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

Last updated: March 14, 2025
Sponsor: CanSino Biologics Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Meningitis

Meningococcal Infection

Treatment

MPSV4

MCV4

Clinical Study ID

NCT06700148
CTP-MCVF-010
  • Ages 7-17
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 7~17 years old at the time of screening

  • Volunteers and their legal guardians or delegates have given informed consent, havevoluntarily signed an informed consent form, are able and willing to comply with therequirements of the clinical trial protocol, and are able to complete 180 days ofstudy follow-up

  • Willingness to discuss medical history with the investigator or physician and toallow access to all medical records related to this trial

Exclusion

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 becomepregnant 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 meningococcalpodoplanoside, group Y meningococcal podoplanoside, group W135 meningococcalpodoplanoside, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphatetrihydrate, potassium dihydrogen phosphate)

  • History of epilepsy, convulsions or seizures or history or family history ofpsychiatric disorders

  • Previous severe allergic reactions due to drugs or vaccines

  • Bleeding constitution or condition associated with prolonged bleeding, which in theopinion 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 (<28days) prior to study entry and/or during study participation

  • Other conditions that, in the judgment of the investigator, make participation inthis clinical trial unsuitable

Study Design

Total Participants: 840
Treatment Group(s): 2
Primary Treatment: MPSV4
Phase: 3
Study Start date:
December 14, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Dengfeng Center for Disease Control and Prevention

    Dengfeng,
    China

    Site Not Available

  • Kaifeng Center for Disease Control and Prevention

    Kaifeng,
    China

    Site Not Available

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