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Completed

NCT Number: NCT04841369

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

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

Age range

6 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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 names: PCV13i

13-valent pneumococcal polysaccharide conjugate vaccine

Biological

0.5mL,Intramuscular

Other names: Prevnar

Primary outcomes

  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 outcomes

  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

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 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 12, 2021
Registry last updated
Apr 2, 2024

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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