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

NCT03205358 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: MET542014-004367-20U1111-1143-8912
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 8

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®

Conditions

Meningitis; Meningococcal Meningitis; Meningococcal Infections

Keywords

Meningitis; Meningococcal Meningitis; MenACYW Conjugate vaccine; NIMENRIX®

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®

  A solicited reaction was defined as an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the case report form (CRF) and considered as related to vaccination. Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 solicited injection site reactions: Tenderness: cries when injected limb was moved or the movement of the injected limb was reduced; Erythema and Swelling: greater than or equal to (≥) 50 millimeter (mm). Grade 3 solicited systemic reactions: Fever: greater than \[\>\] 39.5 degree Celsius (°C); Vomiting: ≥6 episodes per 24 hours or requiring parenteral hydration; crying abnormal: \>3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses ≥3 feeds or refuses most feeds; Irritability: inconsolable.

  Day 0 up to Day 7 post-vaccination

Study Arms (2)

Group 1: MenACYW Conjugate Vaccine

EXPERIMENTAL

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

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

Group 2: NIMENRIX®

ACTIVE COMPARATOR

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

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 (IM)

Also known as: MenACYW Conjugate vaccine

Group 1: MenACYW Conjugate Vaccine

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

0.5 mL, IM

Also known as: NIMENRIX®

Group 2: 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (8)

Investigational Site Number 005

Espoo, 02230, Finland

Location

Investigational Site Number 006

Helsinki, 00100, Finland

Location

Investigational Site Number 002

Helsinki, 00930, Finland

Location

Investigational Site Number 007

Jarvenpaa, 04400, Finland

Location

Investigational Site Number 008

Oulu, 90220, Finland

Location

Investigational Site Number 001

Pori, 28100, Finland

Location

Investigational Site Number 003

Tampere, 33100, Finland

Location

Investigational Site Number 004

Turku, 20520, Finland

Location

Related Publications (1)

• 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.

  PMID: 32233959 RESULT

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: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 2, 2017
• Study Start: March 31, 2015
• Primary Completion: August 19, 2015
• Study Completion: August 19, 2015
• Last Updated: April 4, 2022
• Results First Posted: June 5, 2020

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

FI (8)