Infections, StreptococcalPhase 1NCT00327665
Study to Evaluate the Safety and Immunogenicity of an Investigational Pneumococcal Vaccine in the Elderly Population
A Phase 1 study testing 11-valent pneumococcal vaccine GSK513026, Pneumo 23™ and 10-valent pneumococcal vaccine GSK513026 in people with Infections, Streptococcal, run by GlaxoSmithKline at 3 sites in 3 countries.
Trial summary
As the licensed pneumococcal vaccine is not always satisfactory in elderly, new investigational pneumococcal vaccines are evaluated in the healthy elderly population. Note: The study consists of the primary phase (106068): vaccination and follow-up and the extension (106072) of the primary phase: 1 year follow-up. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- 11-valent pneumococcal vaccine GSK513026, Pneumo 23™ and 10-valent pneumococcal vaccine GSK513026
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 335 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 May 2006to 8 Jan 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- A male or female between 65 and 85 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject.
Who cannot join
- Previous vaccination against Streptococcus pneumoniae.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
- Acute disease at the time of enrolment.
- History of documented radiologically confirmed pneumonia within 3 years prior to first vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
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- Current or history of Parkinson disease, Alzheimer disease, stroke, dementia or any serious neurologic or mental disorders.
- All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
- Subjects with documented anaemia or iron-deficiency.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccine(s) with the exception of a Flu vaccine which can be administered at least 1 week preceding the first dose of vaccine(s) or 1 month after the first dose of the vaccine(s).
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Administration of immunoglobulins and/or any blood products within three months preceding the first dose of study vaccine or planned administration during the study period.
- History of administration of an experimental/licensed vaccine containing MPL or QS21.
- History of chronic alcohol consumption and/or drug abuse.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Phase I/II, Randomized, Observer Blinded Study to Evaluate and Compare the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline Biologicals' Investigational Pneumococcal Vaccine Formulations Versus a Licensed Non-GlaxoSmithKline Biologicals' Vaccine and GlaxoSmithKline Biologicals' Aluminum-based 10-valent Pneumococcal Conjugate Vaccine, in Healthy Elderly Subjects
As the licensed pneumococcal vaccine is not always satisfactory in elderly, new investigational pneumococcal vaccines are evaluated in the healthy elderly population. Note: The study consists of the primary phase (106068): vaccination and follow-up and the extension (106072) of the primary phase: 1 year follow-up.
This protocol posting details the procedures of both the primary \& extension phase.
Read the detailed description
No new subjects will be enrolled in the Extension Phase of the study. All outcome measures at Month 12 will only be evaluated in the subjects in the Belgian site.
Upon request, volunteers will receive flu vaccination free of charge. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
- Conditions
- Infections, Streptococcal
- Being tested
- 11-valent pneumococcal vaccine GSK513026, Pneumo 23™, Placebo, 10-valent pneumococcal vaccine GSK513026
- Keywords
- pneumonia, pneumococcal vaccine, elderly subjects, invasive pneumococcal diseases, Prophylaxis
- Medical subject headings
- Streptococcal Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11-valent pneumococcal vaccine GSK513026Biological
Two-dose intramuscular injection. Each group receiving one of the 3 formulations
Pneumo 23™Biological
Single-dose intramuscular injection.
PlaceboBiological
1 intramuscular injection.
10-valent pneumococcal vaccine GSK513026Biological
Two-dose intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Biological: 11-valent pneumococcal vaccine GSK513026 |
| Group B | Experimental | Not described Receives: Biological: 11-valent pneumococcal vaccine GSK513026 |
| Group C | Experimental | Not described Receives: Biological: 11-valent pneumococcal vaccine GSK513026 |
| Group D | Active comparator | Not described Receives: Biological: Pneumo 23™; Biological: Placebo |
| Group E | Active comparator | Not described Receives: Biological: 10-valent pneumococcal vaccine GSK513026 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence, intensity and relationship to vaccination of any solicited local and general signs and symptoms.
Measured: during a 7-day follow up period after each vaccine dose.
Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms
Measured: during a 31-day follow up period after each vaccine dose.
Occurrence and relationship to vaccination of all serious adverse events (SAEs).
Measured: Throughout the study period.
Post vaccination concentration IgG ≥5 µg/mL and fold increase Post/Pre ≥2 for at least 6 serotypes out of 11
Measured: 1 month after Dose 2 in Groups A, B, C and 1 month after Dose 1 for Group D
Post vaccination concentration and fold increase Post/Pre ≥2 for at least 6 serotypes out of 11, in Groups A through D.
Measured: One month after the first vaccine dose.
Secondary outcomes (7)
Haematological and biochemical levels within or outside the normal ranges in all groups.
Measured: At Months 0, 1, 3, 4 and 12.
IgG antibody concentrations to vaccine pneumococcal serotypes in all groups.
Measured: At Months 0, 1, 3, 4 and 12.
Opsonophagocytic activity titres (OPA) against pneumococcal serotypes in all groups.
Measured: At Months 0, 1, 3, 4 and 12
Frequencies of IgG PS-specific plasma cells generated by in vitro cultivated memory B-cells for 4 serotypes in all groups, and for 11 serotypes in 10 subjects per group.
Measured: At Months 0, 1, 4 and 12.
Anti-protein D, anti-tetanus and anti-diphtheria toxoids IgG antibody concentrations in Groups A, B, C and E.
Measured: At Months 0, 1, 3, 4 and 12.
Frequencies of IgG carrier protein-specific plasma cells generated by in vitro cultivated memory B-cells in a subset of subjects (all subjects minus PS B-cell memory subset) of the Groups A, B, C and E.
Measured: At Months 0, 1, 4 and 12.
Freq. of CD4+&CD8+ T cells with antigen-specific IL-2 &/or INFy &/or TNFa &/or CD40L secretion/expression to carrier protein as determined by ICS, in a subset of subjects (all subjects minus PS B-cell memory subset) of the Groups A, B, C and E.
Measured: At Months 0, 1, 4 and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study start1 May 2006
- Primary completion1 Jan 2007
- Study completion8 Jan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, StreptococcalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327665
- Sponsor's protocol ID
- 106068
- Other IDs
- 106072
- Status last verified
- May 2017
- First submitted
- 17 May 2006
- Last updated
- 8 May 2017
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Randomized, Observer Blinded Study to Evaluate and Compare the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline Biologicals' Investigational Pneumococcal Vaccine Formulations Versus a Licensed Non-GlaxoSmithKline Biologicals' Vaccine and GlaxoSmithKline Biologicals' Aluminum-based 10-valent Pneumococcal Conjugate Vaccine, in Healthy Elderly Subjects
- ClinicalTrials.gov ID
- NCT00327665
- Acronym / sponsor ID
- 106068
- Conditions
- Infections, Streptococcal
- Keywords
- pneumonia, pneumococcal vaccine, elderly subjects, invasive pneumococcal diseases, Prophylaxis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 May 2006 (actual)
- Primary completion
- 1 Jan 2007 (actual)
- Study completion
- 8 Jan 2007 (actual)
- First posted
- 18 May 2006 (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.
As the licensed pneumococcal vaccine is not always satisfactory in elderly, new investigational pneumococcal vaccines are evaluated in the healthy elderly population. Note: The study consists of the primary phase (106068): vaccination and follow-up and the extension (106072) of the primary phase: 1 year follow-up.
This protocol posting details the procedures of both the primary \& extension phase.
Detailed description
No new subjects will be enrolled in the Extension Phase of the study. All outcome measures at Month 12 will only be evaluated in the subjects in the Belgian site.
Upon request, volunteers will receive flu vaccination free of charge. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: 11-valent pneumococcal vaccine GSK513026 |
| Group B | Experimental | Biological: 11-valent pneumococcal vaccine GSK513026 |
| Group C | Experimental | Biological: 11-valent pneumococcal vaccine GSK513026 |
| Group D | Active comparator | Biological: Pneumo 23™, Biological: Placebo |
| Group E | Active comparator | Biological: 10-valent pneumococcal vaccine GSK513026 |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- A male or female between 65 and 85 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject.
Key exclusion criteria (15 listed)
- Previous vaccination against Streptococcus pneumoniae.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
- Acute disease at the time of enrolment.
- History of documented radiologically confirmed pneumonia within 3 years prior to first vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
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 |
|---|---|---|
| 11-valent pneumococcal vaccine GSK513026Two-dose intramuscular injection. Each group receiving one of the 3 formulations | Biological | Group A, Group B, Group C |
| Pneumo 23™Single-dose intramuscular injection. | Biological | Group D |
| Placebo1 intramuscular injection. | Biological | Group D |
| 10-valent pneumococcal vaccine GSK513026Two-dose intramuscular injection | Biological | Group E |
Primary outcome
Occurrence, intensity and relationship to vaccination of any solicited local and general signs and symptoms.
Time frame: during a 7-day follow up period after each vaccine dose.
Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms
Time frame: during a 31-day follow up period after each vaccine dose.
Occurrence and relationship to vaccination of all serious adverse events (SAEs).
Time frame: Throughout the study period.
Post vaccination concentration IgG ≥5 µg/mL and fold increase Post/Pre ≥2 for at least 6 serotypes out of 11
Time frame: 1 month after Dose 2 in Groups A, B, C and 1 month after Dose 1 for Group D
Post vaccination concentration and fold increase Post/Pre ≥2 for at least 6 serotypes out of 11, in Groups A through D.
Time frame: One month after the first vaccine dose.
7 secondary outcomes
Haematological and biochemical levels within or outside the normal ranges in all groups.
Time frame: At Months 0, 1, 3, 4 and 12.
IgG antibody concentrations to vaccine pneumococcal serotypes in all groups.
Time frame: At Months 0, 1, 3, 4 and 12.
Opsonophagocytic activity titres (OPA) against pneumococcal serotypes in all groups.
Time frame: At Months 0, 1, 3, 4 and 12
Frequencies of IgG PS-specific plasma cells generated by in vitro cultivated memory B-cells for 4 serotypes in all groups, and for 11 serotypes in 10 subjects per group.
Time frame: At Months 0, 1, 4 and 12.
Anti-protein D, anti-tetanus and anti-diphtheria toxoids IgG antibody concentrations in Groups A, B, C and E.
Time frame: At Months 0, 1, 3, 4 and 12.
Frequencies of IgG carrier protein-specific plasma cells generated by in vitro cultivated memory B-cells in a subset of subjects (all subjects minus PS B-cell memory subset) of the Groups A, B, C and E.
Time frame: At Months 0, 1, 4 and 12.
Freq. of CD4+&CD8+ T cells with antigen-specific IL-2 &/or INFy &/or TNFa &/or CD40L secretion/expression to carrier protein as determined by ICS, in a subset of subjects (all subjects minus PS B-cell memory subset) of the Groups A, B, C and E.
Time frame: At Months 0, 1, 4 and 12.
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 8 May 2017.
- Results for study 106068 can be found on the GSK Clinical Study RegisterLink provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 11-valent pneumococcal vaccine GSK513026, Pneumo 23™ and 10-valent pneumococcal vaccine GSK513026 in people with Infections, Streptococcal, run by GlaxoSmithKline at 3 sites in 3 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 15 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 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Finland, 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 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?
Occurrence, intensity and relationship to vaccination of any solicited local and general signs and symptoms. (time frame: during a 7-day follow up period after each vaccine dose.). The study lists 5 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 8 May 2017.