Clinical trial NCT07023081: A Study to Understand the Safety of the 20vPnC Vaccine in Healthy Chinese Adults, Children, and Infant
Official title: A Phase 1, Single-Arm Study to Evaluate the Safety and Tolerability of a 20-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Adults, Children, and Infants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2025-06-15
Enrollment: 100
Sex: ALL
Minimum age (years): 42
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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 criteria: 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.

Primary outcomes:
measure: Percentage of participants reporting prespecified local reactions within 7 days following each study intervention
timeFrame: Within 7 days of each study intervention
measure: Percentage of participants reporting prespecified systemic events within 7 days following each study intervention
timeFrame: Within 7 days of each study intervention
measure: Percentage of participants reporting adverse events (AEs) from the first study intervention through 1 month following the last study intervention administration
timeFrame: 1 month after the last vaccination
measure: Percentage of participants reporting AEs from the first study intervention through 1 month following the third study intervention.
timeFrame: From the first study intervention to 1 month after the third study intervention
measure: Percentage of participants reporting AEs from the fourth study intervention to 1 month following the fourth study intervention.
timeFrame: From the fourth study intervention to 1 month after the fourth study intervention
measure: Percentage of participants reporting serious adverse events (SAEs) throughout the study
timeFrame: From the first study intervention to 6 months after the last study intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Nanning
country: China
facility: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
state: Guangxi
city: Chengxiang
country: China
facility: Wuming District Center for Disease Control and Prevention
state: Nanning
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: