Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine
ConditionPneumococcal Infectious Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-5
SponsorSinovac Life Sciences Co., Ltd.
About this trial
A Phase Ⅲ clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 6 weeks)-5 years (before 6th birthday). The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13.
Eligibility criteria
Qualifiers
Healthy infants or children who are aged 2 months (at least 6 weeks), 7-11 months, 12-23 months and 2-5 years (before the 6th birthday);
Participants' guardians provide legal identity document and participants' vaccination record;
Participants' guardians understand and voluntarily sign the informed consent form;
Participants' guardians can follow all study procedures and stay in contact during the study.
Disqualifiers
Received any pneumococcal vaccine prior to enrollment;
History of bacterial pneumonia or invasive pneumococcal diseases (IPDs) caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
History of allergy or adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and abdominal pain;
History of dystocia, asphyxia rescue and nervous system damage at birth for infants under 2 years of age;
Trial design
Treatments tested in this trial
- Sinovac PCV13
- Prevnar®
Treatment groups
3,080 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov