TuberculosisPhase 2NCT00950612

Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Healthy HIV Negative Adolescents

A Phase 2 study testing GSK's investigational vaccine 692342 in people with Tuberculosis, run by GlaxoSmithKline at 1 site in South Africa.

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

This observer blind study will assess the safety and immunogenicity of GSK Biologicals' investigational 692342 vaccine administered at 0, 1 month to healthy adolescents living in a TB-endemic region. Read more about this study

Who is it for?: Ages 13 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Tuberculosis
What is being tested?: GSK's investigational vaccine 692342
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteSouth Africa
Study dates: 8 Dec 2009to 30 Sep 2010
Phase: Phase 2
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 13 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subjects who the investigator believes that they and their parent(s)/ legal guardian(s) can and will comply with the requirements of the protocol.
A male or female between, and including, 13 and 17 years of age at the time of the first vaccination.
Written informed consent obtained from the subject's parent(s) or legal guardian(s).
Written informed assent obtained from the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Seronegative for HIV-1.

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No history of TB disease.
No active pulmonary disease on chest X-ray.
Availability for the duration of the immunisation and follow-up period, with the family not planning to move away from the study area within the next year.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject is abstinent, has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire vaccination period and for 2 months after completion of the vaccination series.

Who cannot join

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Administration of a registered live vaccine not foreseen by the study within 30 days preceding the first dose of study vaccine and administration of a registered inactivated vaccine within 14 days preceding the first dose of study vaccine.
History of previous administration of investigational Mycobacterium tuberculosis vaccines.
History of previous exposure to components of the investigational vaccine.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Any condition or illness (acute, chronic or history) or medication, which in the opinion of the investigator might interfere with the evaluation of the safety or immunogenicity of the study vaccine.

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Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of vaccine, or planned administration during the study.
Planned participation or participation in another experimental clinical study during the study period.
A family history of congenital or hereditary immunodeficiency.
Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements, birth control pills, anti-histamines for seasonal allergies and Specific Serotonin Reuptake Inhibitors (SSRIs).
History of allergic reactions (significant IgE-mediated events) or anaphylaxis to any vaccine.
History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
Pregnant female, lactating female or female planning to become pregnant or discontinue contraceptive precautions.
Drug and/or alcohol abuse

Trial locations and contacts

1 site in 1 country.

South Africa1 site

GSK Investigational Site
Worcester, Western Province, 6850

Other trials in South Africa

About this study

Official title: Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccine (692342) When Administered to Healthy HIV-negative Adolescents Living in a TB Endemic Region

This observer blind study will assess the safety and immunogenicity of GSK Biologicals' investigational 692342 vaccine administered at 0, 1 month to healthy adolescents living in a TB-endemic region.

Conditions: Tuberculosis
Being tested: GSK's investigational vaccine 692342, Placebo
Keywords: Tuberculosis vaccine
Medical subject headings: Tuberculosis

What participants receive

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

GSK's investigational vaccine 692342Biological
Intramuscular injection, 2 doses
PlaceboBiological
Intramuscular injection, 2 doses

Study groups in NCT00950612
Study group	Role	What they receive
Group A	Experimental	Not described Receives: Biological: GSK's investigational vaccine 692342
Group B	Placebo comparator	Not described Receives: Biological: Placebo

What is being measured

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

Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Measured: During the 30-day (Days 0-29) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the entire study period (from Day 0 up to Day 210)
Number of Subjects With Normal Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CREA], haemoglobin [Hgb]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - normal, below and above.
Measured: At Day 0, 7, 30, 37 and 60
Number of Subjects With Normal Haematological Levels
Among haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC].
Levels of haematological parameters assessed in terms of normal laboratory values were - normal, below and above.
Measured: At Day 0, 7, 30, 37 and 60
Number of Subjects With Biochemical and Haematological Above Normal Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CREA], haemoglobin [Hgb]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - normal, below and above.
Measured: At Day 0, 7, 30, 37 and 60
Number of Subjects With Haematological Levels Above Normal
Among haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC].
Levels of haematological parameters assessed in terms of normal laboratory values were - normal, below and above.
Measured: At Day 0, 7, 30, 37 and 60
Number of Subjects With Biochemical and Haematological Below Normal Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CREA], haemoglobin [Hgb]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - normal, below and above.
Measured: At Day 0, 7, 30, 37 and 60
Number of Subjects With Haematological Levels Below Normal
Among haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC].
Levels of haematological parameters assessed in terms of normal laboratory values were - normal, below and above.
Measured: At Day 0, 7, 30, 37 and 60

Secondary outcomes (4)

Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines
Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).
Measured: At Day 0, 7, 30, 37, 60 and 210
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines
Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).
Measured: At Day 0, 7, 30, 37, 60 and 210
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines
Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).
Measured: At Day 0, 7, 30, 37, 60 and 210
Anti-M72 Specific Antibody Concentrations
Antibody concentrations given in Enzyme-Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL) were expressed as Geometric Mean Concentrations (GMCs).
Measured: At Day 0, 30, 60 and 210

Timeline

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

8 Dec 200930 Sep 2010

First posted3 Aug 2009 (estimated)
Study start8 Dec 2009
Primary completion30 Sep 2010
Study completion30 Sep 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for TuberculosisStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00950612
Sponsor's protocol ID: 112898
Status last verified: Nov 2016
First submitted: 23 Jul 2009
Last updated: 17 Aug 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Penn-Nicholson A, Geldenhuys H, Burny W, van der Most R, Day CL, Jongert E, Moris P, Hatherill M, Ofori-Anyinam O, Hanekom W; Vaccine Study Team; Bollaerts A, Demoitie MA, Kany Luabeya AK, De Ruymaeker E, Tameris M, Lapierre D, Scriba TJ. Safety and immunogenicity of candidate vaccine M72/AS01E in adolescents in a TB endemic setting. Vaccine. 2015 Jul 31;33(32):4025-34. doi: 10.1016/j.vaccine.2015.05.088. Epub 2015 Jun 10.
PubMed 26072017

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccine (692342) When Administered to Healthy HIV-negative Adolescents Living in a TB Endemic Region
ClinicalTrials.gov ID: NCT00950612
Acronym / sponsor ID: 112898
Conditions: Tuberculosis
Keywords: Tuberculosis vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: Aeras
Study start: 8 Dec 2009
Primary completion: 30 Sep 2010 (actual)
Study completion: 30 Sep 2010 (actual)
First posted: 3 Aug 2009 (estimated)
Results: Posted 9 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This observer blind study will assess the safety and immunogenicity of GSK Biologicals' investigational 692342 vaccine administered at 0, 1 month to healthy adolescents living in a TB-endemic region.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Biological: GSK's investigational vaccine 692342
Group B	Placebo comparator	Biological: Placebo

Who may qualify

Ages: 13 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (11 listed)

Subjects who the investigator believes that they and their parent(s)/ legal guardian(s) can and will comply with the requirements of the protocol.
A male or female between, and including, 13 and 17 years of age at the time of the first vaccination.
Written informed consent obtained from the subject's parent(s) or legal guardian(s).
Written informed assent 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 (14 listed)

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Administration of a registered live vaccine not foreseen by the study within 30 days preceding the first dose of study vaccine and administration of a registered inactivated vaccine within 14 days preceding the first dose of study vaccine.
History of previous administration of investigational Mycobacterium tuberculosis vaccines.
History of previous exposure to components of the investigational vaccine.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

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
GSK's investigational vaccine 692342Intramuscular injection, 2 doses	Biological	Group A
PlaceboIntramuscular injection, 2 doses	Biological	Group B

Primary outcome

Number of Subjects With Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.
Number of Subjects With Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 30-day (Days 0-29) post-vaccination period
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Day 0 up to Day 210)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With Normal Biochemical and Haematological Levels
Time frame: At Day 0, 7, 30, 37 and 60
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CREA], haemoglobin [Hgb]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - normal, below and above.
Number of Subjects With Normal Haematological Levels
Time frame: At Day 0, 7, 30, 37 and 60
Among haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological parameters assessed in terms of normal laboratory values were - normal, below and above.
Number of Subjects With Biochemical and Haematological Above Normal Levels
Time frame: At Day 0, 7, 30, 37 and 60
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CREA], haemoglobin [Hgb]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - normal, below and above.
Number of Subjects With Haematological Levels Above Normal
Time frame: At Day 0, 7, 30, 37 and 60
Among haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological parameters assessed in terms of normal laboratory values were - normal, below and above.
Number of Subjects With Biochemical and Haematological Below Normal Levels
Time frame: At Day 0, 7, 30, 37 and 60
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CREA], haemoglobin [Hgb]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - normal, below and above.
Number of Subjects With Haematological Levels Below Normal
Time frame: At Day 0, 7, 30, 37 and 60
Among haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological parameters assessed in terms of normal laboratory values were - normal, below and above.

4 secondary outcomes

Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines
Time frame: At Day 0, 7, 30, 37, 60 and 210
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines
Time frame: At Day 0, 7, 30, 37, 60 and 210
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines
Time frame: At Day 0, 7, 30, 37, 60 and 210
Anti-M72 Specific Antibody Concentrations
Time frame: At Day 0, 30, 60 and 210

Results and safety

Results posted to the registry on 9 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK692342 Group	40	40
Placebo Group	20	20

Primary outcome: Number of Subjects With Solicited Local Symptoms

Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses. Number. Unit: Subjects

Measure	GSK692342 Group n = 40	Placebo Group n = 20
Any Pain, Dose 1 [N=40;18]	37	3
Grade 3 Pain, Dose 1 [N=40;18]	3	0
Any Redness, Dose 1 [N=40;18]	7	2
Grade 3 Redness, Dose 1 [N=40;18]	0	0
Any Swelling, Dose 1 [N=40;18]	14	2
Grade 3 Swelling, Dose 1 [N=40;18]	0	0
Any Pain, Dose 2 [N=40;20]	35	5
Grade 3 Pain, Dose 2 [N=40;20]	7	0

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Primary outcome: Number of Subjects With Solicited General Symptoms

Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses. Number. Unit: Subjects

Measure	GSK692342 Group n = 40	Placebo Group n = 20
Any Fatigue, Dose 1 [N=40;18]	11	2
Related Fatigue, Dose 1 [N=40;18]	11	2
Grade 3 Fatigue, Dose 1 [N=40;18]	0	0
Any Gastro, Dose 1 [N=40;18]	9	3
Related Gastro, Dose 1 [N=40;18]	9	3
Grade 3 Gastro, Dose 1 [N=40;18]	1	0
Any Headache, Dose 1 [N=40;18]	16	3
Related Headache, Dose 1 [N=40;18]	15	3

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Primary outcome: Number of Subjects With Unsolicited Adverse Events (AEs)

Time frame: During the 30-day (Days 0-29) post-vaccination period. Number. Unit: Subjects

Measure	GSK692342 Group n = 40	Placebo Group n = 20
Value	9	3

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Primary outcome: Number of Subjects With Serious Adverse Events (SAEs)

Time frame: During the entire study period (from Day 0 up to Day 210). Number. Unit: Subjects

Measure	GSK692342 Group n = 40	Placebo Group n = 20
Value	0	0

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK692342 Group	0 of 40 (0%)	38 of 40 (95%)	Not reported
Placebo Group	0 of 20 (0%)	15 of 20 (75%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26072017Penn-Nicholson A, Geldenhuys H, Burny W, van der Most R, Day CL, Jongert E, Moris P, Hatherill M, Ofori-Anyinam O, Hanekom W; Vaccine Study Team; Bollaerts A, Demoitie MA, Kany Luabeya AK, De Ruymaeker E, Tameris M, Lapierre D, Scriba TJ. Safety and immunogenicity of candidate vaccine M72/AS01E in adolescents in a TB endemic setting. Vaccine. 2015 Jul 31;33(32):4025-34. doi: 10.1016/j.vaccine.2015.05.088. Epub 2015 Jun 10.

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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 2 study testing GSK's investigational vaccine 692342 in people with Tuberculosis, run by GlaxoSmithKline at 1 site in South Africa.

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 11 inclusion and 14 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 17 Aug 2018. 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 South Africa. 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 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?

Yes. Results are posted in the registry (first posted 9 Jan 2017). 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?

Number of Subjects With Solicited Local Symptoms (time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses). The study lists 10 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 NCT00950612, 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 17 Aug 2018.