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Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy

Primary Purpose

Healthy Volunteers (Meningococcal Infection)

Status
Recruiting
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
MenACYW conjugate vaccine
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy Volunteers (Meningococcal Infection)

Eligibility Criteria

12 Months - 23 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Aged 12 to 23 months on the day of inclusion Participants who are healthy as determined by medical evaluation including medical history, physical examination, and judgement of the Investigator Received at least one priming dose of licensed Nimenrix® or Menveo® vaccine during infancy before 12 months of age with an interval of at least 2 months between the last vaccination with Nimenrix® or Menveo® and the MenQuadfi® booster dose Exclusion Criteria: 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 study (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease) Personal history of Guillain-Barré syndrome Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid containing vaccine Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. Prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided Receipt of any vaccine (including COVID-19 vaccines) in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine (including COVID-19 vaccines) in the 4 weeks following the study intervention administration except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after the study intervention. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. Previous vaccination with a Meningococcal C vaccine or Meningococcal B (MenB) vaccine Receipt of immunoglobulins, blood or blood-derived products in the past 3 months Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Investigational Site Number :0320002Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MenACYW conjugate vaccine

Arm Description

participants will receive a single booster dose of the MenACYW conjugate vaccine with an interval of at least 2 months after the last vaccination with Nimenrix® or Menveo® received during infancy before 12 months of age

Outcomes

Primary Outcome Measures

hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W
% of participants achieving antibody titers measured by human complement (hSBA) ≥ predefined threshold of 1:8
Number of participants with immediate adverse events (AEs)
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Number of participants with solicited injection site reactions or systemic reactions
Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF
Number of participants with unsolicited AEs
AEs other than solicited reactions
Number of participants with serious adverse events (SAEs)
SAEs (including adverse events of special interest [AESIs]) reported throughout the study
hSBA antibody titers against meningococcal serogroups A, C, Y, and W
Antibody titers are measured by hSBA and summarized as geometric mean titers (GMTs)
hSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W
Antibody titers are measured by hSBA and summarized as % of participants achieving antibody titers ≥ predefined thresholds
Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by hSBA
hSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse
Vaccine seroresponse, defined as follows: For a participant with a pre-vaccination titer < 1:8, a post vaccination titer ≥ 1:16 and for a participant with a pre-vaccination titer ≥ 1:8, a post vaccination titer at least 4-fold greater that the pre vaccination titer
Anti-tetanus antibody concentrations

Secondary Outcome Measures

Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, Y, and W
rSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W
Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by rSBA
rSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse
Vaccine seroresponse defined as follows: For a participant with a pre-vaccination titer < 1:8, a post vaccination titer ≥ 1:32 and for a participant with a pre-vaccination titer ≥ 1:8, a post vaccination titer at least 4-fold greater that the pre vaccination titer

Full Information

First Posted
June 12, 2023
Last Updated
September 26, 2023
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT05929651
Brief Title
Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy
Official Title
A Descriptive, Phase IV, Open-label, Single-arm Multi-center Study to Assess the Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Healthy Toddlers 12 to 23 Months of Age Who Had Been Primed With at Least 1 Dose of Another Quadrivalent Meningococcal Conjugate Vaccine, ie, Nimenrix® (MCV4-TT) or Menveo® (MCV4-CRM), in Infancy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2023 (Actual)
Primary Completion Date
April 19, 2024 (Anticipated)
Study Completion Date
April 19, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the immunogenicity and safety of a single dose of MenQuadfi® administered as a booster vaccine in toddlers 12 - 23 months of age in Argentina who had been primed with at least 1 dose of the quadrivalent meningococcal conjugate vaccines Nimenrix® or Menveo® during infancy to protect against invasive meningococcal disease (IMD). Participants will receive a single dose of MenQuadfi® at Visit 1. Participants will provide 2 blood samples, one at D01 (Visit 1) pre-vaccination and another at D31 (Visit 2) post-vaccination for the immunogenicity assessments. Study will include 2 visits at D01 (Visit 1) and at D31 (Visit 2), and 1 Telephone call (TC) for safety follow-up at D09 post-study vaccination.
Detailed Description
Study duration is approximately 30 days (+14 days) per participant

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers (Meningococcal Infection)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MenACYW conjugate vaccine
Arm Type
Experimental
Arm Description
participants will receive a single booster dose of the MenACYW conjugate vaccine with an interval of at least 2 months after the last vaccination with Nimenrix® or Menveo® received during infancy before 12 months of age
Intervention Type
Biological
Intervention Name(s)
MenACYW conjugate vaccine
Other Intervention Name(s)
MenQuadfi®
Intervention Description
Pharmaceutical form: Liquid solution Route of administration: Intramuscular (IM) injection
Primary Outcome Measure Information:
Title
hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W
Description
% of participants achieving antibody titers measured by human complement (hSBA) ≥ predefined threshold of 1:8
Time Frame
Day 31 (+14 days) after booster vaccination
Title
Number of participants with immediate adverse events (AEs)
Description
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Time Frame
Within 30 minutes after vaccination
Title
Number of participants with solicited injection site reactions or systemic reactions
Description
Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF
Time Frame
Within 7 days after booster vaccination
Title
Number of participants with unsolicited AEs
Description
AEs other than solicited reactions
Time Frame
From Day 01 to Day 31 (+14 days) after booster vaccination
Title
Number of participants with serious adverse events (SAEs)
Description
SAEs (including adverse events of special interest [AESIs]) reported throughout the study
Time Frame
From Day 01 to Day 31 (+14 days) after booster vaccination
Title
hSBA antibody titers against meningococcal serogroups A, C, Y, and W
Description
Antibody titers are measured by hSBA and summarized as geometric mean titers (GMTs)
Time Frame
Day 01 and Day 31 (+14 days) after booster vaccination
Title
hSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W
Description
Antibody titers are measured by hSBA and summarized as % of participants achieving antibody titers ≥ predefined thresholds
Time Frame
Day 01 and Day 31 (+14 days) after booster vaccination
Title
Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by hSBA
Time Frame
Day 01 and Day 31 (+14 days) after booster vaccination
Title
hSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse
Description
Vaccine seroresponse, defined as follows: For a participant with a pre-vaccination titer < 1:8, a post vaccination titer ≥ 1:16 and for a participant with a pre-vaccination titer ≥ 1:8, a post vaccination titer at least 4-fold greater that the pre vaccination titer
Time Frame
Day 01 and Day 31 (+14 days) after booster vaccination
Title
Anti-tetanus antibody concentrations
Time Frame
Day 01 and Day 31 (+14 days) after booster vaccination
Secondary Outcome Measure Information:
Title
Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, Y, and W
Time Frame
Day 01 and Day 31 (+14 days) after booster vaccination
Title
rSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W
Time Frame
Day 01 and Day 31 (+14 days) after booster vaccination
Title
Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by rSBA
Time Frame
Day 01 and Day 31 (+14 days) after booster vaccination
Title
rSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse
Description
Vaccine seroresponse defined as follows: For a participant with a pre-vaccination titer < 1:8, a post vaccination titer ≥ 1:32 and for a participant with a pre-vaccination titer ≥ 1:8, a post vaccination titer at least 4-fold greater that the pre vaccination titer
Time Frame
Day 01 and Day 31 (+14 days) after booster vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 12 to 23 months on the day of inclusion Participants who are healthy as determined by medical evaluation including medical history, physical examination, and judgement of the Investigator Received at least one priming dose of licensed Nimenrix® or Menveo® vaccine during infancy before 12 months of age with an interval of at least 2 months between the last vaccination with Nimenrix® or Menveo® and the MenQuadfi® booster dose Exclusion Criteria: 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 study (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease) Personal history of Guillain-Barré syndrome Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid containing vaccine Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. Prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided Receipt of any vaccine (including COVID-19 vaccines) in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine (including COVID-19 vaccines) in the 4 weeks following the study intervention administration except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after the study intervention. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. Previous vaccination with a Meningococcal C vaccine or Meningococcal B (MenB) vaccine Receipt of immunoglobulins, blood or blood-derived products in the past 3 months Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Transparency email recommended (Toll free number for US & Canada)
Phone
800-633-1610
Ext
option 6
Email
Contact-US@sanofi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi Pasteur, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number :0320002
City
Buenos Aires
State/Province
Ciudad De Buenos Aires
ZIP/Postal Code
1430
Country
Argentina
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy

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