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

NCT ID: NCT02955797

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 918 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-24
• Study Completion Date: 2017-10-26

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.

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.

Conditions

Meningitis; Meningococcal Meningitis; Meningococcal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5 milliliter (mL), Intramuscular

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Interventions

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

0.5 milliliter (mL), Intramuscular

Intervention Type: BIOLOGICAL

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

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

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

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

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

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

MenACYW Conjugate vaccine; Nimenrix®; MenACYW Conjugate vaccine; Nimenrix®

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 23 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur SA

Locations

Investigational Site 309

Espoo, , Finland

Investigational Site 301

Helsinki, , Finland

Investigational Site 306

Helsinki, , Finland

Investigational Site 302

Järvenpää, , Finland

Investigational Site 304

Kokkola, , Finland

Investigational Site 307

Oulu, , Finland

Investigational Site 303

Pori, , Finland

Investigational Site 305

Seinäjoki, , Finland

Investigational Site 308

Tampere, , Finland

Investigational Site 310

Turku, , Finland

Investigator Site 412

Aschaffenburg, , Germany

Investigator Site 411

Bönnigheim, , Germany

Investigator Site 401

Bramsche, , Germany

Investigator Site 407

Bretten, , Germany

Investigator Site 413

Datteln, , Germany

Investigator Site 408

Goch, , Germany

Investigator Site 406

Hamburg, , Germany

Investigator Site 415

Hamburg, , Germany

Investigator Site 404

Ludwigsfelde, , Germany

Investigator Site 409

Rosenheim, , Germany

Investigator Site 402

Tauberbischofsheim, , Germany

Investigator Site 403

Tauberbischofsheim, , Germany

Investigational Site 102

Budapest, , Hungary

Investigational Site 101

Budapest, , Hungary

Investigational Site 104

Győr, , Hungary

Investigational Site 105

Miskolc, , Hungary

Investigational Site 103

Szeged, , Hungary

Investigational Site 106

Székesfehérvár, , Hungary

Investigator Site 203

Barcelona, , Spain

Investigator Site 204

Galicia, , Spain

Investigator Site 205

Madrid, , Spain

Investigator Site 202

Madrid, , Spain

Investigator Site 201

Seville, , Spain

Countries

Finland; Germany; Hungary; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

U1111-1161-2935

Identifier Type: OTHER

Identifier Source: secondary_id

2016-000749-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MET51

Identifier Type: -

Identifier Source: org_study_id