Pneumococcal InfectionPhase 1NCT01531322
A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects
A Phase 1 study testing 13-valent Pneumococcal Conjugate Vaccine in people with Pneumococcal Infection, run by Pfizer at 2 sites in China.
Trial summary
This study will assess the safety and tolerability of a single dose of 13-valent Pneumococcal Conjugate Vaccine for approximately 1 month after vaccination sequentially in healthy Chinese adults aged 18 through 55 years, followed by children aged 3 through 5 years, and then infants aged approximately 2 months. Read more about this study
- Who is it for?
- Ages 42 days to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infection
- What is being tested?
- 13-valent Pneumococcal Conjugate Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2011to Jan 2012
- 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 42 days to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age at the time of enrollment is:
- 18 through 55 years (before the fifty sixth birthday) for Group 1.
- 3 through 5 years (before the sixth birthday) for Group 2.
- 42 to 98 days for Group 3.
- Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
Who cannot join
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- Previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with pneumococcal vaccine.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Pfizer Investigational Site
Huaian, Jiangsu, 223300
Pfizer Investigational Site
Nanjing, Jiangsu, 210009
About this study
Official title: A Phase 1 Open-label Study to Assess the Safety and Tolerability of a Single Dose of 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Adults, Children and Infants
This study will assess the safety and tolerability of a single dose of 13-valent Pneumococcal Conjugate Vaccine for approximately 1 month after vaccination sequentially in healthy Chinese adults aged 18 through 55 years, followed by children aged 3 through 5 years, and then infants aged approximately 2 months.
- Conditions
- Pneumococcal Infection
- Being tested
- 13-valent Pneumococcal Conjugate Vaccine
- Keywords
- 13vPnC, Healthy subjects, China
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13-valent Pneumococcal Conjugate VaccineBiological
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
13-valent Pneumococcal Conjugate VaccineBiological
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
13-valent Pneumococcal Conjugate VaccineBiological
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Adults aged 18 through 55 years (before the fifty sixth birthday) Receives: Biological: 13-valent Pneumococcal Conjugate Vaccine |
| Group 2 | Experimental | Children aged 3 through 5 years (before the sixth birthday) Receives: Biological: 13-valent Pneumococcal Conjugate Vaccine |
| Group 3 | Experimental | Infants aged approximately 2 months (42 to 98 days) Receives: Biological: 13-valent Pneumococcal Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting Adverse Events
Measured: Baseline to Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startOct 2011
- Primary completionJan 2012
- Study completionJan 2012
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 InfectionStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531322
- Sponsor's protocol ID
- B1851046
- Other IDs
- 6096A1-1000
- Status last verified
- Sep 2018
- First submitted
- 12 Aug 2011
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhu F, Hu Y, Liang Q, Young M Jr, Zhou X, Chen Z, Liang JZ, Gruber WC, Scott DA. Safety and tolerability of 13-valent pneumococcal conjugate vaccine in healthy Chinese adults, children and infants. Ther Adv Drug Saf. 2015 Dec;6(6):206-11. doi: 10.1177/2042098615613985.
PubMed 26668712
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label Study to Assess the Safety and Tolerability of a Single Dose of 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Adults, Children and Infants
- ClinicalTrials.gov ID
- NCT01531322
- Acronym / sponsor ID
- B1851046
- Conditions
- Pneumococcal Infection
- Keywords
- 13vPnC, Healthy subjects, China
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 10 Feb 2012 (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 will assess the safety and tolerability of a single dose of 13-valent Pneumococcal Conjugate Vaccine for approximately 1 month after vaccination sequentially in healthy Chinese adults aged 18 through 55 years, followed by children aged 3 through 5 years, and then infants aged approximately 2 months.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: 13-valent Pneumococcal Conjugate VaccineAdults aged 18 through 55 years (before the fifty sixth birthday) |
| Group 2 | Experimental | Biological: 13-valent Pneumococcal Conjugate VaccineChildren aged 3 through 5 years (before the sixth birthday) |
| Group 3 | Experimental | Biological: 13-valent Pneumococcal Conjugate VaccineInfants aged approximately 2 months (42 to 98 days) |
Who may qualify
- Ages
- 42 days to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age at the time of enrollment is:
- Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
Key exclusion criteria (3 listed)
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- Previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with pneumococcal vaccine.
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 Conjugate Vaccinesuspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose | Biological | Group 1 |
| 13-valent Pneumococcal Conjugate Vaccinesuspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose | Biological | Group 2 |
| 13-valent Pneumococcal Conjugate Vaccinesuspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose | Biological | Group 3 |
Primary outcome
Number of participants reporting Adverse Events
Time frame: Baseline to Month 1
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 7 Sep 2018.
- Derived from this study: PubMed 26668712Zhu F, Hu Y, Liang Q, Young M Jr, Zhou X, Chen Z, Liang JZ, Gruber WC, Scott DA. Safety and tolerability of 13-valent pneumococcal conjugate vaccine in healthy Chinese adults, children and infants. Ther Adv Drug Saf. 2015 Dec;6(6):206-11. doi: 10.1177/2042098615613985.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
2 sites 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 Conjugate Vaccine in people with Pneumococcal Infection, run by Pfizer at 2 sites 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 3 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 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Number of participants reporting Adverse Events (time frame: Baseline to Month 1). 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 NCT01531322, 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 7 Sep 2018.