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

NCT02955797 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: MET51U1111-1161-29352016-000749-30
• Study Type: interventional
• Target: 918
• Locations: 4 countries
• Sites: 33

Brief 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.

Conditions

Meningitis; Meningococcal Meningitis; Meningococcal Infections

Keywords

Meningitis; Meningococcal Meningitis; MenACYW Conjugate vaccine; Nimenrix®; Menjugate®

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 30 (post-vaccination)

• 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.

  Day 30 (post-vaccination)

Secondary Outcomes (3)

• 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

  Day 30 (post-vaccination)

• 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

  Day 30 (post-vaccination)

• 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

  Day 30 (post-vaccination)

Study Arms (4)

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

EXPERIMENTAL

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

Group 2 (Meningococcal Vaccine-Naive): Nimenrix®

EXPERIMENTAL

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

Group 3 (MenC-Primed): MenACYW Conjugate Vaccine

EXPERIMENTAL

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

Group 4 (MenC-Primed): Nimenrix®

EXPERIMENTAL

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

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

0.5 milliliter (mL), Intramuscular

Also known as: MenACYW Conjugate vaccine

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

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

0.5 mL, Intramuscular

Also known as: Nimenrix®

Group 2 (Meningococcal Vaccine-Naive): Nimenrix®

Eligibility Criteria

• Age: 12 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (33)

Investigational Site 309

Espoo, 02230, Finland

Location

Investigational Site 301

Helsinki, 00100, Finland

Location

Investigational Site 306

Helsinki, 00930, Finland

Location

Investigational Site 302

Jarvenpaa, 04400, Finland

Location

Investigational Site 304

Kokkola, 67100, Finland

Location

Investigational Site 307

Oulu, 90220, Finland

Location

Investigational Site 303

Pori, 28100, Finland

Location

Investigational Site 305

Seinäjoki, 60100, Finland

Location

Investigational Site 308

Tampere, 33100, Finland

Location

Investigational Site 310

Turku, 20520, Finland

Location

Investigator Site 412

Aschaffenburg, 63739, Germany

Location

Investigator Site 411

Bönnigheim, 74357, Germany

Location

Investigator Site 401

Bramsche, 49565, Germany

Location

Investigator Site 407

Bretten, 75015, Germany

Location

Investigator Site 413

Datteln, 45711, Germany

Location

Investigator Site 408

Goch, 47574, Germany

Location

Investigator Site 406

Hamburg, 22415, Germany

Location

Investigator Site 415

Hamburg, 22415, Germany

Location

Investigator Site 404

Ludwigsfelde, 14974, Germany

Location

Investigator Site 409

Rosenheim, 83026, Germany

Location

Investigator Site 402

Tauberbischofsheim, 97941, Germany

Location

Investigator Site 403

Tauberbischofsheim, 97941, Germany

Location

Investigational Site 102

Budapest, H 1042, Hungary

Location

Investigational Site 101

Budapest, H 1188, Hungary

Location

Investigational Site 104

Győr, H 9024, Hungary

Location

Investigational Site 105

Miskolc, H 3527, Hungary

Location

Investigational Site 103

Szeged, H 6723, Hungary

Location

Investigational Site 106

Székesfehérvár, H 8000, Hungary

Location

Investigator Site 203

Barcelona, 08950, Spain

Location

Investigator Site 204

Galicia, 15706, Spain

Location

Investigator Site 205

Madrid, 28007, Spain

Location

Investigator Site 202

Madrid, 28046, Spain

Location

Investigator Site 201

Seville, 41014, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Meningitis; Meningitis, Meningococcal; Meningococcal Infections

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

Contact-US@sanofi.com

800-633-1610

Study Officials

• Medical Director

  Sanofi Pasteur SA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 4, 2016
• Study Start: February 24, 2017
• Primary Completion: October 26, 2017
• Study Completion: October 26, 2017
• Last Updated: April 5, 2022
• Results First Posted: June 9, 2020

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (12); FI (10); HU (6); ES (5)