Who may participate

Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.

Condition
Pneumococcal Disease
Sex
Male or Female
Age
42 days - 49 years
Healthy participants
Yes

Eligibility criteria

Study overview

The purpose of this study is to learn about the safety of the 20-valent pneumococcal conjugate vaccine (20vPnC) among adults, children, and infants, as well as the immunogenicity of 20vPnC among infants and children under 2 years of age in China. This vaccine will be given as per the age-specific dosing schedules among healthy adults, children and infants in China.

This study is seeking healthy participants of 6 groups:

  • Group 1: Adults ≥18 to <50 years of age
  • Group 2: Children ≥2 to <6 years of age
  • Group 3: Children ≥12 months to <2 years of age
  • Group 4: Infants ≥7 to <12 months of age
  • Group 5: Infants ≥42 to ≤98 days of age
  • Group 6: Infants ≥42 to ≤98 days of age


All participants in Group 1 to 5, in this study will receive 20vPnC as per the age-specific dosing schedules:

  • Group 1: participants will receive 1 dose of 20vPnC.
  • Group 2: participants will receive 1 dose of 20vPnC.
  • Group 3: participants will receive 2 doses of 20vPnC. Dose 2 will be given 56 to 70 days after Dose 1.
  • Group 4: participants will receive 3 doses of 20vPnC. Dose 2 will be given 28 to 56 days after Dose 1, and Dose 3 will be given at 365 to <455 days of age and at least 56 days after Dose 2.
  • Group 5: participants will receive 4 doses of 20vPnC. Dose 2 will be given 42 to 63 days after Dose 1, and Dose 3 should be given 42 to 63 days after Dose 2, and Dose 4 should be given at 365 to <455 days of age.


Participants in Group 6 will be randomized in a 1:1 ratio to received either 20vPnC or 13vPnC:

\- Group 6: participants will receive 4 doses of 20vPnC or 13vPnC. Dose 2 will be given 42 to 63 days after Dose 1, and Dose 3 should be given 42 to 63 days after Dose 2, and Dose 4 should be given at 365 to <455 days of age.

The study will look at the experiences of people receiving the study vaccine. The study will also look at the immune response of some people receiving the study vaccine. This will help decide if the study vaccine is safe.

The total duration of taking part in the study from each group is:

  • Participants in Group 1 and Group 2 will take part for about 6 months, with 6 visits.
  • Participants in Group 3 will take part for about 8 months, with 9 visits.
  • Participants in Group 4 will take part for about 12 months, with 8 visits.
  • Participants in Group 5 and 6 will take part for about 16 to 19 months, with 11 visits.

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    Miles
    0500

    Nearest Locations found

    2 sites found

    Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

    Nanning, Guangxi, China, 530021
    recruiting status
    Recruiting
    Site Info

    Wuming District Center for Disease Control and Prevention

    Chengxiang, Nanning, China, 530199
    recruiting status
    Recruiting
    Site Info
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    • Site details
    • Study Contact
    • Clinical Trials ID

    Study Locations

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