Trial Outcomes & Findings for Evaluation of a Booster Dose of Pneumococcal Vaccine Formulations in Young Adults (NCT NCT00896064)

Last Updated: 2018-08-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

During the 7-day (Days 0-6) post-booster vaccination period

Results posted on

2018-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	22	21
Overall Study COMPLETED	22	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of a Booster Dose of Pneumococcal Vaccine Formulations in Young Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK2189242A Formulation 1 Group n=22 Participants 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.	GSK2189242A Formulation 2 Group n=21 Participants 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.	Total n=43 Participants Total of all reporting groups
Age, Continuous	26.7 Years STANDARD_DEVIATION 4.80 • n=5 Participants	23.9 Years STANDARD_DEVIATION 4.11 • n=7 Participants	25.33 Years STANDARD_DEVIATION 4.64 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized White-Caucasian/European heritage	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	GSK2189242A Formulation 1 Group n=22 Participants 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.	GSK2189242A Formulation 2 Group n=21 Participants 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.
Number of Subjects With Grade 3 Solicited Local Symptoms Grade 3 Swelling	1 Participants	0 Participants
Number of Subjects With Grade 3 Solicited Local Symptoms Grade 3 Pain	0 Participants	1 Participants
Number of Subjects With Grade 3 Solicited Local Symptoms Grade 3 Redness	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	GSK2189242A Formulation 1 Group n=22 Participants 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.	GSK2189242A Formulation 2 Group n=21 Participants 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.
Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms Grade 3 Fatigue	1 Participants	0 Participants
Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms Related Fatigue	3 Participants	13 Participants
Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms Grade 3 Gastrointestinal symptoms	0 Participants	0 Participants
Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms Related Gastrointestinal symptoms	3 Participants	0 Participants
Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms Grade 3 Headache	0 Participants	0 Participants
Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms Related Headache	5 Participants	8 Participants
Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms Grade 3 Malaise	0 Participants	0 Participants
Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms Related Malaise	2 Participants	3 Participants
Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms Grade 3 Myalgia	0 Participants	0 Participants
Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms Related Myalgia	3 Participants	3 Participants
Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms Grade 3 Fever	0 Participants	0 Participants
Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms Related Fever	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	GSK2189242A Formulation 1 Group n=22 Participants 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.	GSK2189242A Formulation 2 Group n=21 Participants 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.
Number of Subjects With Grade 3 and Vaccine-related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	1 Participants	1 Participants
Number of Subjects With Grade 3 and Vaccine-related Unsolicited Adverse Events (AEs) Related AE(s)	1 Participants	1 Participants

PRIMARY outcome

Timeframe: 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.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	GSK2189242A Formulation 1 Group n=22 Participants 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.	GSK2189242A Formulation 2 Group n=21 Participants 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.
Number of Subjects With Any Vaccine-related Serious Adverse Events (SAEs)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	GSK2189242A Formulation 1 Group n=22 Participants 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.	GSK2189242A Formulation 2 Group n=21 Participants 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.
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities ALT, Day 1	0 Participants	0 Participants
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities AST, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities Cholesterol, Day 1	0 Participants	1 Participants
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities Cholesterol, Day 6	1 Participants	1 Participants
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities CRP, Day 1	0 Participants	0 Participants
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities CRP, Day 6	1 Participants	0 Participants
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities Hemoglobin decrease, Day 1	0 Participants	0 Participants
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities Hemoglobin decrease, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities Haemoglobin, Day 1	0 Participants	0 Participants
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities Haemoglobin, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities LDH, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities Neutrophils, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities RBC, Day 1	0 Participants	0 Participants
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities RBC, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities Reticulocytes, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities WBC, Day 1	0 Participants	0 Participants
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities WBC, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities Overall parameters, Day 1	0 Participants	1 Participants
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities Overall parameters, Day 6	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	GSK2189242A Formulation 1 Group n=22 Participants 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.	GSK2189242A Formulation 2 Group n=20 Participants 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.
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins Anti-dPly, Day 0	41823.0 LU/mL Interval 30264.0 to 57796.7	89612.2 LU/mL Interval 65851.0 to 121947.2
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins Anti-dPly, Day 30	92943.4 LU/mL Interval 65790.6 to 131302.6	144767.0 LU/mL Interval 106911.5 to 196026.4
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins Anti-PhtD, Day 0	26672.0 LU/mL Interval 19423.7 to 36625.0	42111.0 LU/mL Interval 33408.2 to 53080.9
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins Anti-PhtD, Day 30	37850.5 LU/mL Interval 29018.1 to 49371.2	62795.3 LU/mL Interval 51695.6 to 76278.3

SECONDARY outcome

Timeframe: 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.

Antibody titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 6.

Outcome measures

Outcome measures
Measure	GSK2189242A Formulation 1 Group n=22 Participants 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.	GSK2189242A Formulation 2 Group n=20 Participants 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.
Titers for Antibodies Against Pneumolysin Haemolysis (Hem-dPly) Protein Anti-Hem-dPly, Day 0	2161.5 Titers Interval 1772.1 to 2636.4	3028.1 Titers Interval 2210.5 to 4148.1
Titers for Antibodies Against Pneumolysin Haemolysis (Hem-dPly) Protein Anti-Hem-dPly, Day 30	2383.6 Titers Interval 1754.4 to 3238.3	3573.7 Titers Interval 2561.1 to 4986.5

SECONDARY outcome

Timeframe: 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.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Outcome measures
Measure	GSK2189242A Formulation 1 Group n=22 Participants 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.	GSK2189242A Formulation 2 Group n=21 Participants 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.
Number of Subjects With Any Solicited Local Symptoms Any Pain	19 Participants	21 Participants
Number of Subjects With Any Solicited Local Symptoms Any Redness	4 Participants	9 Participants
Number of Subjects With Any Solicited Local Symptoms Any Swelling	2 Participants	8 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	GSK2189242A Formulation 1 Group n=22 Participants 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.	GSK2189242A Formulation 2 Group n=21 Participants 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.
Number of Subjects With Any Solicited General Symptoms Any Myalgia	3 Participants	3 Participants
Number of Subjects With Any Solicited General Symptoms Any Fever	1 Participants	0 Participants
Number of Subjects With Any Solicited General Symptoms Any Fatigue	4 Participants	13 Participants
Number of Subjects With Any Solicited General Symptoms Any Gastrointestinal symptoms	3 Participants	1 Participants
Number of Subjects With Any Solicited General Symptoms Any Headache	5 Participants	8 Participants
Number of Subjects With Any Solicited General Symptoms Any Malaise	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	GSK2189242A Formulation 1 Group n=22 Participants 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.	GSK2189242A Formulation 2 Group n=21 Participants 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.
Number of Subjects With Any Unsolicited AEs	6 Participants	5 Participants

SECONDARY outcome

Timeframe: 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.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	GSK2189242A Formulation 1 Group n=22 Participants 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.	GSK2189242A Formulation 2 Group n=21 Participants 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.
Number of Subjects With Any SAEs	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	GSK2189242A Formulation 1 Group n=22 Participants 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.	GSK2189242A Formulation 2 Group n=21 Participants 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.
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 4 Overall parameters, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 1 ALT, Day 1	0 Participants	1 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 1 AST, Day 6	1 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 1 Cholesterol, Day 1	3 Participants	4 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 1 Cholesterol, Day 6	2 Participants	4 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 1 CRP, Day 1	3 Participants	3 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 1 CRP, Day 6	2 Participants	5 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 1 Hemoglobin decrease, Day 1	7 Participants	7 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 1 Hemoglobin decrease, Day 6	10 Participants	11 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 1 Haemoglobin, Day 1	1 Participants	1 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 1 Haemoglobin, Day 6	2 Participants	2 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 1 LDH, Day 6	1 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 1 Neutrophils, Day 6	2 Participants	2 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 1 RBC, Day 1	7 Participants	5 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 1 RBC, Day 6	6 Participants	4 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 1 Reticulocytes, Day 6	1 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 1 WBC, Day 1	2 Participants	3 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 1 WBC, Day 6	1 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 1 Overall parameters, Day 1	14 Participants	14 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 1 Overall parameters, Day 6	17 Participants	17 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 2 ALT, Day 1	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 2 AST, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 2 Cholesterol, Day 1	1 Participants	2 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 2 Cholesterol, Day 6	1 Participants	2 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 2 CRP, Day 1	1 Participants	1 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 2 CRP, Day 6	2 Participants	1 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 2 Hemoglobin decrease, Day 1	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 2 Hemoglobin decrease, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 2 Haemoglobin, Day 1	1 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 2 Haemoglobin, Day 6	1 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 2 LDH, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 2 Neutrophils, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 2 RBC, Day 1	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 2 RBC, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 2 Reticulocytes, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 2 WBC, Day 1	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 2 WBC, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 2 Overall parameters, Day 1	3 Participants	3 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 2 Overall parameters, Day 6	3 Participants	3 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 4 ALT, Day 1	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 4 AST, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 4 Cholesterol, Day 1	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 4 Cholesterol, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 4 CRP, Day 1	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 4 CRP, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 4 Hemoglobin decrease, Day 1	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 4 Hemoglobin decrease, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 4 Haemoglobin, Day 1	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 4 Haemoglobin, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 4 LDH, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 4 Neutrophils, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 4 RBC, Day 1	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 4 RBC, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 4 Reticulocytes, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 4 WBC, Day 1	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 4 WBC, Day 6	0 Participants	0 Participants
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities Grade 4 Overall parameters, Day 1	0 Participants	0 Participants

Adverse Events

GSK2189242A Formulation 1 Group

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

GSK2189242A Formulation 2 Group

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	GSK2189242A Formulation 1 Group n=22 participants at risk 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.	GSK2189242A Formulation 2 Group n=21 participants at risk 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.
General disorders Pain	86.4% 19/22 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).	100.0% 21/21 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).
General disorders Redness	18.2% 4/22 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).	42.9% 9/21 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).
General disorders Swelling	9.1% 2/22 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).	38.1% 8/21 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).
General disorders Fatigue	18.2% 4/22 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).	61.9% 13/21 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).
General disorders Gastrointestinal symptoms	13.6% 3/22 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).	4.8% 1/21 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).
General disorders Headache	22.7% 5/22 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).	38.1% 8/21 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).
General disorders Malaise	9.1% 2/22 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).	14.3% 3/21 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).
General disorders Myalgia	13.6% 3/22 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).	14.3% 3/21 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).
Gastrointestinal disorders Diarrhoea	9.1% 2/22 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).	0.00% 0/21 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).
Nervous system disorders Headache	9.1% 2/22 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).	0.00% 0/21 • Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER