Pneumococcal Infectious Disease
Conditions
Brief summary
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.
Detailed description
A phase 1b clinical trial of the study of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV24) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Chinese pediatric population aged 2 months (minimum 42 days)-23 months. The trial is a randomized, double-blind, positive controlled study. The objective of this study is to evaluate the safety and immunogenicity of PCV24 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is Prevenar13® manufactured by Pfizer. A total of at least 180 participants aged 2 months (minimum 42 days)-23 months will be enrolled. Participants will be randomized in 1:1 ratio to the test group and control group.
Interventions
BIOLOGICALSinovac PCV24
Sinovac PCV24 (0.5 mL) is administered intramuscularly according to different immunization schedules.
BIOLOGICALPrevnar®
Prevnar® (0.5 mL) is administered intramuscularly according to different immunization schedules.
Sponsors
Sinovac Life Sciences Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
42 Days to 23 Months
Healthy volunteers
Yes
Inclusion criteria
1. Healthy infants who are aged 2 months (42-89 days), 7-11 months, 12-23 months; 2. Participants' guardian provides legal identity document and participants' vaccination record; 3. Participants' guardian understands and voluntarily signs the informed consent form; 4. Follow all study procedures and stay in contact during the study.
Exclusion criteria
1. Received any pneumococcal vaccine prior to enrollment; 2. History of invasive pneumococcal diseases or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests; 3. History of severe adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioneurotic edema, anaphylactic shock; 4. Low birth weight (\<2.5kg), or premature infant (gestation weeks \< 37 weeks) (applies to infants younger than 12 months); 5. History of abnormal labor during delivery (planned cesarean section is excluded), history of asphyxia rescue and nervous system damage (applies to infants younger than 12 months); 6. Congenital malformations or developmental disorders, genetic defects, severe malnutrition; 7. Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases (e.g. congenital heart disease), hematological diseases (e.g. severe anemia), liver and kidney diseases, digestive diseases, respiratory diseases (such as active tuberculosis), malignant tumors and major functional organ transplantation history; 8. Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection); 9. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), potential bleeding (history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture). 10. Have/have suffered from a serious neurological disorder (epilepsy or convulsions, but febrile convulsion is not an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse reactions | 0-30 days after vaccination | Incidence of adverse reactions within 30 days after vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse reactions | 0-7 days after vaccination | Incidence of adverse reactions within 7 days after vaccination |
| Incidence of serious adverse events (SAE) | from vaccination to 6 months after final dose | Incidence of SAE during the period of safety monitoring |
| Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) | 30 days after primary vaccination | IgG GMC 30 days after primary vaccination |
| Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI) | 30 days after primary vaccination | IgG GMI 30 days after primary vaccination |
| Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL | 30 days after primary vaccination | Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL |
| Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate) | 30 days after primary vaccination | Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate) |
Countries
China
Contacts
CONTACTQing Xu
PRINCIPAL_INVESTIGATORQing Xu
Shandong Provincial Center for Disease Control and Prevention
Outcome results
None listed