Pneumococcal InfectionsPhase 1NCT01444352
Study of an Investigational Pneumococcal Vaccine at Three Dose Levels in Healthy Adults
A Phase 1 study testing Pneumococcal vaccine Formulation 1, Pneumococcal vaccine Formulation 2 and Pneumococcal vaccine Formulation 3 in people with Pneumococcal Infections and Streptococcus Pneumoniae Infections, run by Sanofi Pasteur, a Sanofi Company at 1 site in Switzerland.
Trial summary
This study is designed to evaluate the safety, tolerability, and immunogenicity 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, Streptococcus Pneumoniae Infections, Pneumococcal Pneumonia
- What is being tested?
- Pneumococcal vaccine Formulation 1, Pneumococcal vaccine Formulation 2 and Pneumococcal vaccine Formulation 3
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2010to Jan 2011
- 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
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and comply with all trial procedures
- Subject is healthy, as determined by medical history and physical examination
- For a woman of child-bearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to first vaccination until 4 weeks after the last vaccination.
Who cannot join
- History of anaphylactic reaction or asthma
- Unknown pregnancy or positive serum/urine pregnancy test
- Currently breastfeeding a child
- Chronic illness, that in the opinion of the investigator, is at a stage that could interfere with trial conduct or completion
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
Show all 20Show fewer
- Known or suspected congenital or acquired immunodeficiency, receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
- Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
- Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for pandemic influenza vaccination which may be received at least two weeks before the study vaccines
- Planned receipt of any vaccine in the 4 weeks following the trial vaccination, except for pandemic influenza vaccination in the event of a local or national immunization program
- Known seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
- Laboratory confirmed/self-reported thrombocytopenia contraindicating intramuscular (IM) vaccination
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Identified as a study site employee who is involved in the protocol and may have direct access to trial-related data
- Previous vaccination against pneumococcal disease (in the previous 5 years)
- History of pneumococcal infection (confirmed either clinically, serologically, or microbiologically) within 5 years
- At high risk for pneumococcal infection during the trial
- Living in a household with children <5 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to evaluate the safety, tolerability, and immunogenicity of an investigational pneumococcal vaccine in healthy adult volunteers.
Primary Objective:
- To evaluate the safety and tolerability of an investigational pneumococcal vaccine.
Observational Objective:
- To evaluate the immunogenicity of an investigational Pneumococcal vaccine.
Read the detailed description
An initial cohort of 10 participants will receive a single dose of investigational pneumococcal vaccine. After safety assessment of this cohort during a 24-hour in-unit observation period, additional cohorts will receive two injections of the study vaccine 30 days apart, at three dose levels, in ascending doses by cohort, pending safety review at each dose level. All participants will be monitored for safety for 30 days after each vaccination.
- Being tested
- Pneumococcal vaccine Formulation 1, Pneumococcal vaccine Formulation 2, Pneumococcal vaccine Formulation 3, Placebo
- Keywords
- Pneumococcal infections, Streptococcus pneumoniae Infections, Pneumococcal Vaccines
- 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 vaccine Formulation 1Biological
0.5 mL, Intramuscular (Low dose)
Pneumococcal vaccine Formulation 2Biological
0.5 mL, Intramuscular (Middle dose)
Pneumococcal vaccine Formulation 3Biological
0.5 mL, Intramuscular (High dose)
PlaceboBiological
Also called Tris Buffered Saline
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Formulation 1 (Low dose) | Experimental | Participants will receive 2 injections of Pneumococcal Vaccine Formulation 1 (Low dose). Receives: Biological: Pneumococcal vaccine Formulation 1 |
| Vaccine Formulation 2 (Middle dose) | Experimental | Participants will receive 2 injections of Pneumococcal Vaccine Formulation 2, (Middle dose). Receives: Biological: Pneumococcal vaccine Formulation 2 |
| Vaccine Formulation 3 (High dose) | Experimental | Participants will receive 2 injections of Pneumococcal Vaccine Formulation 3, (High dose). Receives: Biological: Pneumococcal vaccine Formulation 3 |
| Placebo Pooled | Placebo comparator | Participants who receive 2 injections of tris buffered saline Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of participants reporting 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: Days 0 through 30 post-vaccination
Secondary outcomes (1)
Immunogenicity of Pneumococcal Vaccine After two Vaccinations
Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA).
Measured: Days 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 startJun 2010
- Primary completionJan 2011
- Study completionJan 2011
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 Sanofi Pasteur, a Sanofi CompanyThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444352
- Sponsor's protocol ID
- PPR06
- Status last verified
- Mar 2015
- First submitted
- 28 Sep 2011
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kamtchoua T, Bologa M, Hopfer R, Neveu D, Hu B, Sheng X, Corde N, Pouzet C, Zimmermann G, Gurunathan S. Safety and immunogenicity of the pneumococcal pneumolysin derivative PlyD1 in a single-antigen protein vaccine candidate in adults. Vaccine. 2013 Jan 2;31(2):327-33. doi: 10.1016/j.vaccine.2012.11.005. Epub 2012 Nov 12.
PubMed 23153437
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of an Investigational Pneumococcal Vaccine at Three Dose Levels in Healthy Adults
- ClinicalTrials.gov ID
- NCT01444352
- Acronym / sponsor ID
- PPR06
- Keywords
- Pneumococcal infections, Streptococcus pneumoniae Infections, Pneumococcal Vaccines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (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 is designed to evaluate the safety, tolerability, and immunogenicity of an investigational pneumococcal vaccine in healthy adult volunteers.
Primary Objective:
- To evaluate the safety and tolerability of an investigational pneumococcal vaccine.
Observational Objective:
- To evaluate the immunogenicity of an investigational Pneumococcal vaccine.
Detailed description
An initial cohort of 10 participants will receive a single dose of investigational pneumococcal vaccine. After safety assessment of this cohort during a 24-hour in-unit observation period, additional cohorts will receive two injections of the study vaccine 30 days apart, at three dose levels, in ascending doses by cohort, pending safety review at each dose level. All participants will be monitored for safety for 30 days after each vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vaccine Formulation 1 (Low dose) | Experimental | Biological: Pneumococcal vaccine Formulation 1Participants will receive 2 injections of Pneumococcal Vaccine Formulation 1 (Low dose). |
| Vaccine Formulation 2 (Middle dose) | Experimental | Biological: Pneumococcal vaccine Formulation 2Participants will receive 2 injections of Pneumococcal Vaccine Formulation 2, (Middle dose). |
| Vaccine Formulation 3 (High dose) | Experimental | Biological: Pneumococcal vaccine Formulation 3Participants will receive 2 injections of Pneumococcal Vaccine Formulation 3, (High dose). |
| Placebo Pooled | Placebo comparator | Biological: PlaceboParticipants who receive 2 injections of tris buffered saline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18 to 50 years on the day of inclusion
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and comply with all trial procedures
- Subject is healthy, as determined by medical history and physical examination
- For a woman of child-bearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to first vaccination until 4 weeks after the last vaccination.
Key exclusion criteria (20 listed)
- History of anaphylactic reaction or asthma
- Unknown pregnancy or positive serum/urine pregnancy test
- Currently breastfeeding a child
- Chronic illness, that in the opinion of the investigator, is at a stage that could interfere with trial conduct or completion
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
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 vaccine Formulation 10.5 mL, Intramuscular (Low dose) | Biological | Vaccine Formulation 1 (Low dose) |
| Pneumococcal vaccine Formulation 20.5 mL, Intramuscular (Middle dose) | Biological | Vaccine Formulation 2 (Middle dose) |
| Pneumococcal vaccine Formulation 30.5 mL, Intramuscular (High dose) | Biological | Vaccine Formulation 3 (High dose) |
| PlaceboAlso: Tris Buffered Saline0.5 mL, Intramuscular | Biological | Placebo Pooled |
Primary outcome
Number and percentage of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial
Time frame: Days 0 through 30 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 two Vaccinations
Time frame: Days 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 18 Mar 2015.
- Derived from this study: PubMed 23153437Kamtchoua T, Bologa M, Hopfer R, Neveu D, Hu B, Sheng X, Corde N, Pouzet C, Zimmermann G, Gurunathan S. Safety and immunogenicity of the pneumococcal pneumolysin derivative PlyD1 in a single-antigen protein vaccine candidate in adults. Vaccine. 2013 Jan 2;31(2):327-33. doi: 10.1016/j.vaccine.2012.11.005. Epub 2012 Nov 12.
- 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 Formulation 1, Pneumococcal vaccine Formulation 2 and Pneumococcal vaccine Formulation 3 in people with Pneumococcal Infections and Streptococcus Pneumoniae Infections, run by Sanofi Pasteur, a Sanofi Company 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 5 inclusion and 20 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 18 Mar 2015. 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. Some participants in this study may receive a placebo. 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 and percentage of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial (time frame: Days 0 through 30 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 NCT01444352, 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 18 Mar 2015.