A Lot-to-Lot Consistency Clinical Trial of PCV13
ConditionPneumococcal Infectious Diseases
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-5
SponsorSinovac Life Sciences Co., Ltd.
About this trial
A Phase IIIb clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13)developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2 to 5 years.
The objective of the study is to evaluate the the Lot-to-Lot consistency, immunogenicity and safety of Sinovac PCV13. The trial is a randomized, double-blind phase IIIb clinical trial.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy children aged 2 to 5 years with stable health status
Participants and their legal representative provide legal proof of identity, as well as vaccination record
Participants' legal representative understand and voluntarily sign the informed consent form
Willing and able to comply with all scheduled visits, sample collection, vaccination and other study procedures, and maintain accessible contact throughout the study period.
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 allergy or adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and anaphylactic shock
History of severe diseases judged by the investigator to interfere with vaccination, including but not limited to cardiovascular and cerebrovascular diseases (e.g., complicated or complex congenital heart disease), hematological diseases (e.g., severe anemia), liver and renal diseases, digestive system diseases, respiratory diseases (e.g., active pulmonary tuberculosis), malignant tumors, history of major solid organ transplantation, etc.
Trial design
Design model
Parallel
Treatments tested in this trial
Sinovac PCV13 lot 1
Biological/VaccineOne dose of Sinovac PCV13 lot 1 (0.5ml) was administered
Sinovac PCV13 lot 2
Biological/VaccineOne dose of Sinovac PCV13 lot 2 (0.5ml) was administered
Sinovac PCV13 lot 3
Biological/VaccineOne dose of Sinovac PCV13 lot 3(0.5ml) was administered
Treatment groups
1,125 Participants
are divided into 3 treatment groupsGroup A: PCV13 Lot 1Experimental treatment 1 intervention
Group B: PCV13 Lot 2Experimental treatment 1 intervention
Group C: PCV13 Lot 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) 30 days after vaccination
Equivalence Criterion: The 95% confidence intervals (CIs) for the ratios of serotype-specific IgG geometric mean concentrations (GMCs) between any two lots shall lie entirely within the range of 0.5 to 2.0,as measured by enzyme-linked immunosorbent assay (ELISA) method
Time frame
30 days after vaccinationSecondary outcomes
1
Percentage of Pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate) 30 days after vaccination
Percentage of IgG antibody concentration ≥0.35 μg/ml at 30 days after vaccination, as measured by ELISA method
Time frame
30 days after vaccination2
Percentage of Pneumococcal serotype-specific IgG antibody concentration ≥1.0 μg/ml 30 days after vaccination
Percentage of IgG antibody concentration ≥1.0 μg/ml at 30 days after vaccination, as measured by ELISA method
Time frame
30 days after vaccination3
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI) from pre-vaccination up to 30 days post-vaccination
IgG GMI for the pneumococcal serotypes were measured by ELISA method
Time frame
Pre-vaccination up to 30 days post-vaccination4
Incidence of adverse reactions within 7 days after vaccination
Incidence of adverse reactions within 7 days after vaccination.Adverse reactions consisted of solicited and unsolicited events. Solicited local (injection-site) symptoms included Pain, swelling, erythema, induration, pruritus, solicited systemic (non-injection-site) symptoms included Fever (axillary temperature), decreased appetite, diarrhoea, vomiting, nausea, cough, lethargy, headache, hypersensitivity reaction
Time frame
0-7 days after vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: