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

A Randomized,Blind, Positive-controlled Phase III Clinical Trial to Evaluate the Safety and Immunogencity of 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） in Healthy People Aged 6 Weeks and Above

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 Overview

• Status: Completed
• Conditions: Pneumococcal Infections; Bacterial Infections; Streptococcal Infections
• Intervention / Treatment: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）; Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

• Study Type: Interventional
• Enrollment (Actual): 3420
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Henan
    • Anyang, Henan, China, 450016
      • Neihuang Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

9

Arms and Interventions

Participant Group / 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: PCV13i
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: Prevnar
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: PCV13i
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: PCV13i
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: Prevnar
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: PCV13i
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: Prevnar
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: PCV13i
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: Prevnar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of PCV13i in preventing pneumococcal infections	Occurance of adverse reactions in all subjects	Within 7 days post each vaccination
Safety of PCV13i in preventing pneumococcal infections	Occurance of adverse reactions in all subjects	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	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	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	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	30 days post vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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	6 months post last dose of vaccination

Collaborators and Investigators

• Sponsor: CanSino Biologics Inc.
• Collaborators: Henan Center for Disease Control and Prevention
• Investigators: Principal Investigator: Shengli Xia, Henan Province Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2021
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): September 20, 2022

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Safety; Immunogenicity; 13 valent Pneumococcal conjugate vaccine; PCV13; Pneumococcal Infections
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Pneumococcal Infections; Bacterial Infections; Streptococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: CS-CTP-PCV-III

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No