Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1A Subjects received four doses of PCV13i at 2 months of age (At least 6 weeks old) |
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
0.5mL,Intramuscular
Other Names:
|
| Active Comparator: 1B Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old) |
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
0.5mL,Intramuscular
Other Names:
|
| Experimental: 2A Subjects received four doses of PCV13i at 3 months of age |
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
0.5mL,Intramuscular
Other Names:
|
| Experimental: 3A Subject received three doses of PCV13i at 7 to 11 months of age |
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
0.5mL,Intramuscular
Other Names:
|
| Active Comparator: 3B Subject received three doses of PCV13 at 7 to 11 months of age |
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
0.5mL,Intramuscular
Other Names:
|
| Experimental: 4A Subjects received two doses of PCV13i at 12 to 23 months of age |
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
0.5mL,Intramuscular
Other Names:
|
| Active Comparator: 4B Subjects received two doses of PCV13 at 12 to 23 months of age |
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
0.5mL,Intramuscular
Other Names:
|
| Active Comparator: 5A Subjects received one dose of PCV13i at 2 to 5 years old. |
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
0.5mL,Intramuscular
Other Names:
|
| Active Comparator: 5B Subjects received one dose of PCV13 at 2 to 5 years old. |
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
0.5mL,Intramuscular
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Safety of PCV13i in preventing pneumococcal infections [Within 7 days post each vaccination]
Occurance of adverse reactions in all subjects
- 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
- 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
Secondary Outcome Measures
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Neihuang Center for Disease Control and Prevention | Anyang | Henan | China | 450016 |
Sponsors and Collaborators
- CanSino Biologics Inc.
- Henan Center for Disease Control and Prevention
Investigators
- Principal Investigator: Shengli Xia, Henan Province Center for Disease Control and Prevention
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CS-CTP-PCV-III