NCT06337071

A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in People Aged 3 Months to 15 Years Old in a Randomized, Double-blind, Parallel Controlled Design

Status unknown Phase 2 Last updated 22 March 2024

What this trial tests

Phase 2 trial testing ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in Meningococcal Meningitis in 1,200 participants. Status unknown.

Timeline

20 March 2024

Primary endpoint
1 June 2024

1 June 2025

Quick facts

Lead sponsor	Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	1,200
Start date	20 March 2024
Primary completion	1 June 2024
Estimated completion	1 June 2025
Sites	1 location across China

Drugs / interventions tested

• ACYW135 Meningococcal Polysaccharide Conjugate Vaccine
• ACYW135 Meningococcal Polysaccharide Vaccine

Conditions studied

• Meningococcal Meningitis — all drugs for Meningococcal Meningitis →

Sponsor

Aimei Vacin BioPharm (Zhejiang) Co., Ltd. — full company profile →

Who can join

Adults 3 Months to 15, any sex, with Meningococcal Meningitis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Immunogenicity 1
  Time frame: 30 days after primary vaccination
  To evaluate the positive conversion rate and geometric mean titer (GMT) of meningococcal serum bactericidal activity (rSBA) antibodies for meningococcal groups A, C, Y, and W135 at 30 days in 3\~5 months old participants after primary vaccination
• Immunogenicity 2
  Time frame: 30 days after two doses vaccination
  To evaluate the positive conversion rate and geometric mean titer (GMT) of meningococcal serum bactericidal activity (rSBA) antibodies for meningococcal groups A, C, Y, and W135 at 30 days in 6\~23 months old participants after two doses vaccination
• Immunogenicity 3
  Time frame: 30 days after one dose vaccination
  To evaluate the positive conversion rate and geometric mean titer (GMT) of meningococcal serum bactericidal activity (rSBA) antibodies for meningococcal groups A, C, Y, and W135 at 30 days in 2\~15 years old participants after one dose vaccination
• Safety 1
  Time frame: 30 days after each dose vaccination
  The incidence of adverse events (AEs)/vaccination-related AEs on days 0 to 30 after each dose of immunization for subjects in each age group

Sponsor's own description

The purpose of this study was to explore the safety and immunogenicity of the experimental vaccine compared with the control vaccines. It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be randomly assigned to the trial in a 1:1 ratio to study group or control group. The 3-5 month-old group will have three doses vaccination at 0, 1 and 2 month, and a booster dose at 12 months of age; the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination; the 2-15 year-old group will have one dose vaccination.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.