Pneumococcal 13-valent Conjugate VaccinePhase 1NCT02544698
Safety Study of Pneumococcal 13-valent Conjugate Vaccine in Healthy People Aged 2 Months and Older
A Phase 1 study testing One dose of PCV13a vaccine and three doses of PCV13a vaccine in people with Pneumococcal 13-valent Conjugate Vaccine, run by Beijing Chaoyang District Centre for Disease Control and Prevention.
Trial summary
This study evaluates the safety of Pneumococcal 13-valent Conjugate Vaccine in Healthy People Aged 2 Months and Older.120 Subjects will be equally divided into 4 groups,including 18 years and older,2-5 years old, 2 months old and 3 months old. Read more about this study
- Who is it for?
- Ages 2 months and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal 13-valent Conjugate Vaccine
- What is being tested?
- One dose of PCV13a vaccine and three doses of PCV13a vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Dec 2016
- 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 2 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy babies with health conditions confirmed according to medical history, medical examination and judgment of researchers;
- Satisfy the age requirements of the clinical trial.(children from 2 months to 5 years old and adults over the age of 18);
- Parents or guardians of the subjects must provide informed consent forms with personally signature and date;
- Parents or guardians of the subjects have been informed of all aspects of the research;
- Subjects or guardians can obey the requirements of the clinical research;
- No pneumococcal vaccine inoculation history, no other preventive vaccination within 7 days;
- Axillary temperature below 37℃
Who cannot join
- People with pneumococcal vaccine inoculation history, no matter experimentally or already on the market;
- People has allergic reaction to any drugs, vaccine or vaccine-related components previously;
- People has allergic reaction to 13vPnC, 7vPnC or other complexes associated with the drug, known or suspected;
- People has hemorrhagic physical constitution or diseases that prolong bleeding time, intramuscular injection taboo;
- People has immune deficiency or immune function inhibition, known or suspected;
- People has irritability, convulsions, epilepsy, brain diseases and mental history or family history;
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- People has culture-confirmed invasive diseases caused by streptococcus pneumoniae history;
- People has serious congenital malformations or serious chronic diseases that are known, people with congenital deformities, stunted or has a clinical diagnosis of serious chronic diseases (such as Down syndrome, diabetes, sickle cell anemia or nerve disorders, Guillain-Barre syndrome);
- People suffers from these diseases: respiratory diseases, acute or chronic active stage of infection, severe cardiovascular disease, kidney and liver diseases, malignant tumors, skin diseases, babies with HIV infected mothers(inspection report is available);
- People with vaccination-related contraindications that other researchers believe;
- People take part in other clinical trials while taking part in this clinical trial or 28 days before this clinical trial. People who participate in purely observational studies are acceptable;
- People received blood products or intravenous immunoglobulin. People who was inoculated Hepatitis B immunoglobulin can be acceptable.
About this study
This study evaluates the safety of Pneumococcal 13-valent Conjugate Vaccine in Healthy People Aged 2 Months and Older.120 Subjects will be equally divided into 4 groups,including 18 years and older,2-5 years old, 2 months old and 3 months old. Subjects aged 18 years and 2-5 years old will receive one dose of PCV13 vaccine,while subjects aged 2 and 3 months will receive 3 doses of PCV13 vaccine,injected at 2, 4, 6 months or 3、4、5 months respectively.
- Conditions
- Pneumococcal 13-valent Conjugate Vaccine
- Being tested
- One dose of PCV13a vaccine, three doses of PCV13a vaccine
- Keywords
- vaccine, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One dose of PCV13a vaccineBiological
One dose of PCV13a vaccineBiological
three doses of PCV13a vaccineBiological
three doses of PCV13a vaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| One dose of PCV13a vaccine in aged 18 years and older | Experimental | One dose of PCV13a vaccine will be given in aged 18 years and older Receives: Biological: One dose of PCV13a vaccine |
| One dose of PCV13a vaccine in aged 2-5 years old | Experimental | One dose of PCV13a vaccine will be given in aged 2-5 years old Receives: Biological: One dose of PCV13a vaccine |
| One dose of PCV13 vaccine will be given at 2, 4, 6 months | Experimental | One dose of PCV13 vaccine will be given at 2, 4, 6 months respectively in aged 2 months old Receives: Biological: three doses of PCV13a vaccine |
| One dose of PCV13 vaccine will be given at 3、4、5 months | Experimental | One dose of PCV13 vaccine will be given at 3、4、5 months respectively in aged 3 months old Receives: Biological: three doses of PCV13a vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the rate of adverse reactions of pneumococcal 13-valent conjugate vaccine
Adverse reactions associated with vaccine will be observed in subjects after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal 13-valent Conjugate VaccineStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chaoyang District Centre for Disease Control and Prevention
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544698
- Sponsor's protocol ID
- cycdc2015-2
- Status last verified
- Aug 2015
- First submitted
- 6 Sep 2015
- Last updated
- 17 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Pneumococcal 13-valent Conjugate Vaccine in Healthy People Aged 2 Months and Older
- ClinicalTrials.gov ID
- NCT02544698
- Acronym / sponsor ID
- cycdc2015-2
- Conditions
- Pneumococcal 13-valent Conjugate Vaccine
- Keywords
- vaccine, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Beijing Chaoyang District Centre for Disease Control and PreventionUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Sep 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.
This study evaluates the safety of Pneumococcal 13-valent Conjugate Vaccine in Healthy People Aged 2 Months and Older.120 Subjects will be equally divided into 4 groups,including 18 years and older,2-5 years old, 2 months old and 3 months old. Subjects aged 18 years and 2-5 years old will receive one dose of PCV13 vaccine,while subjects aged 2 and 3 months will receive 3 doses of PCV13 vaccine,injected at 2, 4, 6 months or 3、4、5 months respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| One dose of PCV13a vaccine in aged 18 years and older | Experimental | Biological: One dose of PCV13a vaccineOne dose of PCV13a vaccine will be given in aged 18 years and older |
| One dose of PCV13a vaccine in aged 2-5 years old | Experimental | Biological: One dose of PCV13a vaccineOne dose of PCV13a vaccine will be given in aged 2-5 years old |
| One dose of PCV13 vaccine will be given at 2, 4, 6 months | Experimental | Biological: three doses of PCV13a vaccineOne dose of PCV13 vaccine will be given at 2, 4, 6 months respectively in aged 2 months old |
| One dose of PCV13 vaccine will be given at 3、4、5 months | Experimental | Biological: three doses of PCV13a vaccineOne dose of PCV13 vaccine will be given at 3、4、5 months respectively in aged 3 months old |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy babies with health conditions confirmed according to medical history, medical examination and judgment of researchers;
- Satisfy the age requirements of the clinical trial.(children from 2 months to 5 years old and adults over the age of 18);
- Parents or guardians of the subjects must provide informed consent forms with personally signature and date;
- Parents or guardians of the subjects have been informed of all aspects of the research;
- Subjects or guardians can obey the requirements of the clinical research;
Key exclusion criteria (12 listed)
- People with pneumococcal vaccine inoculation history, no matter experimentally or already on the market;
- People has allergic reaction to any drugs, vaccine or vaccine-related components previously;
- People has allergic reaction to 13vPnC, 7vPnC or other complexes associated with the drug, known or suspected;
- People has hemorrhagic physical constitution or diseases that prolong bleeding time, intramuscular injection taboo;
- People has immune deficiency or immune function inhibition, known or suspected;
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 |
|---|---|---|
| One dose of PCV13a vaccine | Biological | One dose of PCV13a vaccine in aged 18 years and older |
| One dose of PCV13a vaccine | Biological | One dose of PCV13a vaccine in aged 2-5 years old |
| three doses of PCV13a vaccine | Biological | One dose of PCV13 vaccine will be given at 2, 4, 6 months |
| three doses of PCV13a vaccine | Biological | One dose of PCV13 vaccine will be given at 3、4、5 months |
Primary outcome
Evaluate the rate of adverse reactions of pneumococcal 13-valent conjugate vaccine
Time frame: 3 months
Adverse reactions associated with vaccine will be observed in subjects after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing One dose of PCV13a vaccine and three doses of PCV13a vaccine in people with Pneumococcal 13-valent Conjugate Vaccine, run by Beijing Chaoyang District Centre for Disease Control and Prevention.
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 7 inclusion and 12 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 Jun 2016. 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 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?
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?
Evaluate the rate of adverse reactions of pneumococcal 13-valent conjugate vaccine (time frame: 3 months). 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 Jun 2016.