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A Study to Understand the Safety of the 20vPnC Vaccine in Healthy Chinese Adults, Children, and Infant

A Study to Understand the Safety of the 20vPnC Vaccine in Healthy Chinese Adults, Children, and Infant

Recruiting
42-49 years
All
Phase 1

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Overview

The purpose of this study is to learn about the safety of the 20-valent pneumococcal conjugate vaccine (20vPnC). 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 5 specific age 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

All participants 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.

The study will look at the experiences of 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 will take part for about 16 to 19 months, with 11 visits.

Eligibility

Key inclusion criteria:

  • Male or female participants:
    • Adults ≥18 to <50 years of age
    • Children ≥2 to <6 years of age
    • Children ≥12 months to <2 years of age
    • Infants ≥7 to <12 months of age
    • Infants ≥42 to ≤98 days of age
  • Healthy participants determined by clinical assessment and clinical judgment, to be

    eligible for the study.

Key exclusion criteria:

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention, or any diphtheria toxoid-containing vaccine.
  • History of microbiologically proven invasive disease caused by S pneumoniae.
  • Congenital, functional, or surgical asplenia.
  • Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt during study participation.
  • Determined as not eligible by the investigator based on the participant's past and present health condition(s), medication(s) and treatment(s).

Please refer to the study contact for further eligibility details.

Study details
    Pneumococcal Disease

NCT07023081

Pfizer

16 July 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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