TuberculosisPhase 2NCT00621322

Safety and Immunogenicity Study of GSK Biologicals Tuberculosis Vaccines (692342) to Healthy Adults

A Phase 2 study testing GSK Biologicals' AS01B adjuvant, GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1 and GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2 in people with Tuberculosis, run by GlaxoSmithKline at 1 site in Philippines.

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 different formulations of GSK Biologicals' 692342 tuberculosis vaccine in healthy adults aged 18 to 45 years with a positive PPD skin test. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Tuberculosis
What is being tested?: GSK Biologicals' AS01B adjuvant, GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1 and GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 1 sitePhilippines
Study dates: 3 Apr 2008to 3 Apr 2009
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 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female between, and including, 18 and 45 years of age at the time of the first vaccination.
Written informed consent obtained from the subject prior to any study procedure.
Free of obvious health problems as established by medical history and clinical examination before enrolment into the study.
If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
No evidence of pulmonary pathology as confirmed by chest X-ray.

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No history of extrapulmonary TB.
Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), complete blood count (CBC) and urinalysis.
Seronegative for human immunodeficiency virus-1 and -2 (HIV-1 and -2) antibodies.
Subjects must have a PPD positive skin reactivity 48 to 72 hours after PPD skin test administration.

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.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements, herbal medications, birth control pills, anti-histamines for seasonal allergies and SSRIs.
History of previous administration of experimental Mycobacterium tuberculosis vaccines.
History of previous exposure to experimental products containing MPL or QS21.
Administration of any immunoglobulins, any immunotherapy and/or any blood products within the three months preceding the first dose of study vaccination, or planned administrations during the study period.

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Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
A family history (first generation) of congenital or hereditary immunodeficiency.
History of any acute or chronic illness or medication that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
History of any neurological disorders or seizures.
History of allergic reactions or anaphylaxis to previous immunisations.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
History of chronic alcohol consumption and/or drug abuse.
Major congenital defects.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.

Trial locations and contacts

1 site in 1 country.

Philippines1 site

GSK Investigational Site
Manila, 1000

Other trials in Philippines

About this study

Official title: Dose Range Study Evaluating Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccines (692342) When Administered to Healthy Adults Aged 18 to 45 Years.

Conditions: Tuberculosis
Being tested: GSK Biologicals' AS01B adjuvant, GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1, GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2, GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 3, GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 1
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 Biologicals' AS01B adjuvantBiological
Intramuscular injection, 2 doses
GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1Biological
Intramuscular injection, 2 doses
GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2Biological
Intramuscular injection, 2 doses
GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 3Biological
Intramuscular injection, 2 doses
GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 1Biological
Intramuscular injection, 2 doses
GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 2Biological
Intramuscular injection, 2 doses

Study groups in NCT00621322
Study group	Role	What they receive
Control Group	Placebo comparator	Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Receives: Biological: GSK Biologicals' AS01B adjuvant
GSK692342_F1 Group	Active comparator	Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Receives: Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1
GSK692342_F2 Group	Experimental	Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Receives: Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2
GSK692342_F3 Group	Experimental	Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Receives: Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 3
GSK692342_F4D1 Group	Experimental	Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Receives: Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 1
GSK692342_F4D2 Group	Experimental	Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Receives: Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 2

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 included 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 included 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 ≥ 39.0 °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 outside 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 Different Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.
Measured: At Day 0
Number of Subjects With Different Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.
Measured: At Day 7
Number of Subjects With Different Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.
Measured: At Day 30
Number of Subjects With Different Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.
Measured: At Day 37
Number of Subjects With Different Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.
Measured: At Day 60

Secondary outcomes (3)

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] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or 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, 30, 60 and 210
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule
Expressed cytokine combinations for CD4+ T cells were CD40-L and IL-2 or IFN-γ or TNF-α; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.
For CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines.
Measured: At Day 0, 30, 60 and 210
Anti-M72 Specific Antibody Concentrations
Concentrations given in enzyme-linked immunosorbent assay units per milliliter (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.

3 Apr 20083 Apr 2009

First posted22 Feb 2008 (estimated)
Study start3 Apr 2008
Primary completion3 Apr 2009
Study completion3 Apr 2009

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 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: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00621322
Sponsor's protocol ID: 110345
Status last verified: Jul 2018
First submitted: 12 Feb 2008
Last updated: 24 Aug 2018
Results posted: Yes, on ClinicalTrials.gov

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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All Tuberculosis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dose Range Study Evaluating Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccines (692342) When Administered to Healthy Adults Aged 18 to 45 Years.
ClinicalTrials.gov ID: NCT00621322
Acronym / sponsor ID: 110345
Conditions: Tuberculosis
Keywords: Tuberculosis vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 3 Apr 2008 (actual)
Primary completion: 3 Apr 2009 (actual)
Study completion: 3 Apr 2009 (actual)
First posted: 22 Feb 2008 (estimated)
Results: Posted 3 Feb 2017

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Control Group	Placebo comparator	Biological: GSK Biologicals' AS01B adjuvantHealthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
GSK692342_F1 Group	Active comparator	Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
GSK692342_F2 Group	Experimental	Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
GSK692342_F3 Group	Experimental	Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 3Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
GSK692342_F4D1 Group	Experimental	Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 1Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
GSK692342_F4D2 Group	Experimental	Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 2Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female between, and including, 18 and 45 years of age at the time of the first vaccination.
Written informed consent obtained from the subject prior to any study procedure.
Free of obvious health problems as established by medical history and clinical examination before enrolment into the study.
If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Key exclusion criteria (17 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.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements, herbal medications, birth control pills, anti-histamines for seasonal allergies and SSRIs.
History of previous administration of experimental Mycobacterium tuberculosis vaccines.
History of previous exposure to experimental products containing MPL or QS21.

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 Biologicals' AS01B adjuvantIntramuscular injection, 2 doses	Biological	Control Group
GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1Intramuscular injection, 2 doses	Biological	GSK692342_F1 Group
GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2Intramuscular injection, 2 doses	Biological	GSK692342_F2 Group
GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 3Intramuscular injection, 2 doses	Biological	GSK692342_F3 Group
GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 1Intramuscular injection, 2 doses	Biological	GSK692342_F4D1 Group
GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 2Intramuscular injection, 2 doses	Biological	GSK692342_F4D2 Group

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 included 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 included 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 ≥ 39.0 °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 outside 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 Different Biochemical and Haematological Levels
Time frame: At Day 0
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.
Number of Subjects With Different Biochemical and Haematological Levels
Time frame: At Day 7
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.
Number of Subjects With Different Biochemical and Haematological Levels
Time frame: At Day 30
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.
Number of Subjects With Different Biochemical and Haematological Levels
Time frame: At Day 37
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.
Number of Subjects With Different Biochemical and Haematological Levels
Time frame: At Day 60
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.

3 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, 30, 60 and 210
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule
Time frame: At Day 0, 30, 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 3 Feb 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
Control Group	10	9
GSK692342_F1 Group	10	10
GSK692342_F2 Group	40	38
GSK692342_F3 Group	40	37
GSK692342_F4D1 Group	40	39
GSK692342_F4D2 Group	40	36

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	Control Group n = 10	GSK692342_F1 Group n = 10	GSK692342_F2 Group n = 40	GSK692342_F3 Group n = 40	GSK692342_F4D1 Group n = 40	GSK692342_F4D2 Group n = 40
Any Pain, Dose 1	8	3	35	33	33	32
Grade 3 Pain, Dose 1	0	0	0	0	0	1
Any Redness, Dose 1	1	2	7	3	4	3
Grade 3 Redness, Dose 1	0	0	0	0	0	0
Any Swelling, Dose 1	0	0	8	6	7	6
Grade 3 Swelling, Dose 1	0	0	0	0	0	1
Any Pain, Dose 2	7	4	33	32	36	33
Grade 3 Pain, Dose 2	0	0	0	0	0	1

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from 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	Control Group n = 10	GSK692342_F1 Group n = 10	GSK692342_F2 Group n = 40	GSK692342_F3 Group n = 40	GSK692342_F4D1 Group n = 40	GSK692342_F4D2 Group n = 40
Any Fatigue, Dose 1	1	1	4	5	7	3
Grade 3 Fatigue, Dose 1	0	0	0	0	0	0
Related Fatigue, Dose 1	0	0	1	3	4	2
Any Gastro, Dose 1	2	3	5	3	5	7
Grade 3 Gastro, Dose 1	0	0	0	0	0	0
Related Gastro, Dose 1	2	0	3	1	1	2
Any Headache, Dose 1	4	4	11	16	15	19
Grade 3 Headache, Dose 1	1	1	0	0	0	0

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from 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	Control Group n = 10	GSK692342_F1 Group n = 10	GSK692342_F2 Group n = 40	GSK692342_F3 Group n = 40	GSK692342_F4D1 Group n = 40	GSK692342_F4D2 Group n = 40
Any AEs	7	9	29	33	33	27
Grade 3 AEs	0	0	1	1	0	0
Related AEs	0	1	7	2	5	2

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from 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	Control Group n = 10	GSK692342_F1 Group n = 10	GSK692342_F2 Group n = 40	GSK692342_F3 Group n = 40	GSK692342_F4D1 Group n = 40	GSK692342_F4D2 Group n = 40
Value	0	0	2	0	2	0

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

3 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Control Group	0 of 10 (0%)	10 of 10 (100%)	Not reported
GSK692342_F1 Group	0 of 10 (0%)	9 of 10 (90%)	Not reported
GSK692342_F2 Group	2 of 40 (5%)	40 of 40 (100%)	Not reported
GSK692342_F3 Group	0 of 40 (0%)	39 of 40 (97.5%)	Not reported
GSK692342_F4D1 Group	2 of 40 (5%)	39 of 40 (97.5%)	Not reported
GSK692342_F4D2 Group	0 of 40 (0%)	38 of 40 (95%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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?

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 10 inclusion and 17 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 24 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 Philippines. 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 3 Feb 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 9 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 NCT00621322.

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 24 Aug 2018.