A Clinical Trial to Evaluate the Immunogenicity and Safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in Adults Aged 18 to 55 Years

NCT06131554 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: CTP-MCVF-006
• Study Type: interventional
• Target: 1,480
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blinded, positive controlled study to evaluate the lot-to-lot consistency, immunogenicity and safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in adults aged 18 to 55 years. Subjects will be randomized to receive investigational Lot 1, Lot 2, Lot 3 vaccine or control vaccine in a 1:1:1:1 ratio, with the subjects in experimental group randomly and equally assigned to three different batches of MCV4 for single-dose vaccination.

Conditions

Meningococcal Meningitis

Keywords

Vaccine; Positive controlled; Immunogenicity; Safety; 18-55 years

Outcome Measures

Primary Outcomes (3)

• The geometric mean titer (GMT) of serogroup A, C, Y and W135 meningococcal rSBA titer in all participants.

  Day 30 post vaccination

• The seroconversion rate of serogroup A, C, Y, and W135 meningococcal rSBA titer.

  Day 30 post vaccination

• The incidence of adverse reactions (ARs) in all participants.

  Within 7 days post vaccination

Secondary Outcomes (8)

• The geometric mean fold increase (GMI) of serogroup A, C, Y and W135 meningococcal rSBA titer in all participants.

  Day 30 post vaccination

• The proportion of GMT ≥ 1:128 of serogroup A, C, Y and W135 meningococcal rSBA titer on day 30 post vaccination in all participants.

  Day 30 post vaccination

• The incidence of ARs and adverse events (AEs) in all participants.

  Within 30 days post vaccination

• The incidence of ARs in all participants.

  Within 30 min post vaccination

• The incidence of serious adverse events (SAEs) in all participants.

  Within 365 days post vaccination

Study Arms (4)

batch 1 of MCV4

EXPERIMENTAL

1 dose of Menhycia on Day 0

Biological: batch 1 of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) (MCV4)

batch 2 of MCV4

EXPERIMENTAL

1 dose of Menhycia on Day 0

Biological: batch 2 of MCV4

batch 3 of MCV4

EXPERIMENTAL

1 dose of Menhycia on Day 0

Biological: batch 3 of MCV4

Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

ACTIVE COMPARATOR

1 dose of Menactra on Day 0

Biological: Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Interventions

batch 1 of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) (MCV4) BIOLOGICAL

1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection

Also known as: Menhycia

batch 1 of MCV4

batch 2 of MCV4 BIOLOGICAL

1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection

Also known as: Menhycia

batch 2 of MCV4

batch 3 of MCV4 BIOLOGICAL

1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection

Also known as: Menhycia

batch 3 of MCV4

Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine BIOLOGICAL

1 dose of Menactra (0.5ml) on Day 0, Intramuscular injection

Also known as: Menactra

Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants aged 18-55 years old at the time of screening, who are in good health condition as determined by the study clinician.
• Participants who have not been vaccinated with any meningococcal vaccines (including but not limited to meningococcal group A and C conjugate vaccine, meningococcal group A and C polysaccharide vaccine, Group ACYW135 Meningococcal polysaccharide/conjugate vaccine).
• The participant or participant's legal guardian signs the informed consent form (ICF) and participant agrees to comply with the requirements of protocol and finish the 1-year follow-up.
• Participants who are willing to discuss medical history with investigators or doctors and allow access to all medical records relevant to this trial.
• Participants with child-bearing potential who are willing to practice adequate contraception methods from signing the ICF to 12 months after vaccination. This includes:
• Abstinence from penile-vaginal intercourse,
• Hormonal contraceptives such as oral contraceptives (the pill), injectables, implants, patches or estrogen vaginal ring (a ring-shaped hormonal contraceptive device that is used inside the vagina),
• Intrauterine device (IUD/Spiral),
• Male partner sterilization (vasectomy) prior to the female subject's entry into the study, and this male is the sole partner for that subject,
• Male condom combined with a vaginal spermicide (a substance that can kill the sperm cells inside the vagina) or female diaphragm, whether with or without a vaginal spermicide .
• Be able to communicate well with the investigator, and to understand and comply with the requirements of this clinical trial.

You may not qualify if:

• Axillary temperature \>37.5°C (99°F).
• Have congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
• A history of epilepsy, convulsions or history/family history of mental illness.
• Have meningitis or a history of meningitis illness.
• Positive result of urine pregnancy test (also required for women within one year of menopause), lactating women, or participant /his partner is planning to become pregnant within 1 year.
• Hypersensitivity to a component or excipient of the vaccine used in this clinical trial (mainly: group A, C, Y or W135 meningococcal capsular polysaccharide, diphtheria toxoid or diphtheria antigen, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphate trihydrate, potassium dihydrogen phosphate).
• In the past 6 months (internal time \< 6 months), participants have received immunosuppressive treatment, cytotoxic treatment, glucocorticoid treatment, etc. (excluding local treatment, surface treatment of acute non-concurrent dermatitis, spray treatment of allergic rhinitis).
• Received or plan to receive blood/plasma products or immunoglobulins throughout the study period or 60 days prior to study vaccination.
• Use of non-prescription drugs such as antipyretic (e.g., acetaminophen) and anti-inflammatory drugs (e.g., ibuprofen, naproxen etc.) within 12 hours before the administration of vaccine.
• Have severe hypertension that is not controlled by medication (at the time of field measurement: systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg).
• Suffering from a severe chronic disease or a condition that is in a progressive stage and cannot be well controlled, such as thyroid disease
• Participants with known or suspected diseases that are judged by the investigator to affect the vaccination assessment, for example, acute infectious diseases, severe respiratory disease, severe cardiovascular disease, severe allergic skin disease etc.
• History of serious adverse reactions associated with the vaccine and/or history of severe allergic reactions (e.g., systemic allergic reactions) to any component of the study vaccine.
• Immunocompromised individuals with known or suspected immunodeficiency as determined by medical history and/or physical examination (e.g., HIV infection, history of pancreatic, liver, spleen, kidney disease or history of resection).
• Positive for HIV, Hepatitis B, Hepatitis C or Syphilis.

Sponsors & Collaborators

• CanSino Biologics Inc.: lead

Study Sites (1)

Husada Utama Hospital

Surabaya, 60131, Indonesia

Location

MeSH Terms

Conditions

Meningitis, Meningococcal

Interventions

CRM197 (non-toxic variant of diphtheria toxin); Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Isti Suharjanti, Dr

  Husada Utama Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: March 20, 2024
• Primary Completion: July 12, 2024
• Study Completion: December 1, 2025
• Last Updated: April 3, 2025

Record last verified: 2024-08

Locations

ID (1)