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Completed

NCT Number: NCT04100772

Phase I Clinical Trial of a Candidate PCV13 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.

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Key information

Conditions

Pneumococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

6 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Neihuang Center for Disease Control and Prevention

Anyang, Henan, 450016, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biological

0.5mL,Intramuscular other name:PCV13i

13-valent pneumococcal polysaccharide conjugate vaccine

Biological

0.5mL,Intramuscular other name:Prevnar

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

CanSino Biologics Inc.

Industry

Collaborators

  • Henan Center for Disease Control and Prevention

Registry information

Official study 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

Acronym: PICTPCV13i

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 24, 2019
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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