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This primary purpose of this study is the evaluation of the immunological persistence following completion of the 3-dose primary vaccination course with either a clinical or a commercial lot of pneumococcal conjugate vaccine GSK1024850A in study NCT00808444. In addition, the study will also assess the safety, reactogenicity and immunogenicity of a fourth dose of pneumococcal conjugate vaccine GSK1024850A (commercial lot) when co-administered with Infanrix-IPV/Hib at 18-21 months of age in children primed in study NCT00808444.
The primary vaccination study was conducted in Malaysia and Singapore. The booster vaccination study will not be performed in Malaysia since the pneumococcal conjugate vaccine GSK1024850A has been registered in September 2009. However, subjects in Malaysia will be offered a booster dose of the commercial pneumococcal conjugate vaccine licensed in Malaysia and Infanrix-IPV/Hib vaccine during the second year of life according to the nationally recommended regimen. Administration of the booster dose will be outside the set-up of a clinical trial. Hence no data will be collected, no blood samples will be taken in Malaysia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synflorixâ„¢ Commercial-Commercial + Infanrixâ„¢-IPV/Hib Group | Experimental | children primed with 3 doses of commercial lot of Synflorixâ„¢ co-administered with Rotarixâ„¢ and Infanrixâ„¢-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorixâ„¢ co-administered with Infanrixâ„¢-IPV/Hib. The Synflorixâ„¢ vaccine (commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrixâ„¢-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh. |
|
| Synflorixâ„¢ Clinical-Commercial + Infanrixâ„¢-IPV/Hib Group | Active Comparator | children primed with 3 doses of clinical lot of Synflorixâ„¢ + Rotarixâ„¢ co-administered with Infanrixâ„¢-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorixâ„¢ co-administered with Infanrixâ„¢-IPV/Hib. The Synflorixâ„¢ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrixâ„¢-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal vaccine GSK1024850A | Biological | Intramuscular injection, one dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL. | Before booster vaccination at Month 0 |
| Concentrations of Antibodies Against Protein D (PD). | Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL). | Before booster vaccination at Month 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs). | Solicited AEs = AEs to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of these events is actively solicited from the subject or an observer during a specified post-vaccination follow-up period. Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre (mm). |
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Inclusion Criteria:
Exclusion Criteria:
Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding vaccination, or planned use during the study period.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
A family history of congenital or hereditary immunodeficiency.
Administration of immunoglobulins and/ or any blood products within the 3 months preceding vaccination or planned use during the study period.
Administration of any pneumococcal and/or vaccine containing diphtheria, tetanus, pertussis, poliomyelitis or Haemophilus influenzae type b antigens since the end of study NCT00808444.
Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before vaccination and ending 30 days after vaccination.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
History of any reaction or allergic disease likely to be exacerbated by any component of the study vaccines.
Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures. (Subjects who have had a single uncomplicated febrile convulsion in the past can be included)
Fever at the time of vaccination.
Acute disease at the time of enrolment.
Child in care.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Singapore | 119074 | Singapore | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25278086 | Derived | Lim FS, Koh MT, Tan KK, Chan PC, Chong CY, Shung Yehudi YW, Teoh YL, Shafi F, Hezareh M, Swinnen K, Borys D. A randomised trial to evaluate the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Singapore and Malaysia. BMC Infect Dis. 2014 Oct 2;14:530. doi: 10.1186/1471-2334-14-530. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 113266 | Clinical Study Report | View IPD |
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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This booster study was conducted in Singapore only wheras the primary vaccination phase (NCT00808444) was conducted in Singapore and Malaysia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Synflorixâ„¢ Clinical-Commercial + Infanrixâ„¢-IPV/Hib Group | children primed with 3 doses of clinical lot of Synflorixâ„¢ + Rotarixâ„¢ co-administered with Infanrixâ„¢-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorixâ„¢ co-administered with Infanrixâ„¢-IPV/Hib. The Synflorixâ„¢ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrixâ„¢-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh. |
| FG001 | Synflorixâ„¢ Commercial-Commercial + Infanrixâ„¢-IPV/Hib Group | children primed with 3 doses of commercial lot of Synflorixâ„¢ co-administered with Rotarixâ„¢ and Infanrixâ„¢-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorixâ„¢ co-administered with Infanrixâ„¢-IPV/Hib. The Synflorixâ„¢ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrixâ„¢-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Synflorixâ„¢ Clinical-Commercial + Infanrixâ„¢-IPV/Hib Group | children primed with 3 doses of clinical lot of Synflorixâ„¢ + Rotarixâ„¢ co-administered with Infanrixâ„¢-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorixâ„¢ co-administered with Infanrixâ„¢-IPV/Hib. The Synflorixâ„¢ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrixâ„¢-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL. | The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Before booster vaccination at Month 0 |
|
Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Synflorixâ„¢ Clinical-Commercial + Infanrixâ„¢-IPV/Hib Group | children primed with 3 doses of clinical lot of Synflorixâ„¢ + Rotarixâ„¢ co-administered with Infanrixâ„¢-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorixâ„¢ co-administered with Infanrixâ„¢-IPV/Hib. The Synflorixâ„¢ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrixâ„¢-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
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| Infanrix-IPV/Hib | Biological | Intramuscular injection, one dose |
|
| Within 4 days (Days 0-3) after booster vaccination. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs). | Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (= axillary temperature equal to or above 37.5 degrees Celsius (°C)). Any= occurrence of any general symptom regardless of intensity grade or relationship to vaccination Grade 3 drowsiness = drowsiness which prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = temperature >39.5°C. Related = solicited symptom assessed by the investigator as causally related to study vaccination. | Within 4 days (Days 0-3) after booster vaccination. |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs). | Unsolicited AEs = Any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. | Within 31 days (Days 0-30) after booster vaccination |
| Number of Subjects Reporting Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. | During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1 |
| Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes. | Opsonophagocytic activity (OPA) testing was not performed. | Before and one month after booster vaccination (at Month 0 and Month 1) |
| Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsonophagocytic activity (OPA) testing was not performed. | Before and one month after booster vaccination (at Month 0 and Month 1) |
| Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes. | Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL. | Before booster vaccination at Month 0 |
| Concentrations of Antibodies Against Diphtheria and Tetanus. | Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL. | Before booster vaccination at Month 0 |
| Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN). | Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL. | Before booster vaccination at Month 0 |
| Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP). | Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL. | Before booster vaccination at Month 0 |
| Titers of Antibodies Against Poliovirus Types 1, 2 and 3. | Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8. | Before booster vaccination at Month 0 |
| Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL. | Before and one month after booster vaccination (at Month 0 and Month 1) |
| Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes. | Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL. | Before and one month after booster vaccination (at Month 0 and Month 1) |
| Concentrations of Antibodies Against Protein D (PD). | Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL). | Before and one month after booster vaccination (at Month 0 and Month 1) |
| Concentrations of Antibodies Against Diphtheria and Tetanus. | Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL. | Before and one month after booster vaccination (at Month 0 and Month 1) |
| Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN). | Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL. | Before and one month after booster vaccination (at Month 0 and Month 1) |
| Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP). | Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL. | Before and one month after booster vaccination (at Month 0 and Month 1) |
| Titers of Antibodies Against Poliovirus Types 1, 2 and 3. | Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8. | Before and one month after booster vaccination (at Month 0 and Month 1) |
| Singapore |
| 229899 |
| Singapore |
| GSK Investigational Site | Singapore | 688846 | Singapore |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113266 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113266 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113266 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113266 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113266 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113266 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Other |
|
| BG001 | Synflorixâ„¢ Commercial-Commercial + Infanrixâ„¢-IPV/Hib Group | children primed with 3 doses of commercial lot of Synflorixâ„¢ co-administered with Rotarixâ„¢ and Infanrixâ„¢-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorixâ„¢ co-administered with Infanrixâ„¢-IPV/Hib. The Synflorixâ„¢ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrixâ„¢-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh. |
| BG002 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
children primed with 3 doses of clinical lot of Synflorixâ„¢ + Rotarixâ„¢ co-administered with Infanrixâ„¢-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorixâ„¢ co-administered with Infanrixâ„¢-IPV/Hib. The Synflorixâ„¢ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrixâ„¢-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh. |
| OG001 | Synflorixâ„¢ Commercial-Commercial + Infanrixâ„¢-IPV/Hib Group | children primed with 3 doses of commercial lot of Synflorixâ„¢ co-administered with Rotarixâ„¢ and Infanrixâ„¢-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorixâ„¢ co-administered with Infanrixâ„¢-IPV/Hib. The Synflorixâ„¢ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrixâ„¢-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh. |
|
|
| Primary | Concentrations of Antibodies Against Protein D (PD). | Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL). | The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Before booster vaccination at Month 0 |
|
|
|
| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs). | Solicited AEs = AEs to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of these events is actively solicited from the subject or an observer during a specified post-vaccination follow-up period. Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre (mm). | The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented. The analysis of the solicited symptoms based on the Total Vaccinated cohort included subjects with documented safety data. | Posted | Count of Participants | Participants | Within 4 days (Days 0-3) after booster vaccination. |
|
|
|
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs). | Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (= axillary temperature equal to or above 37.5 degrees Celsius (°C)). Any= occurrence of any general symptom regardless of intensity grade or relationship to vaccination Grade 3 drowsiness = drowsiness which prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = temperature >39.5°C. Related = solicited symptom assessed by the investigator as causally related to study vaccination. | The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented. The analysis of the solicited symptoms based on the Total Vaccinated cohort included subjects with documented safety data. | Posted | Count of Participants | Participants | Within 4 days (Days 0-3) after booster vaccination. |
|
|
|
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | Unsolicited AEs = Any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. | The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented. | Posted | Count of Participants | Participants | Within 31 days (Days 0-30) after booster vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. | The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented. | Posted | Count of Participants | Participants | During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1 |
|
|
|
| Secondary | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes. | Opsonophagocytic activity (OPA) testing was not performed. | Not Posted | Dec 2099 | Before and one month after booster vaccination (at Month 0 and Month 1) | Participants |
| Secondary | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsonophagocytic activity (OPA) testing was not performed. | Not Posted | Dec 2099 | Before and one month after booster vaccination (at Month 0 and Month 1) | Participants |
| Secondary | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes. | Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL. | The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Before booster vaccination at Month 0 |
|
|
|
| Secondary | Concentrations of Antibodies Against Diphtheria and Tetanus. | Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL. | The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Before booster vaccination at Month 0 |
|
|
|
| Secondary | Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN). | Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL. | The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Before booster vaccination at Month 0 |
|
|
|
| Secondary | Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP). | Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL. | The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Before booster vaccination at Month 0 |
|
|
|
| Secondary | Titers of Antibodies Against Poliovirus Types 1, 2 and 3. | Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8. | The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Before booster vaccination at Month 0 |
|
|
|
| Secondary | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL. | The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Before and one month after booster vaccination (at Month 0 and Month 1) |
|
|
|
| Secondary | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes. | Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL. | The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Before and one month after booster vaccination (at Month 0 and Month 1) |
|
|
|
| Secondary | Concentrations of Antibodies Against Protein D (PD). | Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL). | The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Before and one month after booster vaccination (at Month 0 and Month 1) |
|
|
|
| Secondary | Concentrations of Antibodies Against Diphtheria and Tetanus. | Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL. | The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Before and one month after booster vaccination (at Month 0 and Month 1) |
|
|
|
| Secondary | Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN). | Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL. | The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Before and one month after booster vaccination (at Month 0 and Month 1) |
|
|
|
| Secondary | Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP). | Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL. | The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Before and one month after booster vaccination (at Month 0 and Month 1) |
|
|
|
| Secondary | Titers of Antibodies Against Poliovirus Types 1, 2 and 3. | Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8. | The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Before and one month after booster vaccination (at Month 0 and Month 1) |
|
|
|
| 0 |
| 118 |
| 98 |
| 118 |
| EG001 | Synflorixâ„¢ Commercial-Commercial + Infanrixâ„¢-IPV/Hib Group | children primed with 3 doses of commercial lot of Synflorixâ„¢ co-administered with Rotarixâ„¢ and Infanrixâ„¢-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorixâ„¢ co-administered with Infanrixâ„¢-IPV/Hib. The Synflorixâ„¢ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrixâ„¢-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh. | 4 | 120 | 108 | 120 |
| Bronchiolitis | Infections and infestations | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Redness | General disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
|
| Drowsiness | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Irritability | General disorders | Systematic Assessment |
|
| Loss of appetite | General disorders | Systematic Assessment |
|
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.
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| Any redness |
|
| Grade 3 redness |
|
| Any swelling |
|
| Grade 3 swelling |
|
| Related drowsiness |
|
| Fever >= 37.5°C |
|
| Fever > 39.5°C |
|
| Related fever |
|
| Any irritability |
|
| Grade 3 irritability |
|
| Related irritability |
|
| Any loss of appetite |
|
| Grade 3 loss of appetite |
|
| Related loss of appetite |
|
| Anti-19A [pre-booster] |
|
|
| Anti-tetanus [pre-booster] |
|
|
| Anti-FHA [pre-booster] |
|
|
| Anti-PRN [pre-booster] |
|
|
| Anti-polio 3 [pre-booster] |
|
| Anti-1 [post-booster] |
|
|
| Anti-4 [pre-booster] |
|
|
| Anti-4 [post-booster] |
|
|
| Anti-5 [pre-booster] |
|
|
| Anti-5 [post-booster] |
|
|
| Anti-6B [pre-booster] |
|
|
| Anti-6B [post-booster] |
|
|
| Anti-7F [pre-booster] |
|
|
| Anti-7F [post-booster] |
|
|
| Anti-9V [pre-booster] |
|
|
| Anti-9V [post-booster] |
|
|
| Anti-14 [pre-booster] |
|
|
| Anti-14 [post-booster] |
|
|
| Anti-18C [pre-booster] |
|
|
| Anti-18C [post-booster] |
|
|
| Anti-19F [pre-booster] |
|
|
| Anti-19F [post-booster] |
|
|
| Anti-23F [pre-booster] |
|
|
| Anti-23F [post-booster] |
|
|
| Anti-6A [post-booster] |
|
|
| Anti-19A [pre-booster] |
|
|
| Anti-19A [post-booster] |
|
|
| Anti-PD [post-booster] |
|
|
| Anti-diphtheria [post-booster] |
|
|
| Anti-tetanus [pre-booster] |
|
|
| Anti-tetanus [post-booster] |
|
|
| Anti-PT [post-booster] |
|
|
| Anti-FHA [pre-booster] |
|
|
| Anti-FHA [post-booster] |
|
|
| Anti-PRN [pre-booster] |
|
|
| Anti-PRN [post-booster] |
|
|
| Anti-PRP [post-booster] |
|
|
| Anti-polio 1 [post-booster] |
|
|
| Anti-polio 2 [pre-booster] |
|
|
| Anti-polio 2 [post-booster] |
|
|
| Anti-polio 3 [pre-booster] |
|
|
| Anti-polio 3 [post-booster] |
|
|