Clinical Trial of PCV24 in Infants Aged 2-23 Months
ConditionPneumococcal Infectious Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age42-23
SponsorSinovac Life Sciences Co., Ltd.
About this trial
A Phase 1b clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 42 days)-23 months.
The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, positive controlled phase Ib clinical trial.
Eligibility criteria
Qualifiers
Healthy infants who are aged 2 months (42-89 days), 7-11 months, 12-23 months;
Participants' guardian provides legal identity document and participants' vaccination record;
Participants' guardian understands and voluntarily signs the informed consent form;
Follow all study procedures and stay in contact during the study.
Disqualifiers
Received any pneumococcal vaccine prior to enrollment;
History of invasive pneumococcal diseases or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
History of severe adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioneurotic edema, anaphylactic shock;
Low birth weight (<2.5kg), or premature infant (gestation weeks < 37 weeks) (applies to infants younger than 12 months);
Trial design
Treatments tested in this trial
- Sinovac PCV24
- Prevnar®
Treatment groups
180 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov