Prophylaxis Invasive Pneumococcal Diseases and PneumoniaPhase 2NCT00307528

Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly Population

A Phase 2 study testing Pneumococcal vaccine GSK513026 and Pneumovax 23™ in people with Prophylaxis Invasive Pneumococcal Diseases and Pneumonia, run by GlaxoSmithKline at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

As the licensed Pneumovax 23™ vaccine is not always satisfactory in elderly subjects, the safety and the immune response of the new investigational pneumococcal protein vaccine is evaluated in healthy elderly population. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Prophylaxis Invasive Pneumococcal Diseases and Pneumonia
What is being tested?: Pneumococcal vaccine GSK513026 and Pneumovax 23™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 146 participants
Where: 1 siteBelgium
Study dates: 20 Jan 2004to 30 Mar 2005
Phase: Phase 2
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 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Subjects who the investigator believes will comply with the requirements of the protocol
A male or female ≥ 65 years at the time of the first vaccination.
Written informed consent obtained from the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Who cannot join

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 or participation to another pharmaceutical/vaccine study.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Use of any anticoagulants.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccines.
Previous vaccination against Streptococcus pneumoniae.
Bacterial pneumonia within 3 years prior to 1st vaccination.

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Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Current serious neurologic or mental disorders.
Currently smoking > 25 cigarettes per day.
Inflammatory processes such as known chronic active infections
All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
History of administration of an experimental vaccine containing MPL or QS21.
Acute disease at the time of enrolment.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator.
History of chronic alcohol consumption and/or intravenous drug abuse.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

GSK Investigational Site
Ghent, 9000

Other trials in Belgium

About this study

Official title: A Study to Evaluate the Safety, Reactogenicity & Immunogenicity of the GSK Biologicals Candidate Pneumococcal Vaccine Without or With Adjuvant, Administered at 2 Different Concentrations, in Healthy Elderly Subjects

Read the detailed description

Since influenza vaccination is recommended in the age range of the study population, Fluarix™ (GlaxoSmithKline Biologicals) vaccine will be offered free of charge during the study period (for 3 consecutive years starting from September 2004), to be used by Investigators according to national vaccination schedule/practice.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions: Prophylaxis Invasive Pneumococcal Diseases and Pneumonia
Being tested: Pneumococcal vaccine GSK513026, Pneumovax 23™
Medical subject headings: Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pneumococcal vaccine GSK513026Biological
Two-dose intramuscular injection. Five different formulations, each administered to one Group
Pneumovax 23™Biological
Single dose intramuscular injection.

Study groups in NCT00307528
Study group	Role	What they receive
Group A	Active comparator	Not described Receives: Biological: Pneumovax 23™
Group B	Experimental	Not described Receives: Biological: Pneumococcal vaccine GSK513026
Group C	Experimental	Not described Receives: Biological: Pneumococcal vaccine GSK513026
Group D	Experimental	Not described Receives: Biological: Pneumococcal vaccine GSK513026
Group E	Experimental	Not described Receives: Biological: Pneumococcal vaccine GSK513026
Group F	Experimental	Not described Receives: Biological: Pneumococcal vaccine GSK513026

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurrence, intensity and relationship 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 30-day follow up period after each vaccine dose.
Occurrence of all serious adverse events (SAE).
Measured: During the entire study period.
Anti- PhtD antibody concentration
Measured: One month after the first injection
Anti-PhtD antibody concentration.
Measured: One month after 2 injections

Secondary outcomes (11)

Number and percentage of subjects with normal or abnormal values for biochemical assessments and for haematological analysis.
Measured: At each scheduled time point (month 0, 1, 3, 12, 24 and 36).
Anti- PhtD antibody concentration.
Measured: At 12, 24 and 36 months after the first vaccination.
Anti-PhtD antibody avidity.
Measured: At month 0, 1 and 3.
Evaluation of protection afforded by passive transfer of anti PhtD antibodies sera pooled from all individuals.
Measured: At month 0, 1 and 3.
Frequency of PhtD specific plasma cells generated by in vitro cultivated memory B-cells, in a subset of subjects.
Measured: At month 0, 1, 3, 12.
Frequency of CD4 and/or CD8 T cells that produce cytokines (IL-2, IL-4, IFNg, CD40L and/or GM-CSF, and TNFα), upon PhtD re-stimulation in vitro, to evaluate the T-cell response, in a subset of subjects.
Measured: At month 0, 1, 3, 12.
Anti-polysaccharide total IgG concentration in Group A for all vaccine pneumococcal serotypes
Measured: At month 0, 1, 12, 24 and 36.
Anti-PS antibody avidity for 5 serotypes in Group A.
Measured: At month 0 and 1.
Deposition of complement components on the surface of different bacterial strains 3 strains (GSK/CDC, OPA, isogenic TIGR4) of 5 serotypes in Group A.
Measured: At month 0 and 1.
Opsonophagocytic activity titres in Group A to all vaccine pneumococcal serotypes
Measured: At month 0, 1 and 12.
Frequency of PS-specific plasma cells generated by in vitro cultivated memory B-cells in Group A in a subset of subjects.
Measured: At month 0 and month 1.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 200430 Mar 2005

First posted28 Mar 2006 (estimated)
Study start20 Jan 2004
Primary completion30 Mar 2005
Study completion30 Mar 2005

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 Prophylaxis Invasive Pneumococcal Diseases and PneumoniaStudies 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 146 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00307528
Sponsor's protocol ID: 100409
Other IDs: 100463, 100464
Status last verified: Oct 2019
First submitted: 6 Mar 2006
Last updated: 30 Oct 2019
Results posted: No
Individual data sharing: Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

Publications

Leroux-Roels I, Devaster JM, Leroux-Roels G, Verlant V, Henckaerts I, Moris P, Hermand P, Van Belle P, Poolman JT, Vandepapeliere P, Horsmans Y. Adjuvant system AS02V enhances humoral and cellular immune responses to pneumococcal protein PhtD vaccine in healthy young and older adults: randomised, controlled trials. Vaccine. 2015 Jan 15;33(4):577-84. doi: 10.1016/j.vaccine.2013.10.052. Epub 2013 Oct 29.
PubMed 24176494

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Safety, Reactogenicity & Immunogenicity of the GSK Biologicals Candidate Pneumococcal Vaccine Without or With Adjuvant, Administered at 2 Different Concentrations, in Healthy Elderly Subjects
ClinicalTrials.gov ID: NCT00307528
Acronym / sponsor ID: 100409
Conditions: Prophylaxis Invasive Pneumococcal Diseases and Pneumonia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 146 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 20 Jan 2004 (actual)
Primary completion: 30 Mar 2005 (actual)
Study completion: 30 Mar 2005 (actual)
First posted: 28 Mar 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.

Detailed description

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: Single blind (participant)
Number of arms: 6

Arm	Type	Receives
Group A	Active comparator	Biological: Pneumovax 23™
Group B	Experimental	Biological: Pneumococcal vaccine GSK513026
Group C	Experimental	Biological: Pneumococcal vaccine GSK513026
Group D	Experimental	Biological: Pneumococcal vaccine GSK513026
Group E	Experimental	Biological: Pneumococcal vaccine GSK513026
Group F	Experimental	Biological: Pneumococcal vaccine GSK513026

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

Subjects who the investigator believes will comply with the requirements of the protocol
A male or female ≥ 65 years at the time of the first vaccination.
Written informed consent obtained from the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Key exclusion criteria (16 listed)

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 or participation to another pharmaceutical/vaccine study.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Use of any anticoagulants.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccines.
Previous vaccination against Streptococcus pneumoniae.

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 GSK513026Two-dose intramuscular injection. Five different formulations, each administered to one Group	Biological	Group B, Group C, Group D, Group E, Group F
Pneumovax 23™Single dose intramuscular injection.	Biological	Group A

Primary outcome

Occurrence, intensity and relationship 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 30-day follow up period after each vaccine dose.
Occurrence of all serious adverse events (SAE).
Time frame: During the entire study period.
Anti- PhtD antibody concentration
Time frame: One month after the first injection
Anti-PhtD antibody concentration.
Time frame: One month after 2 injections

11 secondary outcomes

Number and percentage of subjects with normal or abnormal values for biochemical assessments and for haematological analysis.
Time frame: At each scheduled time point (month 0, 1, 3, 12, 24 and 36).
Anti- PhtD antibody concentration.
Time frame: At 12, 24 and 36 months after the first vaccination.
Anti-PhtD antibody avidity.
Time frame: At month 0, 1 and 3.
Evaluation of protection afforded by passive transfer of anti PhtD antibodies sera pooled from all individuals.
Time frame: At month 0, 1 and 3.
Frequency of PhtD specific plasma cells generated by in vitro cultivated memory B-cells, in a subset of subjects.
Time frame: At month 0, 1, 3, 12.
Frequency of CD4 and/or CD8 T cells that produce cytokines (IL-2, IL-4, IFNg, CD40L and/or GM-CSF, and TNFα), upon PhtD re-stimulation in vitro, to evaluate the T-cell response, in a subset of subjects.
Time frame: At month 0, 1, 3, 12.
Anti-polysaccharide total IgG concentration in Group A for all vaccine pneumococcal serotypes
Time frame: At month 0, 1, 12, 24 and 36.
Anti-PS antibody avidity for 5 serotypes in Group A.
Time frame: At month 0 and 1.
Deposition of complement components on the surface of different bacterial strains 3 strains (GSK/CDC, OPA, isogenic TIGR4) of 5 serotypes in Group A.
Time frame: At month 0 and 1.
Opsonophagocytic activity titres in Group A to all vaccine pneumococcal serotypes
Time frame: At month 0, 1 and 12.
Frequency of PS-specific plasma cells generated by in vitro cultivated memory B-cells in Group A in a subset of subjects.
Time frame: At month 0 and month 1.

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 Oct 2019.
Derived from this study: PubMed 24176494Leroux-Roels I, Devaster JM, Leroux-Roels G, Verlant V, Henckaerts I, Moris P, Hermand P, Van Belle P, Poolman JT, Vandepapeliere P, Horsmans Y. Adjuvant system AS02V enhances humoral and cellular immune responses to pneumococcal protein PhtD vaccine in healthy young and older adults: randomised, controlled trials. Vaccine. 2015 Jan 15;33(4):577-84. doi: 10.1016/j.vaccine.2013.10.052. Epub 2013 Oct 29.
Individual participant dataSharing planned: Yes. IPD is available via the Clinical Study Data Request site (click on the link provided below)

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pneumococcal vaccine GSK513026 and Pneumovax 23™ in people with Prophylaxis Invasive Pneumococcal Diseases and Pneumonia, run by GlaxoSmithKline at 1 site in Belgium.

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 4 inclusion and 16 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 Oct 2019. 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 Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 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?

On the ClinicalTrials.gov record for NCT00307528, 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 Oct 2019.