Infections, Streptococcal
Conditions
Keywords
Pneumococcal vaccine, Streptococcus pneumoniae, Young adults
Brief summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of pneumococcal vaccines (GSK 2189242A) in young adults. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT 00707798)
Interventions
One dose will be administered intramuscularly at Study Day 0.
One dose will be administered intramuscularly at Study Day 0.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 41 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 18 and 41 years old at the time of vaccination. * Subjects who previously participated in the study NCT00707798 and received one of the two investigational GSK2189242A vaccine formulations during the primary study. * Written informed consent obtained from the subject. * Free of obvious health problems as established by medical history, clinical examination and clinical laboratory assessment before entering into the study. * Female subjects of non-childbearing potential (defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause) may be enrolled in the study. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after vaccination.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the vaccination, or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. * Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the vaccination and ending one month (minimum 30 days) after vaccination. * Administration of any pneumococcal vaccine other than the study vaccine during the period between end of study NCT00707798 and study vaccination. * Bacterial pneumonia within the period between end of study NCT00707798 and study vaccination. * Invasive pneumococcal disease (IPD) within the period between end of study NCT00707798 and study vaccination. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection (no laboratory testing required). * History of thrombocytopenia or bleeding disorder. * Anaphylactic reaction following the previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine. * Current serious neurologic or mental disorders. * Inflammatory processes such as known chronic active infections (e.g. Hepatitis B, C). * All past or current malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders. * Acute disease at the time of enrolment/vaccination. * Fever at the time of vaccination. Fever is defined as temperature \>= 37.5°C on oral setting. * Physical examination positive for acrocyanosis, jaundice, splenomegaly. * Acute or chronic, clinically significant anaemia, pulmonary, cardiovascular, hematologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator * Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration during the study period. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions. * History of chronic alcohol consumption and/or drug abuse. * Other conditions that the principal investigator judges may interfere with study findings.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-booster vaccination period | Assessed solicited local symptoms were pain, redness and swelling. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. |
| Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | During the 7-day (Days 0-6) post-booster vaccination period | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = general symptom assessed by the investigator to be casually related to the study vaccination. |
| Number of Subjects With Grade 3 and Vaccine-related Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) post-booster vaccination period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. 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 Any Vaccine-related Serious Adverse Events (SAEs) | During the entire study period (from Day 0 to Day 30) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | At Days 1 and 6 post-booster vaccination | Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters. Assessment of intensity: Grading of the haematological and biochemical parameters was performed using the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins | Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30) | Anti-dPly and anti-PhtD antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in LU/mL. The reference seropositivity cut-off values were equal to or above (≥) 599 LU/mL for anti-dPly and ≥ 391 LU/mL for anti-PhtD. |
| Titers for Antibodies Against Pneumolysin Haemolysis (Hem-dPly) Protein | Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30) | Antibody titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 6. |
| Number of Subjects With Any Solicited Local Symptoms | During the 7-day (Days 0-6) post-booster vaccination period | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. |
| Number of Subjects With Any Solicited General Symptoms | During the 7-day (Days 0-6) post-booster vaccination period | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. |
| Number of Subjects With Any Unsolicited AEs | During the 31-day (Days 0-30) post-booster vaccination period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Any SAEs | During the entire study period (from Day 0 to Day 30) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | At 1 and 6 days post-booster vaccination | Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters. Assessment of intensity: Grading of the haematological and biochemical parameters was performed using the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSK2189242A Formulation 1 Group Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0. | 22 |
| GSK2189242A Formulation 2 Group Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0. | 21 |
| Total | 43 |
Baseline characteristics
| Characteristic | GSK2189242A Formulation 1 Group | GSK2189242A Formulation 2 Group | Total |
|---|---|---|---|
| Age, Continuous | 26.7 Years STANDARD_DEVIATION 4.8 | 23.9 Years STANDARD_DEVIATION 4.11 | 25.33 Years STANDARD_DEVIATION 4.64 |
| Race/Ethnicity, Customized White-Caucasian/European heritage | 22 Participants | 21 Participants | 43 Participants |
| Sex: Female, Male Female | 15 Participants | 12 Participants | 27 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 21 |
| other Total, other adverse events | 21 / 22 | 21 / 21 |
| serious Total, serious adverse events | 0 / 22 | 0 / 21 |
Outcome results
Primary
Number of Subjects With Any Vaccine-related Serious Adverse Events (SAEs)
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 to Day 30)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2189242A Formulation 1 Group | Number of Subjects With Any Vaccine-related Serious Adverse Events (SAEs) | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Any Vaccine-related Serious Adverse Events (SAEs) | 0 Participants |
Primary
Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = general symptom assessed by the investigator to be casually related to the study vaccination.
Time frame: During the 7-day (Days 0-6) post-booster vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Grade 3 Fatigue | 1 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Related Fatigue | 3 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Related Gastrointestinal symptoms | 3 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Related Headache | 5 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Grade 3 Malaise | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Related Malaise | 2 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Related Myalgia | 3 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Related Fever | 1 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Grade 3 Malaise | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Related Fatigue | 13 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Related Myalgia | 3 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Related Malaise | 3 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Related Gastrointestinal symptoms | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Related Fever | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Related Headache | 8 Participants |
Primary
Number of Subjects With Grade 3 and Vaccine-related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. 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 31-day (Days 0-30) post-booster vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 and Vaccine-related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 1 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 and Vaccine-related Unsolicited Adverse Events (AEs) | Related AE(s) | 1 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 and Vaccine-related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 1 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 and Vaccine-related Unsolicited Adverse Events (AEs) | Related AE(s) | 1 Participants |
Primary
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities
Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters. Assessment of intensity: Grading of the haematological and biochemical parameters was performed using the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening
Time frame: At Days 1 and 6 post-booster vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | CRP, Day 6 | 1 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | LDH, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Cholesterol, Day 1 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Neutrophils, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Hemoglobin decrease, Day 1 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | RBC, Day 1 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | AST, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | RBC, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Hemoglobin decrease, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Reticulocytes, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Cholesterol, Day 6 | 1 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | WBC, Day 1 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Haemoglobin, Day 1 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | WBC, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | ALT, Day 1 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Overall parameters, Day 1 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Haemoglobin, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Overall parameters, Day 6 | 1 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | CRP, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Overall parameters, Day 6 | 1 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | CRP, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | ALT, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | AST, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Cholesterol, Day 1 | 1 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Cholesterol, Day 6 | 1 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | CRP, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Hemoglobin decrease, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Hemoglobin decrease, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Haemoglobin, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Haemoglobin, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | LDH, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Neutrophils, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | RBC, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | RBC, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Reticulocytes, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | WBC, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | WBC, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Overall parameters, Day 1 | 1 Participants |
Primary
Number of Subjects With Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) post-booster vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 1 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Solicited Local Symptoms | Grade 3 Pain | 1 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 3 Solicited Local Symptoms | Grade 3 Redness | 1 Participants |
Secondary
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins
Anti-dPly and anti-PhtD antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in LU/mL. The reference seropositivity cut-off values were equal to or above (≥) 599 LU/mL for anti-dPly and ≥ 391 LU/mL for anti-PhtD.
Time frame: Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom post results were available for at least one assay.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2189242A Formulation 1 Group | Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins | Anti-dPly, Day 0 | 41823.0 LU/mL |
| GSK2189242A Formulation 1 Group | Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins | Anti-dPly, Day 30 | 92943.4 LU/mL |
| GSK2189242A Formulation 1 Group | Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins | Anti-PhtD, Day 0 | 26672.0 LU/mL |
| GSK2189242A Formulation 1 Group | Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins | Anti-PhtD, Day 30 | 37850.5 LU/mL |
| GSK2189242A Formulation 2 Group | Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins | Anti-PhtD, Day 30 | 62795.3 LU/mL |
| GSK2189242A Formulation 2 Group | Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins | Anti-dPly, Day 0 | 89612.2 LU/mL |
| GSK2189242A Formulation 2 Group | Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins | Anti-PhtD, Day 0 | 42111.0 LU/mL |
| GSK2189242A Formulation 2 Group | Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins | Anti-dPly, Day 30 | 144767.0 LU/mL |
Secondary
Number of Subjects With Any SAEs
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 to Day 30)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2189242A Formulation 1 Group | Number of Subjects With Any SAEs | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Any SAEs | 0 Participants |
Secondary
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 7-day (Days 0-6) post-booster vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2189242A Formulation 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Fatigue | 4 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Gastrointestinal symptoms | 3 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Headache | 5 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Malaise | 2 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Myalgia | 3 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever | 1 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Myalgia | 3 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Fatigue | 13 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Malaise | 3 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Gastrointestinal symptoms | 1 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Headache | 8 Participants |
Secondary
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 7-day (Days 0-6) post-booster vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2189242A Formulation 1 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 2 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 19 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 4 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 21 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 9 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 8 Participants |
Secondary
Number of Subjects With Any Unsolicited AEs
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 31-day (Days 0-30) post-booster vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2189242A Formulation 1 Group | Number of Subjects With Any Unsolicited AEs | 6 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Any Unsolicited AEs | 5 Participants |
Secondary
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities
Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters. Assessment of intensity: Grading of the haematological and biochemical parameters was performed using the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening
Time frame: At 1 and 6 days post-booster vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 CRP, Day 1 | 3 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 LDH, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 WBC, Day 1 | 2 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Neutrophils, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Haemoglobin, Day 1 | 1 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 RBC, Day 1 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 WBC, Day 6 | 1 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 RBC, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 AST, Day 6 | 1 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Reticulocytes, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Overall parameters, Day 1 | 14 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 WBC, Day 1 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Haemoglobin, Day 6 | 2 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 WBC, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Overall parameters, Day 6 | 17 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Overall parameters, Day 1 | 3 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 CRP, Day 6 | 2 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Overall parameters, Day 6 | 3 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 ALT, Day 1 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 ALT, Day 1 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 LDH, Day 6 | 1 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 AST, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 AST, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Cholesterol, Day 1 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Cholesterol, Day 6 | 2 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Cholesterol, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Cholesterol, Day 1 | 1 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 CRP, Day 1 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Neutrophils, Day 6 | 2 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 CRP, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Cholesterol, Day 6 | 1 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Hemoglobin decrease, Day 1 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Hemoglobin decrease, Day 1 | 7 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Hemoglobin decrease, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 CRP, Day 1 | 1 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Haemoglobin, Day 1 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 RBC, Day 1 | 7 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Haemoglobin, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 CRP, Day 6 | 2 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 LDH, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Cholesterol, Day 1 | 3 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Neutrophils, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Hemoglobin decrease, Day 1 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 RBC, Day 1 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 RBC, Day 6 | 6 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 RBC, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Hemoglobin decrease, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Reticulocytes, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Hemoglobin decrease, Day 6 | 10 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 WBC, Day 1 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Haemoglobin, Day 1 | 1 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 WBC, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Reticulocytes, Day 6 | 1 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Overall parameters, Day 1 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Haemoglobin, Day 6 | 1 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Overall parameters, Day 6 | 0 Participants |
| GSK2189242A Formulation 1 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 ALT, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Overall parameters, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 ALT, Day 1 | 1 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 AST, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Cholesterol, Day 1 | 4 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Cholesterol, Day 6 | 4 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 CRP, Day 1 | 3 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 CRP, Day 6 | 5 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Hemoglobin decrease, Day 1 | 7 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Hemoglobin decrease, Day 6 | 11 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Haemoglobin, Day 1 | 1 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Haemoglobin, Day 6 | 2 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 LDH, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Neutrophils, Day 6 | 2 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 RBC, Day 1 | 5 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 RBC, Day 6 | 4 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Reticulocytes, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 WBC, Day 1 | 3 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 WBC, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Overall parameters, Day 1 | 14 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 1 Overall parameters, Day 6 | 17 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 ALT, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 AST, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Cholesterol, Day 1 | 2 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Cholesterol, Day 6 | 2 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 CRP, Day 1 | 1 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 CRP, Day 6 | 1 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Hemoglobin decrease, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Hemoglobin decrease, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Haemoglobin, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Haemoglobin, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 LDH, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Neutrophils, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 RBC, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 RBC, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Reticulocytes, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 WBC, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 WBC, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Overall parameters, Day 1 | 3 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 2 Overall parameters, Day 6 | 3 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 ALT, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 AST, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Cholesterol, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Cholesterol, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 CRP, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 CRP, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Hemoglobin decrease, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Hemoglobin decrease, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Haemoglobin, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Haemoglobin, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 LDH, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Neutrophils, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 RBC, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 RBC, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Reticulocytes, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 WBC, Day 1 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 WBC, Day 6 | 0 Participants |
| GSK2189242A Formulation 2 Group | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Grade 4 Overall parameters, Day 1 | 0 Participants |
Secondary
Titers for Antibodies Against Pneumolysin Haemolysis (Hem-dPly) Protein
Antibody titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 6.
Time frame: Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom post results were available for at least one assay.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2189242A Formulation 1 Group | Titers for Antibodies Against Pneumolysin Haemolysis (Hem-dPly) Protein | Anti-Hem-dPly, Day 0 | 2161.5 Titers |
| GSK2189242A Formulation 1 Group | Titers for Antibodies Against Pneumolysin Haemolysis (Hem-dPly) Protein | Anti-Hem-dPly, Day 30 | 2383.6 Titers |
| GSK2189242A Formulation 2 Group | Titers for Antibodies Against Pneumolysin Haemolysis (Hem-dPly) Protein | Anti-Hem-dPly, Day 0 | 3028.1 Titers |
| GSK2189242A Formulation 2 Group | Titers for Antibodies Against Pneumolysin Haemolysis (Hem-dPly) Protein | Anti-Hem-dPly, Day 30 | 3573.7 Titers |