Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579).
No new recruitment will take place during this booster phase of the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Hib-MenCY-TT = GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine.
The study will be conducted in a single blind manner up to 30 days after administration of the booster dose; the extended safety follow-up after the booster dose will be conducted in an unblinded manner.
All subjects will receive Prevnar, M-M-R II and Varivax as study vaccines, preferencially co-administered with the booster dose of Hib-MenCY-TT/PedvaxHIB.
Note: This protocol posting deals with the objectives & outcome measures for the booster phase of the study. The objectives & outcome measures for the primary phase are presented in a separate protocol posting (NCT00345579)
Not provided
Not provided
Not provided
Not provided
| 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 in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). 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 in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). 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 | Booster dose by 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 fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) |
| Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) |
| Number of Subjects Reporting Rash | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae | From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) |
| Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) | |
| 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 fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| Number of Subjects With New Onset of Chronic Illnesses (NOCIs) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subjects should not be administered M-M-R II and Varivax if any of these criteria apply:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35205 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22327493 | Derived | 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 |
|---|---|
| Primary Study | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 105988 | Informed Consent Form | 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.
Not provided
Not provided
Not provided
Not provided
Of the 4021 subjects enrolled, 4020 received a booster vaccination and 3986 completed the booster phase (2985 in the Menhibrix Group and 1001 in the ActHIB Group)
This summary presents results for the booster/fourth dose vaccination phase up to the end of the 6-month safety follow-up. Subjects received 3-vaccine doses in the study NCT00345579 and were followed up to, but excluding, the fourth dose vaccination. This study begins 10 months after the first vaccination in the primary phase.
Not provided
| 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 in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). 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 |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PedvaxHIB | Biological | Booster dose by intramuscular injection |
|
|
| Prevnar | Biological | Booster dose by intramuscular injection |
|
| M-M-R II | Biological | Single dose by subcutaneous injection |
|
|
| Varivax | Biological | Single dose by subcutaneous injection |
|
|
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. |
| From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| Number of Subjects With Rash | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| Birmingham |
| Alabama |
| 35244 |
| United States |
| GSK Investigational Site | Benton | Arkansas | 72015 | United States |
| GSK Investigational Site | Jonesboro | Arkansas | 72401 | 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 | 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 | 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 | Ithaca | New York | 14850 | United States |
| GSK Investigational Site | New Hartford | New York | 13413 | United States |
| GSK Investigational Site | Syracuse | New York | 13210 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | United States |
| GSK Investigational Site | Boardman | Ohio | 44512 | 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 | Erie | Pennsylvania | 16505 | United States |
| GSK Investigational Site | Greenville | Pennsylvania | 16125 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15217 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15220 | 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 | 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 | Salt Lake City | Utah | 84121 | 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 |
| 105988 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105988 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105988 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105988 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105988 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105988 | Dataset Specification | 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 in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). 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 |
|
| NOT COMPLETED |
|
|
Not provided
| 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 in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). 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 in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). 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 |
| |||||||||||||||
| Sex: Female, Male | 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 Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose. | Posted | Number | Subjects | From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose. | Posted | Number | Subjects | From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) |
| |||||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting Rash | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae | The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose. | Posted | Number | Subjects | From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) |
| |||||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose. | Posted | Number | Subjects | From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) |
| ||||||||||||||||||||||||||||||||
| 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 Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose. | Posted | Number | Subjects | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |||||||||||||||||||||||||||||||
| Primary | Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose. | Posted | Number | Subjects | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Rash | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae | The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose. | Posted | Number | Subjects | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits | The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose. | Posted | Number | Subjects | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
|
Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
Not provided
| 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 in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. | 72 | 3,010 | 0 | 3,010 | ||
| 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 in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). 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. | 18 | 1,010 | 0 | 1,010 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Bronchiolitis | Infections and infestations | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Staphylococcal infection | Infections and infestations | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Abscess | Infections and infestations | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Febrile convulsion | Nervous system disorders | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Femur fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Head injury | Injury, poisoning and procedural complications | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Multiple injuries | Injury, poisoning and procedural complications | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Otitis media | Infections and infestations | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Pyrexia | General disorders | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Respiratory syncytial virus infection | Infections and infestations | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Pneumonia | Infections and infestations | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Croup infectious | Infections and infestations | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Thermal burn | Injury, poisoning and procedural complications | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Ataxia | Nervous system disorders | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Bronchopneumonia | Infections and infestations | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Influenza | Infections and infestations | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Lymphadenitis | Blood and lymphatic system disorders | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Pneumonia bacterial | Infections and infestations | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Campylobacter gastroenteritis | Infections and infestations | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Erysipelas | Infections and infestations | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Folliculitis | Infections and infestations | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Henoch-schonlein purpura | Skin and subcutaneous tissue disorders | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Lymphangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Subcutaneous abscess | Infections and infestations | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
| |
| Tracheitis | Infections and infestations | Non-systematic Assessment | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) |
|
Not provided
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 |
|---|---|
| C061964 | Haemophilus influenzae-type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine |
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| D022542 | Measles-Mumps-Rubella Vaccine |
| D012411 | Rubella Vaccine |
| D019433 | Chickenpox Vaccine |
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
| D008458 | Measles Vaccine |
| D014765 | Viral Vaccines |
| D009108 | Mumps Vaccine |
| D022283 | Herpesvirus Vaccines |
Not provided
Not provided
| Male |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|