Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i)

CanSino Biologics Inc.3,420 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

3,420

Conditions

Pneumococcal Infections Streptococcal Infections Bacterial Infections

Interventions

Eligibility

Sex: ALLMin age: 6 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Safety of PCV13i in preventing pneumococcal infections

Occurance of adverse reactions in all subjects

Time frame: Within 7 days post each vaccination

Safety of PCV13i in preventing pneumococcal infections

Occurance of adverse reactions in all subjects

Time frame: Within 30 days post each vaccination

Immunogenicity of PCV13i in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)

Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml

Time frame: 30 days post three doses

Immunogenicity of PCV13i in subjects of 7 to 11 months old (Arm 4A-4B)

Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml

Time frame: 30 days post three doses

Immunogenicity of PCV13i in subjects of 12 months to 5 years old (Arm 5A, 5B, 6A, 6B)

Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml

Time frame: 30 days post last dose of vaccination

Immunogenicity of PCV13i in subjects of age 50 years old and above (Arm 6A, 6B, 7A, 7B)

Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml

Time frame: 30 days post vaccination

Secondary Outcomes

Immuogenicity in terms of GMT in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)

GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio

Time frame: 30 days post three doses

Immunogenicity in terms of IgG concentration in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)

Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml

Time frame: 30 days post three doses

Safety of PCV13i in terms of in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)

Occurance of SAE in subjects of this age group

Time frame: 6 months post one to three doses of vaccination

Immuogenicity in terms of GMT in subjects of 7 to 11 months old (Arm 3A-3B)

GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio

Time frame: 30 days post two doses

Immuogenicity in terms of GMT in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)

GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio

Time frame: 30 days post last dose of vaccination

Immunogenicity in terms of IgG concentration in subjects of 7 to 11 months old (Arm 3A-3B)

Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml

Time frame: 30 days post two doses

Immunogenicity in terms of IgG concentration in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)

Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml

Time frame: 30 days post last dose of vaccination

Safety of PCV13i in terms of SAE in subjects of 7 to 11 months old (Arm 3A-3B)

Occurance of SAE in subjects of this age group

Time frame: 6 months post two doses

Safety of PCV13i in terms of SAE in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)

Occurance of SAE in subjects of this age group

Time frame: 6 months post last dose of vaccination

Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes