Pneumococcal InfectionsPhase 1NCT05602480
Phase I Clinical Trial of a Candidate PCV13 in Healthy People
A Phase 1 study testing 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine in people with Pneumococcal Infections, run by Wuhan BravoVax Co., Ltd. at 1 site in China.
Trial summary
Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year. Since the licensure of PCV7, PCV10, PCV13 and PCV15, the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years is… Read more about this study
- Who is it for?
- Ages 6 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to Dec 2024
- 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
- Satisfy the age requirements of the clinical trial; willing to provide proof of identity;
- Subjects or guardians must provide informed consent forms with personal signature and date;
- Male and female of childbearing age should agree to take effective contraception measures;
- Subjects or guardians can obey the requirements of the clinical study;
- Axillary temperature below 37.3 °C.
Who cannot join
- Laboratory indicators (expect those have no clinical significance) out of normal ranges required;
- Received any pneumococcal vaccine;
- Allergic history to any drugs, vaccine or vaccine-related component;
- Infants with congenital malformations, developmental disorders, genetic defects, or severe malnutrition;
- Infants diagnosed with pathological jaundice that lasts for 2~4 weeks and occurs repeatedly;
- Breast-feeding or pregnant women, or positive U-HCG;
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- High blood pressure uncontrolled by medication;
- Known or suspected immune deficiency or immune suppression;
- Serious congenital malformation, history of organ resection or serious chronic illness;
- Received blood products or intravenous immunoglobulin (except Hepatitis B immunoglobulin);
- History of clinic-proven or serology-proven infectious disease especially caused by streptococcus pneumoniae;
- History of convulsions, epilepsy or encephalopathy or a family history of mental illness;
- A vaccination-related contraindications that other investigator believes;
- Plans to participate in or is participating in any other clinical study;
- Any other factors judged by investigator that may interfere subject's compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangtan Maternal and Child Health Hospital
Xiangtan, Hunan
Tao Huang
About this study
Official title: Phase I Clinical Trial to Evaluate the Safety and Explore the Immunogenicity of a Candidate PCV13 in Healthy People Aged 2 Months (Minimum 6 Weeks) and Above
Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year. Since the licensure of PCV7, PCV10, PCV13 and PCV15, the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years is approximately 60% around the world.
This is a single center, blinded, randomized, positive-controlled phase I clinical trial to evaluate the safety and explore the immunogenicity of a candidate PCV13 in healthy people aged 2 months (minimum 6 weeks) and above.
- Conditions
- Pneumococcal Infections
- Being tested
- 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
- Keywords
- Pneumonia, Pneumococcal
- Medical subject headings
- Pneumococcal Infections, Pneumonia, Pneumococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13-Valent Pneumococcal Polysaccharide Conjugate VaccineBiological
Also called PCV13
0.5mL, Intramuscular
13-Valent Pneumococcal Polysaccharide Conjugate VaccineBiological
Also called Prevnar 13
0.5mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| 1A | Experimental | Subjects received one dose of PCV13 at 18 years of age and above. Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine |
| 2A | Experimental | Subjects received one dose of PCV13 at 6~17 years of age. Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine |
| 3A | Experimental | Subjects received one dose of PCV13 at 2~5 years of age. Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine |
| 4A | Experimental | Subjects received two doses of PCV13 at 12~23 months of age. Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine |
| 5A | Experimental | Subjects received three doses of PCV13 at 7~11 months of age. Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine |
| 6A | Experimental | Subjects received four doses of PCV13 at 3 months of age. Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine |
| 6B | Experimental | Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old). Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine |
| 6C | Active comparator | Subjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old). Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine |
| 7A | Experimental | Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old). Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine |
| 7B | Active comparator | Subjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old). Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety in terms of adverse reactions
Occurrence of AEs on vaccination site (local) and non-vaccination site (systemic) of each subject
Measured: within 30 minutes post each vaccination
Safety in terms of adverse events
Occurrence of solicited AEs of each subject
Measured: within 7 days post each vaccination
Safety in terms of adverse events
Occurrence of non-solicited AEs of each subject
Measured: within 30 days post each vaccination
Safety in terms of SAEs
Occurrence of SAEs of each subject
Measured: within 6 months post last vaccination
Safety in terms of laboratory-based AEs
Occurrence of laboratory-based AEs in subjects of 2 years old and above(Arm 1A-3A)
Measured: within 4 days post each vaccination
Secondary outcomes (4)
Immunogencity in terms of seropositivity rates by ELISA
Seropositivity rates of serotype-specific pneumococcal IgG antibody in subjects of each age group
Measured: 30 days post basic vaccination
Immunogencity in terms of GMC by ELISA
GMC of serotype-specific pneumococcal IgG antibody in subjects of each age group
Measured: 30 days post basic vaccination
Immunogencity in terms of subjects with IgG concentrations ≥1.0 µg/mL
Percentage of subjects with serotype-specific IgG concentrations ≥1.0 µg/mL
Measured: 30 days post basic vaccination
Immunogencity Comparison with control vaccine group
Comparison of the seropositivity rates, GMC of serotype-specific pneumococcal IgG antibody and the Percentage of subjects with serotype-specific IgG concentrations ≥1.0 µg/mL in subjects aged 2 months of Experimental group and Control group
Measured: 30 days post basic vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Nov 2022
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan BravoVax Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hunan Provincial Center for Disease Control and Prevention, Liaoning Chengda Biotechnology CO., LTD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602480
- Sponsor's protocol ID
- CLI-09-I-2020001
- Status last verified
- Nov 2022
- First submitted
- 24 Oct 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Evaluate the Safety and Explore the Immunogenicity of a Candidate PCV13 in Healthy People Aged 2 Months (Minimum 6 Weeks) and Above
- ClinicalTrials.gov ID
- NCT05602480
- Acronym / sponsor ID
- CLI-09-I-2020001
- Conditions
- Pneumococcal Infections
- Keywords
- Pneumonia, Pneumococcal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Wuhan BravoVax Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hunan Provincial Center for Disease Control and Prevention, Liaoning Chengda Biotechnology CO., LTD
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 2 Nov 2022 (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.
Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year. Since the licensure of PCV7, PCV10, PCV13 and PCV15, the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years is approximately 60% around the world.
This is a single center, blinded, randomized, positive-controlled phase I clinical trial to evaluate the safety and explore the immunogenicity of a candidate PCV13 in healthy people aged 2 months (minimum 6 weeks) 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
- 10
| Arm | Type | Receives |
|---|---|---|
| 1A | Experimental | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate VaccineSubjects received one dose of PCV13 at 18 years of age and above. |
| 2A | Experimental | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate VaccineSubjects received one dose of PCV13 at 6~17 years of age. |
| 3A | Experimental | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate VaccineSubjects received one dose of PCV13 at 2~5 years of age. |
| 4A | Experimental | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate VaccineSubjects received two doses of PCV13 at 12~23 months of age. |
| 5A | Experimental | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate VaccineSubjects received three doses of PCV13 at 7~11 months of age. |
| 6A | Experimental | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate VaccineSubjects received four doses of PCV13 at 3 months of age. |
| 6B | Experimental | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate VaccineSubjects received four doses of PCV13 at 2 months of age (At least 6 weeks old). |
| 6C | Active comparator | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate VaccineSubjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old). |
| 7A | Experimental | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate VaccineSubjects received four doses of PCV13 at 2 months of age (At least 6 weeks old). |
| 7B | Active comparator | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate VaccineSubjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old). |
Who may qualify
- Ages
- 6 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Satisfy the age requirements of the clinical trial; willing to provide proof of identity;
- Subjects or guardians must provide informed consent forms with personal signature and date;
- Male and female of childbearing age should agree to take effective contraception measures;
- Subjects or guardians can obey the requirements of the clinical study;
- Axillary temperature below 37.3 °C.
Key exclusion criteria (15 listed)
- Laboratory indicators (expect those have no clinical significance) out of normal ranges required;
- Received any pneumococcal vaccine;
- Allergic history to any drugs, vaccine or vaccine-related component;
- Infants with congenital malformations, developmental disorders, genetic defects, or severe malnutrition;
- Infants diagnosed with pathological jaundice that lasts for 2~4 weeks and occurs repeatedly;
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 |
|---|---|---|
| 13-Valent Pneumococcal Polysaccharide Conjugate VaccineAlso: PCV130.5mL, Intramuscular | Biological | 1A, 2A, 3A, 4A, 5A, 6A, 6B, 7A |
| 13-Valent Pneumococcal Polysaccharide Conjugate VaccineAlso: Prevnar 130.5mL, Intramuscular | Biological | 6C, 7B |
Primary outcome
Safety in terms of adverse reactions
Time frame: within 30 minutes post each vaccination
Occurrence of AEs on vaccination site (local) and non-vaccination site (systemic) of each subject
Safety in terms of adverse events
Time frame: within 7 days post each vaccination
Occurrence of solicited AEs of each subject
Safety in terms of adverse events
Time frame: within 30 days post each vaccination
Occurrence of non-solicited AEs of each subject
Safety in terms of SAEs
Time frame: within 6 months post last vaccination
Occurrence of SAEs of each subject
Safety in terms of laboratory-based AEs
Time frame: within 4 days post each vaccination
Occurrence of laboratory-based AEs in subjects of 2 years old and above(Arm 1A-3A)
4 secondary outcomes
Immunogencity in terms of seropositivity rates by ELISA
Time frame: 30 days post basic vaccination
Immunogencity in terms of GMC by ELISA
Time frame: 30 days post basic vaccination
Immunogencity in terms of subjects with IgG concentrations ≥1.0 µg/mL
Time frame: 30 days post basic vaccination
Immunogencity Comparison with control vaccine group
Time frame: 30 days post basic vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
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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.
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 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine in people with Pneumococcal Infections, run by Wuhan BravoVax 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 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 17 Nov 2022. 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?
Contact Long Xu, Ph.D. (+86 27 8798 8585 ext. 8251, ct@bravovax.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety in terms of adverse reactions (time frame: within 30 minutes post each vaccination). The study lists 5 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 17 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.