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CompletedNCT02955797Updated Apr 5, 2022Results posted

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers

A Phase 3 interventional study of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine and Meningococcal polysaccharide groups A, C, W-135 and Y Conjugate vaccine in Meningitis, Meningococcal Meningitis and Meningococcal Infections, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 33 sites in 4 countries. Open to participants aged 12 Months to 23 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-05.

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

Phase
Phase 3
Study type
Interventional
Enrollment
918
Allocation
Randomized
Ages
12 Months to 23 Months
Sex
All
01

Study summary

The purpose of the study was to evaluate the immunogenicity and describe the safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed Meningococcal polysaccharide groups A, C, W-135 and Y (Nimenrix®) Conjugate vaccine in toddlers 12 to 23 months of age in the European Union (EU). The toddlers were either meningococcal vaccine naïve or had received monovalent meningococcal C (MenC) vaccination during infancy to evaluate any potential impact of the meningococcal vaccine background on the immunogenicity and safety profile of the investigational product.

Primary Objectives:

  • To demonstrate the non-inferiority of the antibody response to meningococcal serogroups A, C, Y, and W after a single dose of MenACYW Conjugate vaccine or Nimenrix® in toddlers who either were meningococcal vaccine naïve or had received monovalent MenC vaccination during infancy.
  • To demonstrate the non-inferiority of the antibody response to meningococcal serogroups A, C, Y, and W after a single dose of MenACYW Conjugate vaccine or Nimenrix® in meningococcal vaccine naïve toddlers.

Secondary Objectives:

  • To compare the antibody responses (geometric mean titers [GMTs]) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW Conjugate vaccine or Nimenrix® as measured by serum bactericidal assay using human complement (hSBA) in toddlers who either were meningococcal vaccine naïve or had received monovalent MenC vaccination during infancy.
  • To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW Conjugate vaccine or Nimenrix® as measured by hSBA in meningococcal vaccine naïve toddlers.
  • To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW Conjugate vaccine or Nimenrix® as measured by hSBA in toddlers who received monovalent MenC vaccination during infancy.
Read the detailed description

Healthy toddlers were randomized depending on their meningococcal priming vaccination background (either meningococcal vaccine naïve or primed with MenC) and received a single dose of either MenACYW Conjugate vaccine or Nimenrix®. They were assessed for immunogenicity at baseline (pre-vaccination) and 30 to 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
  • Nimenrix®
  • Menjugate®
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 918 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
12 Months to 23 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Aged 12 to 23 months on the day of the first study visit.
  • Participants had received all recommended standard-of-care non-meningococcal vaccinations according to his/her age as per local regulations.
  • Informed consent form (ICF) had been signed and dated by the parent/legally acceptable representative.
  • Participant and parent/legally acceptable representative were able to attend all scheduled visits and complied with all trial procedures.
  • Covered by health insurance if required by local regulations.
  • Participants had received any meningococcal vaccine in the second year of life (i.e., from 12 months of age).
  • For Inclusion in Groups 1 and 2: Participants must not had received any vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or Conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent or bivalent meningococcal vaccine).
  • For Inclusion in Groups 3 and 4: Participants must had previously received at least 1 dose of licensed monovalent meningococcal C Conjugate (MenC) vaccine during infancy (i.e., before 12 months of age).

Exclusion criteria

Exclusion Criteria:

  • 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 may be received at least 2 weeks before or after study investigational vaccines. This exception included monovalent pandemic influenza vaccines and multivalent influenza vaccines.
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months.
  • For Groups 1 and 2 only: Vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or Conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent or bivalent meningococcal vaccine).
  • For Groups 3 and 4 only: Vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or Conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent B meningococcal vaccine), except licensed monovalent meningococcal C Conjugate (MenC) vaccination received during infancy.
  • 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 travelling 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.
  • Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine.
  • Personal history of Guillain-Barré Syndrome.
  • Verbal report of thrombocytopenia, as reported by the 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.
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
  • Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has 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
918 participants (actual)

Study arms

  • Experimental
    Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine

    Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.

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

  • Experimental
    Group 2 (Meningococcal Vaccine-Naive): Nimenrix®

    Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.

    Biological: Meningococcal polysaccharide groups A, C, W-135 and Y Conjugate vaccine

  • Experimental
    Group 3 (MenC-Primed): MenACYW Conjugate Vaccine

    Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.

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

  • Experimental
    Group 4 (MenC-Primed): Nimenrix®

    Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.

    Biological: Meningococcal polysaccharide groups A, C, W-135 and Y Conjugate vaccine

Interventions

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

    0.5 milliliter (mL), Intramuscular

    Also known as: MenACYW Conjugate vaccine

  • BiologicalMeningococcal polysaccharide groups A, C, W-135 and Y Conjugate vaccine

    0.5 mL, Intramuscular

    Also known as: Nimenrix®

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

    0.5 mL, Intramuscular

    Also known as: MenACYW Conjugate vaccine

  • BiologicalMeningococcal polysaccharide groups A, C, W-135 and Y Conjugate vaccine

    0.5 mL, Intramuscular

    Also known as: Nimenrix®

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy

    Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine and Nimenrix® reporting groups.

    Time frame: Day 30 (post-vaccination)

  2. Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Meningococcal Vaccine Naïve Toddlers

    Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by hSBA.

    Time frame: Day 30 (post-vaccination)

Secondary outcomes

  1. Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy

    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 Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Vaccine Naive Toddlers

    Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by hSBA.

    Time frame: Day 30 (post-vaccination)

  3. Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Toddlers Who Had Received Monovalent MenC Vaccination During Infancy

    Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by hSBA.

    Time frame: Day 30 (post-vaccination)

07

Results

Posted Jun 9, 2020

Participant flow

Study participants were enrolled in 34 centers in Spain, Hungary, Germany and Finland from 24 February 2017 to 21 September 2017.

Participant flow — Overall Study
MilestoneGroup 1(Meningococcal Vaccine-Naive):MenACYW Conjugate VaccineGroup 2 (Meningococcal Vaccine-Naive): Nimenrix®Group 3 (MenC-Primed) MenACYW Conjugate VaccineGroup 4 (MenC-Primed): Nimenrix®
Started306306203103
Safety analysis set (safas)303306203102
Per protocol analysis set (ppas)29329619899
Completed303303203101
Not completed3302
Withdrew: Protocol violation1001
Withdrew: Withdrawal by subject2201
Withdrew: Lost to follow-up0100

Outcome measures

PrimaryPercentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy

Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine and Nimenrix® reporting groups.

Time frame:
Day 30 (post-vaccination)
Reported as:
Number · percentage of participants
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy
percentage of participantsMenACYW Conjugate Vaccine (Groups 1 and 3)Nimenrix® (Groups 2 and 4)
Serogroup A90.4 (87.4 to 92.9)91.6 (88.4 to 94.2)
Serogroup C99.2 (97.9 to 99.8)85.5 (81.7 to 88.9)
Serogroup Y94.3 (91.8 to 96.2)91.6 (88.5 to 94.2)
Serogroup W84.9 (81.4 to 87.9)84.0 (80.0 to 87.5)
Statistical analysis
  • MenACYW Conjugate Vaccine (Groups 1 and 3) vs Nimenrix® (Groups 2 and 4) · Percentage difference: -2.03 · 95% CI -5.84 to 1.78
  • MenACYW Conjugate Vaccine (Groups 1 and 3) vs Nimenrix® (Groups 2 and 4) · Percentage difference: 12.1 · 95% CI 8.16 to 16.1
  • MenACYW Conjugate Vaccine (Groups 1 and 3) vs Nimenrix® (Groups 2 and 4) · Percentage difference: 2.42 · 95% CI -1.34 to 6.19
  • MenACYW Conjugate Vaccine (Groups 1 and 3) vs Nimenrix® (Groups 2 and 4) · Percentage difference: 0.458 · 95% CI -4.37 to 5.28
PrimaryPercentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Meningococcal Vaccine Naïve Toddlers

Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by hSBA.

Time frame:
Day 30 (post-vaccination)
Reported as:
Number · percentage of participants
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Meningococcal Vaccine Naïve Toddlers
percentage of participantsGroup 1(Meningococcal Vaccine-Naive):MenACYW Conjugate VaccineGroup 2 (Meningococcal Vaccine-Naive): Nimenrix®
Serogroup A90.8 (86.9 to 93.8)89.5 (85.4 to 92.7)
Serogroup C99.3 (97.6 to 99.9)81.4 (76.4 to 85.6)
Serogroup Y93.2 (89.7 to 95.8)91.6 (87.8 to 94.5)
Serogroup W83.6 (78.9 to 87.7)83.4 (78.7 to 87.5)
Statistical analysis
  • Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine vs Group 2 (Meningococcal Vaccine-Naive): Nimenrix® · Percentage difference: 1.3 · 95% CI -3.6 to 6.2
  • Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine vs Group 2 (Meningococcal Vaccine-Naive): Nimenrix® · Percentage difference: 18 · 95% CI 13.6 to 22.8
  • Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine vs Group 2 (Meningococcal Vaccine-Naive): Nimenrix® · Percentage difference: 1.6 · 95% CI -2.76 to 6.03
  • Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine vs Group 2 (Meningococcal Vaccine-Naive): Nimenrix® · Percentage difference: 0.2 · 95% CI -5.85 to 6.18
SecondaryGeometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy

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 in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy
titers (1/dilution)MenACYW Conjugate Vaccine (Groups 1 and 3)Nimenrix® (Groups 2 and 4)
Serogroup A29.9 (26.9 to 33.2)34.5 (30.5 to 39.0)
Serogroup C880 (748 to 1035)77.1 (60.7 to 98.0)
Serogroup Y41.7 (37.5 to 46.5)31.9 (28.4 to 36.0)
Serogroup W24.4 (21.8 to 27.5)17.7 (15.8 to 19.8)
Statistical analysis
  • MenACYW Conjugate Vaccine (Groups 1 and 3) vs Nimenrix® (Groups 2 and 4) · Gmt ratio: 0.819 · 95% CI 0.697 to 0.963
  • MenACYW Conjugate Vaccine (Groups 1 and 3) vs Nimenrix® (Groups 2 and 4) · Gmt ratio: 7.59 · 95% CI 6.05 to 9.52
  • MenACYW Conjugate Vaccine (Groups 1 and 3) vs Nimenrix® (Groups 2 and 4) · Gmt ratio: 1.28 · 95% CI 1.09 to 1.51
  • MenACYW Conjugate Vaccine (Groups 1 and 3) vs Nimenrix® (Groups 2 and 4) · Gmt ratio: 1.32 · 95% CI 1.12 to 1.56
SecondaryGeometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Vaccine Naive Toddlers

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 of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Vaccine Naive Toddlers
titers (1/dilution)Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate VaccineGroup 2 (Meningococcal Vaccine-Naive): Nimenrix®
Serogroup A28.7 (25.2 to 32.6)28.0 (24.4 to 32.1)
Serogroup C436 (380 to 500)26.4 (22.5 to 31.0)
Serogroup Y38.0 (33.0 to 43.9)32.2 (28.0 to 37.0)
Serogroup W22.0 (18.9 to 25.5)16.4 (14.4 to 18.6)
Statistical analysis
  • Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine vs Group 2 (Meningococcal Vaccine-Naive): Nimenrix® · Gmt ratio: 1.03 · 95% CI 0.85 to 1.24
  • Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine vs Group 2 (Meningococcal Vaccine-Naive): Nimenrix® · Gmt ratio: 16.5 · 95% CI 13.4 to 20.4
  • Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine vs Group 2 (Meningococcal Vaccine-Naive): Nimenrix® · Gmt ratio: 1.18 · 95% CI 0.97 to 1.44
  • Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine vs Group 2 (Meningococcal Vaccine-Naive): Nimenrix® · Gmt ratio: 1.34 · 95% CI 1.1 to 1.63
SecondaryGeometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Toddlers Who Had Received Monovalent MenC Vaccination During Infancy

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 of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Toddlers Who Had Received Monovalent MenC Vaccination During Infancy
titers (1/dilution)Group 3 (MenC-Primed): MenACYW Conjugate VaccineGroup 4 (MenC-Primed): Nimenrix®
Serogroup A31.8 (26.5 to 38.1)64.0 (50.9 to 80.5)
Serogroup C2514 (1875 to 3372)1883 (1276 to 2779)
Serogroup Y48.0 (40.6 to 56.7)31.3 (24.8 to 39.5)
Serogroup W28.7 (23.8 to 34.5)22.3 (17.7 to 28.2)
Statistical analysis
  • Group 3 (MenC-Primed): MenACYW Conjugate Vaccine vs Group 4 (MenC-Primed): Nimenrix® · Gmt ratio: 0.496 · 95% CI 0.367 to 0.672
  • Group 3 (MenC-Primed): MenACYW Conjugate Vaccine vs Group 4 (MenC-Primed): Nimenrix® · Gmt ratio: 1.34 · 95% CI 0.814 to 2.19
  • Group 3 (MenC-Primed): MenACYW Conjugate Vaccine vs Group 4 (MenC-Primed): Nimenrix® · Gmt ratio: 1.53 · 95% CI 1.15 to 2.04
  • Group 3 (MenC-Primed): MenACYW Conjugate Vaccine vs Group 4 (MenC-Primed): Nimenrix® · Gmt ratio: 1.29 · 95% CI 0.944 to 1.75

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine0/303 (0%)2/303 (0.7%)261/303 (86.1%)
Group 2 (Meningococcal Vaccine-Naive): Nimenrix®0/306 (0%)1/306 (0.3%)266/306 (86.9%)
Group 3 (MenC-Primed): MenACYW Conjugate Vaccine0/203 (0%)2/203 (1%)151/203 (74.4%)
Group 4 (MenC-Primed): Nimenrix®0/102 (0%)2/102 (2%)65/102 (63.7%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventGroup 1(Meningococcal Vaccine-Naive):MenACYW Conjugate VaccineGroup 2 (Meningococcal Vaccine-Naive): Nimenrix®Group 3 (MenC-Primed): MenACYW Conjugate VaccineGroup 4 (MenC-Primed): Nimenrix®
BronchitisInfections and infestations0/3030/3060/2031/102
Blood Immunoglobulin A DecreasedInvestigations0/3030/3060/2031/102
BronchospasmRespiratory, thoracic and mediastinal disorders0/3030/3060/2031/102
Campylobacter GastroenteritisInfections and infestations0/3030/3061/2030/102
Craniocerebral InjuryInjury, poisoning and procedural complications0/3030/3061/2030/102
SeizureNervous system disorders0/3030/3061/2030/102
Haemolytic Uraemic SyndromeBlood and lymphatic system disorders1/3030/3060/2030/102
Intestinal MalrotationCongenital, familial and genetic disorders1/3030/3060/2030/102
Gastroenteritis Escherichia ColiInfections and infestations1/3030/3060/2030/102
Febrile ConvulsionNervous system disorders1/3030/3060/2030/102
Most frequent other events
Showing 10 of 16
Most frequent other events
EventGroup 1(Meningococcal Vaccine-Naive):MenACYW Conjugate VaccineGroup 2 (Meningococcal Vaccine-Naive): Nimenrix®Group 3 (MenC-Primed): MenACYW Conjugate VaccineGroup 4 (MenC-Primed): Nimenrix®
IrritabilityPsychiatric disorders144/303127/30676/20336/102
Injection Site ErythemaGeneral disorders122/303116/30652/20321/102
Injection Site PainGeneral disorders122/303113/30655/20320/102
CryingGeneral disorders106/303111/30648/20323/102
Decreased AppetiteMetabolism and nutrition disorders91/30394/30656/20328/102
SomnolenceNervous system disorders64/30355/30651/20319/102
Injection Site SwellingGeneral disorders63/30352/30635/2039/102
Upper Respiratory Tract InfectionInfections and infestations49/30339/30614/2037/102
PyrexiaGeneral disorders40/30348/30629/20314/102
VomitingGastrointestinal disorders23/30313/30621/2038/102

Baseline characteristics

Analysis was performed on all randomized participants.

Age, Continuous
Age, Continuous(months)Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate VaccineGroup 2 (Meningococcal Vaccine-Naive): Nimenrix®Group 3 (MenC-Primed): MenACYW Conjugate VaccineGroup 4 (MenC-Primed): Nimenrix®Total
Mean16.1 ± 3.3216.2 ± 3.1914.0 ± 3.0113.8 ± 2.7215.4 ± 3.31
Sex: Female, Male
Sex: Female, Male(Participants)Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate VaccineGroup 2 (Meningococcal Vaccine-Naive): Nimenrix®Group 3 (MenC-Primed): MenACYW Conjugate VaccineGroup 4 (MenC-Primed): Nimenrix®Total
Female1401459753435
Male16616110650483
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate VaccineGroup 2 (Meningococcal Vaccine-Naive): Nimenrix®Group 3 (MenC-Primed): MenACYW Conjugate VaccineGroup 4 (MenC-Primed): Nimenrix®Total
American Indian or Alaska Native00101
Asian11013
Native Hawaiian or Other Pacific Islander00000
Black or African American02013
White11513219799543
More than one race235212
Unknown or Not Reported18816800356
Region of Enrollment
Region of Enrollment(Participants)Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate VaccineGroup 2 (Meningococcal Vaccine-Naive): Nimenrix®Group 3 (MenC-Primed): MenACYW Conjugate VaccineGroup 4 (MenC-Primed): Nimenrix®Total
Hungary009550145
Finland18816800356
Germany11813800256
Spain0010853161
08

Study locations

33 sites
  • Investigational Site 309
    Espoo, 02230, Finland
  • Investigational Site 301
    Helsinki, 00100, Finland
  • Investigational Site 306
    Helsinki, 00930, Finland
  • Investigational Site 302
    Järvenpää, 04400, Finland
  • Investigational Site 304
    Kokkola, 67100, Finland
  • Investigational Site 307
    Oulu, 90220, Finland
  • Investigational Site 303
    Pori, 28100, Finland
  • Investigational Site 305
    Seinäjoki, 60100, Finland
  • Investigational Site 308
    Tampere, 33100, Finland
  • Investigational Site 310
    Turku, 20520, Finland
  • Investigator Site 412
    Aschaffenburg, 63739, Germany
  • Investigator Site 401
    Bramsche, 49565, Germany
  • Investigator Site 407
    Bretten, 75015, Germany
  • Investigator Site 411
    Bönnigheim, 74357, Germany
  • Investigator Site 413
    Datteln, 45711, Germany
  • Investigator Site 408
    Goch, 47574, Germany
  • Investigator Site 406
    Hamburg, 22415, Germany
  • Investigator Site 415
    Hamburg, 22415, Germany
  • Investigator Site 404
    Ludwigsfelde, 14974, Germany
  • Investigator Site 409
    Rosenheim, 83026, Germany
  • Investigator Site 402
    Tauberbischofsheim, 97941, Germany
  • Investigator Site 403
    Tauberbischofsheim, 97941, Germany
  • Investigational Site 102
    Budapest, H 1042, Hungary
  • Investigational Site 101
    Budapest, H 1188, Hungary
  • Investigational Site 104
    Győr, H 9024, Hungary
  • Investigational Site 105
    Miskolc, H 3527, Hungary
  • Investigational Site 103
    Szeged, H 6723, Hungary
  • Investigational Site 106
    Székesfehérvár, H 8000, Hungary
  • Investigator Site 203
    Barcelona, 08950, Spain
  • Investigator Site 204
    Galicia, 15706, Spain
  • Investigator Site 205
    Madrid, 28007, Spain
  • Investigator Site 202
    Madrid, 28046, Spain
  • Investigator Site 201
    Sevilla, 41014, Spain
09

References and documents

Related links

Study documents

  • Study protocol · Jul 20, 2016
  • Statistical analysis plan · Apr 13, 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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02955797
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Responsible party
Sponsor
First posted
Nov 4, 2016
Start date
Feb 24, 2017
Primary completion
Oct 26, 2017
Completion
Oct 26, 2017
Results posted
Jun 9, 2020
Last update
Apr 5, 2022

Study contacts

Medical Director
study director · Sanofi Pasteur SA

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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