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

NCT ID: NCT03205358

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-08-19

Brief Summary

The purpose of the study was to evaluate the immunogenicity and safety profile of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate vaccine when given alone compared to that of the licensed Meningococcal groups A, C, W 135 and Y (NIMENRIX®) Conjugate vaccine.

Observational objectives:

• To evaluate the antibody responses to the antigens (serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine and NIMENRIX® measured by serum bactericidal assay using baby rabbit complement (rSBA) and by serum bactericidal assay using human complement (hSBA)
• To evaluate the antibody responses against tetanus in participants who received MenACYW Conjugate vaccine or NIMENRIX® vaccine
• To evaluate the safety profile of MenACYW Conjugate vaccine and NIMENRIX®

Detailed Description

All participants received 1 dose of MenACYW Conjugate vaccine or NIMENRIX® on Day 0 and were evaluated for immunogenicity and safety profile. The duration of each participant's participation in the trial was 30 to 44 days.

Conditions

Meningitis; Meningococcal Meningitis; Meningococcal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1: MenACYW Conjugate Vaccine

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5 milliliter (mL), Intramuscular (IM)

Group 2: NIMENRIX®

Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of NIMENRIX® vaccine.

Group Type: ACTIVE_COMPARATOR

Meningococcal Polysaccharide groups A, C, W-135 and Y Conjugate Vaccine

Intervention Type: BIOLOGICAL

0.5 mL, IM

Interventions

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

0.5 milliliter (mL), Intramuscular (IM)

Intervention Type: BIOLOGICAL

Meningococcal Polysaccharide groups A, C, W-135 and Y Conjugate Vaccine

0.5 mL, IM

Intervention Type: BIOLOGICAL

Other Intervention Names

MenACYW Conjugate vaccine; NIMENRIX®

Eligibility Criteria

Inclusion Criteria

• Aged 12 to 23 months on the day of the first study visit.
• Born at full term of pregnancy (greater than or equal to [≥] 37 weeks) or with a birth weight ≥2.5 kilogram (kg) (5.5 pounds).
• Inform Consent Form (ICF) had been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations).
• Participant and parent/legally acceptable representative were able to attend all scheduled visits and to comply with all trial procedures.
• Covered by health insurance where applicable.

Exclusion Criteria

• Participation at the time of study enrollment (or 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 preceding the trial vaccination or planned receipt of any vaccine before the final blood draw except for influenza vaccination, which might be received at least 2 weeks before or after the study vaccine.
• Previous vaccination against meningococcal disease with either the trial vaccine or mono-, or polyvalent polysaccharide or Conjugate meningococcal vaccine containing serogroups A, B, C, W, or Y.
• 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 (≥ 2 milligram [mg]/kg/day of 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 (i.e., 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.
• Known systemic hypersensitivity to latex.
• Known thrombocytopenia, as reported by the parent/legally acceptable representative.
• Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination.
• 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 judgment) on the day of vaccination or febrile illness (temperature ≥38.0 degree Celsius (°C). 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.

• 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 Inc.

Locations

Investigational Site Number 005

Espoo, , Finland

Investigational Site Number 006

Helsinki, , Finland

Investigational Site Number 002

Helsinki, , Finland

Investigational Site Number 007

Järvenpää, , Finland

Investigational Site Number 008

Oulu, , Finland

Investigational Site Number 001

Pori, , Finland

Investigational Site Number 003

Tampere, , Finland

Investigational Site Number 004

Turku, , Finland

Countries

Finland

References

Vesikari T, Borrow R, Forsten A, Findlow H, Dhingra MS, Jordanov E. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in healthy toddlers: a Phase II randomized study. Hum Vaccin Immunother. 2020 Jun 2;16(6):1306-1312. doi: 10.1080/21645515.2020.1733869. Epub 2020 Apr 1.

Reference Type: RESULT

PMID: 32233959 (View on PubMed)

Other Identifiers

2014-004367-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1143-8912

Identifier Type: OTHER

Identifier Source: secondary_id

MET54

Identifier Type: -

Identifier Source: org_study_id