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The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age.
This protocol posting deals with objectives & outcome measures of the primary phase of the study. The objectives & outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683).
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
Pediarix/Infanrix Penta and Prevnar should be co-administered to all subjects in all study groups according to a 2, 4, and 6 month schedule concomitantly with study vaccines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menhibrix Group | Experimental | Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of Menhibrix vaccine at 12-15 months of age in the study NCT00345683. Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. |
|
| ActHIB Group | Active Comparator | Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014 | Biological | 3-dose intramuscular injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) |
| Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) |
| Number of Subjects Reporting Rash | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae. | From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) |
| Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) | From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) | |
| Number of Subjects With 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. | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. |
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Inclusion Criteria:
Exclusion criteria:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35235 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21806393 | Background | Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90. | |
| 22327493 | Background | Rinderknecht S, Bryant K, Nolan T, Pavia-Ruz N, Doniz CA, Weber MA, Cohen C, Aris E, Mesaros N, Miller JM. The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY). Hum Vaccin Immunother. 2012 Mar;8(3):304-11. doi: 10.4161/hv.18752. Epub 2012 Feb 13. |
| 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 |
|---|---|---|---|
| 105987 | 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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Of the 4432 subjects enrolled, 4391 were vaccinated and 4162 completed the primary vaccination phase of the study (3114 in the MenHibrix Group and 1048 in the ActHIB Group).
This summary presents results for the primary vaccination phase up to the end of the extended safety follow-up (until, but excluding, the booster dose at 12-15 months of age). For results about the booster/fourth dose phase, see study NCT00345683.
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| ID | Title | Description |
|---|---|---|
| FG000 | MenHibrix Group | Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ActHIB | Biological | 3-dose intramuscular injection |
|
| Pediarix/Infanrix Penta | Biological | 3-dose intramuscular injection |
|
| From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| Number of Subjects With Rash | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| Number of Subjects With Adverse Events Resulting in Emergency Room (ER) | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| Birmingham |
| Alabama |
| 35244 |
| United States |
| GSK Investigational Site | Benton | Arkansas | 72015 | United States |
| GSK Investigational Site | Fayetteville | Arkansas | 72703 | United States |
| GSK Investigational Site | Hot Springs | Arkansas | 71913 | United States |
| GSK Investigational Site | Jonesboro | Arkansas | 72401 | United States |
| GSK Investigational Site | Little Rock | Arkansas | 72201 | United States |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | United States |
| GSK Investigational Site | Fountain Valley | California | 92708 | United States |
| GSK Investigational Site | Fresno | California | 93710 | United States |
| GSK Investigational Site | Fresno | California | 93726 | United States |
| GSK Investigational Site | Madera | California | 93637 | United States |
| GSK Investigational Site | Slinas | California | 93901 | United States |
| GSK Investigational Site | West Covina | California | 91790 | United States |
| GSK Investigational Site | Boulder | Colorado | 80303 | United States |
| GSK Investigational Site | Longmont | Colorado | 80501 | United States |
| GSK Investigational Site | Plantation | Florida | 33324 | United States |
| GSK Investigational Site | Nampa | Idaho | 208 463 3126 | United States |
| GSK Investigational Site | Oak Lawn | Illinois | 60453 | United States |
| GSK Investigational Site | Waukee | Iowa | 50263 | United States |
| GSK Investigational Site | West Desmoines | Iowa | 50266 | United States |
| GSK Investigational Site | Bardstown | Kentucky | 40004 | United States |
| GSK Investigational Site | Lexington | Kentucky | 40503 | United States |
| GSK Investigational Site | Bossier City | Louisiana | 71111 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02111 | United States |
| GSK Investigational Site | Jamaica Plain | Massachusetts | 02130 | United States |
| GSK Investigational Site | Nies | Michigan | 49120 | United States |
| GSK Investigational Site | Portage | Michigan | 49024 | United States |
| GSK Investigational Site | Stevensville | Michigan | 49127 | United States |
| GSK Investigational Site | Saint Paul | Minnesota | 55108 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89104 | United States |
| GSK Investigational Site | New Hartford | New York | 13413 | United States |
| GSK Investigational Site | Syracuse | New York | 13210 | United States |
| GSK Investigational Site | Clyde | North Carolina | 28721 | United States |
| GSK Investigational Site | Deerfield | North Carolina | 28607 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | United States |
| GSK Investigational Site | Sylva | North Carolina | 28779 | United States |
| GSK Investigational Site | Akron | Ohio | 44308-1062 | United States |
| GSK Investigational Site | Canton | Ohio | 44718 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44121 | United States |
| GSK Investigational Site | North Canton | Ohio | 44720 | United States |
| GSK Investigational Site | South Euclid | Ohio | 44121 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15202 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15227 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15236 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15241 | United States |
| GSK Investigational Site | Wexford | Pennsylvania | 15090 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29406 | United States |
| GSK Investigational Site | Kingsport | Tennessee | 37660 | United States |
| GSK Investigational Site | Kingsport | Tennessee | 37664 | United States |
| GSK Investigational Site | Houston | Texas | 77084 | United States |
| GSK Investigational Site | Katy | Texas | 77450 | United States |
| GSK Investigational Site | Layton | Utah | 84041 | United States |
| GSK Investigational Site | Ogden | Utah | 84405 | United States |
| GSK Investigational Site | Orem | Utah | 84057 | United States |
| GSK Investigational Site | Pleasant Gorve | Utah | 84062 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84109 | United States |
| GSK Investigational Site | South Jordan | Utah | 84095 | United States |
| GSK Investigational Site | West Jordan | Utah | 84088 | United States |
| GSK Investigational Site | Madison | Wisconsin | 53792 | United States |
| GSK Investigational Site | Marshfield | Wisconsin | 54449 | United States |
| GSK Investigational Site | Mexico City | 04530 | Mexico |
| GSK Investigational Site | Mexico City | 06720 | Mexico |
For additional information about this study please refer to the GSK Clinical Study Register |
| 105987 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105987 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105987 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105987 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105987 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | ActHIB Group | Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | MenHibrix Group | Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. |
| BG001 | ActHIB Group | Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Days |
| |||||||||||||||
| Gender | Count of Participants | Participants |
|
| 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 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 Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered. | Posted | Number | Subjects | From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered. | Posted | Number | Subjects | From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) |
| |||||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting Rash | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae. | The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered. | Posted | Number | Subjects | From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) |
| |||||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) | The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered. | Posted | Number | Subjects | From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) |
| ||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With 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 Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered. | Posted | Number | Subjects | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |||||||||||||||||||||||||||||||
| Primary | Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered. | Posted | Number | Subjects | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Rash | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae | The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered. | Posted | Number | Subjects | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Adverse Events Resulting in Emergency Room (ER) | The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered. | Posted | Number | Subjects | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
|
Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
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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 | MenHibrix Group | Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. | 157 | 3,278 | 0 | 0 | ||
| EG001 | ActHIB Group | Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. | 48 | 1,113 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile convulsion | Nervous system disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Fractured skull depressed | Injury, poisoning and procedural complications | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Haematoma | Vascular disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Haematuria | Renal and urinary disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Haemorrhage intracranial | Nervous system disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Haemorrhagic infarction | Vascular disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Humerus fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Ileus | Gastrointestinal disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Inguinal hernia, obstructive | Gastrointestinal disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Oedema peripheral | General disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Ovarian cyst | Reproductive system and breast disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Perirectal abscess | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Septic shock | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Skull fractured base | Injury, poisoning and procedural complications | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Varicella | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Gastroenteritis | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Bronchiolitis | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Bronchopneumonia | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Pneumonia | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Viral infection | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Gastroenteritis rotavirus | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Otitis media | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Urinary tract infection | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Head injury | Injury, poisoning and procedural complications | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Pyrexia | General disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Respiratory syncytial virus infection | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Croup infectious | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Intussusception | Gastrointestinal disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Sudden infant death syndrome | General disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Pyelonephritis | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Cellulitis | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Convulsion | Nervous system disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Pharyngitis | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Failure to thrive | Metabolism and nutrition disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Gastroenteritis viral | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Skull fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Tracheitis | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Hypovolaemic shock | Vascular disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Influenza | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Lobar pneumonia | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Nystagmus | Nervous system disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Subcutaneous abscess | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Anaphylactic reaction | Immune system disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Anastomotic leak | Injury, poisoning and procedural complications | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Breath holding | Psychiatric disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Bronchitis | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Burns second degree | Injury, poisoning and procedural complications | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Cardiac failure congestive | Cardiac disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Child abuse | Social circumstances | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Constipation | Gastrointestinal disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Depressed level of consciousness | Nervous system disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Epilepsy | Nervous system disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Eye injury | Injury, poisoning and procedural complications | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Malnutrition | Metabolism and nutrition disorders | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Pharyngitis streptococcal | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Skin injury | Injury, poisoning and procedural complications | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
| |
| Tonsillitis | Infections and infestations | Non-systematic Assessment | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
|
Not provided
Solicited symptoms and unslocited AEs were not collected during this study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C055753 | Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate |
| C472675 | PEDIARIX |
Not provided
Not provided
Not provided
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