UnknownPhase 3

A Phase III Clinical Trial of the Group A and C Meningococcal Polysaccharide Vaccine

China1,280 participantsStarted 2020-09-15

Plain-language summary

This study is a randomized, double-blinded, and controlled phase III clinical trial of the Group A and C meningococcal polysaccharide vaccine to evaluate the safety and immunogenicity of the vaccine in healthy infants aged 2-6 years.

Who can participate

Age range2 Years – 50 Years

SexALL

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Inclusion criteria

✓. Healthy adults aged 18 to 50 years.
✓. Proven legal identity.
✓. Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
✓. Participants should be able to communicate well with investigators, understand and comply with the requirements of this trial.
✓. Axillary temperature ≤37.0℃.

Exclusion criteria

✕. Contraindications for vaccination.
✕. History of allergy to vaccines or drugs.
✕. History of Epidemic Cerebrospinal Meningitis.
✕. Immunization with any Group A meningococcal conjugate vaccine or polysaccharide vaccine within 12 months.
✕. Immunization with any Group A and C meningococcal conjugate vaccine or polysaccharide vaccine within 3 years.
✕. Immunization with any vaccine within 30 days.
✕. Patients with convulsion, epilepsy, encephalopathy and psychiatric history or family history of epilepsy.
✕. History of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors.

What they're measuring

Seroconversion rate of Group A meningococcal bactericidal antibody

Timeframe: 28 days after vaccination

Seroconversion rate of Group C meningococcal bactericidal antibody

Timeframe: 28 days after vaccination

Trial details

NCT IDNCT04689191

SponsorWei Cun

Sponsor typeUNKNOWN

Study typeINTERVENTIONAL

Primary completion2021-05

Contact for this trial

Wei Cun, Doctor

+86-13629464497 cunwei@foxmail.com

View on ClinicalTrials.gov More Meningitis, Meningococcal trials