Neihuang Center for Disease Control and Prevention
Anyang, Henan, 450016, China
NCT Number: NCT04841369
Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year.Since the licensure of PCV7 and PCV13,the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years several years is approximately 60% in Western countries.This is a single center,blind, randomized, positive-controlled clinical trial.The purpose of this study is to preliminary evaluate the safety of PCV13i vaccine in subjects at age of 7 months and above,and to investigate the safety and immunogenicity of PCV13i vaccine at age of 2 and 3 months,compared to PCV13.
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Notify Me6 week and older
All sexes
Interventional
Phase 3
Anyang, Henan, 450016, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.5mL,Intramuscular
Other names: PCV13i
0.5mL,Intramuscular
Other names: Prevnar
Time frame: Within 7 days post each vaccination
Occurance of adverse reactions in all subjects
Time frame: Within 30 days post each vaccination
Occurance of adverse reactions in all subjects
Time frame: 30 days post three doses
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
Time frame: 30 days post three doses
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
Time frame: 30 days post last dose of vaccination
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
Time frame: 30 days post vaccination
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
Time frame: 30 days post three doses
GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio
Time frame: 30 days post three doses
Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml
Time frame: 6 months post one to three doses of vaccination
Occurance of SAE in subjects of this age group
Time frame: 30 days post two doses
GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio
Time frame: 30 days post last dose of vaccination
GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio
Time frame: 30 days post two doses
Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml
Time frame: 30 days post last dose of vaccination
Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml
Time frame: 6 months post two doses
Occurance of SAE in subjects of this age group
Time frame: 6 months post last dose of vaccination
Occurance of SAE in subjects of this age group
CanSino Biologics Inc.
Industry
A Randomized,Blind, Positive-controlled Phase III Clinical Trial to Evaluate the Safety and Immunogencity of 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine(CRM197,TT) in Healthy People Aged 6 Weeks and Above
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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