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

NCT07593924 | Not Yet Recruiting Phase 3

• 1 other identifier: PRO-PCV13-3003
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumococcal Infectious Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (19)

• Percentage of participants with pneumococcal serotype-specific IgG antibody concentrations≥0.35 μg/mL .

  30 days after dose 3.

• Geometric mean concentrations (GMCs ) of serotype-specific IgG antibody.

  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 .

  30 days after dose 3

• GMC fold increases (GMFRs) in IgG antibody concentrations.

  From before dose 3 to 30 days after dose 3

Study Arms (2)

Sinovac PCV 13

EXPERIMENTAL

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

Prevenar 13™

ACTIVE COMPARATOR

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™

Interventions

Sinovac PCV13 BIOLOGICAL

One dose of Sinovac PCV13 (0.5ml) was administered at 2, 4, and 12-15 months of age.

Sinovac PCV 13

Prevenar 13™ BIOLOGICAL

One dose of Prevenar 13™ (0.5ml) was administered at 2, 4, and 12-15 months of age.

Prevenar 13™

Eligibility Criteria

• Age: 42 Days - 89 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Health infants aged approximately 2 months (42 to 89 days)
• Have a parent/legal guardian who has provided written informed consent after being fully informed about the study.
• Be able to provide the vaccination records since birth.
• 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).

You may not qualify if:

• Previous vaccination of any licensed or investigational pneumococcal vaccine, or planned receipt during the study participation;
• Previous vaccination of vaccines containing the component of diphtheria, tetanus, pertussis, poliomyelitis, and/or Hib vaccine.
• Previous receipt of ≥2 doses of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at \>30 days old.
• History of severe adverse reaction to previous vaccinations and/or serious allergic reactions (eg, anaphylaxis) to any vaccine component.
• History of any laboratory confirmed pneumococcal bacterial pneumonia or invasive pneumococcal diseases caused by S pneumoniae.
• Premature infants (born before week 37 of gestation).
• Severe congenital malformations, developmental disorders, clinically significant genetic defects, malnutrition.
• Autoimmune diseases or immunodeficiency/immunosuppression.
• Serious chronic diseases such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders.
• Abnormal coagulation functions (e.g., coagulation factor deficiency, blood coagulation diseases, platelet disorders).
• 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.
• Received blood products before investigational vaccine inoculation, or plan to receive these treatments during study participation.
• Received other investigational drugs/vaccines before enrollment, or plan to receive investigational drugs/vaccines during study participation.
• Received live attenuated vaccines or nucleic-acid vaccines within 14 days before enrollment.
• Received subunit or inactivated vaccines within 7 days before enrollment.

Sponsors & Collaborators

• Sinovac Life Sciences Co., Ltd.: lead

Study Sites (1)

Health Index Multispecialty Clinic (HIMC) Research and Development on Medical Sciences

Imus, Cavite, Philippines

Location

MeSH Terms

Interventions

13-valent pneumococcal vaccine

Study Officials

• Edison Alberto

  Health Index Multispecialty Clinic (HIMC) Research and Development on Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edison Alberto

CONTACT

(046)471-0996/+639171490841; edisonalberto@rocketmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

PH (1)