Clinical trial NCT05929651: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meningococcal Immunisation
Healthy Volunteers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-07-03
Enrollment: 71
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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.

Primary outcomes:
measure: hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W
timeFrame: Day 31 (+14 days) after booster vaccination
measure: Number of participants with immediate adverse events (AEs)
timeFrame: Within 30 minutes after vaccination
measure: Number of participants with solicited injection site reactions or systemic reactions
timeFrame: Within 7 days after booster vaccination
measure: Number of participants with unsolicited AEs
timeFrame: From Day 01 to Day 31 (+14 days) after booster vaccination
measure: Number of participants with serious adverse events (SAEs)
timeFrame: From Day 01 to Day 31 (+14 days) after booster vaccination
measure: hSBA antibody titers against meningococcal serogroups A, C, Y, and W
timeFrame: Day 01 and Day 31 (+14 days) after booster vaccination
measure: hSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W
timeFrame: Day 01 and Day 31 (+14 days) after booster vaccination
measure: Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by hSBA
timeFrame: Day 01 and Day 31 (+14 days) after booster vaccination
measure: hSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse
timeFrame: Day 01 and Day 31 (+14 days) after booster vaccination
measure: Anti-tetanus antibody concentrations
timeFrame: Day 01 and Day 31 (+14 days) after booster vaccination
Secondary outcomes:
measure: Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, Y, and W
timeFrame: Day 01 and Day 31 (+14 days) after booster vaccination
measure: rSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W
timeFrame: Day 01 and Day 31 (+14 days) after booster vaccination
measure: Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by rSBA
timeFrame: Day 01 and Day 31 (+14 days) after booster vaccination
measure: rSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse
timeFrame: Day 01 and Day 31 (+14 days) after booster vaccination
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320002
state: Ciudad De Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: