| ID | Type | Description | Link |
|---|---|---|---|
| 102371 | Other Identifier | GSK |
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This study is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to control groups receiving licensed Hib or MenC conjugate vaccines, each administered at 2, 4, 6, and 12 to 15 months of age. Co-administration with live, attenuated measles, mumps, and rubella combination vaccine; and with live, attenuated varicella vaccine will be assessed with administration of the booster dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
The study will be conducted in 2 stages: a 3-dose primary vaccination at 2, 4 and 6 months of age and a booster vaccination at 12 to 15 months of age. All subjects will have 3 blood samples taken. Half of the subjects of each group will have a blood sample taken just prior to the administration of the third dose of the primary vaccination and the other half of the subjects of each group will have a blood sample taken at one month after the third vaccine dose of the primary vaccination phase. In addition, all subjects of all groups will have a blood sample taken before and 42 days after administration of the booster dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MenHibrix Group | Experimental | Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371. |
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| ActHIB + Meningitec Group | Active Comparator | Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371. |
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| ActHIB/PedvaxHIB Group | Active Comparator | Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MenHibrix (Hib-MenCY-TT) | Biological | One intramuscular dose at 2, 4 and 6 months of age ( group A) and one intramuscular dose at 12 to 15 months of age (groups A and B) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL) | The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure. | One month after the 3-dose primary vaccination course |
| Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128 | The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB + Meningitec groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure. | One month after the 3-dose primary vaccination course |
| Number of Subjects Seroconverted for Anti-measles Antibodies | The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-measles seroconversion is defined as the appearance of antibodies (i.e. concentration greater than or equal to the cut-off value of 150 milli-international units per milliliter (mIU/mL)) in the serum of subjects seronegative (below 150 mIU/mL) before vaccination. | 42 days after the fourth dose vaccination |
| Number of Subjects Seroconverted for Anti-mumps Antibodies | The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-mumps seroconversion is defined as titer greater than or equal to 28 ED50 in subjects seronegative (<28 ED50) before vaccination. ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128. | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | North Adelaide | South Australia | 5006 | Australia | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21806393 | Background | Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90. | |
| 22617844 | Background | Bryant K, McVernon J, Marchant C, Nolan T, Marshall G, Richmond P, Marshall H, Nissen M, Lambert S, Aris E, Mesaros N, Miller J. Immunogenicity and safety of measles-mumps-rubella and varicella vaccines coadministered with a fourth dose of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in toddlers: a pooled analysis of randomized trials. Hum Vaccin Immunother. 2012 Aug;8(8):1036-41. doi: 10.4161/hv.20357. Epub 2012 Aug 1. |
| 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 |
|---|---|---|---|
| 102370 (primary study) | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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One subject who had a subject number allocated, was not vaccinated.
Subjects were randomised at the beginning of the primary vaccination phase and kept their group assignment during the fourth dose vaccination phase. Not all subjects who completed the primary vaccination phase returned for participation in the fourth dose vaccination phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | MenHibrix Group | Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371. |
| FG001 | ActHIB + Meningitec Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Primary Vaccination Phase |
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| Infanrix® Penta | Biological | One intramuscular dose at 2, 4 and 6 months of age |
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| Prevenar® | Biological | One intramuscular dose at 2, 4 and 6 months of age |
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| ActHIB® | Biological | One intramuscular dose at 2, 4 and 6 months of age |
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| Meningitec® | Biological | One intramuscular dose at 2, 4 and 6 months of age |
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| M-M-R®II | Biological | One subcutaneous dose at 12-15 months of age |
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| Varivax® | Biological | One subcutaneous dose at 12 to 15 months of age |
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| PedvaxHIB® | Biological | One intramuscular dose at 12 to 15 months of age |
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| 42 days after the fourth dose vaccination |
| Number of Subjects With an Anti-rubella Seroresponse | The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-rubella seroresponse is defined as post-vaccination concentration greater than or equal to 10 IU/mL (ELISA, Enzygnost) in subjects seronegative (concentration below 4 IU/mL) before vaccination. | 42 days after the fourth dose vaccination |
| Number of Subjects Seroconverted for Anti-varicella Antibodies | The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-varicella seroconversion is defined as post-vaccination titers greater than or equal to 1:5, in subjects seronegative (titers below 1:5) before vaccination. | 42 days after the fourth dose vaccination |
| rSBA-MenC Titers | The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers. | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
| Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128. | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
| rSBA-MenY Titers | The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers. | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
| Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8. | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
| hSBA-MenC Titers | The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers. | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
| Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8. | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
| hSBA-MenY Titers | The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers. | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
| Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL. | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
| Anti-PSC Concentrations | The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations. | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
| Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL. | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
| Anti-PSY Concentrations | The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations. | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
| Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.15 µg/mL and 1.0 µg/mL. | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
| Anti-PRP Concentrations | The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations. | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
| Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL | The cut-off value assessed was 150 mIU/mL. | Just prior to the fourth dose and 42 days after the fourth dose |
| Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50 | ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. | Just prior to the fourth dose and 42 days after the fourth dose |
| Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL | The cut-off value assessed was 4 IU/mL. | Just prior to the fourth dose and 42 days after the fourth dose |
| Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5 | The cut-off value assessed was a titer of 1:5. | Just prior to the fourth dose and 42 days after the fourth dose |
| Number of Subjects With a Fourth Dose Response for hSBA-MenC | Fourth dose response for hSBA-MenC is defined as: •For initially seronegative subjects (i.e., subjects with pre fourth dose hSBA antibody titer below 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:16; •For initially seropositive subjects (i.e., subjects with pre fourth dose antibody titer greater than or equal to 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:128. | 42 days after the fourth dose |
| Number of Subjects With a Fourth Dose Response for hSBA-MenY | Fourth dose response for hSBA-MenY defined as: •For initially seronegative subjects (i.e., pre fourth dose hSBA antibody titer < 1:4), post fourth dose hSBA antibody titer greater than or equal to (≥) 1:16; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:4 and < 1:64, post fourth dose hSBA antibody titer at least 4-fold higher than the pre fourth dose hSBA antibody titer; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:64, post fourth dose hSBA antibody titer at least 2-fold higher than the pre fourth dose hSBA antibody titer. | 42 days after the fourth dose |
| Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | The pre-defined cut-off values were 150 mIU/mL and 200 mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL. | 42 days after the fourth dose |
| Anti-measles Concentrations in Initially Seronegative Subjects | Concentrations are presented as Geometric Mean Concentrations expressed as mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL. | 42 days after the fourth dose |
| Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | The pre-defined cut-off values were 4 IU/mL and 10 IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 4 IU/mL. | 42 days after the fourth dose |
| Anti-rubella Concentrations in Initially Seronegative Subjects | Concentrations are presented as Geometric Mean Concentrations expressed as IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-rubella concentration below 4 IU/mL. | 42 days after the fourth dose |
| Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination | ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. | 42 days after the fourth dose |
| Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | The pre-defined cut-off values were 28 ED50 and 51 ED50. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50. | 42 days after the fourth dose |
| Anti-mumps Titers in Initially Seronegative Subjects | Titers are presented as Geometric Mean Titers expressed as ED50, the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50. | 42 days after the fourth dose |
| Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | The pre-defined cut-off values were 1:5 and 1:40. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5. | 42 days after the fourth dose |
| Anti-varicella Titers in Initially Seronegative Subjects | Titers are presented as Geometric Mean Titers. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5. | 42 days after the fourth dose |
| Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite. | During a 4-day period (Day 0-3) after any vaccine dose in the primary vaccination phase |
| Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite. | During a 4-day period (Day 0-3) after the fourth dose vaccination phase |
| Number of Subjects Reporting Unsolicited Adverse Events | Unsolicited adverse event covers any adverse event 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. | During the 31-day (Day 0-30) post-primary and post-fourth dose vaccination period |
| Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine | Specific solicited general symptoms assessed include fever (temperature greater than or equal to 38 degrees Celcius), meningismus/ febrile convulsion, parotid / salivary gland swelling and rash. | During a 43-day (Day 0-42) after the fourth dose |
| Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase | SAEs: 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. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis. | From enrolment through the day preceding the fourth dose |
| Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase | SAEs: 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. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis. | From the day of administration of the fourth dose until the end of the extended safety follow-up period (last study contact at 18-21 months of age |
| Carlton |
| Victoria |
| 3053 |
| Australia |
| GSK Investigational Site | Perth | Western Australia | Australia |
| 20948453 | Background | Nolan T, Richmond P, Marshall H, McVernon J, Alexander K, Mesaros N, Aris E, Miller J, Poolman J, Boutriau D. Immunogenicity and safety of an investigational combined haemophilus influenzae type B-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine. Pediatr Infect Dis J. 2011 Mar;30(3):190-6. doi: 10.1097/INF.0b013e3181fcb2bf. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 102370 (primary study) | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102370 (primary study) | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102370 (primary study) | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 102370 are summarised with study 102371 on the GSK Clinical Study Register. |
| 102370 (primary study) | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371. |
| FG002 | ActHIB/PedvaxHIB Group | Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
| COMPLETED |
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| NOT COMPLETED |
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| Fourth Dose Vaccination Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | MenHibrix Group | Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371. |
| BG001 | ActHIB + Meningitec Group | Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371. |
| BG002 | ActHIB/PedvaxHIB Group | Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Days |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||
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| Primary | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL) | The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure. | Analysis was performed on half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only, on the Primary According-to-Protocol (ATP) Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point. | Posted | Count of Participants | Participants | One month after the 3-dose primary vaccination course |
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| Primary | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128 | The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB + Meningitec groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure. | Analysis was performed on subjects in the MenHibrix and ActHIB + Meningitec groups only, on the Primary According-to-Protocol Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point. | Posted | Count of Participants | Participants | One month after the 3-dose primary vaccination course |
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| Primary | Number of Subjects Seroconverted for Anti-measles Antibodies | The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-measles seroconversion is defined as the appearance of antibodies (i.e. concentration greater than or equal to the cut-off value of 150 milli-international units per milliliter (mIU/mL)) in the serum of subjects seronegative (below 150 mIU/mL) before vaccination. | Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose. | Posted | Count of Participants | Participants | 42 days after the fourth dose vaccination |
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| Primary | Number of Subjects Seroconverted for Anti-mumps Antibodies | The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-mumps seroconversion is defined as titer greater than or equal to 28 ED50 in subjects seronegative (<28 ED50) before vaccination. ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. | Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose. | Posted | Count of Participants | Participants | 42 days after the fourth dose vaccination |
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| Primary | Number of Subjects With an Anti-rubella Seroresponse | The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-rubella seroresponse is defined as post-vaccination concentration greater than or equal to 10 IU/mL (ELISA, Enzygnost) in subjects seronegative (concentration below 4 IU/mL) before vaccination. | Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose. | Posted | Count of Participants | Participants | 42 days after the fourth dose vaccination |
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| Primary | Number of Subjects Seroconverted for Anti-varicella Antibodies | The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-varicella seroconversion is defined as post-vaccination titers greater than or equal to 1:5, in subjects seronegative (titers below 1:5) before vaccination. | Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose. | Posted | Count of Participants | Participants | 42 days after the fourth dose vaccination |
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| Secondary | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128. | Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point. | Posted | Count of Participants | Participants | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
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| Secondary | rSBA-MenC Titers | The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers. | Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point. | Posted | Geometric Mean | 95% Confidence Interval | titer | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
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| Secondary | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128. | Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point. | Posted | Count of Participants | Participants | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
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| Secondary | rSBA-MenY Titers | The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers. | Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point. | Posted | Geometric Mean | 95% Confidence Interval | Titer | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
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| Secondary | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8. | Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point. | Posted | Count of Participants | Participants | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
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| Secondary | hSBA-MenC Titers | The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers. | Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point. | Posted | Geometric Mean | 95% Confidence Interval | Titer | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
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| Secondary | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8. | Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point. | Posted | Count of Participants | Participants | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
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| Secondary | hSBA-MenY Titers | The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers. | Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point. | Posted | Geometric Mean | 95% Confidence Interval | Titer | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
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| Secondary | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL. | Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point. | Posted | Count of Participants | Participants | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
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| Secondary | Anti-PSC Concentrations | The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations. | Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point. | Posted | Geometric Mean | 95% Confidence Interval | Microgram per milliliter (µg/mL) | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
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| Secondary | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL. | Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point. | Posted | Count of Participants | Participants | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
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| Secondary | Anti-PSY Concentrations | The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations. | Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point. | Posted | Geometric Mean | 95% Confidence Interval | Microgram per milliliter (µg/mL) | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
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| Secondary | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.15 µg/mL and 1.0 µg/mL. | Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point. | Posted | Count of Participants | Participants | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
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| Secondary | Anti-PRP Concentrations | The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations. | Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point. | Posted | Geometric Mean | 95% Confidence Interval | Microgram per milliliter (µg/mL) | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) |
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| Secondary | Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL | The cut-off value assessed was 150 mIU/mL. | Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point. | Posted | Count of Participants | Participants | Just prior to the fourth dose and 42 days after the fourth dose |
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| Secondary | Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50 | ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. | Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point. | Posted | Count of Participants | Participants | Just prior to the fourth dose and 42 days after the fourth dose |
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| Secondary | Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL | The cut-off value assessed was 4 IU/mL. | Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point. | Posted | Count of Participants | Participants | Just prior to the fourth dose and 42 days after the fourth dose |
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| Secondary | Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5 | The cut-off value assessed was a titer of 1:5. | Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point | Posted | Count of Participants | Participants | Just prior to the fourth dose and 42 days after the fourth dose |
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| Secondary | Number of Subjects With a Fourth Dose Response for hSBA-MenC | Fourth dose response for hSBA-MenC is defined as: •For initially seronegative subjects (i.e., subjects with pre fourth dose hSBA antibody titer below 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:16; •For initially seropositive subjects (i.e., subjects with pre fourth dose antibody titer greater than or equal to 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:128. | Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point. | Posted | Count of Participants | Participants | 42 days after the fourth dose |
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| Secondary | Number of Subjects With a Fourth Dose Response for hSBA-MenY | Fourth dose response for hSBA-MenY defined as: •For initially seronegative subjects (i.e., pre fourth dose hSBA antibody titer < 1:4), post fourth dose hSBA antibody titer greater than or equal to (≥) 1:16; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:4 and < 1:64, post fourth dose hSBA antibody titer at least 4-fold higher than the pre fourth dose hSBA antibody titer; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:64, post fourth dose hSBA antibody titer at least 2-fold higher than the pre fourth dose hSBA antibody titer. | Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point. | Posted | Count of Participants | Participants | 42 days after the fourth dose |
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| Secondary | Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | The pre-defined cut-off values were 150 mIU/mL and 200 mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL. | Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point. | Posted | Count of Participants | Participants | 42 days after the fourth dose |
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| Secondary | Anti-measles Concentrations in Initially Seronegative Subjects | Concentrations are presented as Geometric Mean Concentrations expressed as mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL. | Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point. | Posted | Geometric Mean | 95% Confidence Interval | Milli-International Units per Milliliter | 42 days after the fourth dose |
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| Secondary | Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | The pre-defined cut-off values were 4 IU/mL and 10 IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 4 IU/mL. | Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point. | Posted | Count of Participants | Participants | 42 days after the fourth dose |
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| Secondary | Anti-rubella Concentrations in Initially Seronegative Subjects | Concentrations are presented as Geometric Mean Concentrations expressed as IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-rubella concentration below 4 IU/mL. | Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point. | Posted | Geometric Mean | 95% Confidence Interval | International Units per Milliliter | 42 days after the fourth dose |
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| Secondary | Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination | ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. | Analysis was performed on subjects with a pre-vaccination anti-mumps titer below 28 ED50 in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point. | Posted | Count of Participants | Participants | 42 days after the fourth dose |
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| Secondary | Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | The pre-defined cut-off values were 28 ED50 and 51 ED50. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50. | Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point. | Posted | Count of Participants | Participants | 42 days after the fourth dose |
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| Secondary | Anti-mumps Titers in Initially Seronegative Subjects | Titers are presented as Geometric Mean Titers expressed as ED50, the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50. | Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 42 days after the fourth dose |
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| Secondary | Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | The pre-defined cut-off values were 1:5 and 1:40. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5. | Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point. | Posted | Count of Participants | Participants | 42 days after the fourth dose |
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| Secondary | Anti-varicella Titers in Initially Seronegative Subjects | Titers are presented as Geometric Mean Titers. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5. | Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 42 days after the fourth dose |
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| Secondary | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite. | Analysis was performed on all subjects with an available symptom sheet in the Primary Total Vaccinated Cohort, including all subjects vaccinated during the primary vaccination phase. | Posted | Count of Participants | Participants | During a 4-day period (Day 0-3) after any vaccine dose in the primary vaccination phase |
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| Secondary | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite. | Analysis was performed on all subjects with an available symptom sheet in the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the fourth dose vaccination phase. | Posted | Count of Participants | Participants | During a 4-day period (Day 0-3) after the fourth dose vaccination phase |
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| Secondary | Number of Subjects Reporting Unsolicited Adverse Events | Unsolicited adverse event covers any adverse event 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. | Analysis was performed on the Primary Total Vaccinated Cohort and the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the primary and fourth dose vaccination phases, respectively. | Posted | Count of Participants | Participants | During the 31-day (Day 0-30) post-primary and post-fourth dose vaccination period |
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| Secondary | Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine | Specific solicited general symptoms assessed include fever (temperature greater than or equal to 38 degrees Celcius), meningismus/ febrile convulsion, parotid / salivary gland swelling and rash. | Analysis was performed on the Primary Total Vaccinated Cohort and the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the primary and fourth dose vaccination phases, respectively. | Posted | Count of Participants | Participants | During a 43-day (Day 0-42) after the fourth dose |
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase | SAEs: 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. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis. | Analysis was performed on the Primary Total Vaccinated Cohort, including all subjects vaccinated during the primary vaccination phase. | Posted | Count of Participants | Participants | From enrolment through the day preceding the fourth dose |
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase | SAEs: 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. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis. | Analysis was performed on the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the ourth dose vaccination phase. | Posted | Count of Participants | Participants | From the day of administration of the fourth dose until the end of the extended safety follow-up period (last study contact at 18-21 months of age |
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Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase.
SAEs and non-systematically assessed frequent AEs were assessed on the Primary & Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
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 primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371. | 55 | 661 | 657 | 661 | ||
| EG001 | ActHIB + Meningitec Group | Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371. | 21 | 221 | 220 | 221 | ||
| EG002 | ActHIB/PedvaxHIB Group | Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. | 15 | 221 | 220 | 221 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cyanosis | Cardiac disorders | Non-systematic Assessment | Post-primary vaccination phase |
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| Hypertrophic cardiomyopathy | Cardiac disorders | Non-systematic Assessment | Post-primary vaccination phase |
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| Cryptorchism | Congenital, familial and genetic disorders | Non-systematic Assessment | Post-primary vaccination phase |
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| Dermoid cyst | Congenital, familial and genetic disorders | Non-systematic Assessment | Post-primary vaccination phase |
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| Respiratory tract malformation | Congenital, familial and genetic disorders | Non-systematic Assessment | Post-primary vaccination phase |
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| Anal fistula | Gastrointestinal disorders | Non-systematic Assessment | Post-primary vaccination phase |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment | Post-primary vaccination phase |
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| Inguinal hernia | Gastrointestinal disorders | Non-systematic Assessment | Post-primary vaccination phase |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | Post-primary vaccination phase |
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| Food allergy | Immune system disorders | Non-systematic Assessment | Post-primary vaccination phase |
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| Bronchiolitis | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
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| Campylobacter gastroenteritis | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
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| Croup infectious | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
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| Escherichia urinary tract infection | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
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| Exanthema subitum | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
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| Gastroenteritis | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
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| Herpes virus infection | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
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| Lobar pneumonia | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
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| Otitis media | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
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| Otitis media chronic | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
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| Perianal abscess | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
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| Pneumonia | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
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| Pneumonia mycoplasmal | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
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| Pneumonia primary atypical | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Pneumonia viral | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Sepsis | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Staphylococcal sepsis | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Tonsillitis | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Urinary tract infection | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Viral infection | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Femur fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Head injury | Injury, poisoning and procedural complications | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Skin laceration | Injury, poisoning and procedural complications | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Skull fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Thermal burn | Injury, poisoning and procedural complications | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Investigation | Investigations | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Epilepsy | Nervous system disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Febrile convulsion | Nervous system disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Hypotonic-hyporesponsive episode | Nervous system disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Infantile spasms | Nervous system disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Breath holding | Psychiatric disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Vesicoureteric reflux | Renal and urinary disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Febrile convulsion | Nervous system disorders | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Supraventricular tachycardia | Cardiac disorders | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Middle ear effusion | Ear and labyrinth disorders | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Otorrhoea | Ear and labyrinth disorders | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Oesophageal rupture | Gastrointestinal disorders | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Bronchiolitis | Infections and infestations | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Croup infectious | Infections and infestations | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Gastroenteritis | Infections and infestations | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Gastroenteritis rotavirus | Infections and infestations | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Gastroenteritis viral | Infections and infestations | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Otitis media | Infections and infestations | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Otitis media chronic | Infections and infestations | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Pharyngeal abscess | Infections and infestations | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Pneumonia viral | Infections and infestations | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Tonsillitis | Infections and infestations | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Urinary tract infection | Infections and infestations | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Viral infection | Infections and infestations | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Viral tonsillitis | Infections and infestations | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Viral upper respiratory tract infection | Infections and infestations | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Accidental exposure | Injury, poisoning and procedural complications | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Drug toxicity | Injury, poisoning and procedural complications | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Mouth injury | Injury, poisoning and procedural complications | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Thermal burn | Infections and infestations | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Tooth fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment | Post-fourth dose vaccination phase |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain at the injection site | General disorders | Systematic Assessment | This post-primary vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in. |
| |
| Redness at the injection site | General disorders | Systematic Assessment | This post-primary vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in. |
| |
| Swelling at the injection site | General disorders | Systematic Assessment | This post-primary vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in. |
| |
| Pain at the injection site | General disorders | Systematic Assessment | This post-fourth dose vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in. |
| |
| Redness at the injection site | General disorders | Systematic Assessment | This post-fourth dose vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in. |
| |
| Swelling at the injection site | General disorders | Systematic Assessment | This post-fourth dose vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in. |
| |
| Drowsiness | General disorders | Systematic Assessment | This post-primary vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in. |
| |
| Fever | General disorders | Systematic Assessment | This post-primary vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in. |
| |
| Irritability | General disorders | Systematic Assessment | This post-primary vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in. |
| |
| Loss of appetite | General disorders | Systematic Assessment | This post-primary vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in. |
| |
| Drowsiness | General disorders | Systematic Assessment | This post-fourth dose vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in. |
| |
| Fever | General disorders | Systematic Assessment | This post-fourth dose vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in. |
| |
| Irritability | General disorders | Systematic Assessment | This post-fourth dose vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in. |
| |
| Loss of appetite | General disorders | Systematic Assessment | This post-fourth dose vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in. |
| |
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Injection site bruising | General disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Teething | Gastrointestinal disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Irritability | General disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Injection site nodule | General disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Pyrexia | General disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Post-primary vaccination phase |
| |
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Teething | Gastrointestinal disorders | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Irritability | General disorders | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Otitis media | Infections and infestations | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Injection site bruising | General disorders | Non-systematic Assessment | Post-fourth dose vaccination phase |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Post-fourth dose vaccination phase |
|
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 |
|---|---|
| C527605 | Hib-MenCY-TT vaccine |
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| C055753 | Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate |
| D019433 | Chickenpox Vaccine |
| C061964 | Haemophilus influenzae-type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine |
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
Not provided
Not provided
| Male |
|
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|
| ActHIB/PedvaxHIB Group |
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|
| ActHIB/PedvaxHIB Group |
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|
| ActHIB/PedvaxHIB Group |
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|
| ActHIB/PedvaxHIB Group |
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|
| OG002 |
| ActHIB/PedvaxHIB Group |
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
|
|
| OG002 |
| ActHIB/PedvaxHIB Group |
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
|
|
| OG002 |
| ActHIB/PedvaxHIB Group |
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|
| OG002 |
| ActHIB/PedvaxHIB Group |
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|
| ActHIB/PedvaxHIB Group |
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
|
|
| OG002 | ActHIB/PedvaxHIB Group | Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| OG002 | ActHIB/PedvaxHIB Group | Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|
| OG002 | ActHIB/PedvaxHIB Group | Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
|
|