Pneumonia, PneumococcalPhase 3NCT04357522
Immunogenicity and Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in 2-month-old and 3-month-old Healthy Volunteers
A Phase 3 study testing 15-Valent Pneumococcal Conjugate Vaccine and 13-Valent Pneumococcal Conjugate Vaccine in people with Pneumonia, Pneumococcal, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 3 sites in China.
Trial summary
The purpose of this study is to evaluate Immunogenicity and safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged 2 and 3 months. Read more about this study
- Who is it for?
- Ages 6 weeks to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Pneumococcal
- What is being tested?
- 15-Valent Pneumococcal Conjugate Vaccine and 13-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
- 1,950 participants
- Where
- 3 sitesChina
- Study dates
- Jul 2020to Mar 2026
- 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 6 weeks to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged above 2 months (minimum to 6 weeks), term (37-42 weeks gestation) and birth weight ≥2.5 kg.
- The guardian understands the vaccination and research procedures, volunteers to participate in the research and sign the informed consent.
- The guardian can follow the clinical research program, will be able to follow up until 3 years after booster immunization and have the ability to use thermometers, scale and fill in diary and contact cards as required.
- There was no history of other live vaccines in the past 14 days and no history of other inactivated vaccines in the seventh day.
- Subaxillary body temperature <=37.0 C.
- Determine health based on medical history, physical examination, and researcher's judgment.
Who cannot join
- Have been vaccinated a listed or experimental pneumococcal vaccine.
- History of invasive diseases caused by Streptococcus pneumoniae confirmed by bacterial culture in the past.
- In the past, there was any history of vaccination or serious allergy to drugs. In the past, fever of over 39.5 C related to vaccination occurred in biological products for vaccination and prophylaxis.
- History of convulsion, epilepsy, encephalopathy and psychiatry or family history.
- Had abnormal labor (dystocia, device midwifery), history of asphyxia rescue and nerve organ damage.
- History of pathological jaundice confirmed by diagnosis.
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- A history of thrombocytopenia or other coagulation disorders with definite diagnosis.
- Human serum gamma globulin injection after birth.
- There are known or suspected immunological abnormalities, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), HIV infection, etc.
- Congenital malformations, severe malnutrition, developmental disorders, genetic defects (e.g. broad bean disease).
- Severe chronic disease, infectious disease, active infection, liver disease, kidney disease, cardiovascular disease, malignant tumor.
- Severe asthma.
- Systemic rash, dermatophytes, skin pus or blister.
- Participation in other drug clinical trials.
- Anything that the researcher considers likely to affect the evaluation of the study.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Daming Center for Disease Control and Prevention
Daming, Hebei, 056900
Liu Yong, 86 13831030598, dmxcdc@126.com
Laishui Center for Disease Control and Prevention
Laishui, Hebei, 074199
Zhang Po, 86 18903365570, m18903365570@163.com
Zhengding Center for Disease Control and Prevention
Zhengding, Hebei, 050800
Zhang Xinjiang, 86 13933170448, 13473793896@163.com
About this study
Official title: A Single-center, Randomised, Blind, Similar Vaccine Control, Non-inferior Designed Phase III Clinical Trial to Evaluate Immunogenicity and Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in 2-month-old and 3-month-old Healthy Volunteers
The purpose of this study is to evaluate Immunogenicity and safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged 2 and 3 months.
- Conditions
- Pneumonia, Pneumococcal
- Being tested
- 15-Valent Pneumococcal Conjugate Vaccine, 13-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
4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.
13-Valent Pneumococcal Conjugate VaccineBiological
4/1 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(experimental vaccine), 0.5 ml/dose Receives: Biological: 15-Valent Pneumococcal Conjugate Vaccine |
| Positive control group | Active comparator | Received Vaccine: 13-valent pneumococcal Conjugate Vaccine(positive control vaccine), 0.5 ml/dose Receives: Biological: 13-Valent Pneumococcal Conjugate 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 posted22 Apr 2020
- Study startJul 2020 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,950 participants (estimated)
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
- NCT04357522
- Sponsor's protocol ID
- 201904002
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomised, Blind, Similar Vaccine Control, Non-inferior Designed Phase III Clinical Trial to Evaluate Immunogenicity and Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in 2-month-old and 3-month-old Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04357522
- Acronym / sponsor ID
- 201904002
- Conditions
- Pneumonia, Pneumococcal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,950 participants (estimated)
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2020 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 22 Apr 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 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged 2 and 3 months.
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: 15-Valent Pneumococcal Conjugate VaccineReceived Vaccine: 15-valent pneumococcal Conjugate Vaccine(experimental vaccine), 0.5 ml/dose |
| Positive control group | Active comparator | Biological: 13-Valent Pneumococcal Conjugate VaccineReceived Vaccine: 13-valent pneumococcal Conjugate Vaccine(positive control vaccine), 0.5 ml/dose |
Who may qualify
- Ages
- 6 weeks to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged above 2 months (minimum to 6 weeks), term (37-42 weeks gestation) and birth weight ≥2.5 kg.
- The guardian understands the vaccination and research procedures, volunteers to participate in the research and sign the informed consent.
- The guardian can follow the clinical research program, will be able to follow up until 3 years after booster immunization and have the ability to use thermometers, scale and fill in diary and contact cards as required.
- There was no history of other live vaccines in the past 14 days and no history of other inactivated vaccines in the seventh day.
- Subaxillary body temperature <=37.0 C.
Key exclusion criteria (15 listed)
- Have been vaccinated a listed or experimental pneumococcal vaccine.
- History of invasive diseases caused by Streptococcus pneumoniae confirmed by bacterial culture in the past.
- In the past, there was any history of vaccination or serious allergy to drugs. In the past, fever of over 39.5 C related to vaccination occurred in biological products for vaccination and prophylaxis.
- History of convulsion, epilepsy, encephalopathy and psychiatry or family history.
- Had abnormal labor (dystocia, device midwifery), history of asphyxia rescue and nerve organ damage.
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 Vaccine4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine. | Biological | experimental group |
| 13-Valent Pneumococcal Conjugate Vaccine4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine. | Biological | Positive control 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
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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.
Zhengding Center for Disease Control and Prevention
Zhengding, China
Du Lin, Master study chair
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 15-Valent Pneumococcal Conjugate Vaccine and 13-Valent Pneumococcal Conjugate Vaccine in people with Pneumonia, Pneumococcal, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 3 sites 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 15 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 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
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 22 Apr 2020.