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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Sichuan Center For Disease Control and Prevention
RECRUITING
Chengdu
Contact Information
Primary
Xuecheng LIU
534210793@qq.com
+86 189 8195 8206
Time Frame
Start Date: 2023-09-08
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 1920
Treatments
Experimental: Experimental Group
1 dose vaccination of study vaccine
Other: Control Group
1 dose vaccination of control vaccine
Related Therapeutic Areas
Sponsors
Leads: Aimei Vacin BioPharm (Zhejiang) Co., Ltd.

This content was sourced from clinicaltrials.gov