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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Sinovac PCV13
Biological/VaccineOne dose of Sinovac PCV13 (0.5 mL) is administered intramuscularly.
Prevnar®
Biological/VaccineOne dose of Prevnar® (0.5 mL) is administered intramuscularly.
Treatment groups
3,080 Participants
are divided into 2 treatment groupsGroup A: Experimental: Sinovac PCV13Experimental treatment 1 intervention
Group B: Active Comparator: Prevnar®Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)
Proportion of serotype-specific IgG concentration ≥0.35 μg/ml
Time frame
30 days after primary vaccination2
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)
IgG GMC
Time frame
30 days after primary vaccinationSecondary outcomes
1
Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)
Proportion of serotype-specific IgG concentration ≥0.35 μg/ml
Time frame
30 days after booster vaccination2
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)
IgG GMC
Time frame
30 days after booster vaccination3
Proportion of pneumococcal serotype-specific OPA antibody GMT≥1:8
Proportion of participants with pneumococcal serotype-specific OPA antibody titers ≥ 1:8
Time frame
30 days after primary vaccination4
Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT)
Pneumococcal serotype-specific OPA antibody GMT
Time frame
30 days after primary vaccinationOther outcomes
1
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate)
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate)
Time frame
1,2,3 years after final dose2
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL
Time frame
1,2,3 years after final dose3
Pneumococcal serotype-specific IgG geometric mean concentration (GMC)
Pneumococcal serotype-specific IgG geometric mean concentration (GMC)
Time frame
1,2,3 years after final dose4
Proportion of participants aged 2-5 years with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate)
Proportion of participants aged 2-5 years with pneumococcal serotype-specific OPA titers ≥ 1:8
Time frame
1,2,3 years after vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov