Diseases Caused by Streptococcus Pneumoniae SerotypesPhase 3NCT02736240
Immunogenicity and Safety Study of the 13-valent Pneumococcal Polysaccharide Conjugate Vaccine in 2-71 Months Old Healthy Infants and Toddlers (the Youngest Could be 6 Weeks Old)
A Phase 3 study testing 7-valent pneumococcal conjugate vaccine and 13-valent pneumococcal polysaccharide conjugate vaccine in people with Diseases Caused by Streptococcus Pneumoniae Serotypes, run by Walvax Biotechnology Co., Ltd..
Trial summary
The purpose of this study is to investigate and valuate the immunogenicity and safety of the 13-valent pneumococcal polysaccharide conjugate vaccine in 2-71 months old healthy infants and toddlers (the youngest could be 6 weeks old) Read more about this study
- Who is it for?
- Ages 2 to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- Diseases Caused by Streptococcus Pneumoniae Serotypes
- What is being tested?
- 7-valent pneumococcal conjugate vaccine and 13-valent pneumococcal polysaccharide conjugate vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,760 participants
- Where
- No sites listed yet
- Study dates
- 8 Apr 2016to 3 Dec 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 to 71 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 2-71 months (the youngest could be 6 weeks old) infants or toddlers which are positively healthy based on the medical history, the physical examination and the judgment of the investigator;
- The statutory guardian (or the consignor) of the subject agree his/her child participate in the study, and is willing to sign the informed consent form;
- The subject and his/her statutory guardians (or the consignor) are able to comply with the requests of the clinical study protocol;
- Never be immunized with any pneumococcus vaccine, and didn't get immunization with any other preventive product in the past 10 days (didn't get immunized with attenuated live vaccine in the past 14 days);
- The auxillary temperature ≤37℃.
Who cannot join
- Has already been immunized with pneumococcus vaccine no matter it is experimental or marketed;
- With the history of invasive disease caused by streptococcus pneumonia by culture;
- With the history of serious allergy to any vaccine or drug, has got fever higher than 39℃ related to immunization with preventive biological product;
- Infant that the birth weight is lighter than 2.5 kg;
- With the history or the family history of seizure, epilepsy, cerebropathy and psychosis ;
- Infant with the abnormal labor (difficult labor, deliver with apparatus) or with the history of asphyxia or nervous damage;
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- With the history of thrombocytopenia or other coagulation disorders by definite diagnosis;
- Infant or toddler with pathological jaundice by diagnosis;
- Be known with or suspected with immunological dysfunction, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroid hormone, antimetabolites, cytotoxic drug), HIV infection etc. ;
- Be known with serious congenital malformation or serious chronic disease; suffer from congenital malformation or be diagnosed with serious chronic disease (eg. Down syndrome, diabetes mellitus, sickle cell anemia or nervous disease, Guillain-Barre syndrome);
- Be known with or suspected with diseases including: disease of respiratory system, acute infection or the active period of chronic disease, serious cardiovascular disease, hepatic-nephrotic disease, malignant tumor, skin disease;
- Has taken blood product or globulin (the hepatitis B immune globulin is allowed);
- Be participating in other clinical trials;
- Any other situation which is considered to influence the evaluation of the study by investigators .
About this study
Official title: Immunogenicity and Safety Study of the 13-valent Pneumococcal Polysaccharide Conjugate Vaccine Developed Cooperatively by YunNan Walvax Biotechnology Co., Lt and Yuxi Walvax Biotechnology Co., Lt Among 2-71 Months (the Youngest Could be 6 Weeks) Healthy Infants and Toddlers by Randomized Blind Method With Similar Control in Multi-centers.
The purpose of this study is to investigate and valuate the immunogenicity and safety of the 13-valent pneumococcal polysaccharide conjugate vaccine in 2-71 months old healthy infants and toddlers (the youngest could be 6 weeks old)
- Being tested
- 7-valent pneumococcal conjugate vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-valent pneumococcal conjugate vaccineBiological
13-valent pneumococcal polysaccharide conjugate vaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | 7-valent pneumococcal conjugate vaccine Receives: Biological: 7-valent pneumococcal conjugate vaccine |
| Test Arm | Experimental | 13-valent pneumococcal conjugate vaccine 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.
positive rate after infant doses
the rate of the immunoglobulin G ≥0.35μg/ml after infant doses
Measured: 30 days after infant doses
GMC after infant doses
geometrical mean concentration of immunoglobulin G after infant doses
Measured: 30 days after infant doses
positive rate after booster dose
the rate of the immunoglobulin G ≥0.35μg/ml after booster dose
Measured: 30 days after booster dose
GMC after booster dose
geometrical mean concentration of immunoglobulin G after booster dose
Measured: 30 days after booster dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study start8 Apr 2016
- Primary completion3 Dec 2017
- Study completion3 Dec 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 Diseases Caused by Streptococcus Pneumoniae SerotypesStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,760 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walvax Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nianmin Shi, Principal investigator, Beijing Chaoyang disease control and prevention center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736240
- Sponsor's protocol ID
- 022152015003
- Status last verified
- Oct 2020
- First submitted
- 31 Mar 2016
- Last updated
- 14 Oct 2020
- Results posted
- No
Publications
Chen JJ, Yuan L, Huang Z, Shi NM, Zhao YL, Xia SL, Li GH, Li RC, Li YP, Yang SY, Xia JL. Safety and immunogenicity of a new 13-valent pneumococcal conjugate vaccine versus a licensed 7-valent pneumococcal conjugate vaccine: a study protocol of a randomised non-inferiority trial in China. BMJ Open. 2016 Oct 19;6(10):e012488. doi: 10.1136/bmjopen-2016-012488.
PubMed 27798013
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of the 13-valent Pneumococcal Polysaccharide Conjugate Vaccine Developed Cooperatively by YunNan Walvax Biotechnology Co., Lt and Yuxi Walvax Biotechnology Co., Lt Among 2-71 Months (the Youngest Could be 6 Weeks) Healthy Infants and Toddlers by Randomized Blind Method With Similar Control in Multi-centers.
- ClinicalTrials.gov ID
- NCT02736240
- Acronym / sponsor ID
- 022152015003
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,760 participants (actual)
- Lead sponsor
- Walvax Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2016 (actual)
- Primary completion
- 3 Dec 2017 (actual)
- Study completion
- 3 Dec 2017 (actual)
- First posted
- 13 Apr 2016 (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 investigate and valuate the immunogenicity and safety of the 13-valent pneumococcal polysaccharide conjugate vaccine in 2-71 months old healthy infants and toddlers (the youngest could be 6 weeks old)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Biological: 7-valent pneumococcal conjugate vaccine7-valent pneumococcal conjugate vaccine |
| Test Arm | Experimental | Biological: 13-valent pneumococcal polysaccharide conjugate vaccine13-valent pneumococcal conjugate vaccine |
Who may qualify
- Ages
- 2 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 2-71 months (the youngest could be 6 weeks old) infants or toddlers which are positively healthy based on the medical history, the physical examination and the judgment of the investigator;
- The statutory guardian (or the consignor) of the subject agree his/her child participate in the study, and is willing to sign the informed consent form;
- The subject and his/her statutory guardians (or the consignor) are able to comply with the requests of the clinical study protocol;
- Never be immunized with any pneumococcus vaccine, and didn't get immunization with any other preventive product in the past 10 days (didn't get immunized with attenuated live vaccine in the past 14 days);
- The auxillary temperature ≤37℃.
Key exclusion criteria (14 listed)
- Has already been immunized with pneumococcus vaccine no matter it is experimental or marketed;
- With the history of invasive disease caused by streptococcus pneumonia by culture;
- With the history of serious allergy to any vaccine or drug, has got fever higher than 39℃ related to immunization with preventive biological product;
- Infant that the birth weight is lighter than 2.5 kg;
- With the history or the family history of seizure, epilepsy, cerebropathy and psychosis ;
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 |
|---|---|---|
| 7-valent pneumococcal conjugate vaccine | Biological | Control Arm |
| 13-valent pneumococcal polysaccharide conjugate vaccine | Biological | Test Arm |
Primary outcome
positive rate after infant doses
Time frame: 30 days after infant doses
the rate of the immunoglobulin G ≥0.35μg/ml after infant doses
GMC after infant doses
Time frame: 30 days after infant doses
geometrical mean concentration of immunoglobulin G after infant doses
positive rate after booster dose
Time frame: 30 days after booster dose
the rate of the immunoglobulin G ≥0.35μg/ml after booster dose
GMC after booster dose
Time frame: 30 days after booster dose
geometrical mean concentration of immunoglobulin G after booster dose
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 14 Oct 2020.
- Derived from this study: PubMed 27798013Chen JJ, Yuan L, Huang Z, Shi NM, Zhao YL, Xia SL, Li GH, Li RC, Li YP, Yang SY, Xia JL. Safety and immunogenicity of a new 13-valent pneumococcal conjugate vaccine versus a licensed 7-valent pneumococcal conjugate vaccine: a study protocol of a randomised non-inferiority trial in China. BMJ Open. 2016 Oct 19;6(10):e012488. doi: 10.1136/bmjopen-2016-012488.
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.
Nianmin Shi principal investigator
Beijing Chaoyang disease control and prevention center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 7-valent pneumococcal conjugate vaccine and 13-valent pneumococcal polysaccharide conjugate vaccine in people with Diseases Caused by Streptococcus Pneumoniae Serotypes, run by Walvax Biotechnology Co., Ltd..
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 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: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
positive rate after infant doses (time frame: 30 days after infant doses). The study lists 4 primary outcomes in all. 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 NCT02736240, 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 14 Oct 2020.