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This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose catch-up vaccination.
This protocol posting deals with objectives and outcome measures of the booster phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00338351).
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 Booster Group | Experimental | Subjects previously primed with Synflorixâ„¢ and receiving in the current study Havrixâ„¢ co-administered with Infanrixâ„¢ hexa (Dose 1) and Synflorixâ„¢ (Dose 2). |
|
| Synflorix Catch-up Group | Experimental | Subjects previously primed with Havrixâ„¢ co-administered with Infanrixâ„¢ hexa and receiving in the current study Synflorixâ„¢ co-administered with Infanrixâ„¢ hexa (Dose 1) and Synflorixâ„¢ (Dose 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synflorix | Biological | Intramuscular injection, 1 or 2 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited) | Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice). | Within 4 days after the administration of any study vaccine dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling. | Within 4 days after the administration of any study vaccine dose |
| Number of Subjects Reporting Solicited General Symptoms |
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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 | Santiago | Región Metro de Santiago | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21441782 | Background | Lagos RE, Munoz AE, Levine MM, Lepetic A, Francois N, Yarzabal JP, Schuerman L. Safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Chilean children. Hum Vaccin. 2011 May;7(5):511-22. doi: 10.4161/hv.7.5.14634. Epub 2011 May 1. | |
| Background | Lagos R et al. 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) given as booster dose or 2-dose catch-up in Chilean children. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010. |
| 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 |
|---|---|---|---|
| 110031 | Individual Participant Data Set | 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 Booster Group | Subjects previously primed with Synflorixâ„¢ and receiving in the current study Havrixâ„¢ co-administered with Infanrixâ„¢ hexa (Dose 1) and Synflorixâ„¢ (Dose 2). |
| FG001 | Synflorix Catch-up Group | Subjects previously primed with Havrixâ„¢ co-administered with Infanrixâ„¢ hexa and receiving in the current study Synflorixâ„¢ co-administered with Infanrixâ„¢ hexa (Dose 1) and Synflorixâ„¢ (Dose 2). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Synflorix Booster Group | Subjects previously primed with Synflorixâ„¢ and receiving in the current study Havrixâ„¢ co-administered with Infanrixâ„¢ hexa (Dose 1) and Synflorixâ„¢ (Dose 2). |
| BG001 | Synflorix Catch-up Group |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited) | Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice). | Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet. | Posted | Number | subjects | Within 4 days after the administration of any study vaccine 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 Booster Group | Subjects previously primed with Synflorixâ„¢ and receiving in the current study Havrixâ„¢ co-administered with Infanrixâ„¢ hexa (Dose 1) and Synflorixâ„¢ (Dose 2). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thermal burn | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | 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 |
|---|---|
| D013290 | Streptococcal Infections |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| 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 |
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Infanrix Hexa | Biological | 1 Intramuscular injection |
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| Havrix | Biological | 1 Intramuscular injection |
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Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite.
Fever was defined as rectal temperature ≥ 38 degrees Celsius.
| Within 4 days after the administration of any study vaccine dose |
| Number of Subjects Reporting Unsolicited Adverse Events | An Adverse Event 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. | Within 31 days after the administration of any study vaccine dose |
| Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study | A serious adverse event (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. | Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose) |
| Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period | 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. | Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up) |
| Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. | Before (pre) and one month after (post) the administration of Dose 2 |
| 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 ≥ 8 The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. | Before (pre) and one month after (post) the administration of Dose 2 |
| Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value | Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL). | Before (pre) and one month after (post) the administration of Dose 2 |
| Anti-hepatitis A Virus Antibodies Concentration | Concentration of anti-hepatitis A antibodies given as geometric mean concentration (GMC) in milli-international units per milliliter (mIU/mL). | Before (pre) and one month after (post) the administration of Dose 2 |
| Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value | Anti-hepatitis A antibodies cut-off value assessed was ≥ 15 mIU/mL. | Before (pre) and one month after (post) the administration of Dose 2 |
For additional information about this study please refer to the GSK Clinical Study Register |
| 110031 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110031 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110031 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110031 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110031 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Lost to Follow-up |
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| Physician Decision |
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| Visit 3 not done |
|
Subjects previously primed with Havrixâ„¢ co-administered with Infanrixâ„¢ hexa and receiving in the current study Synflorixâ„¢ co-administered with Infanrixâ„¢ hexa (Dose 1) and Synflorixâ„¢ (Dose 2).
| BG002 | Total | Total of all reporting groups |
| Months |
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| Sex: Female, Male | Count of Participants | Participants |
|
Subjects previously primed with Havrixâ„¢ co-administered with Infanrixâ„¢ hexa and receiving in the current study Synflorixâ„¢ co-administered with Infanrixâ„¢ hexa (Dose 1) and Synflorixâ„¢ (Dose 2). |
|
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| Secondary | Number of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling. | Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet. | Posted | Number | subjects | Within 4 days after the administration of any study vaccine dose |
|
|
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| Secondary | Number of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite. Fever was defined as rectal temperature ≥ 38 degrees Celsius. | Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet. | Posted | Number | subjects | Within 4 days after the administration of any study vaccine dose |
|
|
|
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events | An Adverse Event 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 | Within 31 days after the administration of any study vaccine dose |
|
|
|
| Secondary | Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study | A serious adverse event (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 | Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose) |
|
|
|
| Secondary | Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period | 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 | Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up) |
|
|
|
| Secondary | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. | Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results | Posted | Number | subjects | Before (pre) and one month after (post) the administration of Dose 2 |
|
|
|
| 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 ≥ 8 The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. | Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results | Posted | Number | subjects | Before (pre) and one month after (post) the administration of Dose 2 |
|
|
|
| Secondary | Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value | Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL). | Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results | Posted | Number | subjects | Before (pre) and one month after (post) the administration of Dose 2 |
|
|
|
| Secondary | Anti-hepatitis A Virus Antibodies Concentration | Concentration of anti-hepatitis A antibodies given as geometric mean concentration (GMC) in milli-international units per milliliter (mIU/mL). | Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Before (pre) and one month after (post) the administration of Dose 2 |
|
|
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| Secondary | Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value | Anti-hepatitis A antibodies cut-off value assessed was ≥ 15 mIU/mL. | Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results. | Posted | Number | subjects | Before (pre) and one month after (post) the administration of Dose 2 |
|
|
|
| 1 |
| 84 |
| 78 |
| 84 |
| EG001 | Synflorix Catch-up Group | Subjects previously primed with Havrixâ„¢ co-administered with Infanrixâ„¢ hexa and receiving in the current study Synflorixâ„¢ co-administered with Infanrixâ„¢ hexa (Dose 1) and Synflorixâ„¢ (Dose 2). | 0 | 79 | 75 | 79 |
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
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| Injection site induration | General disorders | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Redness | General disorders | Systematic Assessment |
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| Swelling | General disorders | Systematic Assessment |
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| Drowsiness | General disorders | Systematic Assessment |
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| Fever (Rectally) | General disorders | Systematic Assessment |
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| Irritability | General disorders | Systematic Assessment |
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| Loss of appetite | General disorders | Systematic Assessment |
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| Pharyngitis | Infections and infestations | Non-systematic Assessment |
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| Pyrexia | General disorders | Non-systematic Assessment |
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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.
| D045424 |
| Complex Mixtures |
| Swelling |
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| Irritability |
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| Loss of appetite |
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| Anti-4 Pre (N=75; 73) |
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| Anti-4 Post (N=77; 70) |
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| Anti-5 Pre (N=76; 70) |
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| Anti-5 Post (N=78; 70) |
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| Anti-6A Pre (N=76; 72) |
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| Anti-6A Post (N=77; 70) |
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| Anti-6B Pre (N=76; 73) |
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| Anti-6B Post (N=78; 70) |
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| Anti-7F Pre (N=70; 68) |
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| Anti-7F Post (N=78; 70) |
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| Anti-9V Pre (N=78; 72) |
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| Anti-9V Post (N=79; 70) |
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| Anti-14 Pre (N=76; 71) |
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| Anti-14 Post (N=79; 70) |
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| Anti-18C Pre (N=77; 73) |
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| Anti-18C Post (N=78; 70) |
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| Anti-19A Pre (N=78; 73) |
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| Anti-19A Post (N=78; 70) |
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| Anti-19F Pre (N=80; 72) |
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| Anti-19F Post (N=78; 70) |
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| Anti-23F Pre (N=76; 71) |
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| Anti-23F Post (N=78; 70) |
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| Opsono-4 Pre (N=17; 19) |
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| Opsono-4 Post (N=24; 18) |
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| Opsono-5 Pre (N=19; 23) |
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| Opsono-5 Post (N=20; 25) |
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| Opsono-6A Pre (N=20; 25) |
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| Opsono-6A Post (N=19; 19) |
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| Opsono-6B Pre (N=22; 25) |
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| Opsono-6B Post (N=24; 27) |
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| Opsono-7F Pre (N=17; 12) |
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| Opsono-7F Post (N=25; 26) |
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| Opsono-9V Pre (N=20; 17) |
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| Opsono-9V Post (N=23; 23) |
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| Opsono-14 Pre (N=16; 11) |
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| Opsono-14 Post (N=21; 25) |
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| Opsono-18C Pre (N=29; 28) |
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| Opsono-18C Post (N=26; 27) |
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| Opsono-19A Pre (N=18; 18) |
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| Opsono-19A Post (N=23; 19) |
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| Opsono-19F Pre (N=22; 23) |
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| Opsono-19F Post (N=20; 21) |
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| Opsono-23F Pre (N=21; 16) |
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| Opsono-23F Post (N=25; 25) |
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