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RecruitingNCT07710872Updated Sep 22, 2026

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China

A Phase 3 interventional study of MenQuadfi® (Meningococcal Polysaccharide [Serogroups A, C, W, and Y] Tetanus Toxoid Conjugate Vaccine) (Sanofi Pasteur Inc., Swiftwater, PA, USA) and Menhycia® (ACYW135 Meningococcal Conjugate Vaccine [CRM197]) (CanSino Biologics Inc., China) in Meningococcal Infection and Healthy Volunteers, sponsored by Sanofi. Recruiting at 4 sites in China. Open to participants aged 2 Months to 23 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Sanofi · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Started Aug 2026; still recruiting 1 month later.
Phase
Phase 3
Study type
Interventional
Enrollment
4,568
Allocation
Randomized
Ages
2 Months to 23 Months
Sex
All
01

Study summary

The purpose of this study is to describe the safety and immunogenicity of MenACYW conjugate vaccine compared with locally-licensed meningococcal vaccines in healthy infants and toddlers in China.

Study details include:

  • Study duration (including 6-month safety follow-up after the last dose):
  • Cohort I (Groups 1 and 2): approximately 211 or 271 days (approximately 7 or 9 months)
  • Cohort II (Groups 3 and 4): up to 18 months
  • Cohort III (Groups 5 and 6): up to 21 months
  • Cohort III (Group 7): approximately 16 months
  • Vaccination Visits Period:
  • Cohort I (Groups 1 and 2): a 2-dose vaccination at V01 (D01) and V02 (D31) or V03 (D91).

Two blood samples are collected pre-vaccination (D01) and 30 days post the 2nd dose of vaccination (D61 or D121). Telephone calls (TCs) are planned on the 4th, the 9th, and the 21st day after each vaccination, and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit for safety follow-up. For participants receiving the second vaccination with a 3-month interval: an on-site visit is planned 30 days post the 1st dose of vaccination (V02, D31) for participant diary collection.

- Cohort II (Groups 3 and 4): a 2-dose vaccination at V01 (D01) and V02 (D31) or V03 (D91). A 1-dose booster is planned for Group 3 only at 18 MoA (within the 18th month from the participant's birth date).

Up to 4 blood samples will be collected. In the primary vaccination period, blood samples are collected before the first primary vaccination (D01) and 30 days post the 2nd dose of primary vaccination (D61 or D121). A blood sample will be collected from all participants at 18 MoA. A post-booster blood sample will be collected from participants in Group 3, 30 days post their booster vaccination.

Telephone calls are planned on the 4th, the 9th, and the 21st day after each vaccination (including the booster dose), and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit of the primary and the booster vaccination periods, respectively, for safety follow-up.

For participants receiving the second vaccination with a 3-month interval: an on-site visit is planned 30 days post the 1st dose of vaccination (V02, D31) for participant diary collection.

- Cohort III - Groups 5 and 6: a 3-dose primary vaccination at V01 (D01), V02 (D31) and V03 (D61), a 1-dose booster at 12 MoA (within the 12th months from the participant's birth date) on V05 or at 18 MoA (within the 18th months from the participant's birth date) on V06.

In total 4 blood samples are to be collected. In the primary vaccination period, blood samples are to be collected before the first primary vaccination (D01) and 30 days post the 3rd dose of primary vaccination (D91); in the booster vaccination period, blood samples are to be collected before booster vaccination at V05 (for participants receiving the booster at 12 MoA) or V06 (for participants receiving the booster at 18 MoA), and 30 days post booster vaccination (V05 + 30 days or V06 + 30 days).

Telephone calls are planned on the 4th, the 9th, and the 21st day after each vaccination (including the booster dose), and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit of the primary and the booster vaccination periods respectively for safety follow-up.

- Cohort III - Group 7: a 3-dose primary vaccination at V01 (D01), V02 (D61) and V03 (D121), a 1-dose booster at V05 at 12 MoA (within the 12th months from the participant's birth date).

In total 4 blood samples are to be collected. In the primary vaccination period, blood samples are to be collected before the first primary vaccination (D01) and 30 days post the 3rd dose of primary vaccination (D151); in the booster vaccination period, blood samples are to be collected before booster vaccination at V05 and 30 days post booster vaccination (V06).

Telephone calls are planned on the 4th, the 9th, and the 21st day after each vaccination (including the booster dose), and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit of the primary and the booster vaccination periods (ie, V04 and V06), respectively, for safety follow-up. A safety visit is planned on the 9th day after the first vaccination for the ESDR participants (the first 30 participants in this group).

02

Conditions studied

  • Meningococcal Infection
  • Healthy Volunteers
03

In context

Meningococcal Infections

219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.

This study's planned enrollment of 4,568 is above the median of 450 across 190 interventional studies indexed under Meningococcal Infections.

Browse Meningococcal Infections studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 23 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • For Cohort I: Aged 12 months through 23 months on the day of inclusion. For Cohort II: Aged 6 months through 11 months on the day of inclusion. For Cohort III: Aged 2 months through 5 months on the day of inclusion
  • Born at full term of pregnancy (≥37 weeks) or born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator
  • Informed consent form has been signed and dated by the parent(s) or other LAR (and by an independent witness if required by local regulations).
  • Participant and parent/LAR are able to attend all scheduled visits and to comply with all study procedures.

Exclusion criteria

Exclusion Criteria:

  • 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 neurological 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 study
  • Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
  • Self-reported thrombocytopenia, contraindicating intramuscular injection
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
  • 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) or febrile illness (axillary temperature ≥37.5°C [99.5℉]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
  • Receipt of any live vaccines within 14 days preceding the trial vaccination or planned receipt of any live vaccines in 14 days following trial vaccination, and receipt of any inactivated vaccines in 8 days preceding the trial vaccination or planned receipt of any live vaccines in 8 days following trial vaccination
  • For Cohort I (12 to 23 MoA): receipt of any other meningococcal vaccine except the meningococcal group A polysaccharide vaccine included in the NIP. The time since last vaccination of meningococcal group A or groups A and C polysaccharide vaccine of 6 months or less should be excluded.
  • For Cohorts II (6 to 11 MoA) and III (2 to 5 MoA): a vaccination history of any meningococcal vaccine.
  • 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.
  • Participation at the time of study enrollment (or in the 4 weeks preceding the study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
  • In an emergency setting, or being hospitalized
  • Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
4,568 participants (estimated)

Study arms

  • Experimental
    Cohort I: Group 1MenACYW 2-dose schedule

    2 doses of MenACYW conjugate vaccine to participants aged 12 through 23 MoA

    Biological: MenQuadfi® (Meningococcal Polysaccharide [Serogroups A, C, W, and Y] Tetanus Toxoid Conjugate Vaccine) (Sanofi Pasteur Inc., Swiftwater, PA, USA)

  • Active comparator
    Cohort I: Group 2 MenACYW135, CanSino 2-dose schedule

    2 doses of MenACYW135, CanSino conjugate vaccine to participants aged 12 through 23 MoA

    Biological: Menhycia® (ACYW135 Meningococcal Conjugate Vaccine [CRM197]) (CanSino Biologics Inc., China)

  • Experimental
    Cohort II: Group 3MenACYW 2-dose primary vaccination + 1-dose booster schedule

    2-dose primary vaccination and 1-dose booster of MenACYW conjugate vaccine to participants aged 6 through 11 MoA

    Biological: MenQuadfi® (Meningococcal Polysaccharide [Serogroups A, C, W, and Y] Tetanus Toxoid Conjugate Vaccine) (Sanofi Pasteur Inc., Swiftwater, PA, USA)

  • Active comparator
    Cohort II: Group 4 MenACYW135, CanSino 2-dose schedule

    2-dose primary vaccination and 1-dose booster of MenACYW135, CanSino conjugate vaccine to participants aged 6 through 11 MoA

    Biological: Menhycia® (ACYW135 Meningococcal Conjugate Vaccine [CRM197]) (CanSino Biologics Inc., China)

  • Experimental
    Cohort III: Group 5 MenACYW 3-dose primary vaccination + 1-dose booster schedule

    3-dose primary vaccination and 1-dose booster of MenACYW conjugate vaccine to participants aged 3 through 5 MoA

    Biological: MenQuadfi® (Meningococcal Polysaccharide [Serogroups A, C, W, and Y] Tetanus Toxoid Conjugate Vaccine) (Sanofi Pasteur Inc., Swiftwater, PA, USA)

  • Active comparator
    Cohort III: Group 6 MenACYW135, CanSino 3-dose primary vaccination + 1-dose booster schedule

    3-dose primary vaccination and 1-dose booster of MenACYW135, CanSino conjugate vaccine to participants aged 3 through 5 MoA

    Biological: Menhycia® (ACYW135 Meningococcal Conjugate Vaccine [CRM197]) (CanSino Biologics Inc., China)

  • Experimental
    Cohort III: Group 7 MenACYW 3-dose primary vaccination + 1-dose booster schedule

    3-dose primary vaccination and 1-dose booster of MenACYW conjugate vaccine to participants aged 2 MoA

    Biological: MenQuadfi® (Meningococcal Polysaccharide [Serogroups A, C, W, and Y] Tetanus Toxoid Conjugate Vaccine) (Sanofi Pasteur Inc., Swiftwater, PA, USA)

Interventions

  • BiologicalMenQuadfi® (Meningococcal Polysaccharide [Serogroups A, C, W, and Y] Tetanus Toxoid Conjugate Vaccine) (Sanofi Pasteur Inc., Swiftwater, PA, USA)

    Pharmaceutical form:Liquid solution-Route of administration:IM injection

  • BiologicalMenhycia® (ACYW135 Meningococcal Conjugate Vaccine [CRM197]) (CanSino Biologics Inc., China)

    Pharmaceutical form:Lyophilized powder (MenAC conjugate vaccine) and liquid solution (MenYW135 conjugate vaccine)-Route of administration:IM injection

06

What researchers measure

Primary outcomes

  1. Participants 12 through 23 MoA (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W

    30 days post-2nd 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-2nd vaccination for participants with pre-vaccination rSBA titer ≥1:8

    Time frame: 30 days post 2nd vaccination (up to Day 121)

  2. Participants 12 through 23 MoA (Cohort I): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W measured by rSBA

    30 days (+10 days) post-2nd vaccination with MenACYW conjugate vaccine or MenACYW135, CanSino conjugated vaccine

    Time frame: 30 days post 2nd vaccination (up to Day 121)

  3. Participants 6 through 11 MoA (Cohort II): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W

    30 days post-2nd 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-2nd vaccination for participants with pre-vaccination rSBA titer ≥1:8

    Time frame: 30 days post 2nd vaccination (up to Day 121)

  4. Participants 6 through 11 MoA (Cohort II): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA

    30 days (+10 days) post-2nd vaccination of the primary series with MenACYW conjugate vaccine or MenACYW135, CanSino conjugated vaccine

    Time frame: 30 days post 2nd vaccination (up to Day 121)

  5. Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W

    30 days post-3rd 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-3rd vaccination for participants with pre-vaccination rSBA titer ≥1:8

    Time frame: Day 91

  6. Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA

    30 days (+10 days) post-3rd vaccination of the primary series with MenACYW conjugate vaccine or MenACYW135, CanSino conjugate vaccine

    Time frame: Day 91

  7. Participants 2 through 5 MoA (Cohort III - Groups 7 and 6): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W

    30 days post-3rd 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-3rd vaccination for participants with pre-vaccination rSBA titer ≥1:8

    Time frame: Day 151

  8. Participants 2 through 5 MoA (Cohort III - Groups 7 and 6): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA

    30 days (+10 days) post-3rd vaccination of the primary series with MenACYW conjugate vaccine (Group 7) or MenACYW135, CanSino conjugate vaccine (Group 6)

    Time frame: Day 151

Secondary outcomes

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

    Unsolicited systemic AEs that occur within 30 minutes after vaccination

    Time frame: Within 30 minutes post-vaccination

  2. Presence of solicited injection site reactions

    (pre-listed in the participant diary and CRF)

    Time frame: for 8 days, including the day of each study vaccination.

  3. Presence of solicited systemic reactions

    (pre-listed in the participant diary and CRF)

    Time frame: for 8 days, including the day of each study vaccination.

  4. Presence of unsolicited AEs

    Time frame: for 30 days including the day of each study vaccination.

  5. Presence of SAEs

    Time frame: Approximately 7 months to 9 months for Group 1 and Group 2; up to 18 months for participants from Group 3 and Group 4; up to 21◦months for participants from Group 5 and Group 6; Approximately 16 months for participants from Group 7

  6. Presence of AEs leading to study discontinuation

    Time frame: Approximately 7 months to 9 months for Group 1 and Group 2; up to 18 months for participants from Group 3 and Group 4; up to 21◦months for participants from Group 5 and Group 6; Approximately 16 months for participants from Group 7

  7. Participants 12 through 23 MoA (Cohort I) Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W measured by rSBA 30 days (+10 days) post-2nd vaccination with MenACYW conjugate vaccine or MenACYW135, CanSino conjugate vaccine.

    Time frame: 30 days post 2nd vaccination (up to Day 121)

  8. Participants 6 through 11 MoA (Cohort II) Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W measured by rSBA

    30 days (+10 days) post-2nd vaccination of the primary series with MenACYW conjugate vaccine or MenACYW135, CanSino conjugated vaccine.

    Time frame: 30 days post 2nd vaccination (up to Day 121)

  9. Participants 6 through 11 MoA (Cohort II) Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA pre-booster dose at 18 MoA.

    Time frame: at 18 MoA (up to Day 394)

  10. Participants 6 through 11 MoA (Cohort II) Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W measured by rSBA pre-booster dose at 18 MoA

    Time frame: at 18 MoA (up to Day 394)

  11. Participants 6 through 11 MoA (Cohort II) Antibody titers (in terms of GMTs) against booster meningococcal serogroups A, C, Y, and W, measured by rSBA 30 days (+10 days) post-booster vaccination with MenACYW conjugate vaccine given at 18 MoA.

    Time frame: at 18 MoA (up to Day 424)

  12. Participants 6 through 11 MoA (Cohort II) Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W measured by rSBA 30 days (+10 days) after one dose of booster vaccination of MenACYW conjugate vaccine

    Time frame: at 18 MoA (up to Day 424)

  13. Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W measured by rSBA

    30 days (+10 days) post-3rd vaccination of the primary series with MenACYW conjugate vaccine or MenACYW135, CanSino conjugate vaccine.

    Time frame: D91

  14. Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA

    pre-booster dose at 12 and 18 MoA with MenACYW conjugate vaccine or MenACYW135, CanSino conjugate vaccine

    Time frame: at 12 and 18 MoA (up to Day 484)

  15. Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W, measured by rSBA

    pre-booster dose at 12 and 18 MoA with MenACYW conjugate vaccine or MenACYW135, CanSino conjugate vaccine

    Time frame: at 12 and 18 MoA (up to Day 484)

  16. Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA

    30 days (+10 days) post-booster vaccination at 12 and 18 MoA with MenACYW conjugate vaccine or MenACYW135, CanSino conjugate vaccine

    Time frame: 30 days after 12 and 18 MoA (up to Day 514)

  17. Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W, measured by rSBA

    30 days (+10 days) post-booster vaccination at 12 and 18 MoA with MenACYW conjugate vaccine or MenACYW135, CanSino conjugate vaccine

    Time frame: 30 days after 12 and 18 MoA (up to Day 514)

  18. Participants 2 MoA (Cohort III - Group 7): Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W measured by rSBA 30 days (+10 days) post-3rd vaccination of the primary series with MenACYW conjugate vaccine (Group 7).

    Time frame: D151

  19. Participants 2 MoA (Cohort III - Group 7): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA pre-booster dose at 12 MoA (Group 7) with MenACYW conjugate vaccine

    Time frame: at 12 MoA (up to Day 333)

  20. Participants 2 MoA (Cohort III - Group 7): Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W, measured by rSBA pre-booster dose at 12 MoA (Group 7) with MenACYW conjugate vaccine

    Time frame: at 12 MoA (up to Day 333)

  21. Participants 2 MoA (Cohort III - Group 7): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA 30 days (+10 days) post-booster vaccination with MenACYW conjugate vaccine at 12 MoA (Group 7)

    Time frame: 30 days after 12 MoA (up to Day 363)

  22. Participants 2 MoA (Cohort III - Group 7): Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W, measured by rSBA 30 days (+10 days) post-booster vaccination with MenACYW conjugate vaccine at 12 MoA (Group 7)

    Time frame: 30 days after 12 MoA (up to Day 363)

07

Study locations

4 of 4 sites recruiting
  • Investigational Site Number : 1561001
    Jingxi, 533899, China
    Recruiting
  • Investigational Site Number : 1561003
    Liuzhou, 545100, China
    Recruiting
  • Investigational Site Number : 1561000
    Nanning, NaN, China
    Recruiting
  • Investigational Site Number : 1561002
    Tengzhou Town, 543399, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07710872
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Jul 17, 2026
Start date
Aug 22, 2026
Primary completion
Mar 13, 2028 (estimated)
Completion
Jul 26, 2029 (estimated)
Last update
Sep 22, 2026

Study contacts

Trial Transparency email recommended (Toll free for US & Canada)
Contact
Contact-US@sanofi.com
800-633-1610 ext. option 6

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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