Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00621322 | Safety and Immunogenicity Study of GSK Biologicals Tuberculosis Vaccines (692342) to Healthy Adults | PHASE2 | COMPLETED | 180 | — | — | Apr 3, 2008 | Apr 3, 2009 | Aug 24, 2018 | 1 | Philippines |
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' AS01B adjuvant | BIOLOGICAL | Intramuscular injection, 2 doses |
| GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1 | BIOLOGICAL | Intramuscular injection, 2 doses |
| GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2 | BIOLOGICAL | Intramuscular injection, 2 doses |
| GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 3 | BIOLOGICAL | Intramuscular injection, 2 doses |
| GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 1 | BIOLOGICAL | Intramuscular injection, 2 doses |
| GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 2 | BIOLOGICAL | Intramuscular injection, 2 doses |
Inclusion Criteria: * 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 obtain...
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| Viatris, Inc. | VTRS | 1 | PHASE3 | Bedaquiline |
| Johnson & Johnson | JNJ | 1 | PHASE2 | Bedaquiline, Background Regimen |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT164a1, BNT164b1 |
| Harvard Bioscience, Inc. | HBIO | 1 | — | Bdq, Lzd, Lfx, Dlm, Cfz |