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

March 24, 2022 updated by: Sanofi Pasteur, a Sanofi Company

A Phase II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers

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®

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Espoo, Finland, 02230
        • Investigational Site Number 005
      • Helsinki, Finland, 00100
        • Investigational Site Number 006
      • Helsinki, Finland, 00930
        • Investigational Site Number 002
      • Järvenpää, Finland, 04400
        • Investigational Site Number 007
      • Oulu, Finland, 90220
        • Investigational Site Number 008
      • Pori, Finland, 28100
        • Investigational Site Number 001
      • Tampere, Finland, 33100
        • Investigational Site Number 003
      • Turku, Finland, 20520
        • Investigational Site Number 004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1: MenACYW Conjugate Vaccine
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
0.5 milliliter (mL), Intramuscular (IM)
Other Names:
  • MenACYW Conjugate vaccine
ACTIVE_COMPARATOR: Group 2: NIMENRIX®
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
0.5 mL, IM
Other Names:
  • NIMENRIX®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Time Frame: Day 0 up to Day 7 post-vaccination
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 31, 2015

Primary Completion (ACTUAL)

August 19, 2015

Study Completion (ACTUAL)

August 19, 2015

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

June 28, 2017

First Posted (ACTUAL)

July 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 24, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MET54
  • 2014-004367-20 (EUDRACT_NUMBER)
  • U1111-1143-8912 (OTHER: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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