Clinical Trial of PCV13 in Infants Aged Approximately 2 Months (42 to 89 Days)

A Phase III, Randomized, Double-blind, Active Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine Administered as a Series of 2 Infant Doses and 1 Toddler Dose in Healthy Infants

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pneumococcal Infectious Diseases
• Intervention / Treatment: Biological: Sinovac PCV13; Biological: Prevenar 13™

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Edison Alberto; Phone Number: (046)471-0996/+639171490841; Email: edisonalberto@rocketmail.com

Study Locations

• Philippines
  • Cavite
    • Imus, Cavite, Philippines
      • Health Index Multispecialty Clinic (HIMC) Research and Development on Medical Sciences
      • Contact: Edison R. Alberto; Phone Number: (046)471-0996/+639171490841; Email: edisonalberto@rocketmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sinovac PCV 13; 250 participants aged 2 months (42 to 89 days) will receive 3 doses of Sinovac PCV13 at approximately 2, 4 and 12-15 months of age.Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months.	Biological: Sinovac PCV13; One dose of Sinovac PCV13 (0.5ml) was administered at 2, 4, and 12-15 months of age.
Active Comparator: Prevenar 13™; 250 participants aged 2 months (42 to 89 days) will receive 3 doses of Prevenar 13™ at approximately 2, 4 and 12-15 months of age.Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months.	Biological: Prevenar 13™; One dose of Prevenar 13™ (0.5ml) was administered at 2, 4, and 12-15 months of age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with pneumococcal serotype-specific IgG antibody concentrations≥0.35 μg/mL .	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.	30 days after dose 2.
Geometric mean concentrations (GMCs) of serotype-specific IgG antibody.	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.	30 days after dose 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse reactions	Incidence of adverse reactions within 7 days after each dose	0-7 days after each dose
Percentage of participants with pneumococcal serotype-specific IgG antibody concentrations≥0.35 μg/mL .	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.	30 days after dose 3.
Geometric mean concentrations (GMCs ) of serotype-specific IgG antibody.	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.	30 days after dose 3.
Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL	Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL at 30 days after dose 2	30 days after dose 2
Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL .	Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL at 30 days after dose 3.	30 days after dose 3
GMC fold increases (GMFRs) in IgG antibody concentrations.	GMC fold increases (GMFRs) in IgG antibody concentrations from before dose 3 to 30 days after dose 3.	From before dose 3 to 30 days after dose 3
Percentage of participants with serotype-specific opsonophagocytosis assay (OPA) antibody titers ≥1:8	Percentage of participants with serotype-specific OPA antibody titers ≥1:8 at 30 days after the dose 2.	30 days after the dose 2.
Percentage of participants with serotype-specific OPA antibody titers ≥1:8.	Percentage of participants with serotype-specific OPA antibody titers ≥1:8 at 30 days after the dose 3.	30 days after the dose 3.
Geometric mean titers (GMTs) of serotype-specific OPA antibody.	Geometric mean titers (GMTs) of serotype-specific OPA antibody 30 days after dose 2.	30 days after dose 2.
GMTs of serotype-specific OPA antibody .	GMTs of serotype-specific OPA antibody at 30 days after dose 3.	30 days after dose 3.
GMT fold rises (GMFRs) in OPA titers.	GMT fold rises (GMFRs) in OPA titers from before dose 3 to 30 days after dose 3.	From before dose 3 to 30 days after dose 3.
Incidence of adverse reactions	Incidence of adverse reactions within 30 days after each dose.	0-30 days after each dose.
Incidence of serious adverse events(SAEs)	Incidence of SAEs from dose 1 to 30 days after dose 3	From dose 1 to 30 days after dose 3
Percentage of infants with anti-diphtheria toxoid IgG concentrations ≥ 0.1 IU/mL	Percentage of infants with anti-diphtheria toxoid IgG concentrations ≥ 0.1 IU/mL at 30 days after dose 3 of DTwP-HepB-Hib	30 days after dose 3 of DTwP-HepB-Hib
Percentage of infants with anti-tetanus toxoid IgG concentrations ≥ 0.1 IU/mL	Percentage of infants with anti-tetanus toxoid IgG concentrations ≥ 0.1 IU/mL at 30 days after dose 3 of DTwP-HepB-Hib	30 days after dose 3 of DTwP-HepB-Hib
Percentage of participants achieving an anti-acellular pertussis (PT, FHA and PRN antigens) antibody concentration	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	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	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	30 days after dose 3 of DTwP-HepB-Hib
Percentage of infants with anti-Hepatitis B surface antigen (HBsAg) antibody concentrations≥10 mIU/mL	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	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	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	30 days after dose 3 of IPV

Collaborators and Investigators

• Sponsor: Sinovac Life Sciences Co., Ltd.
• Investigators: Principal Investigator: Edison Alberto, Health Index Multispecialty Clinic (HIMC) Research and Development on Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: 13-valent pneumococcal vaccine
• Other Study ID Numbers: PRO-PCV13-3003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No