Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above
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ClinicalTrials.gov Identifier: NCT04278248 |
Recruitment Status :
Completed
First Posted : February 20, 2020
Last Update Posted : February 20, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pneumonia, Pneumococcal | Biological: 23-Valent Pneumococcal Polysaccharide Vaccine | Phase 3 |
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 |
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. |
- Immunogenicity study endpoint [ Time Frame: 30 day after each vaccination ]Percentage of participants with seroresponse to each vaccination
- Safety study endpoint [ Time Frame: 30 day after each vaccination ]Occurrence of adverse events during a 30 day follow-up period after each vaccination
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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 |
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.
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
China, Guangxi | |
Yizhou Center for Disease Control and Prevention | |
Yizhou, Guangxi, China, 530028 |
Study Chair: | Du Lin, Master | Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pneumonia, Pneumococcal Pneumonia Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases Pneumococcal Infections Streptococcal Infections |
Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Pneumonia, Bacterial Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs |