Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i)
- Conditions
- Pneumococcal InfectionsBacterial InfectionsStreptococcal Infections
- Interventions
- Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
- Registration Number
- NCT04841369
- Lead Sponsor
- CanSino Biologics Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3420
- Healthy subjects of 2 months (minimum 6 weeks), 3 months , 7 months and above;
- Willing to provide proof of identity;
- Without vaccination history of pneumococcal vaccine;
- None-pregnancy or do not plan to pregnancy recently;;
- Volunteers of 18 years old and above who have the ability to understand clinical studie progress and sign informed consent;
- Volunteers of 8-17 years old and their guardians who willing sign informed consent;
- Able to understand and sign the informed consent by their guardians or trustees for the volunteers of 8 years old and below;
- Able and willing comply with the requirements of the protocol
- Volunteers whose axillary body temperature was >37.0# before vaccination
- Volunteers who suffered from Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc;
- Volunteers who has a history of epilepsy, convulsions or psychosis;
- Allergic person;
- Any prior administration of blood products in last 3 month;
- Any prior administration of other research medicines in last 1 month;
- Plans to participate in or is participating in any other drug clinical study;
- Any prior administration of attenuated live vaccine in last 14 days;
- Any prior administration of subunit or inactivated vaccines in last 7 days;
- Had fever before vaccination, Volunteers with temperature >37.0°C on axillary setting;
- According to the investigator's judgement, the subjects have any other factors that make them unfit to enroll the clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1A 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） Subjects received four doses of PCV13i at 2 months of age (At least 6 weeks old) 4A 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） Subjects received two doses of PCV13i at 12 to 23 months of age 5A 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） Subjects received one dose of PCV13i at 2 to 5 years old. 3A 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） Subject received three doses of PCV13i at 7 to 11 months of age 4B 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine Subjects received two doses of PCV13 at 12 to 23 months of age 5B 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine Subjects received one dose of PCV13 at 2 to 5 years old. 3B 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine Subject received three doses of PCV13 at 7 to 11 months of age 1B 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old) 2A 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） Subjects received four doses of PCV13i at 3 months of age
- Primary Outcome Measures
Name Time Method Immunogenicity of PCV13i in subjects of age 50 years old and above (Arm 6A, 6B, 7A, 7B) 30 days post vaccination Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
Safety of PCV13i in preventing pneumococcal infections Within 30 days post each vaccination Occurance of adverse reactions in all subjects
Immunogenicity of PCV13i in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B) 30 days post three doses Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
Immunogenicity of PCV13i in subjects of 7 to 11 months old (Arm 4A-4B) 30 days post three doses Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
Immunogenicity of PCV13i in subjects of 12 months to 5 years old (Arm 5A, 5B, 6A, 6B) 30 days post last dose of vaccination Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
- Secondary Outcome Measures
Name Time Method Immuogenicity in terms of GMT in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B) 30 days post last dose of vaccination GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio
Safety of PCV13i in terms of SAE in subjects of 7 to 11 months old (Arm 3A-3B) 6 months post two doses Occurance of SAE in subjects of this age group
Safety of PCV13i in terms of SAE in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B) 6 months post last dose of vaccination Occurance of SAE in subjects of this age group
Immuogenicity in terms of GMT in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B) 30 days post three doses GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio
Safety of PCV13i in terms of in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B) 6 months post one to three doses of vaccination Occurance of SAE in subjects of this age group
Immunogenicity in terms of IgG concentration in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B) 30 days post last dose of vaccination Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml
Immunogenicity in terms of IgG concentration in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B) 30 days post three doses Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml
Immuogenicity in terms of GMT in subjects of 7 to 11 months old (Arm 3A-3B) 30 days post two doses GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio
Immunogenicity in terms of IgG concentration in subjects of 7 to 11 months old (Arm 3A-3B) 30 days post two doses Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml
Trial Locations
- Locations (1)
Neihuang Center for Disease Control and Prevention
🇨🇳Anyang, Henan, China