Clinical Trial of PCV24 in Infants Aged 2-23 Months

NCT06800261 | Recruiting Phase 1

• 1 other identifier: PRO-PCV24-1003
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

A Phase 1b clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 42 days)-23 months. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, positive controlled phase Ib clinical trial.

Conditions

Pneumococcal Infectious Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse reactions

  Incidence of adverse reactions within 30 days after vaccination

  0-30 days after vaccination

Secondary Outcomes (6)

• Incidence of adverse reactions

  0-7 days after vaccination

• Incidence of serious adverse events (SAE)

  from vaccination to 6 months after final dose

• Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)

  30 days after primary vaccination

• Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)

  30 days after primary vaccination

• Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL

  30 days after primary vaccination

Study Arms (2)

Experimental: Sinovac PCV24

EXPERIMENTAL

Participants aged 2 months (minimum 42 days)-23 months will receive Sinovac PCV24 according to different immunization schedules. 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 PCV24

Active Comparator: Prevnar®

ACTIVE COMPARATOR

Participants aged 2 months (minimum 42 days)-23 months will receive Prevnar 13® according to different immunization schedules. 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: Prevnar®

Interventions

Sinovac PCV24 BIOLOGICAL

Sinovac PCV24 (0.5 mL) is administered intramuscularly according to different immunization schedules.

Experimental: Sinovac PCV24

Prevnar® BIOLOGICAL

Prevnar® (0.5 mL) is administered intramuscularly according to different immunization schedules.

Active Comparator: Prevnar®

Eligibility Criteria

• Age: 42 Days - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants who are aged 2 months (42-89 days), 7-11 months, 12-23 months;
• Participants' guardian provides legal identity document and participants' vaccination record;
• Participants' guardian understands and voluntarily signs the informed consent form;
• Follow all study procedures and stay in contact during the study.

You may not qualify if:

• Received any pneumococcal vaccine prior to enrollment;
• History of invasive pneumococcal diseases or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
• History of severe adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioneurotic edema, anaphylactic shock;
• Low birth weight (\<2.5kg), or premature infant (gestation weeks \< 37 weeks) (applies to infants younger than 12 months);
• History of abnormal labor during delivery (planned cesarean section is excluded), history of asphyxia rescue and nervous system damage (applies to infants younger than 12 months);
• Congenital malformations or developmental disorders, genetic defects, severe malnutrition;
• Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases (e.g. congenital heart disease), hematological diseases (e.g. severe anemia), liver and kidney diseases, digestive diseases, respiratory diseases (such as active tuberculosis), malignant tumors and major functional organ transplantation history;
• Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection);
• Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), potential bleeding (history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture).
• Consecutively received immunosuppressive therapy (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis), or other immunoregulatory therapies, or cytotoxic therapy over 14 days within 6 months before vaccination, or plans to receive such therapies during the study.
• Received blood products prior to enrollment within 3 months prior to enrollment, or plans to receive such therapies during the study. Receipt of Hepatitis B immunoglobulin one month prior to enrollment is an exception.
• Received other investigational drugs or vaccines within 30 days prior to enrollment, or plan to receive such drugs or vaccines during the study;
• Received live attenuated vaccine within 14 days prior to enrollment;
• Received subunit or inactivated vaccine within 7 days prior to enrollment;
• Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, known or potentially active infection;

Sponsors & Collaborators

• Sinovac Life Sciences Co., Ltd.: lead

Study Sites (2)

Shandong Provincial Center for Disease Control and Prevention

Jinan, Shandong, 250014, China

NOT YET RECRUITING

Shanxian Center for Disease Control and Prevention

Shancheng, Shandong, 250014, China

RECRUITING

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Study Officials

• Qing Xu

  Shandong Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qing Xu

CONTACT

18853165516; xqepi@163.com

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: January 23, 2025
• First Posted: January 29, 2025
• Study Start: May 8, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

CN (2)