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 other name:PCV13i
0.5mL,Intramuscular other name:Prevnar
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 items of heart rate | day 4 post vaccination | Occurrence of abnormal changes of heart rate in subjects of 18 years old and above(Arm 1A-2A) |
| Safety items of Hematological examination | day 4 post vaccination | Occurrence of abnormal changes of Hematological examination in subjects of 2 years old and above(Arm 1A-4A) |
| Safety items of Urine test | day 4 post vaccination | Occurrence of abnormal changes of Urine test in subjects of 2 years old and above(Arm 1A-4A) |
| Safety items of Blood chemistry test | day 4 post vaccination | Occurrence of abnormal changes of Blood chemistry test in subjects of 2 years old and above(Arm 1A-4A) |
| Safety items of pressure value | day 4 post vaccination | Occurrence of abnormal changes of pressure valus in subjects of 18 years old and above(Arm 1A-2A) |
| Safety items of SAE | within 6 months post last vaccination | Occurrence of SAE of each subject(Arm 1A-7B) |
| Safety items of adverse reactions | within 7 days post each vaccination | Occurrence of adverse reactions of each subject(Arm 1A-7B) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| immunogencity items of GMC by ELISA | day 30 post last vaccination | Serotype specific IgG GMC of each the pneumococcal serotypes in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B) |
| immunogencity items of GMI by ELISA | day 30 post last vaccination | Serotype-specific GMI value pneumococcfor each of the pneunococcal serotypes in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B) |
| immunogencity items of GMT | day 30 post last vaccination | Serological response in terms of GMT for each of the pneumococcal serotypes tested by OPA in subjects aged 2 months post last vaccination(7A、7B) |
| immunogencity items of seropositivity rates by ELISA | day 30 post last vaccination | Serotype-specific seropositivity rates of Immunoglobulin G concentrations above 0.35ug/ml in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B) |
Countries
China
Outcome results
None listed