Pneumonia, PneumococcalPhase 1NCT04108845
Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in Healthy Volunteers Aged Above 2 Months
A Phase 1 study testing 15-Valent Pneumococcal Conjugate 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 safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged above 3 Months. Read more about this study
- Who is it for?
- Ages 6 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Pneumococcal
- What is being tested?
- 15-Valent Pneumococcal Conjugate Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2019to Aug 2020
- Phase
- Phase 1
- 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 6 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 2 months old (at a minimum of 6 weeks old) and above healthy people.
- Subject or legal representative who consent and has signed written informed consent.
- Subject and parent/guardian who is able to comply with all study procedures and to use thermometer, scale and fill in diary card and contact card as required.
- Subject who didn't vaccinate 13-valent or 7-valent pneumococcal conjugate vaccine.
- Subject who 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
- Subject with a history of a prior bacterial culture of an aggressive disease caused by S. pneumoniae.
- Subject with any previous history of severe vaccination or drug allergy, occurrence of fever ≥ 39.0° related to vaccination of biological products for previous vaccination.
- Subject who are allergic to diphtheria toxins.
- Children below 1 year old with abnormal labor（dystocia, instrument midwifery), birth weight <2500g, asphyxia rescue history, nerve organ damage history, and pathological history of yellow plague determined by diagnosis.
- History of allergy，eclampsia, epilepsy,brain trauma,encephalopathy and mental disease or family disease.
- Subject who diagnosis of thrombocytopenia or other history of coagulopathy.
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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: severe cardiovascular disease, liver and kidney disease, malignant tumor, skin disease, serious respiratory system disease, acute infection or chronic disease active period.
- Known or suspected to suffer from immunological abnormalities, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroids, antimetabolic drugs, cytotoxicity drugs), HIV infection, etc.
- Received blood products or immunoglobulin within 3 months before enrolling (hepatitis B immunoglobulin was acceptable), or planned to use it during the clinical trial period (before blood samples were collected after immunization).
- Subject who plan to participate in or is in any other clinical trial (vaccines, drugs, medical devices, etc.).
- In pregnancy or lactation or pregnant women.
- ≥18-year-old subject with blood routine, blood chemistry or urinalysis laboratory collection abnormalities.
- Any condition that, in the judgment of investigator, may affect trial assessment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Laishui Center for Disease Control and Prevention
Laishui, Hebei, 074199
Zhang Po, 86 18903365570, m18903365570@163.com
About this study
Official title: A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of 15-Valent Pneumococcal Conjugate Vaccine in Healthy Volunteers Aged Above 2 Months
The purpose of this study is to evaluate safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged above 3 Months.
- Conditions
- Pneumonia, Pneumococcal
- Being tested
- 15-Valent Pneumococcal Conjugate 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.
15-Valent Pneumococcal Conjugate VaccineBiological
3/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Received Vaccine: 15-valent pneumococcal Conjugate Vaccine, 0.5 ml/dose Receives: Biological: 15-Valent Pneumococcal Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events in 30 minutes
Occurrence of adverse events in 30 minutes after each vaccination
Measured: 30 minutes after each vaccination
Solicited adverse events during 7 days
Occurrence of solicited adverse events during a 7-day follow-up period after each vaccination
Measured: 7 days after each vaccination
Unsolicited adverse events during 30 days
Occurrence of unsolicited adverse events during a 30-day follow-up period after each vaccination
Measured: 30 days after each vaccination
SAE
Occurrence of serious adverse events (SAE) from enrolling to 6 months after all vaccinations
Measured: from enrolling to 6 months after all vaccinations
Blood routine of subjects over 18 years old at the fourth day
Blood routine test results of subjects over 18 years old at the fourth day after vaccination
Measured: 4 days after vaccination
Blood biochemistry of subjects over 18 years old at the fourth day
Blood biochemistry test results of subjects over 18 years old at the fourth day after vaccination
Measured: 4 days after vaccination
Urine routine of subjects over 18 years old at the fourth day
Urine routine test results of subjects over 18 years old at the fourth day after vaccination
Measured: 4 days after vaccination
Secondary outcomes (2)
Subjects ratio of vaccine serotype specific pneumococcal IgG antibody concentration ≥ 0.35 ug/ml or 1.0 ug/ml in 2-month-old and 3-month-old subjects
Subjects ratio of vaccine serotype specific pneumococcal IgG antibody concentration ≥ 0.35 ug/ml or 1.0 ug/ml in 2-month-old and 3-month-old subjects on 30 days after immunization with 15-valent pneumococcal polysaccharide conjugate vaccine
Measured: 30 days after immunization
GMC of vaccine serotype specific pneumococcal IgG antibody in 2-month-old and 3-month-old subjects
Geometric mean concentration (GMC) of vaccine serotype specific pneumococcal IgG antibody in 2-month-old and 3-month-old subjects on 30 days after immunization with 15-valent pneumococcal polysaccharide conjugate vaccine
Measured: 30 days after immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start5 Jun 2019
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hebei Provincial Center for Diseases Control and Prevention, Laishui Center for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Simoon Record Pharma Information Consulting Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Du Lin, Master, Study chair, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108845
- Sponsor's protocol ID
- 201807001
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2019
- Last updated
- 30 Sep 2019
- 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 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of 15-Valent Pneumococcal Conjugate Vaccine in Healthy Volunteers Aged Above 2 Months
- ClinicalTrials.gov ID
- NCT04108845
- Acronym / sponsor ID
- 201807001
- Conditions
- Pneumonia, Pneumococcal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Hebei Provincial Center for Diseases Control and Prevention, Laishui Center for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Simoon Record Pharma Information Consulting Co., Ltd.
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 30 Sep 2019 (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 safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged above 3 Months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Biological: 15-Valent Pneumococcal Conjugate VaccineReceived Vaccine: 15-valent pneumococcal Conjugate Vaccine, 0.5 ml/dose |
Who may qualify
- Ages
- 6 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 2 months old (at a minimum of 6 weeks old) and above healthy people.
- Subject or legal representative who consent and has signed written informed consent.
- Subject and parent/guardian who is able to comply with all study procedures and to use thermometer, scale and fill in diary card and contact card as required.
- Subject who didn't vaccinate 13-valent or 7-valent pneumococcal conjugate vaccine.
- Subject who did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
Key exclusion criteria (14 listed)
- Subject with a history of a prior bacterial culture of an aggressive disease caused by S. pneumoniae.
- Subject with any previous history of severe vaccination or drug allergy, occurrence of fever ≥ 39.0° related to vaccination of biological products for previous vaccination.
- Subject who are allergic to diphtheria toxins.
- Children below 1 year old with abnormal labor（dystocia, instrument midwifery), birth weight <2500g, asphyxia rescue history, nerve organ damage history, and pathological history of yellow plague determined by diagnosis.
- History of allergy，eclampsia, epilepsy,brain trauma,encephalopathy and mental disease or family disease.
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 |
|---|---|---|
| 15-Valent Pneumococcal Conjugate Vaccine3/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine. | Biological | experimental group |
Primary outcome
Adverse events in 30 minutes
Time frame: 30 minutes after each vaccination
Occurrence of adverse events in 30 minutes after each vaccination
Solicited adverse events during 7 days
Time frame: 7 days after each vaccination
Occurrence of solicited adverse events during a 7-day follow-up period after each vaccination
Unsolicited adverse events during 30 days
Time frame: 30 days after each vaccination
Occurrence of unsolicited adverse events during a 30-day follow-up period after each vaccination
SAE
Time frame: from enrolling to 6 months after all vaccinations
Occurrence of serious adverse events (SAE) from enrolling to 6 months after all vaccinations
Blood routine of subjects over 18 years old at the fourth day
Time frame: 4 days after vaccination
Blood routine test results of subjects over 18 years old at the fourth day after vaccination
Blood biochemistry of subjects over 18 years old at the fourth day
Time frame: 4 days after vaccination
Blood biochemistry test results of subjects over 18 years old at the fourth day after vaccination
Urine routine of subjects over 18 years old at the fourth day
Time frame: 4 days after vaccination
Urine routine test results of subjects over 18 years old at the fourth day after vaccination
2 secondary outcomes
Subjects ratio of vaccine serotype specific pneumococcal IgG antibody concentration ≥ 0.35 ug/ml or 1.0 ug/ml in 2-month-old and 3-month-old subjects
Time frame: 30 days after immunization
GMC of vaccine serotype specific pneumococcal IgG antibody in 2-month-old and 3-month-old subjects
Time frame: 30 days after immunization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- 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 1 study testing 15-Valent Pneumococcal Conjugate 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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 30 Sep 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events in 30 minutes (time frame: 30 minutes after each vaccination). The study lists 7 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 30 Sep 2019.