Pneumococcal Infections, Streptococcal Infections, Bacterial Infections
Conditions
Keywords
PCV13, 13 valent Pneumococcal conjugate vaccine, Pneumococcal Infections, Safety, Immunogenicity
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.
Interventions
0.5mL,Intramuscular
0.5mL,Intramuscular
Sponsors
Henan Center for Disease Control and Prevention
CanSino Biologics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of PCV13i in preventing pneumococcal infections | Within 7 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
| 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 |
| 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 |
Countries
China
Outcome results
None listed