Tuberculosis
Conditions
Keywords
Tuberculosis vaccine
Brief summary
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.
Interventions
Intramuscular injection, 2 doses at 0, 1 month
Intramuscular injection, 2 doses at 0, 1 month
BIOLOGICALControl vaccine with physiological saline
Intramuscular injection, 2 doses at 0, 1 month
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who the Investigator believes that they can and will comply with the requirements of the protocol. * A male or female between, and including, 18 and 50 years of age at the time of the first vaccination. * Written informed consent obtained from the subject prior to any study procedure. * Subjects must be HIV-positive and must have: * received Highly Active Antiretroviral therapy for a minimum of 12 consecutive months prior to screening * documented suppressed HIV-1 RNA levels following HAART-treatment. * a protocol defined CD4+ T cell count at screening * If the subject is female, she must be of non-childbearing potential, or 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 vaccination. * Clinically acceptable laboratory values prior to randomisation as determined by the Investigator. * No evidence of TB disease with no pulmonary pathology as confirmed by chest X-ray. * No history of extrapulmonary TB. * No history of chemotherapy for TB.
Exclusion criteria
* Any change in antiretroviral drug regimen within 12 weeks prior to screening. * 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 experimental Mycobacterium tuberculosis vaccines. * History of previous exposure to experimental products containing components of the experimental vaccine. * Chronic administration of immunosuppressive or other immune-modifying drugs within six months prior to the first vaccine dose. * 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. * 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 vaccine. * Planned participation or participation in another experimental protocol during the study period. * A family history of congenital or hereditary immunodeficiency. •Any chronic drug therapy, other than HAART or prophylaxis for opportunistic HIV-related infections to be continued during the study period. Vitamins and/or dietary supplements, birth control pills, anti-histamines for seasonal allergies and SSRIs are allowed. * Subjects taking any of the following medication: systemic steroids, interleukins, systemic interferons or systemic chemotherapy. * History of allergic reactions or anaphylaxis to any vaccine. * 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 which in the Investigator's opinion would put the subject at risk. * Pregnant female, lactating female or female planning to become pregnant or stop contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Haematological Levels Above Normal | 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. |
| Number of Subjects With Normal Biochemical and Haematological Levels | 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. |
| Number of Subjects With Normal Haematological Levels | 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. |
| Number of Subjects With Biochemical and Haematological Levels Below Normal | 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. |
| Number of Subjects With Haematological Levels Below Normal | 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. |
| Number of Subjects With Biochemical and Haematological Levels Above Normal | 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. |
| Number of Subjects With Solicited Local Symptoms | 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. |
| Number of Subjects With Solicited General Symptoms | 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. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | 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 investigator as related to the vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | At Day 0, 30, 60 and 210 | Expressed cytokine combinations for CD4+ T cells were CD40-L and interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\]; 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. |
| Cell Count of CD4+ T Cells | At Day 0, 30, 60 and 210 | CD4+ T cell counts are defined by values greater than (\>) 200 cells per cubic millimeters (mm3) at screening for enrolment into the study. |
| Anti-M72 Specific Antibody Concentrations | At Day 0, 30, 60 and 210 | Concentrations given in Enzyme-Linked Immunosorbent Assay units per milliliter (EL.U/mL) were expressed in Geometric Mean Concentrations (GMCs). |
| Number of Subjects With Significant Highly Active Anti-Retroviral Therapy (HAART) Changes | From Day 60 to Day 210 | Recorded significant HAART change refers to one subject switching the Combivir drug to Truvada as planned by personal physician, with no relationship to vaccination, prior to study enrolment. |
| Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | At Day 0, 30, 60 and 210 | 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). |
Countries
Switzerland
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| GSK692342 Group Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30. | 22 |
| Control Group Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30. | 8 |
| Placebo Group Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30. | 7 |
| Total | 37 |
Baseline characteristics
| Characteristic | Total | GSK692342 Group | Control Group | Placebo Group |
|---|---|---|---|---|
| Age, Continuous | 40.12 Years STANDARD_DEVIATION 6.54 | 39.6 Years STANDARD_DEVIATION 7.43 | 40.0 Years STANDARD_DEVIATION 5.61 | 41.9 Years STANDARD_DEVIATION 4.67 |
| Sex: Female, Male Female | 11 Participants | 8 Participants | 3 Participants | 0 Participants |
| Sex: Female, Male Male | 26 Participants | 14 Participants | 5 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 21 / 22 | 8 / 8 | 6 / 7 |
| serious Total, serious adverse events | 2 / 22 | 0 / 8 | 0 / 7 |
Outcome results
Primary
Number of Subjects With Biochemical and Haematological Levels Above Normal
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.
Time frame: At Day 0, 7, 30, 37 and 60
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | ALT, Day 37-above | 5 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | CREA, Day 7-above | 2 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | AST, Day 60-above | 9 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | EOS, Day 60-above | 2 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | ALT, Day 0-above | 4 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | BAS, Day 0-above | 2 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | EOS, Day 7-above | 1 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | CREA, Day 0-above | 1 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | BAS, Day 7-above | 2 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | ALT, Day 60-above | 6 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | BAS, Day 60-above | 3 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | BAS, Day 30-above | 2 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | EOS, Day 37-above | 1 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | BAS, Day 37-above | 5 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | EOS, Day 0-above | 2 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | AST, Day 0-above | 9 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | ALT, Day 30-above | 5 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | CREA, Day 60-above | 1 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | AST, Day 7-above | 11 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | ALT, Day 7-above | 6 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | CREA, Day 37-above | 3 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | AST, Day 30-above | 11 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | EOS, Day 30-above | 2 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | CREA, Day 30-above | 1 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | AST, Day 37-above | 10 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | CREA, Day 0-above | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | ALT, Day 0-above | 3 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | ALT, Day 7-above | 4 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | ALT, Day 30-above | 3 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | ALT, Day 37-above | 2 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | ALT, Day 60-above | 1 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | AST, Day 0-above | 2 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | AST, Day 7-above | 2 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | AST, Day 30-above | 4 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | AST, Day 37-above | 3 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | AST, Day 60-above | 2 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | BAS, Day 0-above | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | BAS, Day 7-above | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | BAS, Day 30-above | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | BAS, Day 37-above | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | BAS, Day 60-above | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | CREA, Day 7-above | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | CREA, Day 30-above | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | CREA, Day 37-above | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | CREA, Day 60-above | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | EOS, Day 0-above | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | EOS, Day 7-above | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | EOS, Day 30-above | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | EOS, Day 37-above | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | EOS, Day 60-above | 1 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | CREA, Day 7-above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | AST, Day 30-above | 2 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | ALT, Day 0-above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | CREA, Day 30-above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | AST, Day 7-above | 3 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | EOS, Day 30-above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | CREA, Day 37-above | 1 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | AST, Day 0-above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | ALT, Day 7-above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | CREA, Day 60-above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | ALT, Day 60-above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | EOS, Day 60-above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | EOS, Day 0-above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | ALT, Day 37-above | 1 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | BAS, Day 30-above | 2 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | EOS, Day 37-above | 1 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | BAS, Day 37-above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | BAS, Day 7-above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | EOS, Day 7-above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | BAS, Day 60-above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | BAS, Day 0-above | 1 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | AST, Day 60-above | 1 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | CREA, Day 0-above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | AST, Day 37-above | 2 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Above Normal | ALT, Day 30-above | 0 Subjects |
Primary
Number of Subjects With Biochemical and Haematological Levels Below Normal
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.
Time frame: At Day 0, 7, 30, 37 and 60
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | ALT, Day 37-below | 1 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | CREA, Day 7-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | AST, Day 60-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | EOS, Day 60-below | 4 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | ALT, Day 0-below | 1 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | BAS, Day 0-below | 1 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | EOS, Day 7-below | 3 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | CREA, Day 0-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | BAS, Day 7-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | ALT, Day 60-below | 1 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | BAS, Day 60-below | 1 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | BAS, Day 30-below | 2 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | EOS, Day 37-below | 4 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | BAS, Day 37-below | 5 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | EOS, Day 0-below | 4 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | AST, Day 0-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | ALT, Day 30-below | 1 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | CREA, Day 60-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | AST, Day 7-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | ALT, Day 7-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | CREA, Day 37-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | AST, Day 30-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | EOS, Day 30-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | CREA, Day 30-below | 1 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | AST, Day 37-below | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | CREA, Day 0-below | 1 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | ALT, Day 0-below | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | ALT, Day 7-below | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | ALT, Day 30-below | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | ALT, Day 37-below | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | ALT, Day 60-below | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | AST, Day 0-below | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | AST, Day 7-below | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | AST, Day 30-below | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | AST, Day 37-below | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | AST, Day 60-below | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | BAS, Day 0-below | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | BAS, Day 7-below | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | BAS, Day 30-below | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | BAS, Day 37-below | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | BAS, Day 60-below | 1 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | CREA, Day 7-below | 0 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | CREA, Day 30-below | 1 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | CREA, Day 37-below | 1 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | CREA, Day 60-below | 1 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | EOS, Day 0-below | 1 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | EOS, Day 7-below | 1 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | EOS, Day 30-below | 1 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | EOS, Day 37-below | 1 Subjects |
| Control Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | EOS, Day 60-below | 1 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | CREA, Day 7-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | AST, Day 30-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | ALT, Day 0-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | CREA, Day 30-below | 1 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | AST, Day 7-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | EOS, Day 30-below | 3 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | CREA, Day 37-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | AST, Day 0-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | ALT, Day 7-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | CREA, Day 60-below | 1 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | ALT, Day 60-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | EOS, Day 60-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | EOS, Day 0-below | 1 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | ALT, Day 37-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | BAS, Day 30-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | EOS, Day 37-below | 1 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | BAS, Day 37-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | BAS, Day 7-below | 1 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | EOS, Day 7-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | BAS, Day 60-below | 2 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | BAS, Day 0-below | 1 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | AST, Day 60-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | CREA, Day 0-below | 1 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | AST, Day 37-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Levels Below Normal | ALT, Day 30-below | 0 Subjects |
Primary
Number of Subjects With Haematological Levels Above Normal
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.
Time frame: At Day 0, 7, 30, 37 and 60
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | Hct, Day 37-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | MON, Day 7-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | Hgb, Day 60-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | NEU, Day 60-above | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | Hct, Day 0-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | LYM, Day 0-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | NEU, Day 7-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | MON, Day 0-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | LYM, Day 7-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | Hct, Day 60-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | LYM, Day 60-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | LYM, Day 30-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | NEU, Day 37-above | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | LYM, Day 37-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | NEU, Day 0-above | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | Hgb, Day 0-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | Hct, Day 30-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | MON, Day 60-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | Hgb, Day 7-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | Hct, Day 7-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | MON, Day 37-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | Hgb, Day 30-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | NEU, Day 30-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | MON, Day 30-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | Hgb, Day 37-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | MON, Day 0-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | Hct, Day 0-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | Hct, Day 7-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | Hct, Day 30-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | Hct, Day 37-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | Hct, Day 60-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | Hgb, Day 0-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | Hgb, Day 7-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | Hgb, Day 30-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | Hgb, Day 37-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | Hgb, Day 60-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | LYM, Day 0-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | LYM, Day 7-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | LYM, Day 30-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | LYM, Day 37-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | LYM, Day 60-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | MON, Day 7-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | MON, Day 30-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | MON, Day 37-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | MON, Day 60-above | 1 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | NEU, Day 0-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | NEU, Day 7-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | NEU, Day 30-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | NEU, Day 37-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | NEU, Day 60-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | MON, Day 7-above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | Hgb, Day 30-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | Hct, Day 0-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | MON, Day 30-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | Hgb, Day 7-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | NEU, Day 30-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | MON, Day 37-above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | Hgb, Day 0-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | Hct, Day 7-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | MON, Day 60-above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | Hct, Day 60-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | NEU, Day 60-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | NEU, Day 0-above | 2 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | Hct, Day 37-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | LYM, Day 30-above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | NEU, Day 37-above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | LYM, Day 37-above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | LYM, Day 7-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | NEU, Day 7-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | LYM, Day 60-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | LYM, Day 0-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | Hgb, Day 60-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | MON, Day 0-above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | Hgb, Day 37-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | Hct, Day 30-above | 0 Subjects |
Primary
Number of Subjects With Haematological Levels Above Normal
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.
Time frame: At Day 0, 7, 30, 37 and 60
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 0-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 30-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 0-above | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 7-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 7-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 60-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 30-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 30-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 37-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 37-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 60-above | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 0-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 60-above | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 37-above | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 7-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 7-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 0-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 7-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 30-above | 1 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 37-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 60-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 0-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 7-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 30-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 37-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 60-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 0-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 30-above | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 37-above | 1 Subjects |
| Control Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 60-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 0-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 37-above | 2 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 0-above | 2 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 60-above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 37-above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 7-above | 2 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 30-above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 0-above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 30-above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 30-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 7-above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 37-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 7-above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 60-above | 2 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 60-above | 0 Subjects |
Primary
Number of Subjects With Haematological Levels Below Normal
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.
Time frame: At Day 0, 7, 30, 37 and 60
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | Hct, Day 37-below | 6 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | MON, Day 7-below | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | Hgb, Day 60-below | 5 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | NEU, Day 60-below | 5 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | Hct, Day 0-below | 4 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | LYM, Day 0-below | 10 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | NEU, Day 7-below | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | MON, Day 0-below | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | LYM, Day 7-below | 6 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | Hct, Day 60-below | 4 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | LYM, Day 60-below | 6 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | LYM, Day 30-below | 10 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | NEU, Day 37-below | 5 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | LYM, Day 37-below | 4 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | NEU, Day 0-below | 7 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | Hgb, Day 0-below | 3 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | Hct, Day 30-below | 2 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | MON, Day 60-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | Hgb, Day 7-below | 7 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | Hct, Day 7-below | 4 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | MON, Day 37-below | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | Hgb, Day 30-below | 4 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | NEU, Day 30-below | 5 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | MON, Day 30-below | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | Hgb, Day 37-below | 4 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | MON, Day 0-below | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | Hct, Day 0-below | 2 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | Hct, Day 7-below | 2 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | Hct, Day 30-below | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | Hct, Day 37-below | 2 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | Hct, Day 60-below | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | Hgb, Day 0-below | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | Hgb, Day 7-below | 1 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | Hgb, Day 30-below | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | Hgb, Day 37-below | 1 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | Hgb, Day 60-below | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | LYM, Day 0-below | 2 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | LYM, Day 7-below | 2 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | LYM, Day 30-below | 2 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | LYM, Day 37-below | 2 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | LYM, Day 60-below | 2 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | MON, Day 7-below | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | MON, Day 30-below | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | MON, Day 37-below | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | MON, Day 60-below | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | NEU, Day 0-below | 1 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | NEU, Day 7-below | 1 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | NEU, Day 30-below | 1 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | NEU, Day 37-below | 1 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | NEU, Day 60-below | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | MON, Day 7-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | Hgb, Day 30-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | Hct, Day 0-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | MON, Day 30-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | Hgb, Day 7-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | NEU, Day 30-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | MON, Day 37-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | Hgb, Day 0-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | Hct, Day 7-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | MON, Day 60-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | Hct, Day 60-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | NEU, Day 60-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | NEU, Day 0-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | Hct, Day 37-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | LYM, Day 30-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | NEU, Day 37-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | LYM, Day 37-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | LYM, Day 7-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | NEU, Day 7-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | LYM, Day 60-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | LYM, Day 0-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | Hgb, Day 60-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | MON, Day 0-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | Hgb, Day 37-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | Hct, Day 30-below | 0 Subjects |
Primary
Number of Subjects With Haematological Levels Below Normal
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.
Time frame: At Day 0, 7, 30, 37 and 60
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 0-below | 9 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 30-below | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 0-below | 5 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 7-below | 9 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 7-below | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 60-below | 9 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 30-below | 9 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 30-below | 6 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 37-below | 10 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 37-below | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 60-below | 5 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 0-below | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 60-below | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 37-below | 4 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 7-below | 4 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 7-below | 1 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 0-below | 1 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 7-below | 0 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 30-below | 1 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 37-below | 1 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 60-below | 1 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 0-below | 3 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 7-below | 3 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 30-below | 2 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 37-below | 2 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 60-below | 1 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 0-below | 1 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 30-below | 2 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 37-below | 1 Subjects |
| Control Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 60-below | 2 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 0-below | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 37-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 0-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 60-below | 2 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 37-below | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 7-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 30-below | 2 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 0-below | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 30-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 30-below | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 7-below | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 37-below | 2 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 7-below | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 60-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 60-below | 1 Subjects |
Primary
Number of Subjects With Normal Biochemical and Haematological Levels
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.
Time frame: At Day 0, 7, 30, 37 and 60
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 37-normal | 16 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 7-normal | 20 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 60-normal | 13 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | EOS, Day 60-normal | 16 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 0-normal | 17 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | BAS, Day 0-normal | 19 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | EOS, Day 7-normal | 18 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 0-normal | 21 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | BAS, Day 7-normal | 20 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 60-normal | 15 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | BAS, Day 60-normal | 18 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | BAS, Day 30-normal | 18 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | EOS, Day 37-normal | 17 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | BAS, Day 37-normal | 12 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | EOS, Day 0-normal | 16 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 0-normal | 13 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 30-normal | 16 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 60-normal | 21 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 7-normal | 11 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 7-normal | 16 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 37-normal | 19 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 30-normal | 11 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | EOS, Day 30-normal | 20 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 30-normal | 20 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 37-normal | 12 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 0-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 0-normal | 5 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 7-normal | 4 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 30-normal | 5 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 37-normal | 6 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 60-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 0-normal | 6 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 7-normal | 6 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 30-normal | 4 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 37-normal | 5 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 60-normal | 6 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | BAS, Day 0-normal | 8 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | BAS, Day 7-normal | 8 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | BAS, Day 30-normal | 8 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | BAS, Day 37-normal | 8 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | BAS, Day 60-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 7-normal | 8 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 30-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 37-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 60-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | EOS, Day 0-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | EOS, Day 7-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | EOS, Day 30-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | EOS, Day 37-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Biochemical and Haematological Levels | EOS, Day 60-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 7-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 30-normal | 5 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 0-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 30-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 7-normal | 4 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | EOS, Day 30-normal | 4 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 37-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 0-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 7-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 60-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 60-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | EOS, Day 60-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | EOS, Day 0-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 37-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | BAS, Day 30-normal | 5 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | EOS, Day 37-normal | 5 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | BAS, Day 37-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | BAS, Day 7-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | EOS, Day 7-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | BAS, Day 60-normal | 5 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | BAS, Day 0-normal | 5 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 60-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 0-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 37-normal | 5 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 30-normal | 7 Subjects |
Primary
Number of Subjects With Normal Haematological Levels
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.
Time frame: At Day 0, 7, 30, 37 and 60
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | RBC, Day 0-normal | 13 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | PLA, Day 30-normal | 21 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | WBC, Day 0-normal | 16 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | RBC, Day 7-normal | 13 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | PLA, Day 7-normal | 21 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | RBC, Day 60-normal | 13 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | RBC, Day 30-normal | 13 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | WBC, Day 30-normal | 16 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | RBC, Day 37-normal | 12 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | PLA, Day 37-normal | 21 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | WBC, Day 60-normal | 16 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | PLA, Day 0-normal | 21 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | PLA, Day 60-normal | 20 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | WBC, Day 37-normal | 17 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | WBC, Day 7-normal | 18 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | WBC, Day 7-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | PLA, Day 0-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | PLA, Day 7-normal | 8 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | PLA, Day 30-normal | 6 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | PLA, Day 37-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | PLA, Day 60-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | RBC, Day 0-normal | 5 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | RBC, Day 7-normal | 5 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | RBC, Day 30-normal | 6 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | RBC, Day 37-normal | 6 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | RBC, Day 60-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | WBC, Day 0-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | WBC, Day 30-normal | 6 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | WBC, Day 37-normal | 6 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | WBC, Day 60-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | RBC, Day 0-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | WBC, Day 37-normal | 5 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | WBC, Day 0-normal | 5 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | PLA, Day 60-normal | 4 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | PLA, Day 37-normal | 5 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | WBC, Day 7-normal | 5 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | PLA, Day 30-normal | 4 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | PLA, Day 0-normal | 5 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | WBC, Day 30-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | RBC, Day 30-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | PLA, Day 7-normal | 5 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | RBC, Day 37-normal | 5 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | RBC, Day 7-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | WBC, Day 60-normal | 5 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | RBC, Day 60-normal | 6 Subjects |
Primary
Number of Subjects With Normal Haematological Levels
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.
Time frame: At Day 0, 7, 30, 37 and 60
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | Hct, Day 30-normal | 20 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | MON, Day 7-normal | 21 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | Hgb, Day 60-normal | 17 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | NEU, Day 60-normal | 16 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | Hct, Day 0-normal | 18 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | LYM, Day 0-normal | 12 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | NEU, Day 7-normal | 21 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | MON, Day 0-normal | 21 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | LYM, Day 7-normal | 16 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | Hct, Day 60-normal | 18 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | LYM, Day 60-normal | 16 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | LYM, Day 30-normal | 12 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | Hct, Day 7-normal | 18 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | LYM, Day 37-normal | 18 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | NEU, Day 0-normal | 14 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | Hgb, Day 0-normal | 19 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | NEU, Day 37-normal | 16 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | MON, Day 60-normal | 22 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | Hgb, Day 7-normal | 15 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | Hct, Day 37-normal | 16 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | MON, Day 37-normal | 21 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | Hgb, Day 30-normal | 18 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | NEU, Day 30-normal | 17 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | MON, Day 30-normal | 21 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | Hgb, Day 37-normal | 18 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | MON, Day 0-normal | 8 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | Hct, Day 0-normal | 6 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | Hct, Day 7-normal | 6 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | Hct, Day 37-normal | 6 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | Hct, Day 30-normal | 8 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | Hct, Day 60-normal | 8 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | Hgb, Day 0-normal | 8 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | Hgb, Day 7-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | Hgb, Day 30-normal | 8 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | Hgb, Day 37-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | Hgb, Day 60-normal | 8 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | LYM, Day 0-normal | 6 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | LYM, Day 7-normal | 6 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | LYM, Day 30-normal | 6 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | LYM, Day 37-normal | 6 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | LYM, Day 60-normal | 6 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | MON, Day 7-normal | 8 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | MON, Day 30-normal | 8 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | MON, Day 37-normal | 8 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | MON, Day 60-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | NEU, Day 0-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | NEU, Day 7-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | NEU, Day 30-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | NEU, Day 37-normal | 7 Subjects |
| Control Group | Number of Subjects With Normal Haematological Levels | NEU, Day 60-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | MON, Day 7-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | Hgb, Day 30-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | Hct, Day 0-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | MON, Day 30-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | Hgb, Day 7-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | NEU, Day 30-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | MON, Day 37-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | Hgb, Day 0-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | Hct, Day 37-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | MON, Day 60-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | Hct, Day 60-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | NEU, Day 60-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | NEU, Day 0-normal | 5 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | Hct, Day 30-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | LYM, Day 30-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | NEU, Day 37-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | LYM, Day 37-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | LYM, Day 7-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | NEU, Day 7-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | LYM, Day 60-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | LYM, Day 0-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | Hgb, Day 60-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | MON, Day 0-normal | 6 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | Hgb, Day 37-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | Hct, Day 7-normal | 7 Subjects |
Primary
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
Time frame: During the entire study period, from Day 0 up to Day 210
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK692342 Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Subjects |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
| Placebo Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
Primary
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.
Time frame: During the 7-day period (Days 0-6) post vaccination following each dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 2 | 4 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 2 | 18 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 1 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Across | 18 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 1 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Across | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 2 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 2 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Across | 5 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 2 | 5 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 2 | 1 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Across | 1 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 2 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 2 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 1 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 2 | 11 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 1 | 4 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 2 | 6 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 2 | 1 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Across | 6 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 2 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 2 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 1 | 3 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 2 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 2 | 3 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Across | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Across | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 1 | 1 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Across | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Across | 1 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 1 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 1 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Across | 13 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 1 | 3 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Across | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Across | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Across | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 1 | 10 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 1 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 1 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Across | 1 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 1 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 1 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Across | 7 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Across | 7 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Across | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 1 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 1 | 7 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Across | 1 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 1 | 6 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 1 | 2 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 1 | 4 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 1 | 1 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 1 | 2 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 1 | 1 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 2 | 3 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 2 | 2 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 2 | 3 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 2 | 1 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 2 | 1 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 2 | 1 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Across | 6 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Across | 3 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Headache, Across | 4 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Headache, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Across | 1 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Across | 2 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Across | 2 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Across | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 2 | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Across | 3 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 1 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Across | 1 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Across | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 1 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Across | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 1 | 1 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Across | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Across | 1 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 1 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Across | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 1 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Across | 1 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Across | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 1 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 1 | 1 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Headache, Across | 3 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 1 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Across | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Across | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 1 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Across | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Headache, Across | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 1 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 1 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 2 | 1 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 2 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Across | 1 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 2 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 2 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 2 | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 1 | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 2 | 1 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 2 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Across | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 1 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 2 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 1 | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 2 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 2 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Across | 1 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 2 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 2 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Across | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 1 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 2 | 0 Subjects |
Primary
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.
Time frame: During the 7-day period (Days 0-6) post vaccination following each dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 | 8 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 1 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 | 9 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 2 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 20 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 2 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 20 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 3 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 | 8 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 | 7 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across | 21 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across | 4 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across | 13 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across | 2 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across | 10 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across | 2 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 6 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across | 8 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across | 2 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 | 2 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 | 1 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across | 2 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 | 1 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 7 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 1 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across | 3 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across | 0 Subjects |
Primary
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.
Time frame: During the 30-day period (Days 0-29) post vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 11 Subjects |
| GSK692342 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 21 Subjects |
| GSK692342 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 4 Subjects |
| Control Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 2 Subjects |
| Control Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 6 Subjects |
| Control Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 0 Subjects |
| Placebo Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 5 Subjects |
| Placebo Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 0 Subjects |
| Placebo Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 0 Subjects |
Secondary
Anti-M72 Specific Antibody Concentrations
Concentrations given in Enzyme-Linked Immunosorbent Assay units per milliliter (EL.U/mL) were expressed in Geometric Mean Concentrations (GMCs).
Time frame: At Day 0, 30, 60 and 210
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK692342 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, Day 0 [N=22;8;7] | 1.4 EL.U/mL |
| GSK692342 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, Day 30 [N=22;8;7] | 2.1 EL.U/mL |
| GSK692342 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, Day 60 [N=22;8;7] | 282.4 EL.U/mL |
| GSK692342 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, Day 210 [N=21;8;7] | 38.3 EL.U/mL |
| Control Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, Day 210 [N=21;8;7] | 1.4 EL.U/mL |
| Control Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, Day 0 [N=22;8;7] | 1.4 EL.U/mL |
| Control Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, Day 60 [N=22;8;7] | 1.4 EL.U/mL |
| Control Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, Day 30 [N=22;8;7] | 1.4 EL.U/mL |
| Placebo Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, Day 210 [N=21;8;7] | 1.4 EL.U/mL |
| Placebo Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, Day 30 [N=22;8;7] | 1.4 EL.U/mL |
| Placebo Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, Day 60 [N=22;8;7] | 1.4 EL.U/mL |
| Placebo Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, Day 0 [N=22;8;7] | 1.4 EL.U/mL |
Secondary
Cell Count of CD4+ T Cells
CD4+ T cell counts are defined by values greater than (\>) 200 cells per cubic millimeters (mm3) at screening for enrolment into the study.
Time frame: At Day 0, 30, 60 and 210
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK692342 Group | Cell Count of CD4+ T Cells | CD4+ T Cells, Day 0 | 585 T cells/cubic millimeter |
| GSK692342 Group | Cell Count of CD4+ T Cells | CD4+ T Cells, Day 30 | 566 T cells/cubic millimeter |
| GSK692342 Group | Cell Count of CD4+ T Cells | CD4+ T Cells, Day 60 | 567 T cells/cubic millimeter |
| GSK692342 Group | Cell Count of CD4+ T Cells | CD 4+ T Cells, Day 210 | 548.5 T cells/cubic millimeter |
| Control Group | Cell Count of CD4+ T Cells | CD 4+ T Cells, Day 210 | 433 T cells/cubic millimeter |
| Control Group | Cell Count of CD4+ T Cells | CD4+ T Cells, Day 0 | 437 T cells/cubic millimeter |
| Control Group | Cell Count of CD4+ T Cells | CD4+ T Cells, Day 60 | 368 T cells/cubic millimeter |
| Control Group | Cell Count of CD4+ T Cells | CD4+ T Cells, Day 30 | 410.5 T cells/cubic millimeter |
| Placebo Group | Cell Count of CD4+ T Cells | CD 4+ T Cells, Day 210 | 822 T cells/cubic millimeter |
| Placebo Group | Cell Count of CD4+ T Cells | CD4+ T Cells, Day 30 | 799 T cells/cubic millimeter |
| Placebo Group | Cell Count of CD4+ T Cells | CD4+ T Cells, Day 60 | 877 T cells/cubic millimeter |
| Placebo Group | Cell Count of CD4+ T Cells | CD4+ T Cells, Day 0 | 811 T cells/cubic millimeter |
Secondary
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 interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\]; 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.
Time frame: At Day 0, 30, 60 and 210
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK692342 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, Day 0 [N=22;8;7] | 104.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, Day 0 [N=22;8;7] | 88.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, Day 30 [N=22;8;7] | 1389.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, Day 60 [N=22;8;7] | 6771.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, Day 210 [N=21;8;7] | 3953.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, Day 30 [N=22;8;7] | 1140.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, Day 60 [N=22;9;7] | 6640.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, Day 210 [N=21;8;7] | 4166.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-TNF-α, Day 0 [N=22;8;7] | 40.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, Day 30 [N=22;8;7] | 793.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, Day 60 [N=22;8;7] | 4286.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, Day 210 [N=21;8;7] | 2632.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-IFN-γ, Day 0 [N=22;8;7] | 64.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, Day 30 [N=22;8;7] | 413.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, Day 60 [N=22;8;7] | 1733.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, Day 210 [N=21;8;7] | 667.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, Day 30 [N=22;8;7] | 136.5 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, Day 60 [N=22;9;7] | 80.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, Day 210 [N=21;8;7] | 74.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, Day 30 [N=22;8;7] | 99.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-TNF-α, Day 0 [N=22;8;7] | 106.5 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, Day 30 [N=22;8;7] | 27.5 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, Day 210 [N=21;8;7] | 51.5 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, Day 60 [N=22;8;7] | 38.5 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, Day 60 [N=22;8;7] | 102.5 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, Day 0 [N=22;8;7] | 135.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, Day 210 [N=21;8;7] | 54.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, Day 30 [N=22;8;7] | 129.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, Day 60 [N=22;8;7] | 112.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, Day 210 [N=21;8;7] | 71.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, Day 0 [N=22;8;7] | 87.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-IFN-γ, Day 0 [N=22;8;7] | 29.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, Day 60 [N=22;8;7] | 80.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, Day 30 [N=22;8;7] | 93.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-IFN-γ, Day 0 [N=22;8;7] | 67.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, Day 60 [N=22;8;7] | 40.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, Day 60 [N=22;9;7] | 27.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, Day 210 [N=21;8;7] | 40.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, Day 60 [N=22;8;7] | 26.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, Day 210 [N=21;8;7] | 67.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, Day 0 [N=22;8;7] | 110.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, Day 0 [N=22;8;7] | 120.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-TNF-α, Day 0 [N=22;8;7] | 63.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, Day 30 [N=22;8;7] | 106.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, Day 210 [N=21;8;7] | 53.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, Day 30 [N=22;8;7] | 107.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, Day 210 [N=21;8;7] | 54.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, Day 30 [N=22;8;7] | 94.0 T cells/million cells |
Secondary
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).
Time frame: At Day 0, 30, 60 and 210
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 0 [N=22;8;7] | 95.0 T cells/million cells |
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 30 [N=22;8;7] | 1713.5 T cells/million cells |
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 60 [N=22;8;7] | 7003.5 T cells/million cells |
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 210 [N=21;8;7] | 4245.0 T cells/million cells |
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 0 [N=22;8;7] | 167.0 T cells/million cells |
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 30 [N=22;8;7] | 97.0 T cells/million cells |
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 60 [N=22;8;7] | 236.0 T cells/million cells |
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 210 [N=21;8;7] | 195.0 T cells/million cells |
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 60 [N=22;8;7] | 112.0 T cells/million cells |
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 60 [N=22;8;7] | 74.5 T cells/million cells |
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 210 [N=21;8;7] | 83.5 T cells/million cells |
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 0 [N=22;8;7] | 71.5 T cells/million cells |
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 30 [N=22;8;7] | 38.5 T cells/million cells |
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 0 [N=22;8;7] | 154.5 T cells/million cells |
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 30 [N=22;8;7] | 129.0 T cells/million cells |
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 210 [N=21;8;7] | 55.5 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 60 [N=22;8;7] | 26.0 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 30 [N=22;8;7] | 94.0 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 0 [N=22;8;7] | 96.0 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 210 [N=21;8;7] | 67.0 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 60 [N=22;8;7] | 415.0 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 30 [N=22;8;7] | 216.0 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 0 [N=22;8;7] | 364.0 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 210 [N=21;8;7] | 241.0 T cells/million cells |
Secondary
Number of Subjects With Significant Highly Active Anti-Retroviral Therapy (HAART) Changes
Recorded significant HAART change refers to one subject switching the Combivir drug to Truvada as planned by personal physician, with no relationship to vaccination, prior to study enrolment.
Time frame: From Day 60 to Day 210
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK692342 Group | Number of Subjects With Significant Highly Active Anti-Retroviral Therapy (HAART) Changes | 0 Subjects |
| Control Group | Number of Subjects With Significant Highly Active Anti-Retroviral Therapy (HAART) Changes | 1 Subjects |
| Placebo Group | Number of Subjects With Significant Highly Active Anti-Retroviral Therapy (HAART) Changes | 0 Subjects |