

    Time frame: Day 30 (post-vaccination)

  2. Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age

    Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA.

    Time frame: Day 30 (post-vaccination)

  3. Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age

    Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA.

    Time frame: Day 30 (post-vaccination)

  4. Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age

    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>=1:16 for participants with pre-vaccination hSBA titers \<1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.

    Time frame: Day 30 (post-vaccination)

  5. Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years Age

    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>=1:16 for participants with pre-vaccination hSBA titers \<1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.

    Time frame: Day 30 (post-vaccination)

07

Results

Posted Jun 9, 2020

Participant flow

Study participants were enrolled in 36 centers in the United States (US) and Puerto Rico from 17 February 2017 to 30 March 2017.

Participant flow — Overall Study
MilestoneGroup 1: MenACYW Conjugate VaccineGroup 2: MENVEO® Vaccine
Started499501
Safety analysis set (safas)498494
Completed487487
Not completed1214
Withdrew: Protocol violation35
Withdrew: Withdrawal by subject36
Withdrew: Lost to follow-up63

Outcome measures

PrimaryPercentage of Participants Achieving Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titers less than (\<) 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.

Time frame:
Day 30 (post-vaccination)
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine
percentage of participantsGroup 1: MenACYW Conjugate VaccineGroup 2: MENVEO® Vaccine
Serogroup A55.4 (50.7 to 60.0)47.8 (43.2 to 52.5)
Serogroup C95.2 (92.8 to 97.0)47.8 (43.2 to 52.5)
Serogroup Y91.5 (88.5 to 93.9)79.3 (75.3 to 82.9)
Serogroup W78.8 (74.8 to 82.5)64.1 (59.5 to 68.4)
Statistical analysis
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Percentage difference: 7.6 · 95% CI 1.1 to 14
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Percentage difference: 47.4 · 95% CI 42.2 to 52.2
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Percentage difference: 12.2 · 95% CI 7.7 to 16.7
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Percentage difference: 14.8 · 95% CI 8.9 to 20.5
SecondaryGeometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.

Time frame:
Day 30 (post-vaccination)
Reported as:
Geometric mean · titers (1/dilution)
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age
titers (1/dilution)Group 1: MenACYW Conjugate VaccineGroup 2: MENVEO® Vaccine
Serogroup A24.8 (21.9 to 27.9)22.6 (19.7 to 26.0)
Serogroup C238 (209 to 270)17.0 (14.3 to 20.2)
Serogroup Y68.8 (61.3 to 77.3)43.5 (37.7 to 50.4)
Serogroup W37.5 (33.7 to 41.8)26.2 (23.0 to 29.9)
Statistical analysis
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Gmt ratio: 1.09 · 95% CI 0.91 to 1.32
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Gmt ratio: 14 · 95% CI 11.3 to 17.3
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Gmt ratio: 1.58 · 95% CI 1.31 to 1.9
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Gmt ratio: 1.43 · 95% CI 1.21 to 1.69
SecondaryGeometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age

Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA.

Time frame:
Day 30 (post-vaccination)
Reported as:
Geometric mean · titers (1/dilution)
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age
titers (1/dilution)Group 1: MenACYW Conjugate VaccineGroup 2: MENVEO® Vaccine
Serogroup A21.6 (18.2 to 25.5)18.9 (15.5 to 23.0)
Serogroup C208 (175 to 246)11.9 (9.79 to 14.6)
Serogroup Y49.8 (43.0 to 57.6)36.1 (29.2 to 44.7)
Serogroup W28.8 (24.6 to 33.7)20.1 (16.7 to 24.2)
Statistical analysis
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Gmt ratio: 1.14 · 95% CI 0.883 to 1.47
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Gmt ratio: 17.4 · 95% CI 13.4 to 22.6
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Gmt ratio: 1.38 · 95% CI 1.07 to 1.78
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Gmt ratio: 1.43 · 95% CI 1.12 to 1.83
SecondaryGeometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age

Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA.

Time frame:
Day 30 (post-vaccination)
Reported as:
Geometric mean · titers (1/dilution)
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age
titers (1/dilution)Group 1: MenACYW Conjugate VaccineGroup 2: MENVEO® Vaccine
Serogroup A28.4 (23.9 to 33.8)26.8 (22.0 to 32.6)
Serogroup C272 (224 to 330)23.7 (18.2 to 31.0)
Serogroup Y95.1 (80.2 to 113)51.8 (42.5 to 63.2)
Serogroup W48.9 (42.5 to 56.3)33.6 (28.2 to 40.1)
Statistical analysis
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Gmt ratio: 1.06 · 95% CI 0.816 to 1.38
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Gmt ratio: 11.5 · 95% CI 8.24 to 16
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Gmt ratio: 1.84 · 95% CI 1.41 to 2.38
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Gmt ratio: 1.45 · 95% CI 1.16 to 1.82
SecondaryPercentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>=1:16 for participants with pre-vaccination hSBA titers \<1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.

Time frame:
Day 30 (post-vaccination)
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age
percentage of participantsGroup 1: MenACYW Conjugate VaccineGroup 2: MENVEO® Vaccine
Serogroup A52.4 (45.7 to 59.1)44.8 (38.1 to 51.6)
Serogroup C94.3 (90.5 to 96.9)43.2 (36.6 to 50.0)
Serogroup Y88.2 (83.3 to 92.1)77.0 (70.9 to 82.4)
Serogroup W73.8 (67.6 to 79.4)61.3 (54.5 to 67.7)
Statistical analysis
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Percentage difference: 7.6 · 95% CI -1.6 to 16.7
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Percentage difference: 51.1 · 95% CI 43.5 to 57.8
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Percentage difference: 11.2 · 95% CI 4.2 to 18.1
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Percentage difference: 12.5 · 95% CI 3.9 to 20.9
SecondaryPercentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years Age

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>=1:16 for participants with pre-vaccination hSBA titers \<1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.

Time frame:
Day 30 (post-vaccination)
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years Age
percentage of participantsGroup 1: MenACYW Conjugate VaccineGroup 2: MENVEO® Vaccine
Serogroup A58.3 (51.6 to 64.8)50.6 (44.1 to 57.2)
Serogroup C96.1 (92.7 to 98.2)52.1 (45.5 to 58.6)
Serogroup Y94.8 (91.0 to 97.3)81.4 (75.9 to 86.2)
Serogroup W83.8 (78.4 to 88.4)66.7 (60.3 to 72.6)
Statistical analysis
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Percentage difference: 7.7 · 95% CI -1.3 to 16.6
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Percentage difference: 44 · 95% CI 36.8 to 50.6
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Percentage difference: 13.3 · 95% CI 7.6 to 19.2
  • Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO® Vaccine · Percentage difference: 17.2 · 95% CI 9.4 to 24.7

Adverse events

Collected over Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: MenACYW Conjugate Vaccine0/498 (0%)7/498 (1.4%)304/498 (61%)
Group 2: MENVEO® Vaccine0/494 (0%)3/494 (0.6%)335/494 (67.8%)
Most frequent serious events
Most frequent serious events
EventGroup 1: MenACYW Conjugate VaccineGroup 2: MENVEO® Vaccine
Partial SeizuresNervous system disorders0/4981/494
Adenoidal HypertrophyRespiratory, thoracic and mediastinal disorders1/4981/494
AsthmaRespiratory, thoracic and mediastinal disorders1/4981/494
Tonsillar HypertrophyRespiratory, thoracic and mediastinal disorders1/4981/494
OsteomyelitisInfections and infestations1/4980/494
Tethered Cord SyndromeNervous system disorders1/4980/494
Status AsthmaticusRespiratory, thoracic and mediastinal disorders1/4980/494
WheezingRespiratory, thoracic and mediastinal disorders1/4980/494
Circulatory CollapseVascular disorders1/4980/494
Most frequent other events
Showing 10 of 11
Most frequent other events
EventGroup 1: MenACYW Conjugate VaccineGroup 2: MENVEO® Vaccine
Injection Site PainGeneral disorders188/498206/494
Injection Site ErythemaGeneral disorders110/498153/494
MyalgiaMusculoskeletal and connective tissue disorders99/498112/494
Injection Site SwellingGeneral disorders67/498104/494
MalaiseGeneral disorders103/49899/494
HeadacheNervous system disorders64/49860/494
Pharyngitis StreptococcalInfections and infestations18/49834/494
CoughRespiratory, thoracic and mediastinal disorders34/49830/494
PyrexiaGeneral disorders20/49827/494
PharyngitisInfections and infestations24/49825/494

Baseline characteristics

Analysis was performed on all randomized participants.

Age, Continuous
Age, Continuous(years)Group 1: MenACYW Conjugate VaccineGroup 2: MENVEO® VaccineTotal
Mean6.0 ± 2.336.0 ± 2.366.0 ± 2.34
Sex: Female, Male
Sex: Female, Male(Participants)Group 1: MenACYW Conjugate VaccineGroup 2: MENVEO® VaccineTotal
Female245236481
Male254265519
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group 1: MenACYW Conjugate VaccineGroup 2: MENVEO® VaccineTotal
American Indian or Alaska Native101
Asian224
Native Hawaiian or Other Pacific Islander404
Black or African American6661127
White402417819
More than one race212142
Unknown or Not Reported303
Region of Enrollment
Region of Enrollment(Participants)Group 1: MenACYW Conjugate VaccineGroup 2: MENVEO® VaccineTotal
United States4995011000
08

Study locations

36 sites
  • Investigational Site
    Birmingham, Alabama 35205, United States
  • Investigational Site
    Dothan, Alabama 36305, United States
  • Investigational Site
    Tucson, Arizona 85741, United States
  • Investigational Site
    Jonesboro, Arkansas 72401, United States
  • Investigational Site
    Anaheim, California 92804, United States
  • Investigational Site
    Downey, California 90241, United States
  • Investigational Site
    Paramount, California 90723, United States
  • Investigational Site
    San Diego, California 92103, United States
  • Investigational Site
    Council Bluffs, Iowa 51503, United States
  • Investigational Site
    Bardstown, Kentucky 40004, United States
  • Investigational Site
    Nicholasville, Kentucky 40356, United States
  • Investigational Site
    Metairie, Louisiana 70006, United States
  • Investigational Site
    Woburn, Massachusetts 01801, United States
  • Investigational Site
    Bridgeton, Missouri 63044, United States
  • Investigational Site
    Kansas City, Missouri 64114, United States
  • Investigational Site
    Omaha, Nebraska 68134, United States
  • Investigational Site
    Cincinnati, Ohio 45245, United States
  • Investigational Site
    Cleveland, Ohio 44121, United States
  • Investigational Site
    Dayton, Ohio 45414, United States
  • Investigational Site
    Fairfield, Ohio 45014, United States
  • Investigational Site
    Grants Pass, Oregon 97527, United States
  • Investigational Site
    Gresham, Oregon 92103, United States
  • Investigational Site
    Erie, Pennsylvania 16506, United States
  • Investigational Site
    Hermitage, Pennsylvania 16148, United States
  • Investigational Site
    Goodlettsville, Tennessee 37072, United States
  • Investigational Site
    Tullahoma, Tennessee 37388, United States
  • Investigational Site
    Layton, Utah 84041, United States
  • Investigational Site
    Orem, Utah 84057, United States
  • Investigational Site
    Roy, Utah 84067, United States
  • Investigational Site
    Salt Lake City, Utah 84109, United States
  • Investigational Site
    Salt Lake City, Utah 84121, United States
  • Investigational Site
    South Jordan, Utah 84095, United States
  • Investigational Site
    Syracuse, Utah 84075, United States
  • Investigational Site
    West Jordan, Utah 848088, United States
  • Investigational Site
    Midlothian, Virginia 23113, United States
  • Investigational Site
    San Juan, 00918, Puerto Rico
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References and documents

Publications

  • Baccarini CI, Simon MW, Brandon D, Christensen S, Jordanov E, Dhingra MS. Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine in Healthy Meningococcal-Naive Children 2-9 Years of Age: A Phase III, Randomized Study. Pediatr Infect Dis J. 2020 Oct;39(10):955-960. doi: 10.1097/INF.0000000000002832. PubMed 32852352 ↗

Related links

Study documents

  • Study protocol · Feb 23, 2018
  • Statistical analysis plan · Feb 28, 2018

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 Mar 28, 2022, 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
NCT03077438
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Responsible party
Sponsor
First posted
Mar 13, 2017
Start date
Feb 17, 2017
Primary completion
Oct 10, 2017
Completion
Oct 10, 2017
Results posted
Jun 9, 2020
Last update
Mar 28, 2022

Study contacts

Medical Officer, MD
study director · Sanofi Pasteur Inc.

Oversight

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

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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