A Phase 1b Clinical Trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

A Randomized, Double Blinded, Positive Controlled Phase Ⅰb Clinical Trial in Participants Aged 2 Months (42-89 Days) and 2 to 5 Years to Evaluate the Safety and Immunogenicity of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pneumococcal Infectious Disease
• Intervention / Treatment: Biological: Sinovac PCV13; Biological: PREVNAR 13

Detailed Description

A phase Ⅰb 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 Chinese children aged 2 months (42-89 days) and 2 to 5 years. The trial is an randomized, double-blind and active controlled study. The objective of this study is to evaluate the safety and immunogenicity of PCV13 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is the PREVNAR 13 manufactured by Pfizer Inc. A total of 140 participants will be enrolled, including 70 children aged 2-5 years old, and 70 infants aged 2 months (42-89 days). Participants will be randomized to receive either Sinovac PCV13 or Pfizer PCV13 in a 1:1 ratio. Children aged 2-5 years old will receive 1 dose; Infants aged 2 months will receive 4 doses, including 3 doses (two-month interval) in primary vaccination and a booster dose at the age of 12-15 months.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yan Zheng; Phone Number: 18987115640; Email: yaqueer_zy@163.com

Study Locations

• China
  • Yunnan
    • Dali, Yunnan, China, 671600
      • Binchuan County Center for Diseases Control and Prevention
      • Contact: Yan Zheng; Phone Number: 18987115640; Email: yaqueer_zy@163.com
      • Contact: Shimin Zhang; Phone Number: 13987272408; Email: 704128331@qq.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Received any pneumococcal vaccine prior to enrollment.
2. History of culture confirmed bacterial pneumonia or invasive pneumococcal disease (IPD) caused by Streptococcus pneumoniae.
3. 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.
4. History of dystocia, asphyxia rescue, nervous system damage at birth (only applicable to infants aged 2 months (42-89 days))
5. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, asthma etc.
6. Autoimmune disease (such as systemic lupus erythematosus) or immunodeficiency/ immunosuppression (such as HIV, organ transplantation)
7. Severe cardiovascular diseases, such as diabetes, liver diseases, kidney diseases, malignant tumors.
8. Family history of mental illness, severe neurological disease (epilepsy or convulsions) or mental illness.
9. History of thyroidectomy, asplenia, functional asplenia; and asplenia or splenectomy resulting from any condition.
10. 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.
11. 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
12. 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).
13. Receipt of other investigational drugs in the past 60 days or have the plan to participate in other clinical trials during this study.
14. Receipt of attenuated live vaccines in the past 14 days.
15. Receipt of inactivated or subunit vaccines in the past 7 days.
16. Acute diseases or acute exacerbation of chronic diseases in the past 7 days.
17. Axillary temperature ≥37.3 °C.
18. According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infants aged 2 months in experimental group; 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; 0.5 mL dose of Sinovac PCV13 contains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.
Active Comparator: Infants aged 2 months in control group; 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; 0.5 mL dose of PREVNAR 13 contains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.
Experimental: Children aged 2-5 years in experimental group; 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; 0.5 mL dose of Sinovac PCV13 contains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.
Active Comparator: Children aged 2-5 years in control group; 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; 0.5 mL dose of PREVNAR 13 contains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse reactions	Incidence of adverse reactions within 30 days after each dose	0-30 days after each dose

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
Incidence of SAE	Incidence of SAE during the period of safety monitoring	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	The proportion of participants achieving an IgG concentration ≥0.35μg/mL (seropositivity rate) for each serotype 30 days after primary/booster immunization.	30 days after primary/booster immunization
IgG concentration ≥1.0μg/mL for infants aged 2 months	The proportion of participants achieving an IgG concentration ≥1.0μg/mL for each serotype 30 days after primary/booster immunization.	30 days after primary/booster immunization
GMCs for infants aged 2 months	GMCs for each serotype 30 days after primary/booster immunization	30 days after primary/booster immunization
GMIs for infants aged 2 months	GMIs (GMC increase folds) for each serotype 30 days after primary/booster immunization	30 days after primary/booster immunization
IgG concentration ≥0.35μg/mL for children aged 2-5 years	The proportion of participants achieving an IgG concentration ≥0.35μg/mL (seropositivity rate) for each serotype 30 days after vaccination.	30 days after vaccination
IgG concentration ≥1.0μg/mL for children aged 2-5 years	The proportion of participants achieving an IgG concentration ≥1.0μg/mL for each serotype 30 days after vaccination.	30 days after vaccination
GMCs for children aged 2-5 years	GMCs for each serotype 30 days after vaccination	30 days after vaccination
GMIs for children aged 2-5 years	GMIs (GMC increase folds) for each serotype 30 days after vaccination	30 days after vaccination

Collaborators and Investigators

• Sponsor: Sinovac Research and Development Co., Ltd.
• Investigators: Principal Investigator: Yan Zheng, Yunnan Provincial Center for Disease Prevention and Control

Study record dates

Study Major Dates

• Study Start (Estimated): January 4, 2024
• Primary Completion (Estimated): September 2, 2024
• Study Completion (Estimated): April 15, 2025

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Estimated): December 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Pneumococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: PRO-PCV-1002

Drug and device information, study documents

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