Who is sponsoring NCT00707967?

NCT00707967 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00707967?

Interventions in NCT00707967: GSK's candidate Mycobacterium tuberculosis vaccine 692342, Control vaccine with the adjuvant system., Control vaccine with physiological saline.

What condition does NCT00707967 study?

NCT00707967 studies Tuberculosis.

Is NCT00707967 still recruiting?

NCT00707967 is currently completed. Last updated 24 August 2018.

Are results published for NCT00707967?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-08-24 · How we verify

NCT00707967

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults.

Completed Phase 2 Results posted Last updated 24 August 2018

What this trial tests

Phase 2 trial testing GSK's candidate Mycobacterium tuberculosis vaccine 692342 in Tuberculosis in 37 participants. Completed in 27 May 2009.

Timeline

30 June 2008

Primary endpoint
27 May 2009

27 May 2009

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	37
Start date	30 June 2008
Primary completion	27 May 2009
Estimated completion	27 May 2009
Sites	1 location across Switzerland

Drugs / interventions tested

GSK's candidate Mycobacterium tuberculosis vaccine 692342 — full drug profile →
Control vaccine with the adjuvant system. — full drug profile →
Control vaccine with physiological saline — full drug profile →

Conditions studied

Tuberculosis — all drugs for Tuberculosis →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 50, any sex, with Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Solicited Local Symptoms Primary · During the 7-day period (Days 0-6) post vaccination following each dose

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.

Any Pain, Dose 1

Group	Value	95% CI
GSK692342 Group	20
Control Group	6
Placebo Group	1

Grade 3 Pain, Dose 1

Group	Value	95% CI
GSK692342 Group	1
Control Group	0
Placebo Group	0

Any Redness, Dose 1

Group	Value	95% CI
GSK692342 Group	9
Control Group	2
Placebo Group	0

Grade 3 Redness, Dose 1

Group	Value	95% CI
GSK692342 Group	2
Control Group	0
Placebo Group	0

Any Swelling, Dose 1

Group	Value	95% CI
GSK692342 Group	8
Control Group	1
Placebo Group	0

Grade 3 Swelling, Dose 1

Group	Value	95% CI
GSK692342 Group	2
Control Group	0
Placebo Group	0

Any Pain, Dose 2

Group	Value	95% CI
GSK692342 Group	20
Control Group	7
Placebo Group	2

Grade 3 Pain, Dose 2

Group	Value	95% CI
GSK692342 Group	3
Control Group	0
Placebo Group	0

Number of Subjects With Solicited General Symptoms Primary · During the 7-day period (Days 0-6) post vaccination following each dose

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.

Any Fatigue, Dose 1

Group	Value	95% CI
GSK692342 Group	10
Control Group	6
Placebo Group	2

Grade 3 Fatigue, Dose 1

Group	Value	95% CI
GSK692342 Group	1
Control Group	0
Placebo Group	0

Related Fatigue, Dose 1

Group	Value	95% CI
GSK692342 Group	0
Control Group	0
Placebo Group	0

Any Gastro, Dose 1

Group	Value	95% CI
GSK692342 Group	4
Control Group	2
Placebo Group	1

Grade 3 Gastro, Dose 1

Group	Value	95% CI
GSK692342 Group	0
Control Group	0
Placebo Group	0

Related Gastro, Dose 1

Group	Value	95% CI
GSK692342 Group	0
Control Group	0
Placebo Group	0

Any Headache, Dose 1

Group	Value	95% CI
GSK692342 Group	7
Control Group	4
Placebo Group	2

Grade 3 Headache, Dose 1

Group	Value	95% CI
GSK692342 Group	0
Control Group	0
Placebo Group	0

Number of Subjects With Unsolicited Adverse Events (AEs) Primary · During the 30-day period (Days 0-29) post vaccination

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 investig

Any AEs

Group	Value	95% CI
GSK692342 Group	21
Control Group	6
Placebo Group	5

Grade 3 AEs

Group	Value	95% CI
GSK692342 Group	11
Control Group	2
Placebo Group	0

Related AEs

Group	Value	95% CI
GSK692342 Group	4
Control Group	0
Placebo Group	0

Number of Subjects With Serious Adverse Events (SAEs) Primary · 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

Group	Value	95% CI
GSK692342 Group	2
Control Group	0
Placebo Group	0

Number of Subjects With Normal Biochemical and Haematological Levels Primary · At Day 0, 7, 30, 37 and 60

Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophil \[EOS\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.

ALT, Day 0-normal

Group	Value	95% CI
GSK692342 Group	17
Control Group	5
Placebo Group	7

ALT, Day 7-normal

Group	Value	95% CI
GSK692342 Group	16
Control Group	4
Placebo Group	7

ALT, Day 30-normal

Group	Value	95% CI
GSK692342 Group	16
Control Group	5
Placebo Group	7

ALT, Day 37-normal

Group	Value	95% CI
GSK692342 Group	16
Control Group	6
Placebo Group	6

ALT, Day 60-normal

Group	Value	95% CI
GSK692342 Group	15
Control Group	7
Placebo Group	7

AST, Day 0-normal

Group	Value	95% CI
GSK692342 Group	13
Control Group	6
Placebo Group	7

AST, Day 7-normal

Group	Value	95% CI
GSK692342 Group	11
Control Group	6
Placebo Group	4

AST, Day 30-normal

Group	Value	95% CI
GSK692342 Group	11
Control Group	4
Placebo Group	5

Number of Subjects With Normal Haematological Levels Primary · At Day 0, 7, 30, 37 and 60

Among biochemical and haematological parameters assessed were haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.

Hct, Day 0-normal

Group	Value	95% CI
GSK692342 Group	18
Control Group	6
Placebo Group	7

Hct, Day 7-normal

Group	Value	95% CI
GSK692342 Group	18
Control Group	6
Placebo Group	7

Hct, Day 30-normal

Group	Value	95% CI
GSK692342 Group	20
Control Group	8
Placebo Group	7

Hct, Day 37-normal

Group	Value	95% CI
GSK692342 Group	16
Control Group	6
Placebo Group	7

Hct, Day 60-normal

Group	Value	95% CI
GSK692342 Group	18
Control Group	8
Placebo Group	7

Hgb, Day 0-normal

Group	Value	95% CI
GSK692342 Group	19
Control Group	8
Placebo Group	7

Hgb, Day 7-normal

Group	Value	95% CI
GSK692342 Group	15
Control Group	7
Placebo Group	7

Hgb, Day 30-normal

Group	Value	95% CI
GSK692342 Group	18
Control Group	8
Placebo Group	7

Number of Subjects With Normal Haematological Levels Primary · At Day 0, 7, 30, 37 and 60

Among biochemical and haematological parameters assessed were platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.

PLA, Day 0-normal

Group	Value	95% CI
GSK692342 Group	21
Control Group	7
Placebo Group	5

PLA, Day 7-normal

Group	Value	95% CI
GSK692342 Group	21
Control Group	8
Placebo Group	5

PLA, Day 30-normal

Group	Value	95% CI
GSK692342 Group	21
Control Group	6
Placebo Group	4

PLA, Day 37-normal

Group	Value	95% CI
GSK692342 Group	21
Control Group	7
Placebo Group	5

PLA, Day 60-normal

Group	Value	95% CI
GSK692342 Group	20
Control Group	7
Placebo Group	4

RBC, Day 0-normal

Group	Value	95% CI
GSK692342 Group	13
Control Group	5
Placebo Group	6

RBC, Day 7-normal

Group	Value	95% CI
GSK692342 Group	13
Control Group	5
Placebo Group	6

RBC, Day 30-normal

Group	Value	95% CI
GSK692342 Group	13
Control Group	6
Placebo Group	6

Number of Subjects With Biochemical and Haematological Levels Below Normal Primary · At Day 0, 7, 30, 37 and 60

ALT, Day 0-below

Group	Value	95% CI
GSK692342 Group	1
Control Group	0
Placebo Group	0

ALT, Day 7-below

Group	Value	95% CI
GSK692342 Group	0
Control Group	0
Placebo Group	0

ALT, Day 30-below

Group	Value	95% CI
GSK692342 Group	1
Control Group	0
Placebo Group	0

ALT, Day 37-below

Group	Value	95% CI
GSK692342 Group	1
Control Group	0
Placebo Group	0

ALT, Day 60-below

Group	Value	95% CI
GSK692342 Group	1
Control Group	0
Placebo Group	0

AST, Day 0-below

Group	Value	95% CI
GSK692342 Group	0
Control Group	0
Placebo Group	0

AST, Day 7-below

Group	Value	95% CI
GSK692342 Group	0
Control Group	0
Placebo Group	0

AST, Day 30-below

Group	Value	95% CI
GSK692342 Group	0
Control Group	0
Placebo Group	0

Number of Subjects With Haematological Levels Below Normal Primary · At Day 0, 7, 30, 37 and 60

Hct, Day 0-below

Group	Value	95% CI
GSK692342 Group	4
Control Group	2
Placebo Group	0

Hct, Day 7-below

Group	Value	95% CI
GSK692342 Group	4
Control Group	2
Placebo Group	0

Hct, Day 30-below

Group	Value	95% CI
GSK692342 Group	2
Control Group	0
Placebo Group	0

Hct, Day 37-below

Group	Value	95% CI
GSK692342 Group	6
Control Group	2
Placebo Group	0

Hct, Day 60-below

Group	Value	95% CI
GSK692342 Group	4
Control Group	0
Placebo Group	0

Hgb, Day 0-below

Group	Value	95% CI
GSK692342 Group	3
Control Group	0
Placebo Group	0

Hgb, Day 7-below

Group	Value	95% CI
GSK692342 Group	7
Control Group	1
Placebo Group	0

Hgb, Day 30-below

Group	Value	95% CI
GSK692342 Group	4
Control Group	0
Placebo Group	0

Number of Subjects With Haematological Levels Below Normal Primary · At Day 0, 7, 30, 37 and 60

Among biochemical and haematological parameters assessed were \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.

PLA, Day 0-below

Group	Value	95% CI
GSK692342 Group	1
Control Group	1
Placebo Group	1

PLA, Day 7-below

Group	Value	95% CI
GSK692342 Group	1
Control Group	0
Placebo Group	1

PLA, Day 30-below

Group	Value	95% CI
GSK692342 Group	1
Control Group	1
Placebo Group	2

PLA, Day 37-below

Group	Value	95% CI
GSK692342 Group	1
Control Group	1
Placebo Group	1

PLA, Day 60-below

Group	Value	95% CI
GSK692342 Group	1
Control Group	1
Placebo Group	2

RBC, Day 0-below

Group	Value	95% CI
GSK692342 Group	9
Control Group	3
Placebo Group	1

RBC, Day 7-below

Group	Value	95% CI
GSK692342 Group	9
Control Group	3
Placebo Group	1

RBC, Day 30-below

Group	Value	95% CI
GSK692342 Group	9
Control Group	2
Placebo Group	1

Number of Subjects With Biochemical and Haematological Levels Above Normal Primary · At Day 0, 7, 30, 37 and 60

ALT, Day 0-above

Group	Value	95% CI
GSK692342 Group	4
Control Group	3
Placebo Group	0

ALT, Day 7-above

Group	Value	95% CI
GSK692342 Group	6
Control Group	4
Placebo Group	0

ALT, Day 30-above

Group	Value	95% CI
GSK692342 Group	5
Control Group	3
Placebo Group	0

ALT, Day 37-above

Group	Value	95% CI
GSK692342 Group	5
Control Group	2
Placebo Group	1

ALT, Day 60-above

Group	Value	95% CI
GSK692342 Group	6
Control Group	1
Placebo Group	0

AST, Day 0-above

Group	Value	95% CI
GSK692342 Group	9
Control Group	2
Placebo Group	0

AST, Day 7-above

Group	Value	95% CI
GSK692342 Group	11
Control Group	2
Placebo Group	3

AST, Day 30-above

Group	Value	95% CI
GSK692342 Group	11
Control Group	4
Placebo Group	2

Number of Subjects With Haematological Levels Above Normal Primary · At Day 0, 7, 30, 37 and 60

Hct, Day 0-above

Group	Value	95% CI
GSK692342 Group	0
Control Group	0
Placebo Group	0

Hct, Day 7-above

Group	Value	95% CI
GSK692342 Group	0
Control Group	0
Placebo Group	0

Hct, Day 30-above

Group	Value	95% CI
GSK692342 Group	0
Control Group	0
Placebo Group	0

Hct, Day 37-above

Group	Value	95% CI
GSK692342 Group	0
Control Group	0
Placebo Group	0

Hct, Day 60-above

Group	Value	95% CI
GSK692342 Group	0
Control Group	0
Placebo Group	0

Hgb, Day 0-above

Group	Value	95% CI
GSK692342 Group	0
Control Group	0
Placebo Group	0

Hgb, Day 7-above

Group	Value	95% CI
GSK692342 Group	0
Control Group	0
Placebo Group	0

Hgb, Day 30-above

Group	Value	95% CI
GSK692342 Group	0
Control Group	0
Placebo Group	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GSK692342 Group

Serious: 2/22 (9%)

Deaths: —

Control Group

Serious: 0/8 (0%)

Deaths: —

Placebo Group

Serious: 0/7 (0%)

Deaths: —

Serious adverse events (2 terms)

Reaction	System	GSK692342 Group	Control Group	Placebo Group
Appendicitis	Infections and infestations	—	—	—
Cellulitis	Infections and infestations	—	—	—

Other adverse events (33 terms — click to expand)

Reaction	System	GSK692342 Group	Control Group	Placebo Group
Pain	General disorders	—	—	—
Fatigue	General disorders	—	—	—
Redness	General disorders	—	—	—
Headache	General disorders	—	—	—
Swelling	General disorders	—	—	—
Gastrointestinal	General disorders	—	—	—
Myalgia	General disorders	—	—	—
Malaise	General disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Cd4 lymphocytes decreased	Investigations	—	—	—
Temperature (Axillary)	General disorders	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—
Migraine	Nervous system disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Fatigue	General disorders	—	—	—
Feeling hot	General disorders	—	—	—
Injection site pruritus	General disorders	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Pyrexia	General disorders	—	—	—
Pterygium	Eye disorders	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Genital herpes	Infections and infestations	—	—	—
Oral herpes	Infections and infestations	—	—	—
Subcutaneous abscess	Infections and infestations	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Dysmenorrhoea	Reproductive system and breast disorders	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—

Most-reported serious reactions: Appendicitis, Cellulitis.

Data from ClinicalTrials.gov NCT00707967 adverse events section.

Sponsor's own description

This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine (692342) administered at 0, 1 month to HIV-positive adults living in Switzerland.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Key recent advances in TB vaccine development and understanding of protective immune responses against Mycobacterium tuberculosis.
Scriba TJ, Netea MG, Ginsberg AM. · · 2020 · cited 75× · PMID 33279383 · DOI 10.1016/j.smim.2020.101431
A phase IIa trial of the new tuberculosis vaccine, MVA85A, in HIV- and/or Mycobacterium tuberculosis-infected adults.
Scriba TJ, Tameris M, Smit E, van der Merwe L, et al · · 2012 · cited 68× · PMID 22281831 · DOI 10.1164/rccm.201108-1548oc
Safety and immunogenicity of the M72/AS01 candidate tuberculosis vaccine in HIV-infected adults on combination antiretroviral therapy: a phase I/II, randomized trial.
Thacher EG, Cavassini M, Audran R, Thierry AC, et al · · 2014 · cited 43× · PMID 24911353 · DOI 10.1097/qad.0000000000000343
Responses to A(H1N1)pdm09 influenza vaccines in participants previously vaccinated with seasonal influenza vaccine: a randomized, observer-blind, controlled study.
Roy-Ghanta S, Van der Most R, Li P, Vaughn DW. · · 2014 · cited 13× · PMID 24864125 · DOI 10.1093/infdis/jiu284
Developing tuberculosis vaccines for people with HIV: consensus statements from an international expert panel.
Miner MD, Hatherill M, Mave V, Gray GE, et al · · 2022 · cited 12× · PMID 36240834 · DOI 10.1016/s2352-3018(22)00255-7
Post-Immune Antibodies in HIV-1 Infection in the Context of Vaccine Development: A Variety of Biological Functions and Catalytic Activities.
Timofeeva A, Sedykh S, Nevinsky G. · · 2022 · cited 12× · PMID 35335016 · DOI 10.3390/vaccines10030384

Verify or expand the search:

Other trials of GSK's candidate Mycobacterium tuberculosis vaccine 692342

Trials testing the same drug.

NCT00397943 — Safety and Immunogenicity of 2 Formulations of Tuberculosis Vaccine GSK692342 Given at 0,1 Months to Healthy Adults · Phase 2 · completed

Other recruiting trials for Tuberculosis

Currently open trials in the same condition.

NCT05917210 — Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda · NA · recruiting
NCT07170735 — Quantitative Measurement of Plasma and Urine MTB Cell-free DNA Level · recruiting
NCT07484490 — Effects of the Active Cycle of Breathing Technique With and Without Balloon Blowing Therapy in Tuberculosis · NA · recruiting
NCT06318416 — Precision Rifampin Trial for Personalized Dosing · Phase 1 · recruiting
NCT07170800 — A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets · Phase 2 · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00707967 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 24 August 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00707967.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00707967

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (2 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of GSK's candidate Mycobacterium tuberculosis vaccine 692342

Other recruiting trials for Tuberculosis

Other GlaxoSmithKline trials

Verify against primary sources