Pneumococcal InfectionsPhase 1NCT01444001
Study of an Investigational Pneumococcal Vaccine in Healthy Adult Volunteers
A Phase 1 study testing Pneumococcal Vaccine in people with Pneumococcal Infections and Pneumococcal Pneumonia, run by Sanofi at 1 site in Switzerland.
Trial summary
This study was designed to evaluate the safety, tolerability, and immunogenicity of three doses of an investigational pneumococcal vaccine in healthy adult volunteers. Primary Objective: To evaluate the safety and tolerability of an investigational Pneumococcal vaccine. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections, Pneumococcal Pneumonia
- What is being tested?
- Pneumococcal Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2007to Aug 2007
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 50 years on the day of inclusion
- Healthy, as determined by medical history and clinical examination
- Informed consent obtained
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman, inability to bear a child or negative urine pregnancy test at each vaccination visit
- For a woman of child-bearing potential: use of two medically acceptable, effective methods of contraception (oral contraceptive, intrauterine device, diaphragm, spermicide, or condom) or abstinence throughout the study participation starting at least 30 days prior to the first vaccination up to at least 30 days after the last vaccination.
Who cannot join
- Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system) that could interfere with trial conduct or and/or raise a safety concern
- For a woman, breast-feeding
- Participation in another clinical trial in the 30 days preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
Show all 19Show fewer
- Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
- Blood or blood-derived products received in the past 3 months
- Any vaccination in the 30 days preceding the first trial vaccination
- Vaccination planned in the 30 days following any trial vaccination
- Known Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C seropositivity
- Known thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- Febrile illness (≥ 38.0°C [or 100.4°F]) within 72 hours of inclusion/vaccination
- Previous vaccination in the preceding 5 years against pneumococcal disease with another vaccine
- History of pneumococcal infection (confirmed either clinically, serologically, or microbiologically) within 5 years
- Subject at high risk of pneumococcal infection during the trial
- Subjects living in a household with children < 5 years of age
- Antibiotic usage or upper or lower respiratory tract infection within one week before any blood draw for immunogenicity (Visits 1, 3, and 5).
Trial locations and contacts
1 site in 1 country.
About this study
This study was designed to evaluate the safety, tolerability, and immunogenicity of three doses of an investigational pneumococcal vaccine in healthy adult volunteers.
Primary Objective:
- To evaluate the safety and tolerability of an investigational Pneumococcal vaccine.
Read the detailed description
Each volunteer participant will receive two injections with one of three vaccine doses, administered on Day 0 and Day 30, in a dose-ascending manner, pending safety review at each dose level. All participants will be monitored for safety for 30 days after each injection.
- Conditions
- Pneumococcal Infections, Pneumococcal Pneumonia
- Being tested
- Pneumococcal Vaccine
- Keywords
- Pneumococcal Infections, Pneumococcal Vaccines, pneumococcal protein
- Medical subject headings
- Pneumococcal Infections, Pneumonia, Pneumococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal VaccineBiological
0.5 mL, intramuscular
Pneumococcal VaccineBiological
0.5 mL, intramuscular
Pneumococcal VaccineBiological
0.5 mL, intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Pneumococcal Vaccine Dose 1 (Low dose) | Experimental | Participants will receive 2 injections of Dose 1 investigational Pneumococcal vaccine (Low dose) on Day 0 and Day 30, respectively. Receives: Biological: Pneumococcal Vaccine |
| Pneumococcal Vaccine Dose 2 (Middle dose) | Experimental | Participants will receive 2 injections of the investigational Pneumococcal vaccine (Middle dose) on Day 0 and Day 30, respectively. Receives: Biological: Pneumococcal Vaccine |
| Pneumococcal Vaccine Dose 3 (High dose) | Experimental | Participants will receive 2 injections of the investigational Pneumococcal vaccine (High dose) on Day 0 and Day 30, respectively. Receives: Biological: Pneumococcal Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia
Measured: Day 0 up to Day 60 post vaccination
Secondary outcomes (1)
Immunogenicity of pneumococcal vaccine after 2 vaccinations
Evaluation of immune responses to antigen component of the investigational vaccine by enzyme linked immunosorbent assay (ELISA).
Measured: Day 0 and 30 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startFeb 2007
- Primary completionAug 2007
- Study completionAug 2007
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 SanofiThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444001
- Sponsor's protocol ID
- PPR01
- Status last verified
- Sep 2011
- First submitted
- 28 Sep 2011
- Last updated
- 30 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Seiberling M, Bologa M, Brookes R, Ochs M, Go K, Neveu D, Kamtchoua T, Lashley P, Yuan T, Gurunathan S. Safety and immunogenicity of a pneumococcal histidine triad protein D vaccine candidate in adults. Vaccine. 2012 Dec 14;30(52):7455-60. doi: 10.1016/j.vaccine.2012.10.080. Epub 2012 Nov 3.
PubMed 23131206
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of an Investigational Pneumococcal Vaccine in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01444001
- Acronym / sponsor ID
- PPR01
- Conditions
- Pneumococcal Infections, Pneumococcal Pneumonia
- Keywords
- Pneumococcal Infections, Pneumococcal Vaccines, pneumococcal protein
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 30 Sep 2011 (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 was designed to evaluate the safety, tolerability, and immunogenicity of three doses of an investigational pneumococcal vaccine in healthy adult volunteers.
Primary Objective:
- To evaluate the safety and tolerability of an investigational Pneumococcal vaccine.
Detailed description
Each volunteer participant will receive two injections with one of three vaccine doses, administered on Day 0 and Day 30, in a dose-ascending manner, pending safety review at each dose level. All participants will be monitored for safety for 30 days after each injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pneumococcal Vaccine Dose 1 (Low dose) | Experimental | Biological: Pneumococcal VaccineParticipants will receive 2 injections of Dose 1 investigational Pneumococcal vaccine (Low dose) on Day 0 and Day 30, respectively. |
| Pneumococcal Vaccine Dose 2 (Middle dose) | Experimental | Biological: Pneumococcal VaccineParticipants will receive 2 injections of the investigational Pneumococcal vaccine (Middle dose) on Day 0 and Day 30, respectively. |
| Pneumococcal Vaccine Dose 3 (High dose) | Experimental | Biological: Pneumococcal VaccineParticipants will receive 2 injections of the investigational Pneumococcal vaccine (High dose) on Day 0 and Day 30, respectively. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 18 to 50 years on the day of inclusion
- Healthy, as determined by medical history and clinical examination
- Informed consent obtained
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman, inability to bear a child or negative urine pregnancy test at each vaccination visit
Key exclusion criteria (19 listed)
- Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system) that could interfere with trial conduct or and/or raise a safety concern
- For a woman, breast-feeding
- Participation in another clinical trial in the 30 days preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
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 |
|---|---|---|
| Pneumococcal Vaccine0.5 mL, intramuscular | Biological | Pneumococcal Vaccine Dose 1 (Low dose) |
| Pneumococcal Vaccine0.5 mL, intramuscular | Biological | Pneumococcal Vaccine Dose 2 (Middle dose) |
| Pneumococcal Vaccine0.5 mL, intramuscular | Biological | Pneumococcal Vaccine Dose 3 (High dose) |
Primary outcome
The occurrence of solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial
Time frame: Day 0 up to Day 60 post vaccination
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia
1 secondary outcome
Immunogenicity of pneumococcal vaccine after 2 vaccinations
Time frame: Day 0 and 30 days post 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 30 Sep 2011.
- Derived from this study: PubMed 23131206Seiberling M, Bologa M, Brookes R, Ochs M, Go K, Neveu D, Kamtchoua T, Lashley P, Yuan T, Gurunathan S. Safety and immunogenicity of a pneumococcal histidine triad protein D vaccine candidate in adults. Vaccine. 2012 Dec 14;30(52):7455-60. doi: 10.1016/j.vaccine.2012.10.080. Epub 2012 Nov 3.
- Related InfoLink 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.
Medical Director study director
Sanofi Pasteur Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pneumococcal Vaccine in people with Pneumococcal Infections and Pneumococcal Pneumonia, run by Sanofi at 1 site in Switzerland.
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 6 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 30 Sep 2011. 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 Switzerland. 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?
The occurrence of solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial (time frame: Day 0 up to Day 60 post vaccination). 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 NCT01444001, 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 30 Sep 2011.