Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06226714

A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 18-59 Year Olds

This is a randomized, observer-blind, peer-controlled study. There will be 2 treatment groups, screened subjects were given study numbers in the order of enrollment and randomly assigned to the test and control groups in a 1:1 ratio. Subjects were required to complete a 1-dose immunization program with 0.5 ml of vaccine in both the test and control groups.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jiangjin District Center for Disease Control and Prevention, Chongqing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18~59 years old at the time of screening.
  • Should not have received any meningococcal vaccine in the last 3 years.
  • Volunteers have given informed consent, have voluntarily signed an informed consent form, are able and willing to comply with the requirements of the clinical trial protocol, and are able to complete the 180-day study follow-up visit.
  • Volunteers have given informed consent, have voluntarily signed an informed consent form, are able and willing to comply with the requirements of the clinical trial protocol, and are able to complete the 180-day study follow-up visit.
  • Willingness to discuss medical history with the investigator or physician and to allow access to all medical records relevant to this trial.

Exclusion criteria

  • Fever before vaccination, axillary temperature >37.0°C.
  • History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders.
  • Volunteers with current meningitis or a history of meningitis.
  • Blood pregnancy-positive or breastfeeding women with a planned pregnancy within 180 days of the volunteer or her partner.
  • Hypersensitivity to an ingredient or excipient of the medicinal product used in this clinical trial (mainly: group A meningococcal podophyllotoxin, group C meningococcal podophyllotoxin, group Y meningococcal podophyllotoxin, group W135 meningococcal podophyllotoxin, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphate trihydrate, potassium dihydrogen phosphate).
  • Severe hypertension uncontrolled by medication (at on-site measurement: systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg).
  • Previous vaccination-related hospitalizations or emergencies.
  • Bleeding constitution or condition associated with prolonged bleeding that investigators consider contraindicated for intramuscular injection.
  • Other vaccinations within 14 days.
  • Participation in other studies involving interventional studies within 28 days prior to study entry (<28 days) and/or during study participation.
  • Other circumstances that, in the judgment of the investigator, make participation in this clinical trial inappropriate.

Treatment and study plan

MCV4

Biological

1 dose of MCV4 on Day 0

MPSV4

Biological

1 dose of MSPV4 on Day 0

Primary outcomes

  1. Meningococcal antibody positive conversion rates for groups A, C, Y, and W135 in all subjects

    Time frame: 30 days post immunization

  2. Geometric mean titer (GMT) of antibodies to groups A, C, Y, and W135 in all subjects

    Time frame: 30 days post immunization

  3. Incidence of adverse reactions in all subjects

    Time frame: Within 30 mins after immunization

  4. Incidence of adverse reactions/events in all subjects

    Time frame: 7 days post immunization

  5. Incidence of adverse reactions/events in all subjects

    Time frame: Within 30 days after immunization

Secondary outcomes

  1. Meningococcal antibody positivity for groups A, C, Y, and W135

    Time frame: 30 days post immunization

  2. Geometric mean multiplicity (GMI) of increase for groups A, C, Y, and W135

    Time frame: 30 days post immunization

  3. Antibody titer ≥1:128 ratio for groups A, C, Y, and W135

    Time frame: 30 days post immunization

  4. Meningococcal antibody positivity for groups A, C, Y, and W135 in selected subjects

    Time frame: 180 days after immunization

  5. GMT for groups A, C, Y, and W135 in selected subjects

    Time frame: 180 days after immunization

  6. GMI for groups A, C, Y, and W135 in selected subjects

    Time frame: 180 days after immunization

  7. Antibody titer ≥1:128 ratio for groups A, C, Y, and W135 in selected subjects

    Time frame: 180 days after immunization

  8. Incidence of serious adverse events (SAEs) in all subjects

    Time frame: Within 180 days after immunization

  9. Incidence of pregnancy events in all subjects

    Time frame: Within 180 days after immunization

Sponsors and collaborators

Lead sponsor

CanSino Biologics Inc.

Industry

Registry information

Official study title

A Randomized, Blinded, Peer-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in a Population Aged 18-59 Years

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jan 26, 2024
Registry last updated
Jul 29, 2025

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.

Published trials that share one or more normalized conditions with this study.