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

NCT07593924 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-05-18

No results posted yet for this study

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

Interventions

BIOLOGICAL

Prevenar 13™

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

BIOLOGICAL

Sinovac PCV13

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

Sponsors & Collaborators

  • Sinovac Life Sciences Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Edison Alberto · Health Index Multispecialty Clinic (HIMC) Research and Development on Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
89 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07593924 on ClinicalTrials.gov