Pneumococcal Infectious DiseasesPhase 3NCT02285036
Safety and Immunogenicity of a Newly 23-valent Pneumococcal Polysaccharide Vaccine in Chinese Adults and Children
A Phase 3 study testing vaccination PPV23 and vaccination PNEUMOVAX 23 in people with Pneumococcal Infectious Diseases, run by Walvax Biotechnology Co., Ltd. at 1 site in China.
Trial summary
A newly 23-valent pneumococcal polysaccharide vaccine was developed with promising safety and immunogenicity demonstrated in the phase III trial in China. A large scale, double blind, randomized, PNEUMOVAX 23 (Merck \& Co., Inc.) controlled phase 3 clinical trial was conducted. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Pneumococcal Infectious Diseases
- What is being tested?
- vaccination PPV23 and vaccination PNEUMOVAX 23
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,660 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to May 2013
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Healthy participants older than 2 years were recruited and enrolled in September or October 2012.
- Participants with axillary temperature less than Celsius 37 degrees
- Not yet having received pneumococcal vaccine and other prevention products within 7 days.
Who cannot join
- Exclusion criteria were any known primary or secondary immunodeficiency
- Allergy
- Severe cardiovascular disease bleeding disorders
- Receipt of immunoglobulin or blood products within one month and so on.-
Trial locations and contacts
1 site in 1 country.
China1 site
Guangxi Provincial Center for Diseases Control and Prevention
Nanning, Guangxi
About this study
Official title: A Phase III Clinical Trial for a Newly 23-valent Pneumococcal Polysaccharide Vaccine in Chinese Adults and Children
A newly 23-valent pneumococcal polysaccharide vaccine was developed with promising safety and immunogenicity demonstrated in the phase III trial in China. A large scale, double blind, randomized, PNEUMOVAX 23 (Merck \& Co., Inc.) controlled phase 3 clinical trial was conducted.
Read the detailed description
The World Health Organization (WHO) estimated that more than 800 000 children younger than 5 years died from pneumococcal disease in 2000, making it the leading vaccine-preventable cause of death. Pneumococcal polysaccharide vaccines have progressed from 2-valent vaccines to the current 23-valent vaccine, which has been available since the early 1980s. The 23-valent vaccine includes serotypes accounting for 72% to 95% of invasive pneumococcal disease, depending on the geographic area. Many countries have added pneumococcal polysaccharide vaccine to their existing national immunization programs or recommended it for people aged 65 years and older and for individuals aged 2-64 who are at increased risk of pneumococcal disease.
A newly 23-valent pneumococcal polysaccharide vaccine was developed with promising safety and immunogenicity demonstrated in the phase III trial in China. A large scale, double blind, randomized, PNEUMOVAX 23 (Merck \& Co., Inc.) controlled phase 3 clinical trial was conducted.
- Conditions
- Pneumococcal Infectious Diseases
- Being tested
- vaccination PPV23, vaccination PNEUMOVAX 23
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaccination PPV23Biological
All eligible participants were stratified into four age strata namely, 2 to 6 years, 7 to 17 years, 18 to 59 years and more than 60 years. Stratified, block randomization with a size of eight was applied. Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1. Blood samples were obtained from each subject at baseline, day 30-35 after injection, to evaluate immunogenicity.
vaccination PNEUMOVAX 23Biological
Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1.
| Study group | Role | What they receive |
|---|---|---|
| A newly PPV23 | Experimental | The treatment pneumococcal vaccine was developed by Yunnan Walvax Biotech Co., Ltd (Walvax) China, is a sterile, liquid vaccine for intramuscular or subcutaneous injection. It consists of a mixture of highly purified capsular polysaccharides from the 23 most prevalent or invasive pneumococcal types of Streptococcus pneumoniae, including the six serotypes that most frequently cause invasive drug-resistant pneumococcal infections among children and adults in China. The dose of vaccine is an individual with a 0.5ml dose contains 23 kinds of pneumococcal polysaccharide serotypes each 25μg, and does not contain any preservatives. Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1. Receives: Biological: vaccination PPV23 |
| PNEUMOVAX 23 | Active comparator | PNEUMOVAX 23 is an established US-licensed vaccine and manufactured by the Merck Research Laboratories. Each 0.5 mL dose of vaccine contains 25μg of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative.Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1. Receives: Biological: vaccination PNEUMOVAX 23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of 2-fold increase of anti-pneumococcal antibody
Measured: 30 days after the injection of vaccination
Secondary outcomes (2)
geometric mean concentration (GMC)
Measured: 30 days after the injection of vaccination
geometric mean fold increase (GMFI)
Measured: 30 days after the injection of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal Infectious DiseasesStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walvax Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangxi Center for Disease Control and Prevention, Air Force Military Medical University, China
- Responsible party
- Sponsor
- Investigators
- Yanping Li, Principal investigator, Guangxi Provincial Center for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285036
- Sponsor's protocol ID
- Walvax-01
- Status last verified
- Nov 2014
- First submitted
- 28 Oct 2014
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Trial for a Newly 23-valent Pneumococcal Polysaccharide Vaccine in Chinese Adults and Children
- ClinicalTrials.gov ID
- NCT02285036
- Acronym / sponsor ID
- Walvax-01
- Conditions
- Pneumococcal Infectious Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,660 participants (actual)
- Lead sponsor
- Walvax Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Guangxi Center for Disease Control and Prevention, Air Force Military Medical University, China
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 6 Nov 2014 (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.
A newly 23-valent pneumococcal polysaccharide vaccine was developed with promising safety and immunogenicity demonstrated in the phase III trial in China. A large scale, double blind, randomized, PNEUMOVAX 23 (Merck \& Co., Inc.) controlled phase 3 clinical trial was conducted.
Detailed description
The World Health Organization (WHO) estimated that more than 800 000 children younger than 5 years died from pneumococcal disease in 2000, making it the leading vaccine-preventable cause of death. Pneumococcal polysaccharide vaccines have progressed from 2-valent vaccines to the current 23-valent vaccine, which has been available since the early 1980s. The 23-valent vaccine includes serotypes accounting for 72% to 95% of invasive pneumococcal disease, depending on the geographic area. Many countries have added pneumococcal polysaccharide vaccine to their existing national immunization programs or recommended it for people aged 65 years and older and for individuals aged 2-64 who are at increased risk of pneumococcal disease.
A newly 23-valent pneumococcal polysaccharide vaccine was developed with promising safety and immunogenicity demonstrated in the phase III trial in China. A large scale, double blind, randomized, PNEUMOVAX 23 (Merck \& Co., Inc.) controlled phase 3 clinical trial was conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A newly PPV23 | Experimental | Biological: vaccination PPV23The treatment pneumococcal vaccine was developed by Yunnan Walvax Biotech Co., Ltd (Walvax) China, is a sterile, liquid vaccine for intramuscular or subcutaneous injection. It consists of a mixture of highly purified capsular polysaccharides from the 23 most prevalent or invasive pneumococcal types of Streptococcus pneumoniae, including the six serotypes that most frequently cause invasive drug-resistant pneumococcal infections among children and adults in China. The dose of vaccine is an individual with a 0.5ml dose contains 23 kinds of pneumococcal polysaccharide serotypes each 25μg, and does not contain any preservatives. Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1. |
| PNEUMOVAX 23 | Active comparator | Biological: vaccination PNEUMOVAX 23PNEUMOVAX 23 is an established US-licensed vaccine and manufactured by the Merck Research Laboratories. Each 0.5 mL dose of vaccine contains 25μg of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative.Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy participants older than 2 years were recruited and enrolled in September or October 2012.
- Participants with axillary temperature less than Celsius 37 degrees
- Not yet having received pneumococcal vaccine and other prevention products within 7 days.
Key exclusion criteria (4 listed)
- Exclusion criteria were any known primary or secondary immunodeficiency
- Allergy
- Severe cardiovascular disease bleeding disorders
- Receipt of immunoglobulin or blood products within one month and so on.-
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 |
|---|---|---|
| vaccination PPV23All eligible participants were stratified into four age strata namely, 2 to 6 years, 7 to 17 years, 18 to 59 years and more than 60 years. Stratified, block randomization with a size of eight was applied. Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1. Blood samples were obtained from each subject at baseline, day 30-35 after injection, to evaluate immunogenicity. | Biological | A newly PPV23 |
| vaccination PNEUMOVAX 23Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1. | Biological | PNEUMOVAX 23 |
Primary outcome
the rate of 2-fold increase of anti-pneumococcal antibody
Time frame: 30 days after the injection of vaccination
2 secondary outcomes
geometric mean concentration (GMC)
Time frame: 30 days after the injection of vaccination
geometric mean fold increase (GMFI)
Time frame: 30 days after the injection of 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 6 Nov 2014.
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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.
Yanping Li principal investigator
Guangxi Provincial Center for Diseases 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 vaccination PPV23 and vaccination PNEUMOVAX 23 in people with Pneumococcal Infectious Diseases, run by Walvax Biotechnology 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 3 inclusion and 4 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 6 Nov 2014. 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 rate of 2-fold increase of anti-pneumococcal antibody (time frame: 30 days after the injection of vaccination). 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 6 Nov 2014.