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

Sinovac

Status: Completed

Conditions: Pneumococcal Infectious Disease

Treatments: Biological: Influenza vaccine; Biological: 23-valent pneumococcal polysaccharide vaccine

Study type: Observational

Funder types: Industry

Identifiers

NCT07071701

PRO-PPV-MA4002-JS

Details and patient eligibility

About

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.

Enrollment: 19,267 patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

19,267 participants in 2 patient groups

Acitive safety surveillance group

Treatment:

Biological: 23-valent pneumococcal polysaccharide vaccine

Biological: Influenza vaccine

Passive safety surveillance group

Treatment:

Biological: 23-valent pneumococcal polysaccharide vaccine

Biological: Influenza vaccine