Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults and Elderly

NCT ID: NCT02451969

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1760 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-02-28

Brief Summary

The purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) in healthy children, adults and elderly. The control vaccine is a commercialized 23-valent PPV.

Detailed Description

This study is a randomized, double-blind, single-center, controlled phase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) manufactured by Sinovac Biotech Co., Ltd. The primary objective of this study is to demonstrate that the immunogenicity of the investigational vaccine is non-inferior to that of a commercialized 23-valent PPV manufactured by Chengdu Institute of Biological products Co., Ltd.; the secondary objective is to assess the safety of the investigational and control vaccines. Participants will be grouped into three cohorts by age: child cohort (2 - 17 years old), adult cohort (18 - 60 years old) and elderly cohort (≥ 61 years old). In each cohort, the participants will be randomly assigned into experimental group or control group in the ratio 1:1.

Conditions

Pneumococcal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Experimental Group

• Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0
• Intervention: investigational 23-valent PPV

Group Type: EXPERIMENTAL

investigational 23-valent PPV

Intervention Type: BIOLOGICAL

The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.

Control Group

• Single intramuscular injection of the control vaccine (0.5 ml) on Day 0
• Intervention: control 23-valent PPV

Group Type: ACTIVE_COMPARATOR

control 23-valent PPV

Intervention Type: BIOLOGICAL

The control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd.

Interventions

investigational 23-valent PPV

The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.

Intervention Type: BIOLOGICAL

control 23-valent PPV

The control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy volunteer ≥ 2 years old;
• Proven legal identity;
• Written consent of the guardian of participants < 18 years old, and written consent of the participant ≥ 12 years old;
• Complying with the requirement of the study protocol;

Exclusion Criteria

• Prior vaccination with pneumococcal vaccine;
• History of bacterial pneumonia within 3 years prior to this study;
• Pregnant, breast feeding, or women expected to conceive within 60 days after vaccination;
• History of allergy to any vaccine or vaccine ingredient;
• Receipt of any of the following products:

1. Blood product within 3 months prior to study entry;

2. Any live attenuated vaccine within 28 days prior to study entry;

3. Any subunit vaccine or inactivated vaccine within 14 days prior to study entry;

4. Any immunosuppressant within 6 month prior to study entry;

• Congenital malformation, developmental disorders, serious chronic diseases, autoimmune disease, immunodeficiency, serious cardiovascular disease, diabetes, hypertension that cannot be stabilized by medication, liver or kidney disease, or malignant tumor;
• History of asthma, thyroidectomy, angioneurotic edema, severe nervous system disease or mental illness; without spleen or splenectomy; diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities), or obvious bruising or coagulation disorders;
• Acute disease or acute stage of chronic disease within 7 days prior to study entry;
• Axillaty temperature > 37.0 °C;
• Any other factor that in the opinion of the investigator suggesting the volunteer is unsuitable for this study;
• Participants with the following conditions from day 0 - 28 would be included in the full analysis set (FAS), but would be excluded from the per protocol set (PPS):

1. Receipt of any other investigational or unregistered product (drug or vaccine);

2. Receipt of immunosuppressant (corticosteroid dosage that equivalent to or above 0.5 mg prednisone/kg weight/day) for > 14 days, except for inhalant or locally administrated corticosteroid;

3. Receipt of immunoglobulin and/or blood product;

4. Newly diagnosed autoimmune disease or immunodeficiency (e.g., HIV infection);

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinovac Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weiping Ru, BS

Role: PRINCIPAL_INVESTIGATOR

Henan Provincial Center for Disease Control and Prevention

Locations

Kaifeng County Center for Disease Control and Prevention

Kaifeng, Henan, China

Countries

China

References

Huang L, Wang L, Li H, Hu Y, Ru W, Han W, Shi G, Ye Q, Han Z, Xia J, Xia S, Xu M, Li J. A phase III clinical trial to evaluate the safety and immunogenicity of 23-valent pneumococcal polysaccharide vaccine (PPV23) in healthy children, adults, and elderly. Hum Vaccin Immunother. 2019;15(1):249-255. doi: 10.1080/21645515.2018.1509648. Epub 2018 Sep 21.

Reference Type: DERIVED

PMID: 30215583 (View on PubMed)

Other Identifiers

PRO-PPV-3001

Identifier Type: -

Identifier Source: org_study_id