Pneumococcal InfectionsPhase 3NCT02451969
Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults and Elderly
A Phase 3 study testing investigational 23-valent PPV in people with Pneumococcal Infections, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) in healthy children, adults and elderly. The control vaccine is a commercialized 23-valent PPV. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- investigational 23-valent PPV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,760 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Feb 2017
- 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
- Healthy volunteer ≥ 2 years old;
- Proven legal identity;
- Written consent of the guardian of participants < 18 years old, and written consent of the participant ≥ 12 years old;
- Complying with the requirement of the study protocol;
Who cannot join
- Prior vaccination with pneumococcal vaccine;
- History of bacterial pneumonia within 3 years prior to this study;
- Pregnant, breast feeding, or women expected to conceive within 60 days after vaccination;
- History of allergy to any vaccine or vaccine ingredient;
- Receipt of any of the following products:
- Blood product within 3 months prior to study entry;
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- Any live attenuated vaccine within 28 days prior to study entry;
- Any subunit vaccine or inactivated vaccine within 14 days prior to study entry;
- Any immunosuppressant within 6 month prior to study entry;
- Congenital malformation, developmental disorders, serious chronic diseases, autoimmune disease, immunodeficiency, serious cardiovascular disease, diabetes, hypertension that cannot be stabilized by medication, liver or kidney disease, or malignant tumor;
- History of asthma, thyroidectomy, angioneurotic edema, severe nervous system disease or mental illness; without spleen or splenectomy; diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities), or obvious bruising or coagulation disorders;
- Acute disease or acute stage of chronic disease within 7 days prior to study entry;
- Axillaty temperature > 37.0 °C;
- Any other factor that in the opinion of the investigator suggesting the volunteer is unsuitable for this study;
- Participants with the following conditions from day 0 - 28 would be included in the full analysis set (FAS), but would be excluded from the per protocol set (PPS):
- Receipt of any other investigational or unregistered product (drug or vaccine);
- Receipt of immunosuppressant (corticosteroid dosage that equivalent to or above 0.5 mg prednisone/kg weight/day) for > 14 days, except for inhalant or locally administrated corticosteroid;
- Receipt of immunoglobulin and/or blood product;
- Newly diagnosed autoimmune disease or immunodeficiency (e.g., HIV infection);
Trial locations and contacts
1 site in 1 country.
China1 site
Kaifeng County Center for Disease Control and Prevention
Kaifeng, Henan, 475100
About this study
Official title: Phase III Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine: A Double-blind, Randomized and Controlled Clinical Trial With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults, and Elderly
The purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) in healthy children, adults and elderly. The control vaccine is a commercialized 23-valent PPV.
Read the detailed description
This study is a randomized, double-blind, single-center, controlled phase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) manufactured by Sinovac Biotech Co., Ltd. The primary objective of this study is to demonstrate that the immunogenicity of the investigational vaccine is non-inferior to that of a commercialized 23-valent PPV manufactured by Chengdu Institute of Biological products Co., Ltd.; the secondary objective is to assess the safety of the investigational and control vaccines. Participants will be grouped into three cohorts by age: child cohort (2 - 17 years old), adult cohort (18 - 60 years old) and elderly cohort (≥ 61 years old). In each cohort, the participants will be randomly assigned into experimental group or control group in the ratio 1:1.
- Conditions
- Pneumococcal Infections
- Being tested
- investigational 23-valent PPV, control 23-valent PPV
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
investigational 23-valent PPVBiological
The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.
control 23-valent PPVBiological
The control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | * Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0
* Intervention: investigational 23-valent PPV Receives: Biological: investigational 23-valent PPV |
| Control Group | Active comparator | * Single intramuscular injection of the control vaccine (0.5 ml) on Day 0
* Intervention: control 23-valent PPV Receives: Biological: control 23-valent PPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
The seroconversion rates (SCR) of each of the 23 pneumococcal serotypes
For each serotype, the SCR is the percentage of participants with the increase of relative antibody concentration ≥ 2 folds after vaccination. The relative antibody concentrations were measured using Enzyme Linked Immunosorbent Assay (ELISA).
Measured: 28 days
Secondary outcomes (2)
The incidences of adverse events (AEs)
After each injection, a 30-minute safety observation was conducted immediately. The body temperature, occurrence of solicited local and general AEs on day 0 - 7 were reported. Unsolicited AEs occurred during day 0 - 28 were also reported. Each AE case was reviewed by the investigator to determine whether or not it was an adverse reaction (related to the vaccination).
Measured: 28 days
The increases of relative antibody concentration against each of the 23 pneumococcal serotypes
The relative antibody concentrations in the pre- and post-immunization serum samples were measured using ELISA.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,760 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weiping Ru, BS, Principal investigator, Henan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451969
- Sponsor's protocol ID
- PRO-PPV-3001
- Status last verified
- Jul 2015
- First submitted
- 20 May 2015
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Huang L, Wang L, Li H, Hu Y, Ru W, Han W, Shi G, Ye Q, Han Z, Xia J, Xia S, Xu M, Li J. A phase III clinical trial to evaluate the safety and immunogenicity of 23-valent pneumococcal polysaccharide vaccine (PPV23) in healthy children, adults, and elderly. Hum Vaccin Immunother. 2019;15(1):249-255. doi: 10.1080/21645515.2018.1509648. Epub 2018 Sep 21.
PubMed 30215583
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine: A Double-blind, Randomized and Controlled Clinical Trial With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults, and Elderly
- ClinicalTrials.gov ID
- NCT02451969
- Acronym / sponsor ID
- PRO-PPV-3001
- Conditions
- Pneumococcal Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,760 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 22 May 2015 (estimated)
- 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 the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) in healthy children, adults and elderly. The control vaccine is a commercialized 23-valent PPV.
Detailed description
This study is a randomized, double-blind, single-center, controlled phase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) manufactured by Sinovac Biotech Co., Ltd. The primary objective of this study is to demonstrate that the immunogenicity of the investigational vaccine is non-inferior to that of a commercialized 23-valent PPV manufactured by Chengdu Institute of Biological products Co., Ltd.; the secondary objective is to assess the safety of the investigational and control vaccines. Participants will be grouped into three cohorts by age: child cohort (2 - 17 years old), adult cohort (18 - 60 years old) and elderly cohort (≥ 61 years old). In each cohort, the participants will be randomly assigned into experimental group or control group in the ratio 1:1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: investigational 23-valent PPV* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0 * Intervention: investigational 23-valent PPV |
| Control Group | Active comparator | Biological: control 23-valent PPV* Single intramuscular injection of the control vaccine (0.5 ml) on Day 0 * Intervention: control 23-valent PPV |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteer ≥ 2 years old;
- Proven legal identity;
- Written consent of the guardian of participants < 18 years old, and written consent of the participant ≥ 12 years old;
- Complying with the requirement of the study protocol;
Key exclusion criteria (19 listed)
- Prior vaccination with pneumococcal vaccine;
- History of bacterial pneumonia within 3 years prior to this study;
- Pregnant, breast feeding, or women expected to conceive within 60 days after vaccination;
- History of allergy to any vaccine or vaccine ingredient;
- Receipt of any of the following products:
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 |
|---|---|---|
| investigational 23-valent PPVThe investigational vaccine was manufactured by Sinovac Biotech Co., Ltd. | Biological | Experimental Group |
| control 23-valent PPVThe control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd. | Biological | Control Group |
Primary outcome
The seroconversion rates (SCR) of each of the 23 pneumococcal serotypes
Time frame: 28 days
For each serotype, the SCR is the percentage of participants with the increase of relative antibody concentration ≥ 2 folds after vaccination. The relative antibody concentrations were measured using Enzyme Linked Immunosorbent Assay (ELISA).
2 secondary outcomes
The incidences of adverse events (AEs)
Time frame: 28 days
The increases of relative antibody concentration against each of the 23 pneumococcal serotypes
Time frame: 28 days
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 3 May 2017.
- Derived from this study: PubMed 30215583Huang L, Wang L, Li H, Hu Y, Ru W, Han W, Shi G, Ye Q, Han Z, Xia J, Xia S, Xu M, Li J. A phase III clinical trial to evaluate the safety and immunogenicity of 23-valent pneumococcal polysaccharide vaccine (PPV23) in healthy children, adults, and elderly. Hum Vaccin Immunother. 2019;15(1):249-255. doi: 10.1080/21645515.2018.1509648. Epub 2018 Sep 21.
- 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.
Weiping Ru, BS principal investigator
Henan Provincial Center for Disease Control and Prevention
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 investigational 23-valent PPV in people with Pneumococcal Infections, run by Sinovac Biotech 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 4 inclusion and 19 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 3 May 2017. 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?
The seroconversion rates (SCR) of each of the 23 pneumococcal serotypes (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02451969, which also lists 1 linked publication.
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 3 May 2017.