Pneumococcal InfectionsPhase 1NCT01444339
Study of Two Investigational Pneumococcal Vaccines 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 at 1 site in Switzerland.
Trial summary
This study is designed to evaluate the safety, tolerability, and immunogenicity of two investigational pneumococcal vaccines at three dose levels in healthy adults. Primary Objective: To evaluate the safety and tolerability of two investigational pneumococcal vaccines. 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
- 131 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2010to Sep 2010
- 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
- Known 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
- Known or suspected congenital or acquired immunodeficiency, or 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)
Show all 19Show fewer
- Known systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine(s) 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
- Planned receipt of any vaccine in the 4 weeks following the trial vaccination
- Known seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
- Laboratory confirmed / self-reported thrombocytopenia contraindicating intramuscular 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 two investigational pneumococcal vaccines at three dose levels in healthy adults.
Primary Objective:
- To evaluate the safety and tolerability of two investigational pneumococcal vaccines.
Observational Objective:
- To evaluate the immunogenicity of the investigational pneumococcal vaccines.
Read the detailed description
An initial cohort of 6 participants will receive a single dose of one of two investigational pneumococcal vaccines. After safety evaluation of that cohort, additional cohorts will receive 2 injections 30 days apart of same investigational pneumococcal vaccine at same or increased 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, Pneumococcal Vaccine Formulation 4, Pneumococcal Vaccine Formulation 5
- Keywords
- Pneumococcal Infections, Streptococcus Pneumoniae Infections, Pneumococcal Vaccine
- 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 (1 middle dose)
Pneumococcal Vaccine Formulation 2Biological
0.5 mL, intramuscular (2 low doses)
Pneumococcal Vaccine Formulation 3Biological
0.5 mL, intramuscular (2 middle doses)
Pneumococcal Vaccine Formulation 4Biological
0.5 mL, intramuscular (2 middle doses)
Pneumococcal Vaccine Formulation 5Biological
0.5 mL, intramuscular (2 high doses)
PlaceboBiological
Also called Tris buffered saline
0.5 mL, intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Pneumococcal Vaccine Formulation 1 | Experimental | Participants will receive an injection of pneumococcal vaccine (Formulation 1, 1 middle dose) on Day 0 and Day 30, respectively. Receives: Biological: Pneumococcal Vaccine Formulation 1 |
| Pneumococcal Vaccine Formulation 2 | Experimental | Participants will receive an injection of Pneumococcal vaccine (Formulation 2, 2 low doses) on Day 0 and Day 30, respectively. Receives: Biological: Pneumococcal Vaccine Formulation 2 |
| Pneumococcal Vaccine Formulation 3 | Experimental | Participants will receive an injection of pneumococcal vaccine (Formulation 3, 2 middle doses) on Day 0 and Day 30, respectively. Receives: Biological: Pneumococcal Vaccine Formulation 3 |
| Pneumococcal Vaccine Formulation 4 | Experimental | Participants will receive an injection of pneumococcal vaccine (Formulation 4, 2 middle doses) on Day 0 and Day 30, respectively. Receives: Biological: Pneumococcal Vaccine Formulation 4 |
| Pneumococcal Vaccine Formulation 5 | Experimental | Participants will receive an injection of pneumococcal vaccine (Formulation 5, 2 high doses) on Day 0 and Day 30, respectively. Receives: Biological: Pneumococcal Vaccine Formulation 5 |
| Pooled placebo Group | Placebo comparator | Participants will receive an injection of a placebo on Day 0 and Day 30, respectively. 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: 30 days post-vaccination
Secondary outcomes (1)
Immunogenicity of Investigational Pneumococcal vaccines after 2 vaccinations
Evaluation of immune responses to antigen component of the investigational vaccine by enzyme linked immunosorbent assay (ELISA).
Measured: Days 0 and 30 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 2010
- Primary completionSep 2010
- Study completionSep 2010
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 131 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
- NCT01444339
- Sponsor's protocol ID
- PPR05
- Status last verified
- Sep 2011
- First submitted
- 28 Sep 2011
- Last updated
- 30 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Bologa M, Kamtchoua T, Hopfer R, Sheng X, Hicks B, Bixler G, Hou V, Pehlic V, Yuan T, Gurunathan S. Safety and immunogenicity of pneumococcal protein vaccine candidates: monovalent choline-binding protein A (PcpA) vaccine and bivalent PcpA-pneumococcal histidine triad protein D vaccine. Vaccine. 2012 Dec 14;30(52):7461-8. doi: 10.1016/j.vaccine.2012.10.076. Epub 2012 Nov 2.
PubMed 23123106
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 Two Investigational Pneumococcal Vaccines in Healthy Adults
- ClinicalTrials.gov ID
- NCT01444339
- Acronym / sponsor ID
- PPR05
- Keywords
- Pneumococcal Infections, Streptococcus Pneumoniae Infections, Pneumococcal Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (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 two investigational pneumococcal vaccines at three dose levels in healthy adults.
Primary Objective:
- To evaluate the safety and tolerability of two investigational pneumococcal vaccines.
Observational Objective:
- To evaluate the immunogenicity of the investigational pneumococcal vaccines.
Detailed description
An initial cohort of 6 participants will receive a single dose of one of two investigational pneumococcal vaccines. After safety evaluation of that cohort, additional cohorts will receive 2 injections 30 days apart of same investigational pneumococcal vaccine at same or increased 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
- 6
| Arm | Type | Receives |
|---|---|---|
| Pneumococcal Vaccine Formulation 1 | Experimental | Biological: Pneumococcal Vaccine Formulation 1Participants will receive an injection of pneumococcal vaccine (Formulation 1, 1 middle dose) on Day 0 and Day 30, respectively. |
| Pneumococcal Vaccine Formulation 2 | Experimental | Biological: Pneumococcal Vaccine Formulation 2Participants will receive an injection of Pneumococcal vaccine (Formulation 2, 2 low doses) on Day 0 and Day 30, respectively. |
| Pneumococcal Vaccine Formulation 3 | Experimental | Biological: Pneumococcal Vaccine Formulation 3Participants will receive an injection of pneumococcal vaccine (Formulation 3, 2 middle doses) on Day 0 and Day 30, respectively. |
| Pneumococcal Vaccine Formulation 4 | Experimental | Biological: Pneumococcal Vaccine Formulation 4Participants will receive an injection of pneumococcal vaccine (Formulation 4, 2 middle doses) on Day 0 and Day 30, respectively. |
| Pneumococcal Vaccine Formulation 5 | Experimental | Biological: Pneumococcal Vaccine Formulation 5Participants will receive an injection of pneumococcal vaccine (Formulation 5, 2 high doses) on Day 0 and Day 30, respectively. |
| Pooled placebo Group | Placebo comparator | Biological: PlaceboParticipants will receive an injection of a placebo 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 (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 (19 listed)
- Known 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
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 (1 middle dose) | Biological | Pneumococcal Vaccine Formulation 1 |
| Pneumococcal Vaccine Formulation 20.5 mL, intramuscular (2 low doses) | Biological | Pneumococcal Vaccine Formulation 2 |
| Pneumococcal Vaccine Formulation 30.5 mL, intramuscular (2 middle doses) | Biological | Pneumococcal Vaccine Formulation 3 |
| Pneumococcal Vaccine Formulation 40.5 mL, intramuscular (2 middle doses) | Biological | Pneumococcal Vaccine Formulation 4 |
| Pneumococcal Vaccine Formulation 50.5 mL, intramuscular (2 high doses) | Biological | Pneumococcal Vaccine Formulation 5 |
| PlaceboAlso: Tris buffered saline0.5 mL, intramuscular | Biological | Pooled placebo Group |
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: 30 days post-vaccination
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia
1 secondary outcome
Immunogenicity of Investigational Pneumococcal vaccines after 2 vaccinations
Time frame: Days 0 and 30 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 23123106Bologa M, Kamtchoua T, Hopfer R, Sheng X, Hicks B, Bixler G, Hou V, Pehlic V, Yuan T, Gurunathan S. Safety and immunogenicity of pneumococcal protein vaccine candidates: monovalent choline-binding protein A (PcpA) vaccine and bivalent PcpA-pneumococcal histidine triad protein D vaccine. Vaccine. 2012 Dec 14;30(52):7461-8. doi: 10.1016/j.vaccine.2012.10.076. Epub 2012 Nov 2.
- 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 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 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. 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: 30 days 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 NCT01444339, 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.