A Phase 2 interventional study of Pneumococcal vaccine GSK2189242A (formulation 1) and Pneumococcal vaccine GSK2189242A (formulation 2) in Infections, Streptococcal, sponsored by GlaxoSmithKline. Completed at 1 site in Belgium. Open to participants aged 18 Years to 41 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-17.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention
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)
155 studies on the registry are indexed under Streptococcal Infections; 15 are open to participants now.
This study's enrollment of 43 is below the median of 250 across 105 interventional studies indexed under Streptococcal Infections.
Browse Streptococcal Infections studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
One dose will be administered intramuscularly at Study Day 0.
One dose will be administered intramuscularly at Study Day 0.
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
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
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
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)
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
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)
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)
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
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
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
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)
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
| Milestone | GSK2189242A Formulation 1 Group | GSK2189242A Formulation 2 Group |
|---|---|---|
| Started | 22 | 21 |
| Completed | 22 | 21 |
| Not completed | 0 | 0 |
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.
| Participants | GSK2189242A Formulation 1 Group | GSK2189242A Formulation 2 Group |
|---|---|---|
| Grade 3 Pain | 0 | 1 |
| Grade 3 Redness | 0 | 1 |
| Grade 3 Swelling | 1 | 0 |
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.
| Participants | GSK2189242A Formulation 1 Group | GSK2189242A Formulation 2 Group |
|---|---|---|
| Grade 3 Fatigue | 1 | 0 |
| Related Fatigue | 3 | 13 |
| Grade 3 Gastrointestinal symptoms | 0 | 0 |
| Related Gastrointestinal symptoms | 3 | 0 |
| Grade 3 Headache | 0 | 0 |
| Related Headache | 5 | 8 |
| Grade 3 Malaise | 0 | 0 |
| Related Malaise | 2 | 3 |
| Grade 3 Myalgia | 0 | 0 |
| Related Myalgia | 3 | 3 |
| Grade 3 Fever | 0 | 0 |
| Related Fever | 1 | 0 |
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.
| Participants | GSK2189242A Formulation 1 Group | GSK2189242A Formulation 2 Group |
|---|---|---|
| Grade 3 AE(s) | 1 | 1 |
| Related AE(s) | 1 | 1 |
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
| Participants | GSK2189242A Formulation 1 Group | GSK2189242A Formulation 2 Group |
|---|---|---|
| Number of Subjects With Any Vaccine-related Serious Adverse Events (SAEs) | 0 | 0 |
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
| Participants | GSK2189242A Formulation 1 Group | GSK2189242A Formulation 2 Group |
|---|---|---|
| ALT, Day 1 | 0 | 0 |
| AST, Day 6 | 0 | 0 |
| Cholesterol, Day 1 | 0 | 1 |
| Cholesterol, Day 6 | 1 | 1 |
| CRP, Day 1 | 0 | 0 |
| CRP, Day 6 | 1 | 0 |
| Hemoglobin decrease, Day 1 | 0 | 0 |
| Hemoglobin decrease, Day 6 | 0 | 0 |
| Haemoglobin, Day 1 | 0 | 0 |
| Haemoglobin, Day 6 | 0 | 0 |
| LDH, Day 6 | 0 | 0 |
| Neutrophils, Day 6 | 0 | 0 |
| RBC, Day 1 | 0 | 0 |
| RBC, Day 6 | 0 | 0 |
| Reticulocytes, Day 6 | 0 | 0 |
| WBC, Day 1 | 0 | 0 |
| WBC, Day 6 | 0 | 0 |
| Overall parameters, Day 1 | 0 | 1 |
| Overall parameters, Day 6 | 1 | 1 |
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.
| LU/mL | GSK2189242A Formulation 1 Group | GSK2189242A Formulation 2 Group |
|---|---|---|
| Anti-dPly, Day 0 | 41823.0 (30264.0 to 57796.7) | 89612.2 (65851.0 to 121947.2) |
| Anti-dPly, Day 30 | 92943.4 (65790.6 to 131302.6) | 144767.0 (106911.5 to 196026.4) |
| Anti-PhtD, Day 0 | 26672.0 (19423.7 to 36625.0) | 42111.0 (33408.2 to 53080.9) |
| Anti-PhtD, Day 30 | 37850.5 (29018.1 to 49371.2) | 62795.3 (51695.6 to 76278.3) |
Antibody titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 6.
| Titers | GSK2189242A Formulation 1 Group | GSK2189242A Formulation 2 Group |
|---|---|---|
| Anti-Hem-dPly, Day 0 | 2161.5 (1772.1 to 2636.4) | 3028.1 (2210.5 to 4148.1) |
| Anti-Hem-dPly, Day 30 | 2383.6 (1754.4 to 3238.3) | 3573.7 (2561.1 to 4986.5) |
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
| Participants | GSK2189242A Formulation 1 Group | GSK2189242A Formulation 2 Group |
|---|---|---|
| Any Pain | 19 | 21 |
| Any Redness | 4 | 9 |
| Any Swelling | 2 | 8 |
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.
| Participants | GSK2189242A Formulation 1 Group | GSK2189242A Formulation 2 Group |
|---|---|---|
| Any Fatigue | 4 | 13 |
| Any Gastrointestinal symptoms | 3 | 1 |
| Any Headache | 5 | 8 |
| Any Malaise | 2 | 3 |
| Any Myalgia | 3 | 3 |
| Any Fever | 1 | 0 |
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.
| Participants | GSK2189242A Formulation 1 Group | GSK2189242A Formulation 2 Group |
|---|---|---|
| Number of Subjects With Any Unsolicited AEs | 6 | 5 |
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
| Participants | GSK2189242A Formulation 1 Group | GSK2189242A Formulation 2 Group |
|---|---|---|
| Number of Subjects With Any SAEs | 0 | 0 |
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
| Participants | GSK2189242A Formulation 1 Group | GSK2189242A Formulation 2 Group |
|---|---|---|
| Grade 1 ALT, Day 1 | 0 | 1 |
| Grade 1 AST, Day 6 | 1 | 0 |
| Grade 1 Cholesterol, Day 1 | 3 | 4 |
| Grade 1 Cholesterol, Day 6 | 2 | 4 |
| Grade 1 CRP, Day 1 | 3 | 3 |
| Grade 1 CRP, Day 6 | 2 | 5 |
| Grade 1 Hemoglobin decrease, Day 1 | 7 | 7 |
| Grade 1 Hemoglobin decrease, Day 6 | 10 | 11 |
| Grade 1 Haemoglobin, Day 1 | 1 | 1 |
| Grade 1 Haemoglobin, Day 6 | 2 | 2 |
| Grade 1 LDH, Day 6 | 1 | 0 |
| Grade 1 Neutrophils, Day 6 | 2 | 2 |
| Grade 1 RBC, Day 1 | 7 | 5 |
| Grade 1 RBC, Day 6 | 6 | 4 |
| Grade 1 Reticulocytes, Day 6 | 1 | 0 |
| Grade 1 WBC, Day 1 | 2 | 3 |
| Grade 1 WBC, Day 6 | 1 | 0 |
| Grade 1 Overall parameters, Day 1 | 14 | 14 |
| Grade 1 Overall parameters, Day 6 | 17 | 17 |
| Grade 2 ALT, Day 1 | 0 | 0 |
| Grade 2 AST, Day 6 | 0 | 0 |
| Grade 2 Cholesterol, Day 1 | 1 | 2 |
| Grade 2 Cholesterol, Day 6 | 1 | 2 |
| Grade 2 CRP, Day 1 | 1 | 1 |
| Grade 2 CRP, Day 6 | 2 | 1 |
| Grade 2 Hemoglobin decrease, Day 1 | 0 | 0 |
| Grade 2 Hemoglobin decrease, Day 6 | 0 | 0 |
| Grade 2 Haemoglobin, Day 1 | 1 | 0 |
| Grade 2 Haemoglobin, Day 6 | 1 | 0 |
| Grade 2 LDH, Day 6 | 0 | 0 |
| Grade 2 Neutrophils, Day 6 | 0 | 0 |
| Grade 2 RBC, Day 1 | 0 | 0 |
| Grade 2 RBC, Day 6 | 0 | 0 |
| Grade 2 Reticulocytes, Day 6 | 0 | 0 |
| Grade 2 WBC, Day 1 | 0 | 0 |
| Grade 2 WBC, Day 6 | 0 | 0 |
| Grade 2 Overall parameters, Day 1 | 3 | 3 |
| Grade 2 Overall parameters, Day 6 | 3 | 3 |
| Grade 4 ALT, Day 1 | 0 | 0 |
| Grade 4 AST, Day 6 | 0 | 0 |
| Grade 4 Cholesterol, Day 1 | 0 | 0 |
| Grade 4 Cholesterol, Day 6 | 0 | 0 |
| Grade 4 CRP, Day 1 | 0 | 0 |
| Grade 4 CRP, Day 6 | 0 | 0 |
| Grade 4 Hemoglobin decrease, Day 1 | 0 | 0 |
| Grade 4 Hemoglobin decrease, Day 6 | 0 | 0 |
| Grade 4 Haemoglobin, Day 1 | 0 | 0 |
| Grade 4 Haemoglobin, Day 6 | 0 | 0 |
| Grade 4 LDH, Day 6 | 0 | 0 |
| Grade 4 Neutrophils, Day 6 | 0 | 0 |
| Grade 4 RBC, Day 1 | 0 | 0 |
| Grade 4 RBC, Day 6 | 0 | 0 |
| Grade 4 Reticulocytes, Day 6 | 0 | 0 |
| Grade 4 WBC, Day 1 | 0 | 0 |
| Grade 4 WBC, Day 6 | 0 | 0 |
| Grade 4 Overall parameters, Day 1 | 0 | 0 |
| Grade 4 Overall parameters, Day 6 | 0 | 0 |
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GSK2189242A Formulation 1 Group | 0/22 (0%) | 0/22 (0%) | 21/22 (95.5%) |
| GSK2189242A Formulation 2 Group | 0/21 (0%) | 0/21 (0%) | 21/21 (100%) |
| Event | GSK2189242A Formulation 1 Group | GSK2189242A Formulation 2 Group |
|---|---|---|
| PainGeneral disorders | 19/22 | 21/21 |
| FatigueGeneral disorders | 4/22 | 13/21 |
| RednessGeneral disorders | 4/22 | 9/21 |
| SwellingGeneral disorders | 2/22 | 8/21 |
| HeadacheGeneral disorders | 5/22 | 8/21 |
| MalaiseGeneral disorders | 2/22 | 3/21 |
| MyalgiaGeneral disorders | 3/22 | 3/21 |
| Gastrointestinal symptomsGeneral disorders | 3/22 | 1/21 |
| DiarrhoeaGastrointestinal disorders | 2/22 | 0/21 |
| HeadacheNervous system disorders | 2/22 | 0/21 |
| Age, Continuous(Years) | GSK2189242A Formulation 1 Group | GSK2189242A Formulation 2 Group | Total |
|---|---|---|---|
| Mean | 26.7 ± 4.80 | 23.9 ± 4.11 | 25.33 ± 4.64 |
| Sex: Female, Male(Participants) | GSK2189242A Formulation 1 Group | GSK2189242A Formulation 2 Group | Total |
|---|---|---|---|
| Female | 15 | 12 | 27 |
| Male | 7 | 9 | 16 |
| Race/Ethnicity, Customized(Participants) | GSK2189242A Formulation 1 Group | GSK2189242A Formulation 2 Group | Total |
|---|---|---|---|
| White-Caucasian/European heritage | 22 | 21 | 43 |
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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