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

Healthy Volunteers Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05929651
• Other study ID #: MEQ00086
• Secondary ID: U1111-1277-6838
• Status: Recruiting
• Phase: Phase 4
• Start date: September 7, 2023
• Est. completion date: August 12, 2024

Study information

• Verified date: February 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free number for US &
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Study duration is approximately 30 days (+14 days) per participant

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 12, 2024
• Est. primary completion date: April 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 23 Months

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Meningococcal Infection
• Meningococcal Infections

Intervention

Biological:
• MenACYW conjugate vaccine
Pharmaceutical form: Liquid solution Route of administration: Intramuscular (IM) injection

Locations

Country	Name	City	State
Argentina	Investigational Site Number : 0320002	Buenos Aires	Ciudad De Buenos Aires
Argentina	Investigational Site Number : 0320001	Ciudad Autonoma Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 31 (+14 days) after booster vaccination
Primary	Number of participants with immediate adverse events (AEs)	Unsolicited systemic AEs that occur within 30 minutes after vaccination	Within 30 minutes after vaccination
Primary	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	Within 7 days after booster vaccination
Primary	Number of participants with unsolicited AEs	AEs other than solicited reactions	From Day 01 to Day 31 (+14 days) after booster vaccination
Primary	Number of participants with serious adverse events (SAEs)	SAEs (including adverse events of special interest [AESIs]) reported throughout the study	From Day 01 to Day 31 (+14 days) after booster vaccination
Primary	hSBA antibody titers against meningococcal serogroups A, C, Y, and W	Antibody titers are measured by hSBA and summarized as geometric mean titers (GMTs)	Day 01 and Day 31 (+14 days) after booster vaccination
Primary	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	Day 01 and Day 31 (+14 days) after booster vaccination
Primary	Percentage of Participants who achieved =4-fold rise in antibody titers over baseline measured by hSBA		Day 01 and Day 31 (+14 days) after booster vaccination
Primary	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	Day 01 and Day 31 (+14 days) after booster vaccination
Primary	Anti-tetanus antibody concentrations		Day 01 and Day 31 (+14 days) after booster vaccination
Secondary	Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, Y, and W		Day 01 and Day 31 (+14 days) after booster vaccination
Secondary	rSBA antibody titers = several pre-defined thresholds against meningococcal serogroups A, C, Y, and W		Day 01 and Day 31 (+14 days) after booster vaccination
Secondary	Percentage of Participants who achieved =4-fold rise in antibody titers over baseline measured by rSBA		Day 01 and Day 31 (+14 days) after booster vaccination
Secondary	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	Day 01 and Day 31 (+14 days) after booster vaccination