Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, Children, and Toddlers in India and Healthy Adolescents and Children in the Republic of South Africa

NCT04143061 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: MET55U1111-1183-65812020-004341-36
• Study Type: interventional
• Target: 1,328
• Locations: 2 countries
• Sites: 17

Brief Summary

This will be a Phase III, modified double-blind (open-label for toddlers in India), randomized, parallel-group, active-controlled, step-wise, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adults, adolescents, children, and toddlers in India and a modified double-blind, randomized, parallel-group, active-controlled, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adolescents and children in RSA.

Conditions

Meningococcal Immunization; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Group 5 + 7 and Group 6 + 8: Percentage of Participants Who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W

  Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Percentages are rounded off to the tenth decimal place. As pre-specified in protocol, the endpoint was assessed in children and adolescents aged 2 to 17 years in India and RSA as combined groups: Group 5 + Group 7 and Group 6 + Group 8 as they received the same dose of MenACYW conjugate vaccine and Menactra® respectively.

  Day 30 (30 days post-vaccination on Day 0)

Secondary Outcomes (9)

• Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W

  Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

• Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W

  Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

• Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W

  Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

• Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W

  Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

• Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W

  Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

Study Arms (8)

Group 1

EXPERIMENTAL

MenACYW conjugate vaccine, 1 vaccination, adults in India aged 18 to 55 years

Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine

Group 2

ACTIVE COMPARATOR

Menactra® conjugate vaccine, 1 vaccination, adults in India aged 18 to 55 years

Biological: Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine

Group 3

EXPERIMENTAL

MenACYW conjugate vaccine, 1 vaccination, adults in India aged ≥ 56 years

Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine

Group 4

ACTIVE COMPARATOR

Quadri Meningo™, 1 vaccination, adults in India aged ≥ 56 years

Biological: Meningococcal polysaccharide (serogroups A, C, Y and W-135) vaccine

Group 5

EXPERIMENTAL

MenACYW conjugate vaccine, 1 vaccination, children and adolescents in India aged 2 to 17 years

Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine

Group 6

ACTIVE COMPARATOR

Menactra®, 1 vaccination, children and adolescents in India aged 2 to 17 years

Biological: Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine

Group 7

EXPERIMENTAL

MenACYW conjugate vaccine, 1 vaccination, children and adolescents in RSA aged 2 to 17 years

Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine

Group 8

ACTIVE COMPARATOR

Menactra®, 1 vaccination, children and adolescents in RSA aged 2 to 17 years

Biological: Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine

Interventions

Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine BIOLOGICAL

Pharmaceutical form: solution for injection; Route of administration: intramuscular, 0.5 mL

Also known as: MenACYW conjugate vaccine

Group 1; Group 3; Group 5; Group 7

Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine BIOLOGICAL

Pharmaceutical form: sterile aqueous solution; Route of administration: intramuscular, 0.5 mL

Also known as: Menactra®

Group 2; Group 6; Group 8

Meningococcal polysaccharide (serogroups A, C, Y and W-135) vaccine BIOLOGICAL

Pharmaceutical form: reconstituted solution for injection; Route of administration: intramuscular, 0.5 mL

Also known as: Quadri Meningo™

Group 4

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Z-score of ≥ -2 standard deviations (SD) on the Weight-for-height table of the World Health Organization (WHO) Child Growth Standards: For toddlers and children: Toddlers aged 12 to 23 months and Children aged 2 to 5 years had a Z-score of ≥ -2 SD on the Weight-for-height table of the WHO Child Growth Standards
• Informed consent obtained For adults: Informed consent form has been signed and dated by the subject and by an independent witness, if required by local regulations For toddlers, children, and adolescents: Assent form has been signed and dated by the subject (for subjects 7 to 17 years of age), and informed consent form has been signed and dated by the parent(s) or legally acceptable representative and by an independent witness, if required by local regulations
• Were able to attend all scheduled visits and to comply with all trial procedures For adults: Were able to attend all scheduled visits and to comply with all trial procedures For toddlers, children, and adolescents: Participants and parent / legally acceptable representative were able to attend all scheduled visits and to comply with all trial procedures
• For Toddlers: All toddlers were due to receive an age-recommended RPV on D0

You may not qualify if:

• Participant was pregnant, or lactating, or of childbearing potential and was not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile
• 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 trial investigating a vaccine, drug, medical device, or medical procedure
• Receipt of any vaccine in the 4 weeks (28 days) preceding the IMP or planned receipt of any vaccine in the 4 weeks following vaccination except for oral poliovirus vaccine (OPV) in India, received during national immunization days. In India, OPV might have been received with a gap of at least 2 weeks before the IMP. This exception included monovalent and bivalent OPV.
• Previous vaccination against meningococcal disease with either the IMP or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup containing vaccine)
• Receipt of immune globulins, blood or blood-derived products in the past 3 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 within the past 3 months)
• History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
• At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects traveling to countries with high endemic or epidemic disease)
• Known systemic hypersensitivity to latex or to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
• Verbal report of thrombocytopenia, as reported by the subject or the subject's parent / legally acceptable representative, contraindicating intramuscular vaccination in the Investigator's opinion
• Personal history of Guillain-Barré syndrome
• Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within 10 years of the proposed study vaccination
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Current alcohol abuse or drug addiction
• Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (17)

Investigational Site Number : 3560002

Bangalore, 560054, India

Location

Investigational Site Number : 3560016

Belagavi, 590002, India

Location

Investigational Site Number : 3560007

Chennai, 603203, India

Location

Investigational Site Number : 3560004

Hyderabad, 500018, India

Location

Investigational Site Number : 3560011

Kolkata, 700017, India

Location

Investigational Site Number : 3560012

Mysore, 570004, India

Location

Investigational Site Number : 3560015

Odisha, 751003, India

Location

Investigational Site Number : 3560003

Pune, 411011, India

Location

Investigational Site Number : 3560008

Pune, 411043, India

Location

Investigational Site Number : 3560010

Punjab, 141008, India

Location

Investigational Site Number : 7100004

Bertsham, 2013, South Africa

Location

Investigational Site Number : 7100007

Bloemfontein, 9301, South Africa

Location

Investigational Site Number : 7100005

Cape Town, 7505, South Africa

Location

Investigational Site Number : 7100002

Cape Town, 7937, South Africa

Location

Investigational Site Number : 7100001

Middelburg, 1055, South Africa

Location

Investigational Site Number : 7100006

Pretoria, 0002, South Africa

Location

Investigational Site Number : 7100003

Soweto, 1818, South Africa

Location

MeSH Terms

Interventions

Meningococcal Vaccines; Vaccines

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This trial is a modified double-blind trial (except for toddlers in India), which means that the participant's parent / legally acceptable representative, the Investigator, and other study personnel remain unaware of the treatment assignments throughout the trial. An unblinded vaccine administrator administer the appropriate vaccine but is not involved in safety data collection. The Sponsor and laboratory personnel performing the serology testing are also blinded to treatment assignments throughout the trial until database lock. It will be open-label for toddlers population in India.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Toddlers (open-label), children, adolescents and adults aged 12 months and above are enrolled in India, and children and adolescents aged 2 to 17 years are included in RSA. The older populations (adults) are recruited before initiating the study in children and adolescents younger than 17 years of age in India.

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: December 30, 2019
• Primary Completion: January 28, 2023
• Study Completion: January 28, 2023
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

IN (10); ZA (7)