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

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infections
• Intervention / Treatment: Biological: investigational 23-valent PPV; Biological: control 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.

• Study Type: Interventional
• Enrollment (Actual): 1760
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Henan
    • Kaifeng, Henan, China, 475100
      • Kaifeng County Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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);

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; Intervention: investigational 23-valent PPV	Biological: investigational 23-valent PPV; The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.
Active Comparator: Control Group; Single intramuscular injection of the control vaccine (0.5 ml) on Day 0; Intervention: control 23-valent PPV	Biological: control 23-valent PPV; The control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The seroconversion rates (SCR) of each of the 23 pneumococcal serotypes	For each serotype, the SCR is the percentage of participants with the increase of relative antibody concentration ≥ 2 folds after vaccination. The relative antibody concentrations were measured using Enzyme Linked Immunosorbent Assay (ELISA).	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidences of adverse events (AEs)	After each injection, a 30-minute safety observation was conducted immediately. The body temperature, occurrence of solicited local and general AEs on day 0 - 7 were reported. Unsolicited AEs occurred during day 0 - 28 were also reported. Each AE case was reviewed by the investigator to determine whether or not it was an adverse reaction (related to the vaccination).	28 days
The increases of relative antibody concentration against each of the 23 pneumococcal serotypes	The relative antibody concentrations in the pre- and post-immunization serum samples were measured using ELISA.	28 days

Collaborators and Investigators

• Sponsor: Sinovac Biotech Co., Ltd
• Investigators: Principal Investigator: Weiping Ru, BS, Henan Provincial Center for Disease Control and Prevention

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: May 20, 2015
• First Submitted That Met QC Criteria: May 20, 2015
• First Posted (Estimate): May 22, 2015

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 1, 2017
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections
• Other Study ID Numbers: PRO-PPV-3001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO