Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine

Recruiting Phase 3 Interventional Study
Pneumococcal Infectious Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
6 Weeks – 5
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
3,080 (estimated)
Sponsor
Sinovac Life Sciences Co., Ltd. · Industry
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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 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); 2. Participants' guardians provide legal identity document and participants' vaccination record; 3. Participants' guardians understand and …
Contacts

Yanxia Wang

13613816598

wangyanxia99@163.com

CONTACT

Xiaoqiang Liu

15911568282

lxq7611@126.com

CONTACT