A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2+
SponsorAimei Vacin BioPharm (Zhejiang) Co., Ltd.

About this trial

This study is a randomized, blinded, parallel controlled phase 3 clinical trial to evaluate the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in healthy people aged 2 years and above.

Eligibility criteria

Qualifiers

Healthy subjects who meet the observation age of this clinical trial (2 years old and above) and are determined based on medical history, physical examination and the researcher's judgment;

Subjects who voluntarily participate and/or the subjects' legal guardians Or the entrusted person voluntarily agrees for his or her child to participate and signs an informed consent form (subjects aged 8-17 years old must also sign an informed notification form);

The subject and/or the subject's legal guardian or principal can abide by the clinical Relevant requirements of the research protocol;

*Axillary body temperature <37.3°C on the day of enrollment. For criteria marked with an asterisk (*), if the subject has the conditions specified in the criterion, the visit can be rescheduled when they no longer have those conditions.

Disqualifiers

Previous vaccination with marketed or experimental pneumococcal vaccines;

Previous culture-confirmed history of invasive diseases caused by pneumococcal bacteria;

History or family history of convulsions, epilepsy, encephalopathy, and mental illness;

Have a history of severe allergy to any vaccination or drug in the past, be allergic to the ingredients of the experimental vaccine (mainly including pneumococcal polysaccharide, sodium dihydrogen phosphate, disodium hydrogen phosphate, and sodium chloride), and have a history of vaccination-related fever (39℃ or above );

Trial design

Treatments tested in this trial

  • 23-valent pneumococcal polysaccharide vaccine
  • control pneumococcal polysaccharide vaccine

Treatment groups

1,920 Participants
are divided into 2 treatment groups