Pneumonia, PneumococcalPhase 3NCT04278248
Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above
A Phase 3 study testing 23-Valent Pneumococcal Polysaccharide Vaccine in people with Pneumonia, Pneumococcal, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Pneumococcal
- What is being tested?
- 23-Valent Pneumococcal Polysaccharide Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,940 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2018to 7 Jun 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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 ℃.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Yizhou Center for Disease Control and Prevention
Yizhou, Guangxi, 530028
About this study
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
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.
- Conditions
- Pneumonia, Pneumococcal
- Being tested
- 23-Valent Pneumococcal Polysaccharide Vaccine
- Medical subject headings
- Pneumonia, Pneumococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
23-Valent Pneumococcal Polysaccharide VaccineBiological
1 dose according to age of subjects. Single intramuscular dose contains 0.5ml 23-Valent Pneumococcal Polysaccharide Vaccine.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Received Vaccine: 23-valent Pneumococcal Polysaccharide Vaccine(experimental vaccine), 0.5 ml/dose Receives: Biological: 23-Valent Pneumococcal Polysaccharide Vaccine |
| Positive control group | Active comparator | Received Vaccine: 23-valent Pneumococcal Polysaccharide Vaccine (positive control vaccine), 0.5 ml/dose Receives: Biological: 23-Valent Pneumococcal Polysaccharide Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity study endpoint
Percentage of participants with seroresponse to each vaccination
Measured: 30 day after each vaccination
Safety study endpoint
Occurrence of adverse events during a 30 day follow-up period after each vaccination
Measured: 30 day after each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start12 Jan 2018
- Primary completion7 Jun 2018
- Study completion7 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, PneumococcalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,940 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Du Lin, Master, Study chair, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278248
- Sponsor's protocol ID
- 201719906
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04278248
- Acronym / sponsor ID
- 201719906
- Conditions
- Pneumonia, Pneumococcal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,940 participants (actual)
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 7 Jun 2018 (actual)
- Study completion
- 7 Jun 2018 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Biological: 23-Valent Pneumococcal Polysaccharide VaccineReceived Vaccine: 23-valent Pneumococcal Polysaccharide Vaccine(experimental vaccine), 0.5 ml/dose |
| Positive control group | Active comparator | Biological: 23-Valent Pneumococcal Polysaccharide VaccineReceived Vaccine: 23-valent Pneumococcal Polysaccharide Vaccine (positive control vaccine), 0.5 ml/dose |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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 ℃.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 23-Valent Pneumococcal Polysaccharide Vaccine1 dose according to age of subjects. Single intramuscular dose contains 0.5ml 23-Valent Pneumococcal Polysaccharide Vaccine. | Biological | Positive control group, experimental group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Du Lin, Master study chair
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 23-Valent Pneumococcal Polysaccharide Vaccine in people with Pneumonia, Pneumococcal, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity study endpoint (time frame: 30 day after each vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.