NCT07071701

Brief Summary

An open clinical trial of a 23-valent pneumococcal polysaccharide vaccine (PPV23) developed by Sinovac Life Science Co., Ltd was conducted to evaluate the safety of Sinovac PPV23 in target population of individuals aged 2 years and above. All participants received 1 dose of PPV23 and self-selected whether to receive 1 dose of influenza vaccine at the same time.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19,267

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

1.8 years

First QC Date

July 8, 2025

Last Update Submit

July 8, 2025

Conditions

Pneumococcal Infectious Disease

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse reactions to 23-valent pneumonia vaccine within 0-28 days after single and combined vaccination.

    28 days after the vaccination

Secondary Outcomes (2)

  • Incidence of adverse events to 23-valent pneumonia vaccine within 0-28 days after single and combined vaccination.

    28 days after the vaccination

  • Incidence of adverse events to 23-valent pneumonia vaccine within 0-7 days after single and combined vaccination.

    7 days after the vaccination

Study Arms (2)

Acitive safety surveillance group

Biological: 23-valent pneumococcal polysaccharide vaccineBiological: Influenza vaccine

Passive safety surveillance group

Biological: 23-valent pneumococcal polysaccharide vaccineBiological: Influenza vaccine

Interventions

23-valent pneumococcal polysaccharide vaccineBIOLOGICAL

23-valent pneumococcal polysaccharide vaccine

Acitive safety surveillance groupPassive safety surveillance group
Influenza vaccineBIOLOGICAL

Influenza vaccine

Acitive safety surveillance groupPassive safety surveillance group

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants aged 2 years old and above.

You may qualify if:

  • Have voluntarily and at their own expense received the 23-valent pneumococcal polysaccharide vaccine;
  • Participants and/or their guardians are able to understand and voluntarily participate in this study and sign an informed consent form;
  • Provide valid legal identification.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Provincial Center for Disease Prevention and Control

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

23-valent pneumococcal capsular polysaccharide vaccineInfluenza Vaccines

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2025

First Posted

July 17, 2025

Study Start

July 2, 2022

Primary Completion

April 5, 2024

Study Completion

April 5, 2024

Last Updated

July 17, 2025

Record last verified: 2025-07

Locations

CN(1)