NCT06183216

Brief Summary

A phase 1b clinical trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2 months (42-89 days) and 2 to 5 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV13. The trial is a randomized, double blinded, positive controlled study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 27, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

January 4, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2025

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

December 13, 2023

Last Update Submit

January 26, 2026

Conditions

Pneumococcal Infectious Disease

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse reactions

    Incidence of adverse reactions within 30 days after each dose

    0-30 days after each dose

Secondary Outcomes (10)

  • Incidence of adverse reactions

    0-7 days after each dose

  • Incidence of SAE

    6 months after vaccination for children aged 2-5 years; 1 month after completion of booster vaccination for infants aged 2 months.

  • IgG concentration ≥0.35μg/mL for infants aged 2 months

    30 days after primary/booster immunization

  • IgG concentration ≥1.0μg/mL for infants aged 2 months

    30 days after primary/booster immunization

  • GMCs for infants aged 2 months

    30 days after primary/booster immunization

  • +5 more secondary outcomes

Study Arms (4)

Infants aged 2 months in experimental group

EXPERIMENTAL

35 participants aged 2 months will be randomized to receive Sinovac PCV13. Route of administration is intramuscular injection at anterolateral aspect of thigh; immunization schedule is 4 doses, including 3 doses (two-month interval) in primary vaccination and a booster dose at the age of 12-15 months.

Biological: Sinovac PCV13

Infants aged 2 months in control group

ACTIVE COMPARATOR

35 participants aged 2 months will be randomized to receive PREVNAR 13. Route of administration is intramuscular injection at anterolateral aspect of thigh; immunization schedule is 4 doses, including 3 doses (two-month interval) in primary vaccination and a booster dose at the age of 12-15 months.

Biological: PREVNAR 13

Children aged 2-5 years in experimental group

EXPERIMENTAL

35 children aged 2-5 years will be randomized to receive Sinovac PCV13. The route of administration is intramuscular injection at deltoid muscle of the upper arm, and immunization schedule is 1 dose for children aged 2-5 years old.

Biological: Sinovac PCV13

Children aged 2-5 years in control group

ACTIVE COMPARATOR

35 children aged 2-5 years will be randomized to receive PREVNAR 13. The route of administration is intramuscular injection at deltoid muscle of the upper arm, and immunization schedule is 1 dose for children aged 2-5 years old.

Biological: PREVNAR 13

Interventions

Sinovac PCV13BIOLOGICAL

0.5 mL dose of Sinovac PCV13 contains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.

Children aged 2-5 years in experimental groupInfants aged 2 months in experimental group
PREVNAR 13BIOLOGICAL

0.5 mL dose of PREVNAR 13 contains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.

Children aged 2-5 years in control groupInfants aged 2 months in control group

Eligibility Criteria

Age6 Weeks - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy infants aged 2 months (42-89 days); Healthy children aged 2-5 years.
  • Proven vaccination certificate, birth certificate and legal identification documents
  • The participants' guardians can understand and voluntarily sign the informed consent form.
  • Participants and their guardians can obey requirements of the protocol.

You may not qualify if:

  • Received any pneumococcal vaccine prior to enrollment.
  • History of culture confirmed bacterial pneumonia or invasive pneumococcal disease (IPD) caused by Streptococcus pneumoniae.
  • History of allergy to the vaccine or vaccine components, including pneumococcal polysaccharide for each serotype, diphtheria CRM197, aluminum phosphate, succinic acid, polysorbate 80 and sodium chloride; or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and asthma.
  • History of dystocia, asphyxia rescue, nervous system damage at birth (only applicable to infants aged 2 months (42-89 days))
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, asthma etc.
  • Autoimmune disease (such as systemic lupus erythematosus) or immunodeficiency/ immunosuppression (such as HIV, organ transplantation)
  • Severe cardiovascular diseases, such as diabetes, liver diseases, kidney diseases, malignant tumors.
  • Family history of mental illness, severe neurological disease (epilepsy or convulsions) or mental illness.
  • History of thyroidectomy, asplenia, functional asplenia; and asplenia or splenectomy resulting from any condition.
  • Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets), history of obvious bleeding or bruising after intramuscular injection or venipuncture.
  • Infants 2 months of age (42-89 days) prior to enrollment/children 2 to 5 years of age 6 months prior to enrollment had been treated with corticosteroids, other immunosuppressive agents (excluding corticosteroid spray therapy for allergic rhinitis, superficial corticosteroid therapy for acute non-concurrent dermatitis) or cytotoxic therapy for ≥14 days
  • Infants 2 months of age (42-89 days) prior to enrollment/children 2 to 5 years of age 3 months prior to enrollment received blood products within the past 3 months (excluding hepatitis B immunoglobulin within 1 month).
  • Receipt of other investigational drugs in the past 60 days or have the plan to participate in other clinical trials during this study.
  • Receipt of attenuated live vaccines in the past 14 days.
  • Receipt of inactivated or subunit vaccines in the past 7 days.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Binchuan County Center for Diseases Control and Prevention

Dali, Yunnan, 671600, China

Location

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Yan Zheng

    Yunnan Provincial Center for Disease Prevention and Control

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
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

December 13, 2023

First Posted

December 27, 2023

Study Start

January 4, 2024

Primary Completion

March 26, 2025

Study Completion

March 26, 2025

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

CN(1)