Infections, StreptococcalPhase 1NCT00707798
Evaluation of Pneumococcal Vaccine Formulations in Young Adults
A Phase 1 study testing Pneumococcal vaccine GSK2189242A and Pneumo 23™ in people with Infections, Streptococcal, run by GlaxoSmithKline at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of pneumococcal vaccines in young adults. Subjects will be vaccinated twice with an interval of two months. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- Pneumococcal vaccine GSK2189242A and Pneumo 23™
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Jun 2008to 15 Jan 2009
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who the investigator believes will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- A male or female between, and including, 18 and 40 years old at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Free of obvious health problems as established by medical history, clinical examination and clinical laboratory assessment before entering into the study.
- If the subject is female, and of child-bearing potential, she agrees to use adequate contraception and not become pregnant for the duration of the study.
Who cannot join
- Previous vaccination against Streptococcus pneumoniae.
- Vaccination with diphtheria/tetanus toxoids within one month preceding the first dose of study vaccine.
- 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.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine, with the exception of the influenza vaccine which can be administered > 7 days preceding or > 7 days following each vaccine dose (after collection of 7-day safety data).
- Bacterial pneumonia within 3 years prior to 1st vaccination.
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- Invasive pneumococcal disease (IPD) within 3 years prior to 1st vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- History of thrombocytopenia or bleeding disorder.
- History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
- Current serious neurologic or mental disorders.
- Inflammatory processes such as known chronic active infections (e.g. Hepatitis B, C).
- All past or current malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders.
- Acute disease at the time of enrolment/vaccination.
- Physical examination positive for acrocyanosis, jaundice, splenomegaly.
- Acute or chronic, clinically significant anaemia, pulmonary, cardiovascular, hematologic , hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator.
- Laboratory evidence of haematological abnormalities.
- Laboratory evidence of biochemical abnormalities
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of chronic alcohol consumption and/or drug abuse.
- Other conditions that the principal investigator judges may interfere with study findings.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189242A) in Young Adults.
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of pneumococcal vaccines in young adults. Subjects will be vaccinated twice with an interval of two months.
Read the detailed description
This amendment was due to
- The addition of secondary endpoints for safety. The collection of data related to these secondary safety endpoints was already planned and the corresponding statistical analyses were described in the statistical section.
- The addition of an exclusion criterion regarding the administration of immunoglobulins and blood products. It is already included in the elimination criteria section. It impacts only immunogenicity.
- Conditions
- Infections, Streptococcal
- Being tested
- Pneumococcal vaccine GSK2189242A, Pneumo 23™
- Keywords
- Young adults, Pneumococcal vaccine,, Streptococcus pneumoniae,
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal vaccine GSK2189242ABiological
Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
Pneumo 23™Biological
One dose of 0.5 ml will be administered intramuscularly at Month 0, and a placebo dose to keep the blinding at Month 2
| Study group | Role | What they receive |
|---|---|---|
| Formulation 1 | Experimental | Not described Receives: Biological: Pneumococcal vaccine GSK2189242A |
| Formulation 2 | Experimental | Not described Receives: Biological: Pneumococcal vaccine GSK2189242A |
| Formulation 3 | Experimental | Not described Receives: Biological: Pneumococcal vaccine GSK2189242A |
| Formulation 4 | Experimental | Not described Receives: Biological: Pneumococcal vaccine GSK2189242A |
| Formulation 5 | Experimental | Not described Receives: Biological: Pneumococcal vaccine GSK2189242A |
| Formulation 6 | Experimental | Not described Receives: Biological: Pneumococcal vaccine GSK2189242A |
| 23 valent pneumococcal vaccine | Active comparator | Not described Receives: Biological: Pneumo 23™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any vaccine related and grade 3 solicited local and general adverse events
Measured: During a 7-day follow up period after each vaccine dose
Occurrence of any vaccine related and grade 3 unsolicited adverse events
Measured: During a 31-day follow up period after each vaccine dose
Occurrence of any vaccine related serious adverse events (SAE)
Measured: From Visit 1 to study conclusion
Occurrence of any grade 3 laboratory abnormalities
Measured: During a 7-day follow up period after each vaccine dose
Secondary outcomes (4)
Occurrence of any solicited local and general adverse events
Measured: During a 7-day follow up period after each vaccine dose.
Occurrence of any unsolicited adverse events
Measured: During a 31-day follow up period after each vaccine dose
Occurrence of any haematological, biochemical, or urinary abnormalities
Measured: At 1 and 7 days after each vaccine dose
Anti-pneumococcal and anti-NTHi candidate vaccine antigens
Measured: At Days 0, 30 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2008 (estimated)
- Study start30 Jun 2008
- Primary completion15 Jan 2009
- Study completion15 Jan 2009
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 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
- 157 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
- NCT00707798
- Sponsor's protocol ID
- 111651
- Status last verified
- May 2017
- First submitted
- 30 Jun 2008
- Last updated
- 10 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.
Publications
Leroux-Roels G, Maes C, De Boever F, Traskine M, Ruggeberg JU, Borys D. Safety, reactogenicity and immunogenicity of a novel pneumococcal protein-based vaccine in adults: a phase I/II randomized clinical study. Vaccine. 2014 Nov 28;32(50):6838-46. doi: 10.1016/j.vaccine.2014.02.052. Epub 2014 Mar 6.
PubMed 24607003
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189242A) in Young Adults.
- ClinicalTrials.gov ID
- NCT00707798
- Acronym / sponsor ID
- 111651
- Conditions
- Infections, Streptococcal
- Keywords
- Young adults, Pneumococcal vaccine,, Streptococcus pneumoniae,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2008 (actual)
- Primary completion
- 15 Jan 2009 (actual)
- Study completion
- 15 Jan 2009 (actual)
- First posted
- 1 Jul 2008 (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.
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of pneumococcal vaccines in young adults. Subjects will be vaccinated twice with an interval of two months.
Detailed description
This amendment was due to
- The addition of secondary endpoints for safety. The collection of data related to these secondary safety endpoints was already planned and the corresponding statistical analyses were described in the statistical section.
- The addition of an exclusion criterion regarding the administration of immunoglobulins and blood products. It is already included in the elimination criteria section. It impacts only immunogenicity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Formulation 1 | Experimental | Biological: Pneumococcal vaccine GSK2189242A |
| Formulation 2 | Experimental | Biological: Pneumococcal vaccine GSK2189242A |
| Formulation 3 | Experimental | Biological: Pneumococcal vaccine GSK2189242A |
| Formulation 4 | Experimental | Biological: Pneumococcal vaccine GSK2189242A |
| Formulation 5 | Experimental | Biological: Pneumococcal vaccine GSK2189242A |
| Formulation 6 | Experimental | Biological: Pneumococcal vaccine GSK2189242A |
| 23 valent pneumococcal vaccine | Active comparator | Biological: Pneumo 23™ |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects who the investigator believes will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- A male or female between, and including, 18 and 40 years old at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Free of obvious health problems as established by medical history, clinical examination and clinical laboratory assessment before entering into the study.
- If the subject is female, and of child-bearing potential, she agrees to use adequate contraception and not become pregnant for the duration of the study.
Key exclusion criteria (23 listed)
- Previous vaccination against Streptococcus pneumoniae.
- Vaccination with diphtheria/tetanus toxoids within one month preceding the first dose of study vaccine.
- 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.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine, with the exception of the influenza vaccine which can be administered > 7 days preceding or > 7 days following each vaccine dose (after collection of 7-day safety data).
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 GSK2189242ATwo doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested | Biological | Formulation 1, Formulation 2, Formulation 3, Formulation 4, Formulation 5, Formulation 6 |
| Pneumo 23™One dose of 0.5 ml will be administered intramuscularly at Month 0, and a placebo dose to keep the blinding at Month 2 | Biological | 23 valent pneumococcal vaccine |
Primary outcome
Occurrence of any vaccine related and grade 3 solicited local and general adverse events
Time frame: During a 7-day follow up period after each vaccine dose
Occurrence of any vaccine related and grade 3 unsolicited adverse events
Time frame: During a 31-day follow up period after each vaccine dose
Occurrence of any vaccine related serious adverse events (SAE)
Time frame: From Visit 1 to study conclusion
Occurrence of any grade 3 laboratory abnormalities
Time frame: During a 7-day follow up period after each vaccine dose
4 secondary outcomes
Occurrence of any solicited local and general adverse events
Time frame: During a 7-day follow up period after each vaccine dose.
Occurrence of any unsolicited adverse events
Time frame: During a 31-day follow up period after each vaccine dose
Occurrence of any haematological, biochemical, or urinary abnormalities
Time frame: At 1 and 7 days after each vaccine dose
Anti-pneumococcal and anti-NTHi candidate vaccine antigens
Time frame: At Days 0, 30 and 90
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 10 May 2017.
- Derived from this study: PubMed 24607003Leroux-Roels G, Maes C, De Boever F, Traskine M, Ruggeberg JU, Borys D. Safety, reactogenicity and immunogenicity of a novel pneumococcal protein-based vaccine in adults: a phase I/II randomized clinical study. Vaccine. 2014 Nov 28;32(50):6838-46. doi: 10.1016/j.vaccine.2014.02.052. Epub 2014 Mar 6.
- 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.
- Results for study 111651 can be found on the GSK Clinical Study RegisterLink 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
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 GSK2189242A and Pneumo 23™ in people with Infections, Streptococcal, 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 5 inclusion and 23 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 10 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 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 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 of any vaccine related and grade 3 solicited local and general adverse events (time frame: During a 7-day follow up period after each vaccine dose). The study lists 4 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 NCT00707798, 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 10 May 2017.