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The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Taiwanese infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined vaccine and rotavirus vaccine in children during the first 6 months of life.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synflorix group | Experimental | Subjects receiving Synflorix co-administered with Infanrixâ„¢ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarixâ„¢ at 1.5 and 3 months of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synflorix | Biological | Intramuscular injection, 3 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Anti-Protein D Antibodies | Concentrations are given as geometric mean concentrations (GMC) and expressed in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL). | One month after the third dose |
| Concentration of Anti-Pneumococcal Antibodies | Concentrations are given as geometric mean titers (GMC) and expressed in microgram per milliliter (µg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F. | One month after the third dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anti-Protein D Antibody Concentrations Above the Cut-Off Value | Anti-protein D antibody cut-off value assessed was greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL). | Before the first dose (pre) and one month after (post) the third dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Taipei | 100 | Taiwan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23021506 | Background | Lin TY, Lu CY, Chang LY, Chiu CH, Huang YC, Bock HL, Tang H, Francois N, Moreira M, Schuerman L, Huang LM. Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Taiwan. J Formos Med Assoc. 2012 Sep;111(9):495-503. doi: 10.1016/j.jfma.2011.07.014. Epub 2012 Mar 18. |
| 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 |
|---|---|---|---|
| 109861 | Study Protocol | 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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| ID | Title | Description |
|---|---|---|
| FG000 | Synflorix Group | Subjects receiving Synflorix co-administered with Infanrixâ„¢ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarixâ„¢ at 1.5 and 3 months of age. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Synflorix Group | Subjects receiving Synflorix co-administered with Infanrixâ„¢ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarixâ„¢ at 1.5 and 3 months of age. |
| 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 | Concentration of Anti-Protein D Antibodies | Concentrations are given as geometric mean concentrations (GMC) and expressed in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL). | Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | One month after the third dose |
|
|
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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 | Synflorix Group | Subjects receiving Synflorix co-administered with Infanrixâ„¢ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarixâ„¢ at 1.5 and 3 months of age. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C547294 | PHiD-CV vaccine |
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
| C492457 | RIX4414 vaccine |
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| Infanrix hexa | Biological | Intramuscular injection, 3 doses. |
|
|
| Rotarix | Biological | Oral, 2 doses. |
|
|
| Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value |
Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F. |
| Before the first dose (pre) and one month after (post) the third dose |
| Number of Subjects With Cross-Reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL). | One month after the third dose |
| Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value | Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer. | One month after the third dose |
| Number of Subjects With Opsonophagocytic Activity Against Cross-Reactive Pneumococcal Serotypes Above the Cut-Off Value | Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer. | One month after the third dose |
| Number of Subjects With Anti-Polyribosyl-Ribitol Phosphate Antibody Concentrations Above the Cut-Off Value | Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was greater than or equal to 0.15 microgram per milliliter (μg/mL). | One month after the third dose |
| Number of Subjects With Anti-Diphteria and Anti-Tetanus Toxoids Antibody Concentrations Above the Cut-Off Value | Anti-diphteria and anti-tetanus toxoids antibody cut-off values assessed were greater than or equal to 0.10 International Units per milliliter (IU/mL). | One month after the third dose |
| Number of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value | Anti-PT, anti-FHA and anti-PRN cut-off values assessed were greater than or equal to 5 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL). | One month after the third dose |
| Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value | Anti-HBs antibody cut-off value assessed was greater than or equal to 10 milli-International Units per milliliter (mIU/mL). | One month after the third dose |
| Number of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value | Anti-poliovirus 1, 2 and 3 antibody cut-off value assessed was greater than or equal to 1:8 titer. | One month after the third dose |
| Number of Subjects With Anti-rotavirus Immunoglobulin A Antibody Concentrations Above the Cut-Off Value | Anti-rotavirus IgA antibody cut-off value assessed was greater than or equal to 20 Units per milliliter (U/mL). | Four months after the administration of the second dose of Rotarixâ„¢ vaccine |
| Number of Subjects Reporting Solicited Symptoms | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include diarrhoea, drowsiness, fever, irritability, loss of appetite, and vomiting | During the 4-day (Day 0-3) period after each dose |
| Number of Subjects Reporting Unsolicited Adverse Events (AE) | 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 | During the 31-day (Day 0-30) period after each dose |
| Number of Subjects Reporting Serious Adverse Events (SAE) | 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, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. | Up to one month after the third dose |
| Taipei |
| 105 |
| Taiwan |
| GSK Investigational Site | Taoyuan Hsien | Taiwan |
For additional information about this study please refer to the GSK Clinical Study Register |
| 109861 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109861 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109861 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109861 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109861 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109861 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Concentration of Anti-Pneumococcal Antibodies | Concentrations are given as geometric mean titers (GMC) and expressed in microgram per milliliter (µg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F. | Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | One month after the third dose |
|
|
|
| Secondary | Number of Subjects With Anti-Protein D Antibody Concentrations Above the Cut-Off Value | Anti-protein D antibody cut-off value assessed was greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL). | Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results | Posted | Number | subjects | Before the first dose (pre) and one month after (post) the third dose |
|
|
|
| Secondary | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F. | Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results | Posted | Number | subjects | Before the first dose (pre) and one month after (post) the third dose |
|
|
|
| Secondary | Number of Subjects With Cross-Reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL). | Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results | Posted | Number | subjects | One month after the third dose |
|
|
|
| Secondary | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value | Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer. | Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results | Posted | Number | subjects | One month after the third dose |
|
|
|
| Secondary | Number of Subjects With Opsonophagocytic Activity Against Cross-Reactive Pneumococcal Serotypes Above the Cut-Off Value | Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer. | Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results | Posted | Number | subjects | One month after the third dose |
|
|
|
| Secondary | Number of Subjects With Anti-Polyribosyl-Ribitol Phosphate Antibody Concentrations Above the Cut-Off Value | Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was greater than or equal to 0.15 microgram per milliliter (μg/mL). | Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results | Posted | Number | subjects | One month after the third dose |
|
|
|
| Secondary | Number of Subjects With Anti-Diphteria and Anti-Tetanus Toxoids Antibody Concentrations Above the Cut-Off Value | Anti-diphteria and anti-tetanus toxoids antibody cut-off values assessed were greater than or equal to 0.10 International Units per milliliter (IU/mL). | Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results | Posted | Number | subjects | One month after the third dose |
|
|
|
| Secondary | Number of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value | Anti-PT, anti-FHA and anti-PRN cut-off values assessed were greater than or equal to 5 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL). | Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results | Posted | Number | subjects | One month after the third dose |
|
|
|
| Secondary | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value | Anti-HBs antibody cut-off value assessed was greater than or equal to 10 milli-International Units per milliliter (mIU/mL). | Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results | Posted | Number | subjects | One month after the third dose |
|
|
|
| Secondary | Number of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value | Anti-poliovirus 1, 2 and 3 antibody cut-off value assessed was greater than or equal to 1:8 titer. | Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results | Posted | Number | subjects | One month after the third dose |
|
|
|
| Secondary | Number of Subjects With Anti-rotavirus Immunoglobulin A Antibody Concentrations Above the Cut-Off Value | Anti-rotavirus IgA antibody cut-off value assessed was greater than or equal to 20 Units per milliliter (U/mL). | Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results | Posted | Number | subjects | Four months after the administration of the second dose of Rotarixâ„¢ vaccine |
|
|
|
| Secondary | Number of Subjects Reporting Solicited Symptoms | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include diarrhoea, drowsiness, fever, irritability, loss of appetite, and vomiting | Posted | Number | subjects | During the 4-day (Day 0-3) period after each dose |
|
|
|
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 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 | Posted | Number | subjects | During the 31-day (Day 0-30) period after each dose |
|
|
|
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAE) | 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, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. | Posted | Number | subjects | Up to one month after the third dose |
|
|
|
| 15 |
| 224 |
| 230 |
| Bronchiolitis | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastroenteritis bacterial | Infections and infestations | Non-systematic Assessment |
|
| Kawasaki's disease | Infections and infestations | Non-systematic Assessment |
|
| Meningitis aseptic | Infections and infestations | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Vesicoureteric reflux | Renal and urinary disorders | 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 |
|
| Vomiting | 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.
| D013290 |
| Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| Title | Measurements |
|---|---|
|
| Anti-6B |
|
| Anti-7F |
|
| Anti-9V |
|
| Anti-14 |
|
| Anti-18C |
|
| Anti-19F |
|
| Anti-23F |
|
| Title | Measurements |
|---|---|
|
| Anti-4 Post (N=219) |
|
| Anti-5 Pre (N=217) |
|
| Anti-5 Post (N=219) |
|
| Anti-6B Pre (N=217) |
|
| Anti-6B Post (N=219) |
|
| Anti-7F Pre (N=218) |
|
| Anti-7F Post (N=219) |
|
| Anti-9V Pre (N=218) |
|
| Anti-9V Post (N=219) |
|
| Anti-14 Pre (N=218) |
|
| Anti-14 Post (N=219) |
|
| Anti-18C Pre (N=219) |
|
| Anti-18C Post (N=219) |
|
| Anti-19F Pre (N=219) |
|
| Anti-19F Post (N=219) |
|
| Anti-23F Pre (N=219) |
|
| Anti-23F Post (N=219) |
|
| Title | Measurements |
|---|---|
|
| Opsono-6B (N=102) |
|
| Opsono-7F (N=103) |
|
| Opsono-9V (N=98) |
|
| Opsono-14 (N=102) |
|
| Opsono-18C (N=101) |
|
| Opsono-19F (N=103) |
|
| Opsono-23F (N=102) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title |
|---|
| Measurements |
|---|
|
| Diarrhoea |
|
| Drowsiness |
|
| Fever |
|
| Irritability |
|
| Loss of appetite |
|
| Vomiting |
|