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

Pneumococcal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02451969
• Other study ID #: PRO-PPV-3001
• Status: Completed
• Phase: Phase 3
• First received: May 20, 2015
• Last updated: May 1, 2017
• Start date: April 2015
• Est. completion date: February 2017

Study information

• Verified date: July 2015
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1760
• Est. completion date: February 2017
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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);

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

Biological:
• investigational 23-valent PPV
The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.
• control 23-valent PPV
The control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd.

Locations

Country	Name	City	State
China	Kaifeng County Center for Disease Control and Prevention	Kaifeng	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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