Clinical Trial of PCV24 in Infants and Children Aged 2 Months to 5 Years
ConditionPneumococcal Infectious Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age42-5
SponsorSinovac Life Sciences Co., Ltd.
About this trial
A Phase 2 clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in the pediatric population aged 2 months (minimum 42 days) to 5 years.
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 2 clinical trial.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy infants who are aged 2 months (42-89 days), 7-11 months, 12-23 months, and 2-5 years;
The participants' guardian provides a legal identity document and the participants' vaccination record;
The participant's 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
Design model
Parallel
Treatments tested in this trial
Sinovac PCV24
Biological/VaccineSinovac PCV24 (0.5 mL) is administered intramuscularly according to different immunization schedules.
Prevnar®
Biological/VaccinePrevnar® (0.5 mL) is administered intramuscularly according to different immunization schedules.
Treatment groups
420 Participants
are divided into 2 treatment groupsGroup A: Sinovac PCV24Experimental treatment 1 intervention
Group B: Prevnar®Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)
Time frame
30 days after primary vaccination2
Incidence of adverse reactions
Time frame
0-30 days after vaccinationSecondary outcomes
1
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)
Time frame
30 days after the 2nd dose of the primary vaccination (2-month-olds), 30 days after primary vaccination (all participants)2
OPA antibody levels for each pneumococcal serotype
Time frame
30 days after vaccination3
Incidence of adverse reactions
Time frame
0-7 days after vaccination4
Incidence of serious adverse events (SAE)
Time frame
from vaccination to 6 months after final doseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov