Pneumococcal Infectious Diseases
Conditions
Brief summary
A Phase III clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13)developed by Sinovac Life Science Co., Ltd will be conducted in infants aged approximately 2 months (42 to 89 days). The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13. The trial is a randomized, double-blind, active controlled phase III clinical trial.
Detailed description
A phase III clinical trial of the study of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Philippines infants aged approximately 2 months (42 to 89 days). The trial is a randomized, double-blind, active controlled study. The objective of this study is to evaluate the immunogenicity and safety of PCV13 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is Prevenar 13™ manufactured by Pfizer. About 500 infants aged approximately 2 months (42 to 89 days) will be enrolled. Participants will be randomized in 1:1 ratio to the test group and control group.
Interventions
BIOLOGICALSinovac PCV13
One dose of Sinovac PCV13 (0.5ml) was administered at 2, 4, and 12-15 months of age.
BIOLOGICALPrevenar 13™
One dose of Prevenar 13™ (0.5ml) was administered at 2, 4, and 12-15 months of age.
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 89 Days
Healthy volunteers
Yes
Inclusion criteria
1. Health infants aged approximately 2 months (42 to 89 days) 2. Have a parent/legal guardian who has provided written informed consent after being fully informed about the study. 3. Be able to provide the vaccination records since birth. 4. The infant's mother is tested negative for HIV, syphilis, hepatitis B, and hepatitis C before the infant's enrollment to this study (test results obtained during pregnancy are acceptable, if provided).
Exclusion criteria
1. Previous vaccination of any licensed or investigational pneumococcal vaccine, or planned receipt during the study participation; 2. Previous vaccination of vaccines containing the component of diphtheria, tetanus, pertussis, poliomyelitis, and/or Hib vaccine. 3. Previous receipt of ≥2 doses of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at \>30 days old. 4. History of severe adverse reaction to previous vaccinations and/or serious allergic reactions (eg, anaphylaxis) to any vaccine component. 5. History of any laboratory confirmed pneumococcal bacterial pneumonia or invasive pneumococcal diseases caused by S pneumoniae. 6. Premature infants (born before week 37 of gestation). 7. Severe congenital malformations, developmental disorders, clinically significant genetic defects, malnutrition. 8. Autoimmune diseases or immunodeficiency/immunosuppression. 9. Serious chronic diseases such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders. 10. Abnormal coagulation functions (e.g., coagulation factor deficiency, blood coagulation diseases, platelet disorders). 11. Received immunosuppressive for ≥14 days (e.g., prednisone equivalent of ≥2 mg/kg), or cytotoxic drug before enrollment, or plans to receive these treatments during the study participation. 12. Received blood products before investigational vaccine inoculation, or plan to receive these treatments during study participation. 13. Received other investigational drugs/vaccines before enrollment, or plan to receive investigational drugs/vaccines during study participation. 14. Received live attenuated vaccines or nucleic-acid vaccines within 14 days before enrollment. 15. Received subunit or inactivated vaccines within 7 days before enrollment. 16. Acute diseases or acute exacerbations of chronic diseases within 7 days before enrollment. 17. Axillary temperature ≥ 37.5°C before enrollment. 18. Any other factors judged by the investigators as unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with pneumococcal serotype-specific IgG antibody concentrations≥0.35 μg/mL . | 30 days after dose 2. | Non-inferiority criterion: The lower limit of the two-sided 95% CI for the difference (Sinovac-PCV13 minus Prevenar 13™) \> -10% for each serotype at 30 days after dose 2. |
| Geometric mean concentrations (GMCs) of serotype-specific IgG antibody. | 30 days after dose 2 | Non-inferiority criterion: The lower limit of the two-sided 95% CI for the GMC ratio (Sinovac-PCV13/Prevenar 13™) \> 0.5 for each serotype at 30 days after dose 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with pneumococcal serotype-specific IgG antibody concentrations≥0.35 μg/mL . | 30 days after dose 3. | Non-inferiority criterion: The lower limit of the two-sided 95% CI for the difference (Sinovac-PCV13 minus Prevenar 13™) \> -10% for each serotype at 30 days after dose 3. |
| Geometric mean concentrations (GMCs ) of serotype-specific IgG antibody. | 30 days after dose 3. | Non-inferiority criterion: The lower limit of the two-sided 95% CI for the GMC ratio (Sinovac-PCV13/Prevenar 13™) \> 0.5 for each serotype at 30 days after dose 3. |
| Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL | 30 days after dose 2 | Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL at 30 days after dose 2 |
| Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL . | 30 days after dose 3 | Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL at 30 days after dose 3. |
| GMC fold increases (GMFRs) in IgG antibody concentrations. | From before dose 3 to 30 days after dose 3 | GMC fold increases (GMFRs) in IgG antibody concentrations from before dose 3 to 30 days after dose 3. |
| Percentage of participants with serotype-specific opsonophagocytosis assay (OPA) antibody titers ≥1:8 | 30 days after the dose 2. | Percentage of participants with serotype-specific OPA antibody titers ≥1:8 at 30 days after the dose 2. |
| Percentage of participants with serotype-specific OPA antibody titers ≥1:8. | 30 days after the dose 3. | Percentage of participants with serotype-specific OPA antibody titers ≥1:8 at 30 days after the dose 3. |
| Geometric mean titers (GMTs) of serotype-specific OPA antibody. | 30 days after dose 2. | Geometric mean titers (GMTs) of serotype-specific OPA antibody 30 days after dose 2. |
| GMTs of serotype-specific OPA antibody . | 30 days after dose 3. | GMTs of serotype-specific OPA antibody at 30 days after dose 3. |
| GMT fold rises (GMFRs) in OPA titers. | From before dose 3 to 30 days after dose 3. | GMT fold rises (GMFRs) in OPA titers from before dose 3 to 30 days after dose 3. |
| Incidence of adverse reactions | 0-30 days after each dose. | Incidence of adverse reactions within 30 days after each dose. |
| Incidence of serious adverse events(SAEs) | From dose 1 to 30 days after dose 3 | Incidence of SAEs from dose 1 to 30 days after dose 3 |
| Percentage of infants with anti-diphtheria toxoid IgG concentrations ≥ 0.1 IU/mL | 30 days after dose 3 of DTwP-HepB-Hib | Percentage of infants with anti-diphtheria toxoid IgG concentrations ≥ 0.1 IU/mL at 30 days after dose 3 of DTwP-HepB-Hib |
| Percentage of infants with anti-tetanus toxoid IgG concentrations ≥ 0.1 IU/mL | 30 days after dose 3 of DTwP-HepB-Hib | Percentage of infants with anti-tetanus toxoid IgG concentrations ≥ 0.1 IU/mL at 30 days after dose 3 of DTwP-HepB-Hib |
| Percentage of participants achieving an anti-acellular pertussis (PT, FHA and PRN antigens) antibody concentration | 30 days after dose 3 of DTwP-HepB-Hib | Percentage of participants achieving an anti-acellular pertussis (PT, FHA and PRN antigens) antibody concentration ≥ the observed anti-pertussis antibody concentration achieved by 95% of Prevenar 13™ recipients at 30 days after dose 3 of DTwP-HepB-Hib |
| Percentage of infants with anti-Haemophilus influenzae type b (PRP) IgG concentration≥0.15 µg/mL | 30 days after dose 3 of DTwP-HepB-Hib | Percentage of infants with anti-Haemophilus influenzae type b (PRP) IgG concentration≥0.15 µg/mL at 30 days after dose 3 of DTwP-HepB-Hib |
| Percentage of infants with anti-Hepatitis B surface antigen (HBsAg) antibody concentrations≥10 mIU/mL | 30 days after dose 3 of DTwP-HepB-Hib | Percentage of infants with anti-Hepatitis B surface antigen (HBsAg) antibody concentrations≥10 mIU/mL at 30 days after dose 3 of DTwP-HepB-Hib |
| Percentage of infants with anti-poliovirus types 1, 2 and 3 neutralizing antibody titers≥1:8 | 30 days after dose 3 of IPV | Percentage of infants with anti-poliovirus types 1, 2 and 3 neutralizing antibody titers≥1:8 measured at 30 days after dose 3 of IPV |
Countries
Philippines
Contacts
CONTACTEdison Alberto
PRINCIPAL_INVESTIGATOREdison Alberto
Health Index Multispecialty Clinic (HIMC) Research and Development on Medical Sciences
Outcome results
None listed