Phase I Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above

NCT04100772 | Completed Phase 1

• 1 other identifier: CS-CTP-PCV
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumococcal Infections; Streptococcal Infections; Bacterial Infections

Keywords

PCV13; 13 valent Pneumococcal conjugate vaccine; Pneumococcal Infections; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (8)

• Safety items of adverse reactions

  Occurrence of adverse reactions of each subject(Arm 1A-7B)

  within 7 days post each vaccination

• Safety items of SAE

  Occurrence of SAE of each subject(Arm 1A-7B)

  within 6 months post last vaccination

• Safety items of Hematological examination

  Occurrence of abnormal changes of Hematological examination in subjects of 2 years old and above(Arm 1A-4A)

  day 4 post vaccination

• Safety items of Urine test

  Occurrence of abnormal changes of Urine test in subjects of 2 years old and above(Arm 1A-4A)

  day 4 post vaccination

• Safety items of Blood chemistry test

  Occurrence of abnormal changes of Blood chemistry test in subjects of 2 years old and above(Arm 1A-4A)

  day 4 post vaccination

• Safety items of pressure value

  Occurrence of abnormal changes of pressure valus in subjects of 18 years old and above(Arm 1A-2A)

  day 4 post vaccination

• Safety items of heart rate

  Occurrence of abnormal changes of heart rate in subjects of 18 years old and above(Arm 1A-2A)

  day 4 post vaccination

• Safety items of adverse reactions

  Occurrence of adverse reactions of each subject(Arm 1A-7B)

  within 30 days post each vaccination

Secondary Outcomes (4)

• immunogencity items of seropositivity rates by ELISA

  day 30 post last vaccination

• immunogencity items of GMC by ELISA

  day 30 post last vaccination

• immunogencity items of GMI by ELISA

  day 30 post last vaccination

• immunogencity items of GMT

  day 30 post last vaccination

Study Arms (8)

vaccine 1A

EXPERIMENTAL

Subjects received one dose of PCV13i at 18 to 49 years old

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）

vaccine 2A

EXPERIMENTAL

Subjects received one dose of PCV13i at 50 years old and above

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）

vaccine 3A

EXPERIMENTAL

Subjects received one dose of PCV13i at 6 to 17 years old

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）

vaccine 4A

EXPERIMENTAL

Subjects received one dose of PCV13i at 2 to 5 years old

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）

vaccine 5A

EXPERIMENTAL

Subjects received two doses of PCV13i at 7 months to 2 years old

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）

vaccine 6A

EXPERIMENTAL

Subjects received three doses of PCV13i at 3,4,5 months of age

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）

vaccine 7A

EXPERIMENTAL

Subjects received three doses of PCV13i at 2,4,6 months of age

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）

vaccine 7B

ACTIVE COMPARATOR

Subjects received three doses of PCV13 at 2,4,6 months of age

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Interventions

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） BIOLOGICAL

0.5mL,Intramuscular other name:PCV13i

vaccine 1A; vaccine 2A; vaccine 3A; vaccine 4A; vaccine 5A; vaccine 6A; vaccine 7A

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine BIOLOGICAL

0.5mL,Intramuscular other name:Prevnar

vaccine 7B

Eligibility Criteria

• Age: 6 Weeks+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ;

You may not qualify if:

• 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

Sponsors & Collaborators

• CanSino Biologics Inc.: lead
• Henan Center for Disease Control and Prevention: collaborator

Study Sites (1)

Neihuang Center for Disease Control and Prevention

Anyang, Henan, 450016, China

Location

MeSH Terms

Conditions

Pneumococcal Infections; Streptococcal Infections; Bacterial Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Xia Shengli

  Henan Province Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 24, 2019
• Study Start: May 18, 2020
• Primary Completion: June 23, 2021
• Study Completion: August 23, 2022
• Last Updated: October 31, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)