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Active, Not Recruiting

NCT Number: NCT06700148

A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 7 to 17 Year Olds

This is a randomized, blinded, 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, afterwards some subjects entered the immune persistence group.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dengfeng Center for Disease Control and Prevention, Dengfeng, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 7~17 years old at the time of screening
  • Volunteers and their legal guardians or delegates 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 180 days of study follow-up
  • Willingness to discuss medical history with the investigator or physician and to allow access to all medical records related to this trial

Exclusion criteria

  • Fever on the day of vaccination, axillary temperature >37.0°C
  • Have a moderate or severe acute illness/infection
  • Positive urine pregnancy test for females of childbearing age, or plan to become pregnant within 30 days after vaccination
  • Current meningitis or history of meningitis
  • Allergy to certain components or excipients of the drugs used in this clinical trial (mainly including: group A meningococcal podoplanoside, group C meningococcal podoplanoside, group Y meningococcal podoplanoside, group W135 meningococcal podoplanoside, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphate trihydrate, potassium dihydrogen phosphate)
  • History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders
  • Previous severe allergic reactions due to drugs or vaccines
  • Bleeding constitution or condition associated with prolonged bleeding, which in the opinion of the investigator makes intramuscular injection contraindicated
  • Any meningococcal vaccine in the last 1 year
  • Any other vaccine within 14 days
  • Participation in other studies involving interventional studies within 28 days (<28 days) prior to study entry and/or during study participation
  • Other conditions that, in the judgment of the investigator, make participation in this clinical trial unsuitable

Treatment and study plan

MCV4

Biological

1 dose of MCV4 on Day 0

MPSV4

Biological

1 dose of MPSV4 on Day0

Primary outcomes

  1. Meningococcal Antibody Positive Conversion Rates and GMT for Groups A, C, Y, and W135 in All Subjects

    Time frame: 30 Days After Immunization

  2. Geometric Mean Titer (GMT) for Groups A, C, Y, and W135 in All Subjects

    Time frame: 30 Days after 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: Within 7 days after 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 after immunization

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

    Time frame: 30 days after immunization

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

    Time frame: 30 days after 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) for 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 7-17 Year Olds

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 21, 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.

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