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
1 other identifier
interventional
1,760
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 20, 2015
CompletedFirst Posted
Study publicly available on registry
May 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedMay 3, 2017
July 1, 2015
2 months
May 20, 2015
May 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
The incidences of adverse events (AEs)
28 days
The increases of relative antibody concentration against each of the 23 pneumococcal serotypes
28 days
Study Arms (2)
Experimental Group
EXPERIMENTAL* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0 * Intervention: investigational 23-valent PPV
Control Group
ACTIVE COMPARATOR* Single intramuscular injection of the control vaccine (0.5 ml) on Day 0 * Intervention: control 23-valent PPV
Interventions
The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.
The control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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:
- Blood product within 3 months prior to study entry;
- Any live attenuated vaccine within 28 days prior to study entry;
- Any subunit vaccine or inactivated vaccine within 14 days prior to study entry;
- 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):
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaifeng County Center for Disease Control and Prevention
Kaifeng, Henan, 475100, China
Related Publications (1)
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.
PMID: 30215583DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weiping Ru, BS
Henan Provincial Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2015
First Posted
May 22, 2015
Study Start
April 1, 2015
Primary Completion
June 1, 2015
Study Completion
February 1, 2017
Last Updated
May 3, 2017
Record last verified: 2015-07
Data Sharing
- IPD Sharing
- Will not share