Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 110871 | Other Identifier | GSK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to characterize the immunogenicity & safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.
The purpose of this study is to evaluate the titer of antibody for serogroups A, C, Y and W-135 and the safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given to toddlers who were primed with GSK Biological's Hib-meningococcal vaccine 792014. In addition, this study will provide immunogenicity and safety data on the co-administration of Infanrix with meningococcal vaccine 134612 as compared to Infanrix administered alone.
Depending on the group the subject is assigned to, one or two blood samples will be taken out of the subject's arm during the study.
The protocol posting has been updated following a protocol amendment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menhibrix 1 Group | Experimental | Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during the Primary Vaccination Phase. For the Booster Vaccination Phase, subjects were re-randomized and received either 1 dose of Nimenrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 1 Group] or a fourth dose of Menhibrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Menhibrix 2 Group], or 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 2 Group]. |
|
| ActHIB- Infanrix Group | Active Comparator | Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age and 1 booster dose of Infanrix vaccine at 15-18 months of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix) | Biological | One dose in the booster phase as intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group | The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8 | One month post vaccination at 12-15 months of age (Month 11) |
| Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group | The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8 | One month post vaccination at 15-18 months of age (Month 14) |
| Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group | Antibody titers were expressed as Geometric mean titers (GMTs) | One month post vaccination at 12-15 months of age (Month 11) |
| Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group | Antibody titers were expressed as Geometric mean titers (GMTs) | One month post vaccination at 15-18 months of age (Month 14) |
| Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group | The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL). | One month post vaccination at 15-18 months of age (Month 14) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group | The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4 | One month after vaccination at 12-15 months of age (Month 11) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria for enrolment (primary phase)
Exclusion criteria for enrolment (booster phase)
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 |
|---|---|---|---|
| 25305567 | Derived | Leonardi M, Latiolais T, Sarpong K, Simon M, Twiggs J, Lei P, Rinderknecht S, Blatter M, Bianco V, Baine Y, Friedland LR, Baccarini C, Miller JM. Immunogenicity and reactogenicity of Infanrix when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix and Pediarix. Vaccine. 2015 Feb 11;33(7):924-32. doi: 10.1016/j.vaccine.2014.09.064. Epub 2014 Oct 8. | |
| 25152325 |
| 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 |
|---|---|---|---|
| 110870 | 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
A total of 1558 subjects (1276 in the Menhibrix 1 Group and 282 in ActHIB- Infanrix Group) were enrolled; however, 4 of these subjects never received vaccine. Thus, 1554 subjects (1272 in the Menhibrix 1 Group and 282 in ActHIB- Infanrix Group) were vaccinated during primary vaccination phase.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Menhibrix 1 Group | Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during the Primary Vaccination Phase. For the Booster Vaccination Phase, subjects were re-randomized and received either 1 dose of Nimenrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 1 Group] or a fourth dose of Menhibrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Menhibrix 2 Group], or 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 2 Group]. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Primary Vaccination Phase |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix) | Biological | Three doses in the priming phase and, for Menhibrix 2 Group, one dose in the booster phase as intramuscular injection |
|
|
| Infanrix® | Biological | One dose as intramuscular injection |
|
| ActHIB® | Biological | Three doses in the priming phase as intramuscular injection |
|
| Pediarix® | Biological | Three doses in the priming phase as intramuscular injection |
|
| Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group |
Antibody titers were expressed as Geometric mean titers (GMTs) |
| One month post vaccination at 12-15 months of age (Month 11) |
| Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Menhibrix 2 Group | The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8 | One month post vaccination at 12-15 months of age (Month 11) |
| Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group | Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) | One month after vaccination at 15-18 months of age (Month 14) |
| Number of Subjects With hSBA-MenA and hSBA MenW-135 Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group |
The cut-off values assessed for hSBA-MenA and hSBA-MenW-135 were greater than or equal to (≥) 1:4 |
| One month after vaccination at 12-15 months of age (Month 11) |
| Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group | Antibody titers were expressed as Geometric mean titers (GMTs) | One month after vaccination at 12-15 months of age (Month 11) |
| Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group | Antibody titers were expressed as Geometric mean titers (GMTs) | Prior to vaccination at 15-18 months of age (Month 13) |
| Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group | The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4 and ≥ 1:8 | Prior to vaccination at 15-18 months of age (Month 13) |
| Anti-D and Anti-T Geometric Mean Antibody Concentrations | Concentrations were provided as Geometric Mean Concentrations(GMCs) and expressed as International Units per milliliter (IU/mL). | One month after vaccination with Infanrix at 15-18 months of age (Month 14) |
| Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL). | One month after vaccination with Infanrix at 15-18 months of age (Month 14) |
| Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | The cut-off values assessed were greater than or equal to (≥) 5 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) | One month after vaccination with Infanrix at 15-18 months of age (Month 14) |
| Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group | Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) | One month after vaccination at 15-18 months of age (Month 14) |
| Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group | The cut-off values assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL). | One month after vaccination at 15-18 months of age (Month 14) |
| Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group | The cut-off values assessed for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY were greater than or equal to (≥) 1:4 | One month after vaccination at 15-18 months of age (Month 14) |
| Geometric Mean Antibody Titers for hSBA-MenA and hSBA-MenW-135 in Nimenrix 2 Group | Antibody titers were expressed as Geometric mean titers (GMTs) | One month after vaccination with Infanrix at 15-18 months of age (Month 14) |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was greater than (>) 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. | During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 fever was axillary temperature > 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination. | During the 8-day follow-up period (Day 0-7) after dose 4 and dose 5 vaccination |
| Number of Subjects Reporting Any Rash | Examples of rash included hives, idiopathic thrombocytopenic purpura, petechiae. | From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22) |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was > 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. | During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase |
| Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits | NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. | From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22) |
| Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits | NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. | From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13) |
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. | During a 31-day follow-up period (Day 0-30) |
| Number of Subjects Reporting Any Unsolicited AEs in Nimenrix 1 Group and Menhibrix 2 Group After the Second Booster Phase Vaccination | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. | During the 31-day follow-up period (Day 0-30) |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. | From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13). |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. | From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22) |
| Birmingham |
| Alabama |
| 35244 |
| United States |
| GSK Investigational Site | Dothan | Alabama | 36305 | United States |
| GSK Investigational Site | Benton | Arkansas | 72019 | United States |
| GSK Investigational Site | Fayetteville | Arkansas | 72703 | 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 | 93726 | United States |
| GSK Investigational Site | Huntington Beach | California | 92647 | United States |
| GSK Investigational Site | West Covina | California | 91790 | United States |
| GSK Investigational Site | Plantation | Florida | 33324 | United States |
| GSK Investigational Site | West Palm Beach | Florida | 33407 | United States |
| GSK Investigational Site | Marietta | Georgia | 30062 | United States |
| GSK Investigational Site | Woodstock | Georgia | 30189 | United States |
| GSK Investigational Site | Nampa | Idaho | 208 463 3126 | United States |
| GSK Investigational Site | Des Moines | Iowa | 50312 | United States |
| GSK Investigational Site | West Des Moines | Iowa | 50266 | United States |
| GSK Investigational Site | Arkansas City | Kansas | 67005 | 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 | Fall River | Massachusetts | 02724 | United States |
| GSK Investigational Site | Kalamazoo | Michigan | 49008 | United States |
| GSK Investigational Site | Niles | Michigan | 49120 | United States |
| GSK Investigational Site | Portage | Michigan | 49024 | United States |
| GSK Investigational Site | Richland | Michigan | 49083 | United States |
| GSK Investigational Site | Stevensville | Michigan | 49127 | United States |
| GSK Investigational Site | Saint Paul | Minnesota | 55108 | United States |
| GSK Investigational Site | Henderson | Nevada | 89015 | United States |
| GSK Investigational Site | Clyde | North Carolina | 28721 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44121 | United States |
| GSK Investigational Site | Huber Heights | Ohio | 45424 | United States |
| GSK Investigational Site | Gresham | Oregon | 97030 | United States |
| GSK Investigational Site | Erie | Pennsylvania | 16505 | United States |
| GSK Investigational Site | Greenville | Pennsylvania | 16125 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15220 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15236 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15241 | United States |
| GSK Investigational Site | Uniontown | Pennsylvania | 15401 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29406 | United States |
| GSK Investigational Site | Kingsport | Tennessee | 37660 | United States |
| GSK Investigational Site | Amarillo | Texas | 79124 | United States |
| GSK Investigational Site | Galveston | Texas | 77555-1119 | United States |
| GSK Investigational Site | Sugar Land | Texas | 77479 | 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 | Provo | Utah | 84604 | United States |
| GSK Investigational Site | Roy | Utah | 84067 | United States |
| GSK Investigational Site | South Jordan | Utah | 84095 | United States |
| GSK Investigational Site | St. George | Utah | 84790 | United States |
| GSK Investigational Site | Syracuse | Utah | 84075 | United States |
| GSK Investigational Site | Marshfield | Wisconsin | 54449 | United States |
| Derived |
| Leonardi M, Latiolais T, Sarpong K, Simon M, Twiggs J, Lei P, Rinderknecht S, Blatter M, Bianco V, Baine Y, Friedland LR, Miller JM. Quadrivalent meningococcal (MenACWY-TT) conjugate vaccine or a fourth dose of H. influenzae-N. meningitidis C/Y conjugate vaccine (HibMenCY-TT) is immunogenic in toddlers who previously received three doses of HibMenCY-TT in infancy. Vaccine. 2015 Feb 11;33(7):933-41. doi: 10.1016/j.vaccine.2014.08.027. Epub 2014 Aug 21. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 110870 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110870 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110870 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110870 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110870 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110870 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | ActHIB- Infanrix Group | Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase. |
| FG002 | Nimenrix 1 Group | Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
| FG003 | Menhibrix 2 Group | Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
| FG004 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Booster Vaccination Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Menhibrix 1 Group | Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase. |
| BG001 | ActHIB- Infanrix Group | Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase. |
| 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 | Weeks |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group | The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8 | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group. | Posted | Count of Participants | Participants | One month post vaccination at 12-15 months of age (Month 11) |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group | The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8 | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group. | Posted | Count of Participants | Participants | One month post vaccination at 15-18 months of age (Month 14) |
| ||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group | Antibody titers were expressed as Geometric mean titers (GMTs) | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group. | Posted | Geometric Mean | 95% Confidence Interval | titer | One month post vaccination at 12-15 months of age (Month 11) |
| |||||||||||||||||||||||||||||||
| Primary | Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group | Antibody titers were expressed as Geometric mean titers (GMTs) | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group. | Posted | Geometric Mean | 95% Confidence Interval | titer | One month post vaccination at 15-18 months of age (Month 14) |
| |||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group | The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL). | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. It was performed on the Nimenrix 2 and ActHIB- Infanrix Group. | Posted | Count of Participants | Participants | One month post vaccination at 15-18 months of age (Month 14) |
| ||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group | Antibody titers were expressed as Geometric mean titers (GMTs) | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Menhibrix 2 Group. | Posted | Geometric Mean | 95% Confidence Interval | titer | One month post vaccination at 12-15 months of age (Month 11) |
| |||||||||||||||||||||||||||||||
| Primary | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Menhibrix 2 Group | The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8 | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Menhibrix 2 Group. | Posted | Count of Participants | Participants | One month post vaccination at 12-15 months of age (Month 11) |
| ||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group | Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on Nimenrix 2 and ActHIB- Infanrix Group. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | One month after vaccination at 15-18 months of age (Month 14) |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group | The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4 | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group. | Posted | Count of Participants | Participants | One month after vaccination at 12-15 months of age (Month 11) |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With hSBA-MenA and hSBA MenW-135 Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group | The cut-off values assessed for hSBA-MenA and hSBA-MenW-135 were greater than or equal to (≥) 1:4 | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group. | Posted | Count of Participants | Participants | One month after vaccination at 12-15 months of age (Month 11) |
| ||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group | Antibody titers were expressed as Geometric mean titers (GMTs) | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group. | Posted | Geometric Mean | 95% Confidence Interval | titer | One month after vaccination at 12-15 months of age (Month 11) |
| |||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group | Antibody titers were expressed as Geometric mean titers (GMTs) | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group. | Posted | Geometric Mean | 95% Confidence Interval | titer | Prior to vaccination at 15-18 months of age (Month 13) |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group | The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4 and ≥ 1:8 | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group. | Posted | Count of Participants | Participants | Prior to vaccination at 15-18 months of age (Month 13) |
| ||||||||||||||||||||||||||||||||
| Secondary | Anti-D and Anti-T Geometric Mean Antibody Concentrations | Concentrations were provided as Geometric Mean Concentrations(GMCs) and expressed as International Units per milliliter (IU/mL). | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | One month after vaccination with Infanrix at 15-18 months of age (Month 14) |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL). | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. | Posted | Count of Participants | Participants | One month after vaccination with Infanrix at 15-18 months of age (Month 14) |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | The cut-off values assessed were greater than or equal to (≥) 5 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. | Posted | Count of Participants | Participants | One month after vaccination with Infanrix at 15-18 months of age (Month 14) |
| ||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group | Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | One month after vaccination at 15-18 months of age (Month 14) |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group | The cut-off values assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL). | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group. | Posted | Count of Participants | Participants | One month after vaccination at 15-18 months of age (Month 14) |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group | The cut-off values assessed for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY were greater than or equal to (≥) 1:4 | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group. | Posted | Count of Participants | Participants | One month after vaccination at 15-18 months of age (Month 14) |
| ||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Antibody Titers for hSBA-MenA and hSBA-MenW-135 in Nimenrix 2 Group | Antibody titers were expressed as Geometric mean titers (GMTs) | Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group. | Posted | Geometric Mean | 95% Confidence Interval | titer | One month after vaccination with Infanrix at 15-18 months of age (Month 14) |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was greater than (>) 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. | The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed. | Posted | Count of Participants | Participants | During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 fever was axillary temperature > 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination. | The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed. | Posted | Count of Participants | Participants | During the 8-day follow-up period (Day 0-7) after dose 4 and dose 5 vaccination |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any Rash | Examples of rash included hives, idiopathic thrombocytopenic purpura, petechiae. | The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase. | Posted | Count of Participants | Participants | From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22) |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was > 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. | The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed. | Posted | Count of Participants | Participants | During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits | NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. | The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase. | Posted | Count of Participants | Participants | From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22) |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits | NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. | The analysis was performed on Primary Total Vaccinated cohort which included all subjects who had received a study vaccine during the primary phase. | Posted | Count of Participants | Participants | From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13) |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. | The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase. | Posted | Count of Participants | Participants | During a 31-day follow-up period (Day 0-30) |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any Unsolicited AEs in Nimenrix 1 Group and Menhibrix 2 Group After the Second Booster Phase Vaccination | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. | The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group. | Posted | Count of Participants | Participants | During the 31-day follow-up period (Day 0-30) |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. | The analysis was performed on Primary Total Vaccinated cohort which included all subjects who had received a study vaccine during the primary phase. | Posted | Count of Participants | Participants | From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13). |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. | The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase. | Posted | Count of Participants | Participants | From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22) |
|
Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively.
Other Adverse Events were not collected for Menhibrix 1 Group.
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 1 Group | Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase. | 58 | 1,272 | 0 | 0 | ||
| EG001 | ActHIB- Infanrix Group | Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase. | 14 | 282 | 181 | 233 | ||
| EG002 | Nimenrix 1 Group | Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. | 15 | 432 | 387 | 432 | ||
| EG003 | Menhibrix 2 Group | Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. | 3 | 229 | 211 | 229 | ||
| EG004 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. | 9 | 409 | 337 | 409 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Gastroenteritis | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Convulsion | Nervous system disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Croup infectious | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Otitis media | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Pyrexia | General disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Cellulitis | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Pneumonia | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Skull fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Otitis media acute | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Respiratory syncytial virus infection | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Subcutaneous abscess | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Sudden infant death syndrome | General disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Viral infection | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Apparent life threatening event | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Beta haemolytic streptococcal infection | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Bronchitis | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Bronchopneumonia | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Burns second degree | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Clostridium difficile colitis | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Cyanosis | Cardiac disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Failure to thrive | Metabolism and nutrition disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Febrile convulsion | Nervous system disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Gastric volvulus | Gastrointestinal disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Haematemesis | Gastrointestinal disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Haemolytic uraemic syndrome | Blood and lymphatic system disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Hypotonia | Nervous system disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Influenza | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Irritability | General disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Lower respiratory tract infection | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Meningitis viral | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Obstructive uropathy | Renal and urinary disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Pertussis | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Pneumonia bacterial | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Pyelonephritis | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Pyelonephritis acute | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Septic shock | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Skin burning sensation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Staphylococcal infection | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Tachycardia | Cardiac disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Urinary tract infection | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Urosepsis | Infections and infestations | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group. |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Abscess | Infections and infestations | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Acidosis | Metabolism and nutrition disorders | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Adenoidectomy | Surgical and medical procedures | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Encephalitis viral | Infections and infestations | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Floppy infant | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Gastroenteritis viral | Infections and infestations | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Herpes oesophagitis | Infections and infestations | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Pancytopenia | Blood and lymphatic system disorders | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Postoperative respiratory distress | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Somnolence | Nervous system disorders | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Upper respiratory infection | Infections and infestations | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Wound infection | Infections and infestations | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Otitis media | Infections and infestations | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Pneumonia | Infections and infestations | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Febrile convulsion | Nervous system disorders | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Gastroenteritis | Infections and infestations | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Pyrexia | General disorders | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Respiratory syncitial virus bronchiolitis | Infections and infestations | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Staphylococcal infection | Infections and infestations | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Cellulitis | Infections and infestations | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Croup infectious | Infections and infestations | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
| |
| Viral infection | Infections and infestations | Non-systematic Assessment | SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22). |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment | Pain was experienced during the 8-day (Days0-7) post-vaccination period following each dose with Nimenrix or MenHibrix vaccine in the booster phase. |
| |
| Redness | General disorders | Systematic Assessment | Redness was experienced during the 8-day (Days0-7) post-vaccination period following each dose with Nimenrix or MenHibrix vaccine in the booster phase. |
| |
| Swelling | General disorders | Systematic Assessment | Swelling was experienced during the 8-day (Days0-7) post-vaccination period following each dose with Nimenrix or MenHibrix vaccine in the booster phase. |
| |
| Pain | General disorders | Systematic Assessment | Pain was experienced during the 8-day (Days0-7) post-vaccination period with Infanrix vaccine in the booster phase. |
| |
| Redness | General disorders | Systematic Assessment | Redness was experienced during the 8-day (Days0-7) post-vaccination period with Infanrix vaccine in the booster phase. |
| |
| Swelling | General disorders | Systematic Assessment | Swelling was experienced during the 8-day (Days0-7) post-vaccination period with Infanrix vaccine in the booster phase. |
| |
| Drowsiness | General disorders | Systematic Assessment | Symptom experienced at Dose 4 vaccination with Nimenrix [ for Nimenrix 1 Group], MenHibrix [ for MenHibrix 2 Group], Nimenrix co-administered with Infanrix [ for Nimenrix 2 Group] and Infanrix [ for ActHIB-Infanrix Group]. |
| |
| Fever | General disorders | Systematic Assessment | Symptom experienced at Dose 4 vaccination with Nimenrix [ for Nimenrix 1 Group], MenHibrix [ for MenHibrix 2 Group], Nimenrix co-administered with Infanrix [ for Nimenrix 2 Group] and Infanrix [ for ActHIB-Infanrix Group]. |
| |
| Irritability | General disorders | Systematic Assessment | Symptom experienced at Dose 4 vaccination with Nimenrix [ for Nimenrix 1 Group], MenHibrix [ for MenHibrix 2 Group], Nimenrix co-administered with Infanrix [ for Nimenrix 2 Group] and Infanrix [ for ActHIB-Infanrix Group]. |
| |
| Loss of appetite | General disorders | Systematic Assessment | Symptom experienced at Dose 4 vaccination with Nimenrix [ for Nimenrix 1 Group], MenHibrix [ for MenHibrix 2 Group], Nimenrix co-administered with Infanrix [ for Nimenrix 2 Group] and Infanrix [ for ActHIB-Infanrix Group]. |
| |
| Drowsiness | General disorders | Systematic Assessment | Symptom experienced at Dose 5 vaccination with Infanrix vaccine for Nimenrix 1 Group and MenHibrix 2 Group. |
| |
| Fever | General disorders | Systematic Assessment | Symptom experienced at Dose 5 vaccination with Infanrix vaccine for Nimenrix 1 Group and MenHibrix 2 Group. |
| |
| Irritability | General disorders | Systematic Assessment | Symptom experienced at Dose 5 vaccination with Infanrix vaccine for Nimenrix 1 Group and MenHibrix 2 Group. |
| |
| Loss of appetite | General disorders | Systematic Assessment | Symptom experienced at Dose 5 vaccination with Infanrix vaccine for Nimenrix 1 Group and MenHibrix 2 Group. |
| |
| Otitis media | Infections and infestations | Non-systematic Assessment | Symptom experienced during the 31-day (Days 0-30) period after the first or single booster phase vaccination in all groups corresponding to Booster phase of study. |
| |
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment | Symptom experienced during the 31-day (Days 0-30) period after the first or single booster phase vaccination in all groups corresponding to Booster phase of study. |
| |
| Otitis media | Infections and infestations | Non-systematic Assessment | Symptom experienced during the 31-day (Days 0-30) period after the second booster phase vaccination in Nimenrix 1 Group and MenHibrix 2 Group. |
| |
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment | Symptom experienced during the 31-day (Days 0-30) period after the second booster phase vaccination in Nimenrix 1 Group and MenHibrix 2 Group. |
| |
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment | Symptom experienced during the 31-day (Days 0-30) period after the second booster phase vaccination in Nimenrix 1 Group and MenHibrix 2 Group. |
|
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 |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C527605 | Hib-MenCY-TT vaccine |
| D022681 | Diphtheria-Tetanus-acellular Pertussis Vaccines |
| C055753 | Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate |
| C472675 | PEDIARIX |
| ID | Term |
|---|---|
| D010567 | Pertussis Vaccine |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D004168 | Diphtheria Toxoid |
| D014121 | Toxoids |
| D013745 | Tetanus Toxoid |
| D017778 | Vaccines, Combined |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
Not provided
Not provided
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Other |
|
| Male |
|
| American Indian or Alaskan native |
|
| Asian - Central/South Asian heritage |
|
| Asian - East Asian heritage |
|
| Asian - Japanese heritage |
|
| Asian - South East Asian heritage |
|
| Native Hawaiian or other Pacific Islander |
|
| White - Arabic / North African heritage |
|
| White - Caucasian / European heritage |
|
| Unspecified |
|
|
| hSBA-MenC |
|
|
| hSBA-MenW-135 |
|
|
| hSBA-MenY |
|
|
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
| Menhibrix 2 Group |
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
| Nimenrix 2 Group |
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
| OG002 |
| Menhibrix 2 Group |
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age.during Booster Vaccination Phase.
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age.during Booster Vaccination Phase. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Menhibrix 2 Group |
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
| OG003 | Nimenrix 2 Group | Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase. |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
|
|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
|
|
|
|