Pneumococcal InfectionsPhase 3NCT00546572
Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
A Phase 3 study testing 13 valent Pneumococcal Conjugate Vaccine and 23vPS in people with Pneumococcal Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 58 sites in 2 countries.
Trial summary
This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5 years ago. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- 13 valent Pneumococcal Conjugate Vaccine and 23vPS
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 938 participants
- Where
- 58 sitesin 2 countries
- Study dates
- Nov 2007to Jul 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male or Female aged 70 years or older.
- Documented vaccination with 1 dose of 23vPS at least 5 years previous.
- Healthy.
Who cannot join
- Receipt of more than one dose of 23vPS prior to enrollment.
- History of severe adverse reaction to a vaccine.
- Immunodeficiency.
Trial locations and contacts
58 sites in 2 countries.
58 sites in 2 countries
United States51 sites
Pfizer Investigational Site
Atlanta, Georgia, 30305
Pfizer Investigational Site
Atlanta, Georgia, 30328
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Baltimore, Maryland, 21209
Pfizer Investigational Site
Bristol, Tennessee, 37620
Pfizer Investigational Site
Butte, Montana, 59701
Pfizer Investigational Site
Carnegie, Pennsylvania, 15106
Pfizer Investigational Site
Cary, North Carolina, 27511
Pfizer Investigational Site
Charlotte, North Carolina, 28209
Pfizer Investigational Site
Cincinnati, Ohio, 45229
Pfizer Investigational Site
Cincinnati, Ohio, 45236
Pfizer Investigational Site
Clearwater, Florida, 33761
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Coral Gables, Florida, 33134
Pfizer Investigational Site
Corvallis, Oregon, 97330
Pfizer Investigational Site
Denver, Colorado, 80262
Pfizer Investigational Site
Downington, Pennsylvania, 19335
Pfizer Investigational Site
Durham, North Carolina, 27705
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Fargo, North Dakota, 58103
Pfizer Investigational Site
Fountain Valley, California, 92708
Pfizer Investigational Site
Greer, South Carolina, 29651
Pfizer Investigational Site
Grove City, Pennsylvania, 16127
Pfizer Investigational Site
Hickory, North Carolina, 28601
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Las Vegas, Nevada, 89146
Pfizer Investigational Site
Lexington, Kentucky, 40536
Pfizer Investigational Site
Mesa, Arizona, 85203
Pfizer Investigational Site
Mesa, Arizona, 85213
Pfizer Investigational Site
Minneapolis, Minnesota, 55417
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464
Pfizer Investigational Site
Nashville, Tennessee, 37232
Pfizer Investigational Site
Norfolk, Virginia, 23507
Pfizer Investigational Site
Penndel, Pennsylvania, 19047
Pfizer Investigational Site
Pinellas Park, Florida, 33781
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15241
Pfizer Investigational Site
Raleigh, North Carolina, 27612
Pfizer Investigational Site
Rochester, Minnesota, 55905
Pfizer Investigational Site
Rochester, New York, 14642
Pfizer Investigational Site
Salisbury, North Carolina, 28144
Pfizer Investigational Site
Seattle, Washington, 998101
Pfizer Investigational Site
Shawnee Mission, Kansas, 66128
Pfizer Investigational Site
St Louis, Missouri, 63104
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Stockbridge, Georgia, 30328
Pfizer Investigational Site
Tampa, Florida, 33614
Pfizer Investigational Site
Upper Saint Clair, Pennsylvania, 15241
Pfizer Investigational Site
Waterbury, Connecticut, 06708
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Sweden7 sites
Pfizer Investigational Site
Arlöv, 23234
Pfizer Investigational Site
Boden, 96131
Pfizer Investigational Site
Degeberga, 29731
Pfizer Investigational Site
Gothenburg, 40014
Pfizer Investigational Site
Malmö, 21120
Pfizer Investigational Site
Umeå, 90736
Pfizer Investigational Site
Uppsala, 75185
About this study
Official title: A Phase 3, Randomized, Active-Controlled, Modified Double-Blind Trial, Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) Compared To A 23-Valent Pneumococcal Polysaccharide (23vPS) Vaccine in Ambulatory Elderly Individuals Aged 70 Years And Older Who Received One Dose of 23vPS At Least 5 Years Prior To Study Enrollment
This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5 years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of 13vPnC 1 year after the initial dose of study vaccine.
- Conditions
- Pneumococcal Infections
- Being tested
- 13 valent Pneumococcal Conjugate Vaccine, 23vPS
- 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
0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
23vPSBiological
0.5-mL dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 1
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Receives 13vPnC at year 0 and 13vPnC at year 1 Receives: Biological: 13 valent Pneumococcal Conjugate Vaccine |
| 2 | Active comparator | Receives 23vPS at year 0 and 13vPnC at year 1 Receives: Biological: 23vPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0)
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Measured: 1 month after Vax 1 / Year 0
Percentage of Participants Achieving a ≥ 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0)
OPA titer for the 6A serotype measured for at least a 4-fold increase from the prevaccination to postvaccination blood sample collection. Exact 2-sided CI (Clopper and Pearson) based upon the observed percentage of participants.
Measured: Baseline, 1 month after Vax 1 / Year 0
Secondary outcomes (4)
Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0)
Antibody geometric mean titer as measured by OPA assay for the 6A pneumococcal serotype. Confidence intervals for the GMT are back transformation of a CI based on the Student t distribution for the mean logarithm of the titer.
Measured: 1 month after Vax 1 / Year 0
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Antibody geometric mean titers as measured by OPA assays for the 13 serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Measured: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)
Antibody geometric mean titers as measured by OPA assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Measured: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1
Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)
Antibody geometric mean titer as measured by OPA assay for the 6A serotype. Confidence intervals (CI) for the GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titer.
Measured: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pneumococcal InfectionsStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 938 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546572
- Sponsor's protocol ID
- 6115A1-3005
- Other IDs
- B1851024
- Status last verified
- Jul 2011
- First submitted
- 18 Oct 2007
- Last updated
- 14 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Active-Controlled, Modified Double-Blind Trial, Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) Compared To A 23-Valent Pneumococcal Polysaccharide (23vPS) Vaccine in Ambulatory Elderly Individuals Aged 70 Years And Older Who Received One Dose of 23vPS At Least 5 Years Prior To Study Enrollment
- ClinicalTrials.gov ID
- NCT00546572
- Acronym / sponsor ID
- 6115A1-3005
- Conditions
- Pneumococcal Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 938 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 19 Oct 2007 (estimated)
- Results
- Posted 30 May 2011
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 evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5 years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of 13vPnC 1 year after the initial dose of study vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: 13 valent Pneumococcal Conjugate VaccineReceives 13vPnC at year 0 and 13vPnC at year 1 |
| 2 | Active comparator | Biological: 23vPSReceives 23vPS at year 0 and 13vPnC at year 1 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Male or Female aged 70 years or older.
- Documented vaccination with 1 dose of 23vPS at least 5 years previous.
- Healthy.
Key exclusion criteria (3 listed)
- Receipt of more than one dose of 23vPS prior to enrollment.
- History of severe adverse reaction to a vaccine.
- Immunodeficiency.
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 Vaccine0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1 | Biological | 1 |
| 23vPS0.5-mL dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 1 | Biological | 2 |
Primary outcome
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0)
Time frame: 1 month after Vax 1 / Year 0
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Percentage of Participants Achieving a ≥ 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0)
Time frame: Baseline, 1 month after Vax 1 / Year 0
OPA titer for the 6A serotype measured for at least a 4-fold increase from the prevaccination to postvaccination blood sample collection. Exact 2-sided CI (Clopper and Pearson) based upon the observed percentage of participants.
4 secondary outcomes
Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0)
Time frame: 1 month after Vax 1 / Year 0
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Time frame: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)
Time frame: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1
Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)
Time frame: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
58 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 13 valent Pneumococcal Conjugate Vaccine and 23vPS in people with Pneumococcal Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 58 sites in 2 countries.
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 3 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 14 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Sweden. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) (time frame: 1 month after Vax 1 / Year 0). The study lists 2 primary outcomes in all. 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 14 Jul 2011.