Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04841369
Recruitment Status : Recruiting
First Posted : April 12, 2021
Last Update Posted : April 23, 2021
Sponsor:
Collaborator:
Henan Center for Disease Control and Prevention
Information provided by (Responsible Party):
CanSino Biologics Inc.

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.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Streptococcal Infections Bacterial Infections Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine(CRM197,TT) Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : April 13, 2021
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Prevnar




Primary Outcome Measures :
  1. Safety of PCV13i in preventing pneumococcal infections [ Time Frame: Within 7 days post each vaccination ]
    Occurance of adverse reactions in all subjects

  2. Safety of PCV13i in preventing pneumococcal infections [ Time Frame: Within 30 days post each vaccination ]
    Occurance of adverse reactions in all subjects

  3. Immunogenicity of PCV13i in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B) [ Time Frame: 30 days post three doses ]
    Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml

  4. Immunogenicity of PCV13i in subjects of 7 to 11 months old (Arm 4A-4B) [ Time Frame: 30 days post three doses ]
    Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml

  5. Immunogenicity of PCV13i in subjects of 12 months to 5 years old (Arm 5A, 5B, 6A, 6B) [ Time Frame: 30 days post last dose of vaccination ]
    Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml

  6. Immunogenicity of PCV13i in subjects of age 50 years old and above (Arm 6A, 6B, 7A, 7B) [ Time Frame: 30 days post vaccination ]
    Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml


Secondary Outcome Measures :
  1. Immuogenicity in terms of GMT in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B) [ Time Frame: 30 days post three doses ]
    GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio

  2. Immunogenicity in terms of IgG concentration in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B) [ Time Frame: 30 days post three doses ]
    Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml

  3. Safety of PCV13i in terms of in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B) [ Time Frame: 6 months post one to three doses of vaccination ]
    Occurance of SAE in subjects of this age group

  4. Immuogenicity in terms of GMT in subjects of 7 to 11 months old (Arm 3A-3B) [ Time Frame: 30 days post two doses ]
    GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio

  5. Immuogenicity in terms of GMT in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B) [ Time Frame: 30 days post last dose of vaccination ]
    GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio

  6. Immunogenicity in terms of IgG concentration in subjects of 7 to 11 months old (Arm 3A-3B) [ Time Frame: 30 days post two doses ]
    Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml

  7. Immunogenicity in terms of IgG concentration in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B) [ Time Frame: 30 days post last dose of vaccination ]
    Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml

  8. Safety of PCV13i in terms of SAE in subjects of 7 to 11 months old (Arm 3A-3B) [ Time Frame: 6 months post two doses ]
    Occurance of SAE in subjects of this age group

  9. Safety of PCV13i in terms of SAE in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B) [ Time Frame: 6 months post last dose of vaccination ]
    Occurance of SAE in subjects of this age group



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 protoc

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04841369


Contacts
Layout table for location contacts
Contact: Lili Huang +8613643826177 13643826177@163.com

Locations
Layout table for location information
China, Henan
Neihuang Center for Disease Control and Prevention Recruiting
Anyang, Henan, China, 450016
Contact: Huang Lili    13643826177    13643826177@163.com   
Sponsors and Collaborators
CanSino Biologics Inc.
Henan Center for Disease Control and Prevention
Investigators
Layout table for investigator information
Principal Investigator: Shengli Xia Henan Province Center for Disease Control and Prevention
Layout table for additonal information
Responsible Party: CanSino Biologics Inc.
ClinicalTrials.gov Identifier: NCT04841369    
Other Study ID Numbers: CS-CTP-PCV-III
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CanSino Biologics Inc.:
PCV13
13 valent Pneumococcal conjugate vaccine
Pneumococcal Infections
Safety
Immunogenicity
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Bacterial Infections
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs