Clinical trial NCT02451969: Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults and Elderly
Official title: Phase III Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine: A Double-blind, Randomized and Controlled Clinical Trial With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults, and Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2015-05-22
Enrollment: 1760
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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);

Primary outcomes:
measure: The seroconversion rates (SCR) of each of the 23 pneumococcal serotypes
timeFrame: 28 days
Secondary outcomes:
measure: The incidences of adverse events (AEs)
timeFrame: 28 days
measure: The increases of relative antibody concentration against each of the 23 pneumococcal serotypes
timeFrame: 28 days
Other outcomes:
Locations:
city: Kaifeng
country: China
facility: Kaifeng County Center for Disease Control and Prevention
state: Henan
Study officials:
affiliation: Henan Provincial Center for Disease Control and Prevention
name: Weiping Ru, BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.