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MeningitisPhase 3NCT02955797

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

A Phase 3 study testing 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 people with Meningitis and Meningococcal Meningitis, run by Sanofi Pasteur, a Sanofi Company at 33 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 23 monthsHealthy volunteers can take part
What is being tested?
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine and Meningococcal polysaccharide groups A, C, W-135 and Y Conjugate vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
918 participants
Where
33 sitesin 4 countries
Study dates
24 Feb 2017to 26 Oct 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 23 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

33 sites in 4 countries.

33 sites in 4 countries

Germany12 sites

  • Investigator Site 412

    Aschaffenburg, 63739

  • Investigator Site 411

    Bönnigheim, 74357

  • Investigator Site 401

    Bramsche, 49565

  • Investigator Site 407

    Bretten, 75015

  • Investigator Site 413

    Datteln, 45711

  • Investigator Site 408

    Goch, 47574

  • Investigator Site 406

    Hamburg, 22415

  • Investigator Site 415

    Hamburg, 22415

  • Investigator Site 404

    Ludwigsfelde, 14974

  • Investigator Site 409

    Rosenheim, 83026

  • Investigator Site 402

    Tauberbischofsheim, 97941

  • Investigator Site 403

    Tauberbischofsheim, 97941

Other trials in Germany

Finland10 sites

  • Investigational Site 309

    Espoo, 02230

  • Investigational Site 301

    Helsinki, 00100

  • Investigational Site 306

    Helsinki, 00930

  • Investigational Site 302

    Jarvenpaa, 04400

  • Investigational Site 304

    Kokkola, 67100

  • Investigational Site 307

    Oulu, 90220

  • Investigational Site 303

    Pori, 28100

  • Investigational Site 305

    Seinäjoki, 60100

  • Investigational Site 308

    Tampere, 33100

  • Investigational Site 310

    Turku, 20520

Other trials in Finland

Hungary6 sites

  • Investigational Site 102

    Budapest, H 1042

  • Investigational Site 101

    Budapest, H 1188

  • Investigational Site 104

    Győr, H 9024

  • Investigational Site 105

    Miskolc, H 3527

  • Investigational Site 103

    Szeged, H 6723

  • Investigational Site 106

    Székesfehérvár, H 8000

Other trials in Hungary

Spain5 sites

  • Investigator Site 203

    Barcelona, 08950

  • Investigator Site 204

    Galicia, 15706

  • Investigator Site 205

    Madrid, 28007

  • Investigator Site 202

    Madrid, 28046

  • Investigator Site 201

    Seville, 41014

Other trials in Spain

About this study

Official title: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers 12 to 23 Months of Age.

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:

Read more
  • 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.

Being tested
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal polysaccharide groups A, C, W-135 and Y Conjugate vaccine
Keywords
Meningitis, Meningococcal Meningitis, MenACYW Conjugate vaccine, Nimenrix®, Menjugate®
Medical subject headings
Meningitis, Meningitis, Meningococcal, Meningococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called MenACYW Conjugate vaccine

    0.5 milliliter (mL), Intramuscular

  • Meningococcal polysaccharide groups A, C, W-135 and Y Conjugate vaccineBiological

    Also called Nimenrix®

    0.5 mL, Intramuscular

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

    Also called MenACYW Conjugate vaccine

    0.5 mL, Intramuscular

  • Meningococcal polysaccharide groups A, C, W-135 and Y Conjugate vaccineBiological

    Also called Nimenrix®

    0.5 mL, Intramuscular

Study groups in NCT02955797
Study groupRoleWhat they receive
Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate VaccineExperimentalHealthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
Receives: Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Group 2 (Meningococcal Vaccine-Naive): Nimenrix®ExperimentalHealthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
Receives: Biological: Meningococcal polysaccharide groups A, C, W-135 and Y Conjugate vaccine
Group 3 (MenC-Primed): MenACYW Conjugate VaccineExperimentalHealthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
Receives: Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Group 4 (MenC-Primed): Nimenrix®ExperimentalHealthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
Receives: Biological: Meningococcal polysaccharide groups A, C, W-135 and Y Conjugate vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Day 30 (post-vaccination)

Secondary outcomes (3)

  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.

    Measured: 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.

    Measured: 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.

    Measured: Day 30 (post-vaccination)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2016 (estimated)
  2. Study start24 Feb 2017
  3. Primary completion26 Oct 2017
  4. Study completion26 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
918 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02955797
Sponsor's protocol ID
MET51
Other IDs
U1111-1161-2935, 2016-000749-30, 2016
Status last verified
Mar 2022
First submitted
3 Nov 2016
Last updated
5 Apr 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 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 people with Meningitis and Meningococcal Meningitis, run by Sanofi Pasteur, a Sanofi Company at 33 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Germany, Finland, Hungary, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Day 30 (post-vaccination)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02955797.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.

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