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Active, Not Recruiting

NCT Number: NCT07135986

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China

This is a Phase 3, modified double-blind, randomized, parallel-group, active-controlled, multicenter study with 2 arms and 4 groups to evaluate the immunogenicity and safety of MenACYW conjugate vaccine in children and adolescents versus control meningococcal vaccines licensed in China.

Study details include:

* The study duration will be approximately 180 days. * The vaccination visit will be Visit 1. * The visit frequency will be 2 on-site visits with a 30-day interval. A safety visit/telephone call is planned on the ninth day after the vaccination for all groups; a safety follow-up telephone call is planned for all groups 180 days post the last vaccination.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Meningococcal Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Healthy Volunteers Infections Meningococcal Infections Neisseriaceae Infections

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number : 1561000, Nanning, Guangxi, China

Loading trial locations.

About this study

The duration of each participant's participation will be approximately 180 days.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For Cohort I: Aged 7 to 17 years on the day of inclusion ("7 to 17 years" means from the day of the 7th birthday to the day before the 18th birthday.). For Cohort II: Aged 2 to 6 years on the day of inclusion (2 to 6 years" means from the day of the 2nd birthday to the day before the 7th birthday.)
  • Participants who are healthy as determined by medical evaluation including medical history and physical examination.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding

Exclusion criteria

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

  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy; or long-term systemic corticosteroid therapy
  • History of meningococcal infection
  • History of any neurologic disorders
  • History of Guillain-Barré syndrome
  • History of an Arthus-type hypersensitivity reaction after a previous dose of tetanus toxoid-containing vaccine
  • At high risk for meningococcal infection during the trial
  • Known systemic hypersensitivity to any of the vaccine components
  • Self-reported thrombocytopenia, contraindicating intramuscular vaccination.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
  • Moderate or severe acute illness/infection
  • Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination.
  • The time since last vaccination of meningococcal vaccine was 2 years or less.
  • Receipt of immune globulins, 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.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

MenACYW conjugate vaccine

Biological

Pharmaceutical form:Liquid solution-Route of administration:Intramuscular (IM) injection

Other names: MenQuadfi

MenACYW135 polysaccharide vaccine

Biological

Pharmaceutical form: Lyophilized powder-Route of administration:IM injection

MenAC conjugate vaccine

Biological

Pharmaceutical form:Lyophilized powder-Route of administration:IM injection

Primary outcomes

  1. Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W

    Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)

    30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer <1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8

  2. Participants 7 through 17 years of age (Cohort I): Geometric mean titers (GMTs) of antibodies against meningococcal serogroups A, C, Y, and W

    Time frame: Day 31 (post- vaccination)

    Antibodies titers are expressed as geometric mean titers

  3. Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups W and Y will be assessed in participants receiving MenACYW conjugate vaccine

    Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)

    30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer <1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post-vaccination for participants with pre vaccination rSBA titer ≥1:8

  4. Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups A and C

    Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)

    30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer <1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8

  5. Participants 2 through 6 years of age (Cohort II): Geometric mean titers (GMTs) of antibodies against meningococcal serogroups A and C

    Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)

    Antibody titers are expressed as geometric mean titers

  6. Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups W and Y in participants receiving MenACYW conjugate vaccine

    Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)

    30 days post-vaccination rSBA titer ≥1:8 for participants with pre-vaccination rSBA titer <1:8, or At least 4-fold increase in rSBA titer from pre- to 30◦days post-vaccination for participants with pre vaccination rSBA titer ≥1:8

Secondary outcomes

  1. Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W (Group 1)

    Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)

    30 days post vaccination rSBA titer ≥1:8 for participants with pre vaccination rSBA titer <1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post vaccination for participants with pre vaccination rSBA titer ≥1:8

  2. Number of participants with immediate adverse events (AEs)

    Time frame: Within 30 minutes post-vaccination

    Unsolicited systemic AEs that occur within 30 minutes after vaccination

  3. Presence of solicited injection site reactions

    Time frame: Within 7 days post-vaccination

    Solicited injection site reactions include injection site pain, erythema and swelling

  4. Presence of solicited systemic reactions

    Time frame: Within 7 days post-vaccination

    Solicited systemic reactions include fever, headache, malaise and myalgia

  5. Presence of unsolicited AEs

    Time frame: Within 30 days post-vaccination

  6. Presence of SAEs

    Time frame: Up to Day 181 post-vaccination

    SAEs, including adverse events of special interest (AESIs), reported throughout the study

  7. Participants 7 through 17 years of age (Cohort I): Antibody titers against meningococcal serogroups A, C, Y, and W in Groups 1 and 2

    Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)

    Antibody titers measured by rSBA titer ≥1:8, ≥1:128

  8. Participants 2 through 6 years of age (Cohort II): Antibody titers against meningococcal serogroups A, C, Y, and W in Group 3 and against meningococcal serogroups A and C in Group 4

    Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)

    Antibody titers measured by rSBA titer ≥1:8, ≥1:128

  9. Participants 2 through 6 years of age (Cohort II): Antibody titers in terms of GMTs against meningococcal serogroups Y and W in Group 3

    Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)

    Antibodies titers are expressed as geometric mean titers

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Phase 3, Modified Double-blind, Multi-center Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents (2 to 17 Years of Age) in China

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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