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Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04278248
Recruitment Status : Completed
First Posted : February 20, 2020
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Brief Summary:
The purpose of this study is to evaluate Immunogenicity and safety of 23-Valent Pneumococcal Polysaccharide Vaccine in healthy volunteers aged 2 Years and above.

Condition or disease Intervention/treatment Phase
Pneumonia, Pneumococcal Biological: 23-Valent Pneumococcal Polysaccharide Vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1940 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Blinded, Parallel Controlled, Phase Ⅲ Clinical Trial to Evaluate Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above
Actual Study Start Date : January 12, 2018
Actual Primary Completion Date : June 7, 2018
Actual Study Completion Date : June 7, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: experimental group
Received Vaccine: 23-valent Pneumococcal Polysaccharide Vaccine(experimental vaccine), 0.5 ml/dose
Biological: 23-Valent Pneumococcal Polysaccharide Vaccine
1 dose according to age of subjects. Single intramuscular dose contains 0.5ml 23-Valent Pneumococcal Polysaccharide Vaccine.

Active Comparator: Positive control group
Received Vaccine: 23-valent Pneumococcal Polysaccharide Vaccine (positive control vaccine), 0.5 ml/dose
Biological: 23-Valent Pneumococcal Polysaccharide Vaccine
1 dose according to age of subjects. Single intramuscular dose contains 0.5ml 23-Valent Pneumococcal Polysaccharide Vaccine.




Primary Outcome Measures :
  1. Immunogenicity study endpoint [ Time Frame: 30 day after each vaccination ]
    Percentage of participants with seroresponse to each vaccination

  2. Safety study endpoint [ Time Frame: 30 day after each vaccination ]
    Occurrence of adverse events during a 30 day follow-up period after each vaccination



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 2 years old and above healthy people.
  • Subject or legal representative who consent and has signed written informed consent.
  • Subject or legal representative who is able to comply with all study procedures.
  • Subject who didn't vaccinate pneumococcal vaccines and did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
  • Axillary temperature ≤37.0 ℃.

Exclusion Criteria:

  • History of allergy,eclampsia, epilepsy, encephalopathy and mental disease or family disease.
  • Allergic history after vaccination.
  • Known allergy to any component of the test vaccine(the test vaccine mainly contains 23 types of pneumococcal polysaccharide and PBS buffer)
  • Subjects who diagnosis of thrombocytopenia or other history of coagulopathy.
  • Known immunological impairment or dysfunction.
  • Subjects who have received whole blood, plasma, and immunoglobulin therapy within one month.
  • Known severe congenital malformations, developmental disorders; clinically diagnosed serious chronic diseases: down's syndrome, diabetes, sickle cell anemia or neurological disorders, Guillain Barre syndrome.
  • Known or suspected to suffer from: respiratory system disease,acute infection or chronic disease active period,severe cardiovascular disease, liver and kidney disease, malignant tumor, skin disease,children's mother has HIV infection and other serious and infectious diseases.
  • In pregnancy or lactation or pregnant women.
  • Subjects aged 18 years and above whose systolic blood pressure≥160mmHg and diastolic blood pressure≥100mmHg.
  • Any contraindications that investigators consider related to vaccination.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04278248


Locations
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China, Guangxi
Yizhou Center for Disease Control and Prevention
Yizhou, Guangxi, China, 530028
Sponsors and Collaborators
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Investigators
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Study Chair: Du Lin, Master Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
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Responsible Party: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT04278248    
Other Study ID Numbers: 201719906
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia, Pneumococcal
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs