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Phase I 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04100772
Recruitment Status : Active, not recruiting
First Posted : September 24, 2019
Last Update Posted : August 4, 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 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 237 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 I Clinical Trial to Preliminary 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 : May 18, 2020
Estimated Primary Completion Date : September 20, 2021
Estimated Study Completion Date : December 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/treatment
Experimental: vaccine 1A
Subjects received one dose of PCV13i at 18 to 49 years old
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine(CRM197,TT)
0.5mL,Intramuscular other name:PCV13i

Experimental: vaccine 2A
Subjects received one dose of PCV13i at 50 years old and above
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine(CRM197,TT)
0.5mL,Intramuscular other name:PCV13i

Experimental: vaccine 3A
Subjects received one dose of PCV13i at 6 to 17 years old
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine(CRM197,TT)
0.5mL,Intramuscular other name:PCV13i

Experimental: vaccine 4A
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

Experimental: vaccine 5A
Subjects received two doses of PCV13i at 7 months to 2 years old
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine(CRM197,TT)
0.5mL,Intramuscular other name:PCV13i

Experimental: vaccine 6A
Subjects received three doses of PCV13i at 3,4,5 months of age
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine(CRM197,TT)
0.5mL,Intramuscular other name:PCV13i

Experimental: vaccine 7A
Subjects received three doses of PCV13i at 2,4,6 months of age
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine(CRM197,TT)
0.5mL,Intramuscular other name:PCV13i

Active Comparator: vaccine 7B
Subjects received three doses of PCV13 at 2,4,6 months of age
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
0.5mL,Intramuscular other name:Prevnar




Primary Outcome Measures :
  1. Safety items of adverse reactions [ Time Frame: within 7 days post each vaccination ]
    Occurrence of adverse reactions of each subject(Arm 1A-7B)

  2. Safety items of SAE [ Time Frame: within 6 months post last vaccination ]
    Occurrence of SAE of each subject(Arm 1A-7B)

  3. Safety items of Hematological examination [ Time Frame: day 4 post vaccination ]
    Occurrence of abnormal changes of Hematological examination in subjects of 2 years old and above(Arm 1A-4A)

  4. Safety items of Urine test [ Time Frame: day 4 post vaccination ]
    Occurrence of abnormal changes of Urine test in subjects of 2 years old and above(Arm 1A-4A)

  5. Safety items of Blood chemistry test [ Time Frame: day 4 post vaccination ]
    Occurrence of abnormal changes of Blood chemistry test in subjects of 2 years old and above(Arm 1A-4A)

  6. Safety items of pressure value [ Time Frame: day 4 post vaccination ]
    Occurrence of abnormal changes of pressure valus in subjects of 18 years old and above(Arm 1A-2A)

  7. Safety items of heart rate [ Time Frame: day 4 post vaccination ]
    Occurrence of abnormal changes of heart rate in subjects of 18 years old and above(Arm 1A-2A)

  8. Safety items of adverse reactions [ Time Frame: within 30 days post each vaccination ]
    Occurrence of adverse reactions of each subject(Arm 1A-7B)


Secondary Outcome Measures :
  1. immunogencity items of seropositivity rates by ELISA [ Time Frame: 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)

  2. immunogencity items of GMC by ELISA [ Time Frame: 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)

  3. immunogencity items of GMI by ELISA [ Time Frame: 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)

  4. immunogencity items of GMT [ Time Frame: 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)



Information from the National Library of Medicine

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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 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

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): NCT04100772


Locations
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China, Henan
Neihuang Center for Disease Control and Prevention
Anyang, Henan, China, 450016
Sponsors and Collaborators
CanSino Biologics Inc.
Henan Center for Disease Control and Prevention
Investigators
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Principal Investigator: Xia Shengli Henan Province Center for Disease Control and Prevention
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Responsible Party: CanSino Biologics Inc.
ClinicalTrials.gov Identifier: NCT04100772    
Other Study ID Numbers: CS-CTP-PCV
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: In order to maintain the rights of the subject, do not open the IPD

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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:
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Infections
Communicable Diseases
Bacterial Infections
Pneumococcal Infections
Streptococcal Infections
Disease Attributes
Pathologic Processes
Bacterial Infections and Mycoses
Gram-Positive Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs