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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003210-27 | EudraCT Number |
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The purpose of this study is to assess if there is any immune interference between the Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant vaccinations currently in use in the US, namely Pediarix®, Hiberix® and Prevenar 13® as compared to the currently licensed lyophilized formulation of the HRV vaccine when co-administered with the same routine vaccinations in healthy infants 6-12 weeks of age
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRV PCV-free Liq Group | Experimental | Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used. |
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| HRV Lyo Group | Active Comparator | Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotarix | Biological | Two doses administered orally according to a 0, 2 month schedule as per the immunization schedule for HRV vaccine administration in the US. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Above or Equal to Cut-off Value. | Immunogenicity was assessed using Enzyme Linked Immunosorbent Assay (ELISA) in terms of seroprotection rates against diphtheria toxoid. A seroprotected subject is a subject whose antibody concentration is greater than or equal to (≥) the level defining clinical protection. The following seroprotection thresholds were applicable:anti-D antibody concentrations ≥ 0.1 International Units/milliliter (IU/mL), anti-T antibody concentrations ≥ 0.1 IU/mL. | At Month 5 (One month after Dose 3 of co-administered vaccines) |
| Number of Seroprotected Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above or Equal to Cut-off Value. | Immunogenicity was assessed using ChemiLuminescence ImmunoAssay (CLIA) in terms of seroprotection rates against Hepatitis B. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-HB antibody concentrations ≥ 10 milli International Units/milliliter (mIU/mL). | At Month 5 (One month after Dose 3 of co-administered vaccines) |
| Number of Seroprotected Subjects With Anti-polio Virus Types 1, 2 and 3 Antibody Titers Above or Equal to Cut-off Value. | Immunogenicity was assessed using virus micro-neutralization test in terms of seroprotection rates against polio virus types 1, 2 and 3. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-polio virus types 1, 2 and 3 types antibody titers ≥ 8 Estimated Dose 50% (ED50). | At Month 5 (One month after Dose 3 of co-administered vaccines) |
| Immunogenicity in Terms of Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations. | Antibody concentrations against PT, FHA and PRN were determined and expressed as Geometric Mean Concentrations (GMCs).The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seropositive Subjects With Anti-Rota Virus Immunoglobulin A (Anti-RV IgA) Antibody Concentrations Above or Equal to Cut-off Value of 20 Units/Milliliter (U/mL). | Immunogenicity was assessed in terms of seropositivity against Rota virus IgA antibodies. The cut off used was ≥ 20 U/mL. | At Month 5 (Three months after Dose 2 of HRV vaccine) |
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Inclusion Criteria:
Exclusion Criteria:
Child in care.
Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day-29 to Day 1), or planned use during the study period.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone (≥0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Administration of long-acting immune-modifying drugs at any time during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of vaccine administration and ending at Visit 4, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study, if administered at a site which is different from the sites used to administer the co-administered vaccines.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
Uncorrected congenital malformation of the gastrointestinal tract that would predispose for Intussusception (IS).
History of IS.
Very prematurely born infants (born ≤28 weeks of gestation).
Family history of congenital or hereditary immunodeficiency.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Major congenital defects or serious chronic illness.
Previous vaccination against Haemophilus type b (Hib), diphtheria, tetanus, pertussis, pneumococcus, RV and/or poliovirus.
Previous confirmed occurrence of RV GE, Hib, diphtheria, tetanus, pertussis, pneumococcus, hepatitis B and/or polio disease.
Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
GE within 7 days preceding the study vaccine administration.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
Hypersensitivity to latex.
History of any neurological disorders or seizures.
History of Severe combined immunodeficiency (SCID).
Acute disease and/or fever at the time of enrolment.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35205 | United States | ||
| GSK Investigational Site |
IPD for this study is available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Out of 1280 subjects enrolled in the study, 7 subjects did not receive any study treatment and 1 subject was eliminated from all analyses as there was a deviation in informed consent.
1272 subjects were vaccinated and included in the Exposed Set, 1148 subjects completed the study.
The study was conducted at 48 centers in the United States (US).
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| ID | Title | Description |
|---|---|---|
| FG000 | HRV Porcine Circovirus (PCV)-Free Liquid Group | Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 27, 2016 | Oct 8, 2019 |
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| Pediarix | Biological | Three doses administered intramuscularly according to a 0, 2, 4 month schedule. |
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| Hiberix | Biological | Three doses administered intramuscularly according to a 0, 2, 4 month schedule. |
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| Prevenar 13 | Biological | Three doses administered intramuscularly according to a 0, 2, 4 month schedule. |
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| At Month 5 (One month after Dose 3 of co-administered vaccines) |
| Immunogenicity in Terms of Anti-pneumococcal Serotypes (Anti-PnPS) Antibody Concentrations. | Antibody concentrations against pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) were determined and expressed as GMCs in micrograms per milliliter (µg/mL).The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations. | At Month 5 (One month after Dose 3 of co-administered vaccines) |
| Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 0.15 µg/mL. | Immunogenicity was assessed in terms of seroprotection rates against PRP antibodies. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-PRP antibody concentrations ≥ 0.15 µg/mL. | At Month 5 (One month after Dose 3 of co-administered vaccines) |
| Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 1.0 µg/mL. | Immunogenicity was assessed in terms of seroprotection rates against PRP antibodies. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-PRP antibody concentrations ≥ 1.0 µg/mL. | At Month 5 (One month after Dose 3 of co-administered vaccines) |
| Number of Subjects With Seroresponse to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies. | Seroresponse is defined as the percentage of subjects showing an antibody concentration above a threshold that leads to 95% seroresponse in the HRV lyophilized Group. The cut-offs used were as follows: anti-PT (18.566 IU/mL), anti-FHA (35.711 IU/mL) and anti-PRN (11.034 IU/mL). | At Month 5 (One month after Dose 3 of co-administered vaccines) |
| Number of Seropositive Subjects With Anti-RV IgA Antibody Concentrations Above or Equal to Cut-off Value of 90 U/mL. | Immunogenicity was assessed in terms of seropositivity against Rota virus IgA antibodies. The cut off used was ≥ 90 U/mL. | At Month 5 (Three months after Dose 2 of HRV vaccine) |
| Number of Seropositive Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above or Equal to Cut-off Value. | Immunogenicity was assessed using ELISA technique in terms of seropositivity against PT, FHA and PRN antibodies. The cut-offs for antibodies were the Lower Limit Of Quantification (LLOQ) of the assays which were ≥ 2.693 IU/mL (anti-PT), ≥ 2.046 IU/mL (anti-FHA) and ≥ 2.187 IU/mL (anti-PRN). The Limit of Quantification is the lowest analyte concentration that can be quantitatively detected with a stated accuracy and precision, and LLOQ is the lowest standard curve point obtained by extrapolation, that can still be used for quantification. | At Month 5 (One month after Dose 3 of co-administered vaccines) |
| Number of Seropositive Subjects With Anti-PnPS Antibody Concentrations Above or Equal to Cut-off Value. | Immunogenicity was assessed using ELISA technique in terms of seropositivity against Pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) antibodies. The cut-off used was ≥ 0.35 µg/mL. | At Month 5 (One month after Dose 3 of co-administered vaccines) |
| Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations. | Antibody concentrations against diphtheria and tetanus were determined and expressed as GMCs. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations. | At Month 5 (One month after Dose 3 of co-administered vaccines) |
| Immunogenicity in Terms of Anti-PRP Antibody Concentrations. | Antibody concentrations against PRP were determined and expressed as GMCs. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations. | At Month 5 (One month after Dose 3 of co-administered vaccines) |
| Immunogenicity in Terms of Anti-HBs Antibody Concentrations. | Antibody concentrations against Hepatitis B were determined and expressed as GMCs. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations. | At Month 5 (One month after Dose 3 of co-administered vaccines) |
| Immunogenicity in Terms of Anti-poliovirus Types 1, 2 and 3 Antibody Titers. | Antibody concentrations against Poliovirus types 1, 2 and 3 were determined and expressed as Geometric Mean Titers (GMTs). | At Month 5 (One month after Dose 3 of co-administered vaccines) |
| Number of Subjects With Any Solicited General Adverse Events (AEs). | Assessed solicited general AEs were cough/runny nose; diarrhoea; fever measured by 3 routes which were oral, axillary and rectal, defined as temperature ≥ 38.0 degrees Celsius (°C); irritability; loss of appetite and vomiting. Any = any solicited general AE irrespective of its intensity grade and relationship to vaccination | During the 8-day (Days 1-8) follow-up period after each HRV vaccination. |
| Number of Subjects With Any Unsolicited AEs. | Unsolicited AEs assessed include any AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any= Any unsolicited AE irrespective of its intensity grade and relationship to vaccination. | During the 31-day (Days 1-31) follow-up period after each HRV vaccination. |
| Number of Subjects With Any Serious Adverse Events (SAEs). | SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. | During the entire study period (Day 1 to Month 10) |
| Fayetteville |
| Arkansas |
| 72703 |
| United States |
| GSK Investigational Site | Jonesboro | Arkansas | 72401 | United States |
| GSK Investigational Site | Daly City | California | 94015 | United States |
| GSK Investigational Site | Oakland | California | 94611 | United States |
| GSK Investigational Site | Walnut Creek | California | 94596 | United States |
| GSK Investigational Site | West Covina | California | 91790 | United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80922 | United States |
| GSK Investigational Site | Altamonte Springs | Florida | 32701 | United States |
| GSK Investigational Site | Boynton Beach | Florida | 33435 | United States |
| GSK Investigational Site | Miami | Florida | 33142 | United States |
| GSK Investigational Site | Tampa | Florida | 33617 | United States |
| GSK Investigational Site | Nampa | Idaho | 83686 | United States |
| GSK Investigational Site | Bardstown | Kentucky | 40004 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40202 | United States |
| GSK Investigational Site | Frederick | Maryland | 21702 | United States |
| GSK Investigational Site | Fall River | Massachusetts | 02721 | United States |
| GSK Investigational Site | Bingham Farms | Michigan | 48025 | United States |
| GSK Investigational Site | Lincoln | Nebraska | 68504 | United States |
| GSK Investigational Site | Lincoln | Nebraska | 68505 | United States |
| GSK Investigational Site | Lincoln | Nebraska | 68522 | United States |
| GSK Investigational Site | Syracuse | New York | 13202 | United States |
| GSK Investigational Site | The Bronx | New York | 10468 | United States |
| GSK Investigational Site | Boone | North Carolina | 28607 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44121 | United States |
| GSK Investigational Site | Dayton | Ohio | 45406 | United States |
| GSK Investigational Site | Dayton | Ohio | 45414 | United States |
| GSK Investigational Site | Dayton | Ohio | 45419 | United States |
| GSK Investigational Site | Grove City | Ohio | 43123 | United States |
| GSK Investigational Site | Hermitage | Pennsylvania | 16148 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29407 | United States |
| GSK Investigational Site | North Charleston | South Carolina | 29406-9170 | United States |
| GSK Investigational Site | Kingsport | Tennessee | 37660 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76107 | United States |
| GSK Investigational Site | Galveston | Texas | 77555 | United States |
| GSK Investigational Site | Tomball | Texas | 77375 | United States |
| GSK Investigational Site | Kaysville | Utah | 84037 | United States |
| GSK Investigational Site | Layton | Utah | 84041 | United States |
| GSK Investigational Site | Murray | Utah | 84107 | 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 | Syracuse | Utah | 84075 | United States |
| GSK Investigational Site | Charlottesville | Virginia | 22902 | United States |
| GSK Investigational Site | Marshfield | Wisconsin | 54449 | United States |
| FG001 | HRV Lyophilized Group | Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HRV Porcine Circovirus (PCV)-Free Liquid Group | Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used. |
| BG001 | HRV Lyophilized Group | Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Above or Equal to Cut-off Value. | Immunogenicity was assessed using Enzyme Linked Immunosorbent Assay (ELISA) in terms of seroprotection rates against diphtheria toxoid. A seroprotected subject is a subject whose antibody concentration is greater than or equal to (≥) the level defining clinical protection. The following seroprotection thresholds were applicable:anti-D antibody concentrations ≥ 0.1 International Units/milliliter (IU/mL), anti-T antibody concentrations ≥ 0.1 IU/mL. | Analysis was performed on the Per protocol set (PPS) for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Posted | Count of Participants | Participants | At Month 5 (One month after Dose 3 of co-administered vaccines) |
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| Primary | Number of Seroprotected Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above or Equal to Cut-off Value. | Immunogenicity was assessed using ChemiLuminescence ImmunoAssay (CLIA) in terms of seroprotection rates against Hepatitis B. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-HB antibody concentrations ≥ 10 milli International Units/milliliter (mIU/mL). | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Posted | Count of Participants | Participants | At Month 5 (One month after Dose 3 of co-administered vaccines) |
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| Primary | Number of Seroprotected Subjects With Anti-polio Virus Types 1, 2 and 3 Antibody Titers Above or Equal to Cut-off Value. | Immunogenicity was assessed using virus micro-neutralization test in terms of seroprotection rates against polio virus types 1, 2 and 3. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-polio virus types 1, 2 and 3 types antibody titers ≥ 8 Estimated Dose 50% (ED50). | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Posted | Count of Participants | Participants | At Month 5 (One month after Dose 3 of co-administered vaccines) |
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| Primary | Immunogenicity in Terms of Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations. | Antibody concentrations against PT, FHA and PRN were determined and expressed as Geometric Mean Concentrations (GMCs).The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations. | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At Month 5 (One month after Dose 3 of co-administered vaccines) |
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| Primary | Immunogenicity in Terms of Anti-pneumococcal Serotypes (Anti-PnPS) Antibody Concentrations. | Antibody concentrations against pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) were determined and expressed as GMCs in micrograms per milliliter (µg/mL).The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations. | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Month 5 (One month after Dose 3 of co-administered vaccines) |
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| Primary | Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 0.15 µg/mL. | Immunogenicity was assessed in terms of seroprotection rates against PRP antibodies. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-PRP antibody concentrations ≥ 0.15 µg/mL. | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Posted | Count of Participants | Participants | At Month 5 (One month after Dose 3 of co-administered vaccines) |
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| Primary | Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 1.0 µg/mL. | Immunogenicity was assessed in terms of seroprotection rates against PRP antibodies. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-PRP antibody concentrations ≥ 1.0 µg/mL. | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Posted | Count of Participants | Participants | At Month 5 (One month after Dose 3 of co-administered vaccines) |
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| Primary | Number of Subjects With Seroresponse to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies. | Seroresponse is defined as the percentage of subjects showing an antibody concentration above a threshold that leads to 95% seroresponse in the HRV lyophilized Group. The cut-offs used were as follows: anti-PT (18.566 IU/mL), anti-FHA (35.711 IU/mL) and anti-PRN (11.034 IU/mL). | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Posted | Count of Participants | Participants | At Month 5 (One month after Dose 3 of co-administered vaccines) |
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| Secondary | Number of Seropositive Subjects With Anti-Rota Virus Immunoglobulin A (Anti-RV IgA) Antibody Concentrations Above or Equal to Cut-off Value of 20 Units/Milliliter (U/mL). | Immunogenicity was assessed in terms of seropositivity against Rota virus IgA antibodies. The cut off used was ≥ 20 U/mL. | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Posted | Count of Participants | Participants | At Month 5 (Three months after Dose 2 of HRV vaccine) |
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| Secondary | Number of Seropositive Subjects With Anti-RV IgA Antibody Concentrations Above or Equal to Cut-off Value of 90 U/mL. | Immunogenicity was assessed in terms of seropositivity against Rota virus IgA antibodies. The cut off used was ≥ 90 U/mL. | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Posted | Count of Participants | Participants | At Month 5 (Three months after Dose 2 of HRV vaccine) |
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| Secondary | Number of Seropositive Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above or Equal to Cut-off Value. | Immunogenicity was assessed using ELISA technique in terms of seropositivity against PT, FHA and PRN antibodies. The cut-offs for antibodies were the Lower Limit Of Quantification (LLOQ) of the assays which were ≥ 2.693 IU/mL (anti-PT), ≥ 2.046 IU/mL (anti-FHA) and ≥ 2.187 IU/mL (anti-PRN). The Limit of Quantification is the lowest analyte concentration that can be quantitatively detected with a stated accuracy and precision, and LLOQ is the lowest standard curve point obtained by extrapolation, that can still be used for quantification. | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Posted | Count of Participants | Participants | At Month 5 (One month after Dose 3 of co-administered vaccines) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Seropositive Subjects With Anti-PnPS Antibody Concentrations Above or Equal to Cut-off Value. | Immunogenicity was assessed using ELISA technique in terms of seropositivity against Pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) antibodies. The cut-off used was ≥ 0.35 µg/mL. | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Posted | Count of Participants | Participants | At Month 5 (One month after Dose 3 of co-administered vaccines) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations. | Antibody concentrations against diphtheria and tetanus were determined and expressed as GMCs. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations. | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At Month 5 (One month after Dose 3 of co-administered vaccines) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Immunogenicity in Terms of Anti-PRP Antibody Concentrations. | Antibody concentrations against PRP were determined and expressed as GMCs. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations. | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Month 5 (One month after Dose 3 of co-administered vaccines) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Immunogenicity in Terms of Anti-HBs Antibody Concentrations. | Antibody concentrations against Hepatitis B were determined and expressed as GMCs. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations. | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Month 5 (One month after Dose 3 of co-administered vaccines) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Immunogenicity in Terms of Anti-poliovirus Types 1, 2 and 3 Antibody Titers. | Antibody concentrations against Poliovirus types 1, 2 and 3 were determined and expressed as Geometric Mean Titers (GMTs). | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Month 5 (One month after Dose 3 of co-administered vaccines) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any Solicited General Adverse Events (AEs). | Assessed solicited general AEs were cough/runny nose; diarrhoea; fever measured by 3 routes which were oral, axillary and rectal, defined as temperature ≥ 38.0 degrees Celsius (°C); irritability; loss of appetite and vomiting. Any = any solicited general AE irrespective of its intensity grade and relationship to vaccination | Analysis was performed on the Exposed set (ES). The ES included all subjects with at least one study vaccine administration documented. A safety analysis based on the ES included all vaccinated subjects. | Posted | Count of Participants | Participants | During the 8-day (Days 1-8) follow-up period after each HRV vaccination. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any Unsolicited AEs. | Unsolicited AEs assessed include any AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any= Any unsolicited AE irrespective of its intensity grade and relationship to vaccination. | Analysis was performed on the Exposed set (ES). The ES included all subjects with at least one study vaccine administration documented. A safety analysis based on the ES included all vaccinated subjects. | Posted | Count of Participants | Participants | During the 31-day (Days 1-31) follow-up period after each HRV vaccination. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any Serious Adverse Events (SAEs). | SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. | Analysis was performed on the Exposed set (ES). The ES included all subjects with at least one study vaccine administration documented. A safety analysis based on the ES included all vaccinated subjects. | Posted | Count of Participants | Participants | During the entire study period (Day 1 to Month 10) |
|
Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after each HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 10).
Not provided
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 | HRV Porcine Circovirus (PCV)-Free Liquid Group | Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used. | 1 | 632 | 20 | 632 | 571 | 632 |
| EG001 | HRV Lyophilized Group | Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). | 0 | 640 | 19 | 640 | 589 | 640 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Adenovirus infection | Infections and infestations | Systematic Assessment |
| ||
| Blood glucose abnormal | Investigations | Systematic Assessment |
| ||
| Botulism | Infections and infestations | Systematic Assessment |
| ||
| Bronchiolitis | Infections and infestations | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Corona virus infection | Infections and infestations | Systematic Assessment |
| ||
| Croup infectious | Infections and infestations | Systematic Assessment |
| ||
| Cyanosis | Cardiac disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Enterovirus infection | Infections and infestations | Systematic Assessment |
| ||
| Failure to thrive | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Fluid intake reduced | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Intussusception | Gastrointestinal disorders | Systematic Assessment |
| ||
| Laryngomalacia | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Mental status changes | Psychiatric disorders | Systematic Assessment |
| ||
| Metabolic acidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Metapneumovirus infection | Infections and infestations | Systematic Assessment |
| ||
| Otitis media | Infections and infestations | Systematic Assessment |
| ||
| Pharyngeal perforation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Polyuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Systematic Assessment |
| ||
| Radius fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory syncytial virus bronchiolitis | Infections and infestations | Systematic Assessment |
| ||
| Respiratory syncytial virus bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Respiratory syncytial virus infection | Infections and infestations | Systematic Assessment |
| ||
| Rhinovirus infection | Infections and infestations | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Seizure like phenomena | Nervous system disorders | Systematic Assessment |
| ||
| Skin laceration | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Skull fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Sudden infant death syndrome | General disorders | Systematic Assessment |
| ||
| Tibia fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Ulna fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Ankyloglossia congenital | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Atrial septal defect | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Birth mark | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Congenital musculoskeletal anomaly | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Congenital torticollis | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Dacryostenosis congenital | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Macrocephaly | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Plagiocephaly | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Cerumen impaction | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Ear pain | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Otorrhoea | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Tympanic membrane perforation | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
| ||
| Dacryostenosis acquired | Eye disorders | Systematic Assessment |
| ||
| Eye discharge | Eye disorders | Systematic Assessment |
| ||
| Eye swelling | Eye disorders | Systematic Assessment |
| ||
| Eyelid irritation | Eye disorders | Systematic Assessment |
| ||
| Ocular hyperaemia | Eye disorders | Systematic Assessment |
| ||
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abnormal faeces | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Faeces discoloured | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastric haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haematochezia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Impaired gastric emptying | Gastrointestinal disorders | Systematic Assessment |
| ||
| Infantile colic | Gastrointestinal disorders | Systematic Assessment |
| ||
| Infantile vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Infrequent bowel movements | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mucous stools | Gastrointestinal disorders | Systematic Assessment |
| ||
| Post-tussive vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pylorospasm | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rectal fissure | Gastrointestinal disorders | Systematic Assessment |
| ||
| Salivary hypersecretion | Gastrointestinal disorders | Systematic Assessment |
| ||
| Teething | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Crying | General disorders | Systematic Assessment |
| ||
| Discomfort | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Influenza like illness | General disorders | Systematic Assessment |
| ||
| Injection site discomfort | General disorders | Systematic Assessment |
| ||
| Injection site erythema | General disorders | Systematic Assessment |
| ||
| Injection site inflammation | General disorders | Systematic Assessment |
| ||
| Injection site mass | General disorders | Systematic Assessment |
| ||
| Injection site nodule | General disorders | Systematic Assessment |
| ||
| Injection site pain | General disorders | Systematic Assessment |
| ||
| Injection site swelling | General disorders | Systematic Assessment |
| ||
| Nodule | General disorders | Systematic Assessment |
| ||
| Oedema | General disorders | Systematic Assessment |
| ||
| Peripheral swelling | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Swelling | General disorders | Systematic Assessment |
| ||
| Vaccination site pain | General disorders | Systematic Assessment |
| ||
| Milk allergy | Immune system disorders | Systematic Assessment |
| ||
| Atypical pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Bronchiolitis | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Candida infection | Infections and infestations | Systematic Assessment |
| ||
| Candida nappy rash | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile infection | Infections and infestations | Systematic Assessment |
| ||
| Conjunctivitis | Infections and infestations | Systematic Assessment |
| ||
| Conjunctivitis bacterial | Infections and infestations | Systematic Assessment |
| ||
| Corona virus infection | Infections and infestations | Systematic Assessment |
| ||
| Croup infectious | Infections and infestations | Systematic Assessment |
| ||
| Ear infection | Infections and infestations | Systematic Assessment |
| ||
| Ear infection bacterial | Infections and infestations | Systematic Assessment |
| ||
| Enterovirus infection | Infections and infestations | Systematic Assessment |
| ||
| Eye infection | Infections and infestations | Systematic Assessment |
| ||
| Fungal skin infection | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis viral | Infections and infestations | Systematic Assessment |
| ||
| Impetigo | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Laryngitis | Infections and infestations | Systematic Assessment |
| ||
| Laryngotracheitis obstructive | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Neonatal candida infection | Infections and infestations | Systematic Assessment |
| ||
| Oral candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Otitis media | Infections and infestations | Systematic Assessment |
| ||
| Otitis media acute | Infections and infestations | Systematic Assessment |
| ||
| Parainfluenzae virus infection | Infections and infestations | Systematic Assessment |
| ||
| Paronychia | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis streptococcal | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Systematic Assessment |
| ||
| Respiratory syncytial virus bronchiolitis | Infections and infestations | Systematic Assessment |
| ||
| Respiratory syncytial virus infection | Infections and infestations | Systematic Assessment |
| ||
| Respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Respiratory tract infection viral | Infections and infestations | Systematic Assessment |
| ||
| Rhinitis | Infections and infestations | Systematic Assessment |
| ||
| Rhinovirus infection | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Skin bacterial infection | Infections and infestations | Systematic Assessment |
| ||
| Skin candida | Infections and infestations | Systematic Assessment |
| ||
| Skin infection | Infections and infestations | Systematic Assessment |
| ||
| Streptococcal infection | Infections and infestations | Systematic Assessment |
| ||
| Subcutaneous abscess | Infections and infestations | Systematic Assessment |
| ||
| Subglottic laryngitis | Infections and infestations | Systematic Assessment |
| ||
| Tonsillitis | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Urogenital infection fungal | Infections and infestations | Systematic Assessment |
| ||
| Viral infection | Infections and infestations | Systematic Assessment |
| ||
| Viral pharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Viral rash | Infections and infestations | Systematic Assessment |
| ||
| Viral upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Vulvovaginal mycotic infection | Infections and infestations | Systematic Assessment |
| ||
| Arthropod bite | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Craniocerebral injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Exposure to communicable disease | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Exposure to toxic agent | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Eyelid injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Head injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Mouth injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Respiratory fume inhalation disorder | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vaccination complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Body temperature increased | Investigations | Systematic Assessment |
| ||
| Cardiac murmur | Investigations | Systematic Assessment |
| ||
| Urine output decreased | Investigations | Systematic Assessment |
| ||
| Viral test positive | Investigations | Systematic Assessment |
| ||
| Breast milk substitute intolerance | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Cow's milk intolerance | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Failure to thrive | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Feeding disorder | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Increased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Milk soy protein intolerance | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Underweight | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Weight gain poor | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Acquired plagiocephaly | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Joint noise | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Torticollis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Drooling | Nervous system disorders | Systematic Assessment |
| ||
| Febrile convulsion | Nervous system disorders | Systematic Assessment |
| ||
| Hypersomnia | Nervous system disorders | Systematic Assessment |
| ||
| Lethargy | Nervous system disorders | Systematic Assessment |
| ||
| Poor quality sleep | Nervous system disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Irritability | Psychiatric disorders | Systematic Assessment |
| ||
| Restlessness | Psychiatric disorders | Systematic Assessment |
| ||
| Sleep disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Urethral discharge | Renal and urinary disorders | Systematic Assessment |
| ||
| Urine odour abnormal | Renal and urinary disorders | Systematic Assessment |
| ||
| Breast cyst | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Breast mass | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Genital labial adhesions | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Penile adhesion | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Testicular retraction | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Choking | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Lower respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Acne infantile | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Cafe au lait spots | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dermatitis atopic | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dermatitis contact | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dermatitis diaper | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Eczema infantile | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Erythema toxicum neonatorum | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Miliaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Perioral dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash erythematous | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash generalised | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash macular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Seborrhoea | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin discolouration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin fissures | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin induration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin lesion | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Swelling face | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Umbilical haemorrhage | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 1, 2017 | Oct 8, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
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| ID | Term |
|---|---|
| C492457 | RIX4414 vaccine |
| C472675 | PEDIARIX |
| D013745 | Tetanus Toxoid |
| D017325 | Hepatitis B Vaccines |
| D011054 | Poliovirus Vaccine, Inactivated |
| C514867 | Hiberix |
| C538862 | 13-valent pneumococcal vaccine |
| C028581 | CRM197 (non-toxic variant of diphtheria toxin) |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D015164 | Vaccines, Inactivated |
| D023321 | Poliovirus Vaccines |
Not provided
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| Male |
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| Asian |
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| Black Or African American |
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| Native Hawaiian Or Other Pacific Islander |
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| White |
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| Other, not specified |
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| Anti-T |
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| Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 0.1 IU/mL) of anti-T antibodies. | Difference in anti-T concentration | -0.00 | 2-Sided | 95 | -0.79 | 0.77 | Non-Inferiority | Lower limit (LL) of the two-sided asymptotic standardized 95% Confidence Interval (CI) for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-T antibodies should be ≥-10%. |
Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). |
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Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). |
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Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).
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Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).
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Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).
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| OG001 | HRV Lyophilized Group | Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). |
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