A Phase 3 interventional study of 23-valent pneumococcal polysaccharide vaccine and control pneumococcal polysaccharide vaccine in Pneumococcal Disease, sponsored by Aimei Vacin BioPharm (Zhejiang) Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Aimei Vacin BioPharm (Zhejiang) Co., Ltd. · Phase 3, Interventional, and Prevention
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.
281 studies on the registry are indexed under Pneumococcal Infections; 27 are open to participants now.
This study's planned enrollment of 1,920 is above the median of 379 across 230 interventional studies indexed under Pneumococcal Infections.
Browse Pneumococcal Infections studies →Aimei Vacin BioPharm (Zhejiang) Co., Ltd. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
1 dose vaccination of study vaccine
Biological: 23-valent pneumococcal polysaccharide vaccine
1 dose vaccination of control vaccine
Biological: control pneumococcal polysaccharide vaccine
23-valent pneumococcal polysaccharide vaccine from Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
23-valent pneumococcal polysaccharide vaccine from Merck Sharp \& Dohme Corp
2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination,
2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination,
Time frame: 30 days
Geometric mean concentration (GMC) of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination
Geometric mean concentration (GMC) of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination
Time frame: 30 days
Incidence of adverse reactions/events within 30 minutes of vaccination
Incidence of adverse reactions/events within 30 minutes of vaccination
Time frame: 30 min after vaccination
Incidence of adverse reactions/events on days 0 to 7 after vaccination
Incidence of adverse reactions/events on days 0 to 7 after vaccination
Time frame: 7 days
Incidence of adverse reaction/event on days 0 to 30 after vaccination
Incidence of adverse reaction/event on days 0 to 30 after vaccination
Time frame: 30 days
Incidence of serious adverse events (SAE) within 6 months after vaccination
Incidence of serious adverse events (SAE) within 6 months after vaccination
Time frame: 6 months
Geometric mean fold increase (GMFI) of IgG antibodies against 23 pneumococcal serotypes 30 days after vaccination
Geometric mean fold increase (GMFI) of IgG antibodies against 23 pneumococcal serotypes 30 days after vaccination
Time frame: 30 days
GMC of 23 pneumococcal serotype IgG antibodies in the 3rd and 6th year after vaccination
GMC of 23 pneumococcal serotype IgG antibodies in the 3rd and 6th year after vaccination
Time frame: 3, 6 years after vaccination
The proportion of subjects with ≥0.35ug/mL IgG antibodies to 23 pneumococcal serotypes 30 days after vaccination,
The proportion of subjects with ≥0.35ug/mL IgG antibodies to 23 pneumococcal serotypes 30 days after vaccination,
Time frame: 30 days
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Aimei Vacin BioPharm (Zhejiang) Co., Ltd.