A Clinical Trial to Observe the Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Target Population

Sinovac Biotech Co., Ltd19,267 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

19,267

Conditions

Pneumococcal Infectious Disease

Interventions

23-valent pneumococcal polysaccharide vaccineBIOLOGICAL

23-valent pneumococcal polysaccharide vaccine

Influenza vaccineBIOLOGICAL

Influenza vaccine

Eligibility

Sex: ALLMin age: 2 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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.

Locations (1)

Jiangsu Provincial Center for Disease Prevention and Control

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

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

Time frame: 28 days after the vaccination

Secondary Outcomes

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

Time frame: 28 days after the vaccination

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

Time frame: 7 days after the vaccination

Data from ClinicalTrials.gov

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