Study on a MenACYW Conjugate Vaccine Administered as a Single Dose in Participants Aged 12 Months and Older in Vietnam

Phase 3

Completed

Conditions: Meningococcal Infection
Healthy Volunteers

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

Registration Number: NCT06228586

Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary: The MEQ00074 study was a Phase III, open-label, single-center study aimed at describing the immunogenicity and safety of a single dose of investigational quadrivalent Meningococcal Polysaccharide (serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine (MenACYW conjugate vaccine) in participants aged 12 months and older in Vietnam.

The primary objectives of the study were:

* To describe the antibody responses to meningococcal serogroups A, C, W, and Y before and 30 days after the administration of a single dose of MenACYW conjugate vaccine

* To describe the safety profile of a single dose of MenACYW conjugate vaccine The duration of each participant's participation will be approximately 30 to 44 days.

Detailed Description: The duration of each participant's participation was approximately 30 to 44 days.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 447

Inclusion Criteria

- Aged 12 months and above on the day of inclusion

Adults:

Aged 18 and above on the day of inclusion
A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies:
- Was of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile.
- OR Was of childbearing potential and agreed to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration.

A female participant of childbearing potential would have a negative highly sensitive pregnancy test (urine) within 1 week before the dose of study intervention.

Informed consent form was signed and dated
Was able to attend all scheduled visits and to comply with all study procedures

Adolescents:

Aged 10 to 17 years on the day of inclusion
A female participant was eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
- Was of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche.
- OR Was of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration.

A female participant of childbearing potential would have a negative highly sensitive pregnancy test (urine) within 1 week before the dose of study intervention.

Informed consent form was signed and dated by both the participant and the parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations Assent form was signed and dated by the participant (assent form required for participants aged 12 to 15 years) or verbal consent was obtained (for participants aged 10 to 11 years), and informed consent form was signed and dated by the parent(s) or another 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 study procedures

Children:

Aged 2 to 9 years on the day of inclusion
Verbal consent was obtained (for participants aged 7 to 9 years), and informed consent form was signed and dated by the parent(s) or another 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 study procedures

Toddlers

Aged 12 to 23 months on the day of inclusion
Informed consent form has 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 are able to attend all scheduled visits and to comply with all study procedures

Exclusion Criteria

Participants were excluded from the study if any of the following criteria apply:

Adults (aged 18 years and above), Adolescents (aged 10 to 17 years), Children (aged 2 to 9 years) and Toddlers (aged 12 to 23 months)

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 study investigating a vaccine, drug, medical device, or medical procedure
Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 4 weeks following study intervention administration except for influenza vaccination, which may be received at least 2 weeks before or after study vaccine. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y; or meningococcal B serogroup-containing vaccine)
Receipt of immune globulins, blood or blood-derived products in the past 3 months
History of any N. meningitidis infection, confirmed either clinically, serologically, or microbiologically
At high risk for meningococcal disease 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)
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
Personal history of Guillain-Barré syndrome (GBS)
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥ 37.5 C) or hypothermia (axillary temperature ≤ 35.5 C) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw

Adults (aged 18 years and above) and Adolescents (aged 10 to 17 years)

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)
Personal history of an Arthus-like reaction after vaccination with a tetanus toxoidcontaining vaccine within at least 10 years of the proposed study vaccination
Self-reported thrombocytopenia, contraindicating intramuscular injection
Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study

Children (aged 2 to 9 years)

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)
Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
Thrombocytopenia as reported by the parent/legally acceptable representative, or suspected thrombocytopenia contraindicating intramuscular injection
Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study

Toddlers (aged 12 to 23 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 (prednisone or equivalent for more than 2 consecutive weeks since birth)
Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
Thrombocytopenia as reported by the parent/legally acceptable representative, or suspected thrombocytopenia contraindicating intramuscular injection
Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MenACYW conjugate vaccine	Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine	MenACYW conjugate vaccine single injection on Day 01

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W	Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)	Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay utilizing the human complement (hSBA).
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=4-Fold Rise From Pre-Vaccination to Post-Vaccination	Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)	Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured by hSBA. Percentages are rounded off to the tenth decimal place.
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8	Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)	Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured by hSBA. Percentages are rounded off to the tenth decimal place.
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Vaccine Seroresponse for Serogroups A, C, Y, and W	Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)	Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured by hSBA. hSBA vaccine seroresponse was defined as follows: for a participant with a pre-vaccination titer \<1:8, the post-vaccination titer must be \>=1:16, and for a participant with a pre-vaccination titer \>=1:8, the post-vaccination titer must be at least 4-fold greater than the pre-vaccination titer. Percentages are rounded off to the tenth decimal place.
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)	Up to 30 minutes post-vaccination on Day 1	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. Immediate events were recorded to capture medically relevant unsolicited systemic AEs (including those related to the study vaccine administered) which occurred within the first 30 minutes after vaccination.
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions	From the study vaccine administration (Day 1) up to 7 days post-vaccination, up to Day 8	A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site considered to be related to the study vaccine administered and were commonly inflammatory reactions. Systemic ARs were all ARs that were not injection site reactions and included systemic manifestations such as headache, fever, as well as localized or topical manifestations.
Number of Participants With Unsolicited Non-Serious Adverse Events	From the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	From the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An SAE was any AE that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was other medically important event. An AESI (serious or non-serious) was one of scientific and medical concern specific to the Sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor was appropriate.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (4): Investigational Site Number : 7040001
🇻🇳
Hanoi, Vietnam
Investigational Site Number : 7040002
🇻🇳
Thái Bình, Vietnam
Investigational Site Number : 7040003
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Thái Bình, Vietnam
Investigational Site Number : 7040004
🇻🇳
Thái Bình, Vietnam
Investigational Site Number : 7040001
🇻🇳Hanoi, Vietnam