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

NCT07710872 | Recruiting Phase 3

• 2 other identifiers: MEQ00093U1111-1316-0126
• Study Type: interventional
• Target: 4,568
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Meningococcal Infection; Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

• 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

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

• 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

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

• 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

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

• 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

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

• 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

  Day 91

• 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

  Day 91

• 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

  Day 151

• 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)

  Day 151

Secondary Outcomes (22)

• Number of participants with immediate adverse events (AEs)

  Within 30 minutes post-vaccination

• Presence of solicited injection site reactions

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

• Presence of solicited systemic reactions

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

• Presence of unsolicited AEs

  for 30 days including the day of each study vaccination.

• Presence of SAEs

  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

Study Arms (7)

Cohort I: Group 1MenACYW 2-dose schedule

EXPERIMENTAL

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)

Cohort I: Group 2 MenACYW135, CanSino 2-dose schedule

ACTIVE COMPARATOR

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)

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

EXPERIMENTAL

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)

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

ACTIVE COMPARATOR

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)

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

EXPERIMENTAL

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)

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

ACTIVE COMPARATOR

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)

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

EXPERIMENTAL

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

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

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

Cohort I: Group 2 MenACYW135, CanSino 2-dose schedule; Cohort II: Group 4 MenACYW135, CanSino 2-dose schedule; Cohort III: Group 6 MenACYW135, CanSino 3-dose primary vaccination + 1-dose booster schedule

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

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

Cohort I: Group 1MenACYW 2-dose schedule; Cohort II: Group 3MenACYW 2-dose primary vaccination + 1-dose booster schedule; Cohort III: Group 5 MenACYW 3-dose primary vaccination + 1-dose booster schedule; Cohort III: Group 7 MenACYW 3-dose primary vaccination + 1-dose booster schedule

Eligibility Criteria

• Age: 2 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (4)

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

MeSH Terms

Conditions

Meningococcal Infections

Interventions

CRM197 (non-toxic variant of diphtheria toxin)

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: \[Specify Complex Masking\]
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Group 7 in Cohort III will be open-label

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 17, 2026
• Study Start: August 22, 2026
• Primary Completion (Estimated): March 13, 2028
• Study Completion (Estimated): July 26, 2029
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (4)