Infections, Streptococcal, Streptococcus Pneumoniae
Conditions
Keywords
Haemophilus influenzae, Streptococcus pneumoniae, safety, Pneumococcal conjugate vaccine, immunogenicity
Brief summary
The aim of this study is to assess the immune response, safety and reactogenicity following administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4 years of age in children previously vaccinated with 3 primary doses of GSK 1024850A or Prevenar™ vaccine within the first 6 months of life and a booster dose of plain polysaccharide pneumococcal (Pneumovax 23™) vaccine at 11-14 months of age. Antibody persistence will also be assessed at approximately 4 years of age in children previously vaccinated with 3 doses of either GSK 1024850A or Prevenar™ vaccine followed by a booster dose of Pneumovax 23™. This protocol posting deals with objectives & outcome measures of the extension phase at year 4. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT 00307541). The objectives & outcome measures of the booster phase are presented in a separate protocol posting (NCT 00333450).
Interventions
BIOLOGICALPneumococcal conjugate vaccine GSK 1024850A
One dose of vaccine will be injected intramuscularly into the deltoid.
BIOLOGICALPneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)
One dose of vaccine will be injected intramuscularly into the deltoid.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
46 Months to 50 Months
Healthy volunteers
Yes
Inclusion criteria
* Male or female between, and including, 46-50 months of age at the time of vaccination. * Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * Subjects who previously participated in study NCT00333450 in centres with more than 2 subjects and received a booster dose of Pneumovax 23™. * Written informed consent obtained from both parents/guardians of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination. * Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before study vaccination and during the entire study period. * Administration of any pneumococcal vaccine since the end of study NCT00333450. * Administration of immunoglobulins and/or any blood products less than 3 months prior to the vaccination or planned use during the study period. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical * History of any neurologic disorders or seizures * Anaphylactic reaction following previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine. * History of hypotonic-hyporesponsive episode after any previous vaccination. * Major congenital defects or serious chronic illness. * History of invasive pneumococcal diseases. * Acute disease at the time of vaccination * Rectal temperature \>= 38.0°C or oral/axillary/tympanic temperature \>= 37.5°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaccine Pneumococcal Serotype Antibody Concentrations | Before (PRE) and one month after (POST) the additional dose | The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cross-reactive Pneumococcal Serotype Antibody Concentrations | Before (PRE) and one month after (POST) the additional dose | The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The cross-reactive pneumococcal serotypes assessed include 6A and 19A. |
| Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes | Before (PRE) and one month after (POST) the additional dose | The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The cross-reactive pneumococcal serotypes assessed include 6A and 19A. |
| Anti-protein D Antibody Concentrations | Before (PRE) and one month after (POST) the additional dose | The anti-protein D antibody cut-off value (greater than or equal to ≥100 EL.U/mL) was assessed by Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL). |
| Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | Before (PRE) and one month after (POST) the additional dose | The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 8-day (Days 0-7) post-additional dose | Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal everyday activities. Grade 3 loss of appetite was defined as the subject not eating at all. Any is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | Within 31 days (Day 0-30) post-additional vaccination | An AE is 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. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | Throughout the entire study period (approximately 1 month per subject) | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | During the 8-day (Days 0-7) post-additional dose | Solicited local symptoms assessed include pain, redness, and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger (\>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity. |
Countries
Germany
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| Prevnar Group Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age. | 25 |
| GSK 1024850A Group Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age. | 27 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Prevnar Group | GSK 1024850A Group | Total |
|---|---|---|---|
| Age, Continuous | 46.6 Months STANDARD_DEVIATION 0.91 | 46.7 Months STANDARD_DEVIATION 0.72 | 46.65 Months STANDARD_DEVIATION 0.81 |
| Sex: Female, Male Female | 9 Participants | 17 Participants | 26 Participants |
| Sex: Female, Male Male | 16 Participants | 10 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 27 |
| other Total, other adverse events | 17 / 25 | 20 / 27 |
| serious Total, serious adverse events | 0 / 25 | 0 / 27 |
Outcome results
Primary
Vaccine Pneumococcal Serotype Antibody Concentrations
The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Time frame: Before (PRE) and one month after (POST) the additional dose
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-19F PRE | 2.02 μg/mL |
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-19F POST | 5.68 μg/mL |
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-1 PRE | 0.14 μg/mL |
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-1 POST | 0.16 μg/mL |
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-4 PRE | 0.27 μg/mL |
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-4 POST | 4.3 μg/mL |
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-5 PRE | 0.11 μg/mL |
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-5 POST | 0.15 μg/mL |
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-6B PRE | 0.65 μg/mL |
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-6B POST | 7.46 μg/mL |
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-7F PRE | 0.18 μg/mL |
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-7F POST | 0.19 μg/mL |
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-9V PRE | 0.48 μg/mL |
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-9V POST | 6.88 μg/mL |
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-14 PRE | 1.5 μg/mL |
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-14 POST | 25.82 μg/mL |
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-18C PRE | 0.34 μg/mL |
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-18C POST | 4.23 μg/mL |
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-23F PRE | 0.33 μg/mL |
| Prevnar Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-23F POST | 5.82 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-18C POST | 6.4 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-19F PRE | 2.37 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-7F PRE | 0.39 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-19F POST | 15.61 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-1 PRE | 0.38 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-14 POST | 9.71 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-7F POST | 2.53 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-1 POST | 1.35 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-23F POST | 1.27 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-4 PRE | 0.12 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-9V PRE | 0.44 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-4 POST | 6.76 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-18C PRE | 0.48 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-5 PRE | 0.5 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-9V POST | 2.13 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-5 POST | 1.78 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-23F PRE | 0.23 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-6B PRE | 0.48 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-14 PRE | 1.98 μg/mL |
| GSK 1024850A Group | Vaccine Pneumococcal Serotype Antibody Concentrations | ANTI-6B POST | 1.68 μg/mL |
Secondary
Anti-protein D Antibody Concentrations
The anti-protein D antibody cut-off value (greater than or equal to ≥100 EL.U/mL) was assessed by Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
Time frame: Before (PRE) and one month after (POST) the additional dose
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prevnar Group | Anti-protein D Antibody Concentrations | ANTI-PD PRE | 104.1 EL.U/mL |
| Prevnar Group | Anti-protein D Antibody Concentrations | ANTI-PD POST | 85.9 EL.U/mL |
| GSK 1024850A Group | Anti-protein D Antibody Concentrations | ANTI-PD POST | 1135.6 EL.U/mL |
| GSK 1024850A Group | Anti-protein D Antibody Concentrations | ANTI-PD PRE | 173.1 EL.U/mL |
Secondary
Cross-reactive Pneumococcal Serotype Antibody Concentrations
The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
Time frame: Before (PRE) and one month after (POST) the additional dose
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prevnar Group | Cross-reactive Pneumococcal Serotype Antibody Concentrations | ANTI-6A PRE | 0.22 μg/mL |
| Prevnar Group | Cross-reactive Pneumococcal Serotype Antibody Concentrations | ANTI-6A POST | 1.78 μg/mL |
| Prevnar Group | Cross-reactive Pneumococcal Serotype Antibody Concentrations | ANTI-19A PRE | 0.39 μg/mL |
| Prevnar Group | Cross-reactive Pneumococcal Serotype Antibody Concentrations | ANTI-19A POST | 0.8 μg/mL |
| GSK 1024850A Group | Cross-reactive Pneumococcal Serotype Antibody Concentrations | ANTI-19A POST | 1.24 μg/mL |
| GSK 1024850A Group | Cross-reactive Pneumococcal Serotype Antibody Concentrations | ANTI-6A PRE | 0.19 μg/mL |
| GSK 1024850A Group | Cross-reactive Pneumococcal Serotype Antibody Concentrations | ANTI-19A PRE | 0.29 μg/mL |
| GSK 1024850A Group | Cross-reactive Pneumococcal Serotype Antibody Concentrations | ANTI-6A POST | 0.47 μg/mL |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness, and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger (\>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity.
Time frame: During the 8-day (Days 0-7) post-additional dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prevnar Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain | 11 Participants |
| Prevnar Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| Prevnar Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness | 13 Participants |
| Prevnar Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 7 Participants |
| Prevnar Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling | 7 Participants |
| Prevnar Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 4 Participants |
| GSK 1024850A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling | 9 Participants |
| GSK 1024850A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain | 16 Participants |
| GSK 1024850A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 3 Participants |
| GSK 1024850A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 2 Participants |
| GSK 1024850A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 1 Participants |
| GSK 1024850A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness | 14 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal everyday activities. Grade 3 loss of appetite was defined as the subject not eating at all. Any is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.
Time frame: During the 8-day (Days 0-7) post-additional dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 4 Participants |
| Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 0 Participants |
| Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 0 Participants |
| Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 1 Participants |
| Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 0 Participants |
| Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 0 Participants |
| Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 2 Participants |
| Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite | 3 Participants |
| Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite | 0 Participants |
| Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite | 1 Participants |
| Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 5 Participants |
| GSK 1024850A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 9 Participants |
| GSK 1024850A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 12 Participants |
| GSK 1024850A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite | 12 Participants |
| GSK 1024850A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 1 Participants |
| GSK 1024850A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 1 Participants |
| GSK 1024850A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 8 Participants |
| GSK 1024850A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite | 7 Participants |
| GSK 1024850A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 8 Participants |
| GSK 1024850A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 7 Participants |
| GSK 1024850A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| GSK 1024850A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite | 2 Participants |
| GSK 1024850A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 6 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above.
Time frame: Throughout the entire study period (approximately 1 month per subject)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prevnar Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| GSK 1024850A Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
An AE is 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. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Time frame: Within 31 days (Day 0-30) post-additional vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prevnar Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 8 Participants |
| GSK 1024850A Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 6 Participants |
Secondary
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes
The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
Time frame: Before (PRE) and one month after (POST) the additional dose
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prevnar Group | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes | OPSONO-19A PRE | 10.4 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes | OPSONO-6A PRE | 106.9 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes | OPSONO-19A POST | 101.3 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes | OPSONO-6A POST | 2320.4 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes | OPSONO-19A POST | 153.9 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes | OPSONO-19A PRE | 19.6 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes | OPSONO-6A POST | 966.2 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes | OPSONO-6A PRE | 117.7 Titers |
Secondary
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Time frame: Before (PRE) and one month after (POST) the additional dose
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-4 POST | 4814 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-9V PRE | 612.9 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-1 PRE | 4 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-1 POST | 5.5 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-4 PRE | 20.7 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-5 PRE | 4.2 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-5 POST | 4.4 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-6B PRE | 188.2 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-6B POST | 6734.3 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-7F PRE | 1202.9 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-7F POST | 1304.2 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-9V POST | 5829.4 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-14 PRE | 149.7 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-14 POST | 5400.8 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-18C PRE | 16.1 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-18C POST | 1615.2 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-19F PRE | 26.1 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-19F POST | 241.6 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-23F PRE | 1430.2 Titers |
| Prevnar Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-23F POST | 23977.2 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-19F POST | 837.3 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-4 POST | 4380.7 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-7F POST | 4657.1 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-9V PRE | 442 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-18C POST | 2806.6 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-1 PRE | 5.8 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-9V POST | 2843.5 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-1 POST | 49.3 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-23F POST | 4865.1 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-4 PRE | 12.3 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-14 PRE | 330 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-5 PRE | 7.5 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-19F PRE | 35.8 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-5 POST | 50.6 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-14 POST | 2812.4 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-6B PRE | 66.3 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-23F PRE | 1383.2 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-6B POST | 1424.5 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-18C PRE | 23.7 Titers |
| GSK 1024850A Group | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes | OPSONO-7F PRE | 1498.9 Titers |