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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001117-41 | EudraCT Number |
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The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' Infanrix hexa, given in the primary vaccination schedule to infants born to pregnant women who participated in study 116945 [DTPA (BOOSTRIX)-047]. This study will help us evaluate if the presence of transplacentally transferred maternal antibodies interfere with the immune response to primary vaccination with Infanrix hexa and a co-administered pneumococcal conjugate vaccine given as a part of this study in infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dTpa Group | Experimental | This group will consist of infants born to mothers belonging to the dTpa Group in study 116945 [DTPA (BOOSTRIX)-047] i.e. who received a single dose of BoostrixTM during pregnancy and a dose of placebo immediately post-delivery. All infants in this group will receive Infanrix hexaTM co-administered with Prevenar 13®. |
|
| Control Group | Active Comparator | This group will consist of infants born to mothers belonging to the Control group in study 116945 [DTPA (BOOSTRIX)-047], i.e. who received a single dose of placebo during pregnancy and a dose of BoostrixTM immediately post-delivery. All infants in this group will receive Infanrix hexaTM co-administered with Prevenar 13®. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infanrix hexa | Biological | • All subjects will receive Infanrix hexa at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. Infanrix hexa is administered intramuscularly to the right thigh. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens | Vaccine response to the PT, FHA and PRN antigens, is defined as the appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations lower than (<) the cut-off value of the assay), or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations greater than or equal to (≥) the cut-off value of the assay). Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, 2.187 IU/mL for anti-PRN. | 1 month after the last dose of the primary vaccination |
| Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off | A seroprotected subject is a subject whose antibody concentration/titre was ≥ the level defining clinical protection, of 0.1 International Units per milliliter (IU/mL). | 1 month after the last dose of the primary vaccination |
| Number of Seroprotected Subjects With Anti Hepatitis B (Anti-HBs) Antibody Concentration Above or Equal to the Assay Cut-off | A seroprotected subject is a subject whose antibody concentration/titre was ≥ to the level defining clinical protection, of 10 micro International Units per milliliter (mIU/mL). | 1 month after the last dose of the primary vaccination |
| Number of Seroprotected Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentration Above or Equal to 8 | A seroprotected subject is a subject whose antibody titre was ≥ the level defining clinical protection, of 8 ED50. | 1 month after the last dose of the primary vaccination |
| Number of Seroprotected Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Above or Equal to the Assay Cut-off |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off. | A seroprotected subject is a subject whose antibody concentration was ≥ the level defining clinical protection, of 0.1 IU/mL. | Before the first dose of Infanrix hexa |
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Inclusion Criteria:
Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
A male or female between, 6 and 14 weeks of age (including 6 weeks and up to and including 14 weeks and 6 days of age) at the time of the first vaccination.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Born to a mother enrolled in study 116945 [DTPA (BOOSTRIX)-047].
Medically stable* prematurely born infants, born after a gestation period of 27-36 weeks may be enrolled in the study at the discretion of the investigator.
Exclusion Criteria:
Child in care
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting at birth prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥0.5mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
Administration of any chronic drug therapy to be continued during the study period.
A vaccine not foreseen by the study protocol administered during the period starting from 30 days before each dose of vaccine and ending 30 days after*, with the exception of inactivated influenza vaccine and other vaccines given as a part of the national/regional immunisation schedule, that are allowed at any time during the study period.
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 (pharmaceutical product or device).
Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, and/or poliovirus since birth.
History of Hib, diphtheria, tetanus, pertussis, pneumococcal, poliovirus and hepatitis B diseases.
Any confirmed or suspected immunosuppressive or immunodeficient condition including severe combined immunodeficiency disease (SCID), based on medical history and physical examination (no laboratory testing required).
Family history of congenital or hereditary immunodeficiency.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Major congenital defects
Serious chronic illness.
History of any neurological disorders or seizures.
Acute disease and/or fever at the time of enrolment.
Administration of immunoglobulins and/or any blood products during the period starting at birth before the first dose of study vaccines or planned administration during the study period.
Hypersensitivity to latex.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Carlton | Victoria | 3053 | Australia | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31776027 | Derived | Perrett KP, Halperin SA, Nolan T, Carmona Martinez A, Martinon-Torres F, Garcia-Sicilia J, Virta M, Vanderkooi OG, Zuccotti GV, Manzoni P, Kostanyan L, Meyer N, Ceregido MA, Cheuvart B, Kuriyakose SO, Stranak Z, Merino Arribas JM, Cilleruelo Ortega MJ, Miranda-Valdivieso M, Arias Novas B, Ramos Amador JT, Omenaca F, Baca M, Marchisio PG, Mesaros N. Impact of tetanus-diphtheria-acellular pertussis immunization during pregnancy on subsequent infant immunization seroresponses: follow-up from a large randomized placebo-controlled trial. Vaccine. 2020 Feb 18;38(8):2105-2114. doi: 10.1016/j.vaccine.2019.10.104. Epub 2019 Nov 24. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | dTpa Group | Infants born to mothers belonging to the Boostrix Group in study NCT02377349 [DTPA (BOOSTRIX)-047] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule. |
| 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 | Sep 6, 2016 | Mar 7, 2019 |
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| Prevnar13 | Drug | • All subjects will receive Infanrix hexa co-administered with Prevenar13* at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. *In some countries/regions with an Infanrix hexa 3-dose vaccination schedule, Prevenar 13 could be administered as 2-doses or 3-doses primary vaccination schedule (according to the routine national immunisation schedule). Prevnar13 is administered intramuscularly to the left thigh. |
|
A seroprotected subject is a subject whose antibody concentration/titre was ≥ the level defining clinical protection, of 0.15 micrograms per milliliter (µg/mL). |
| 1 month after the last dose of the primary vaccination |
| Anti-D and Anti-T Antibody Concentrations |
Antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in IU/mL. |
| Before the first dose of Infanrix hexa |
| Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off. | A seropositive subject is a subject whose antibody concentration is ≥ the assay cut-off defined. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA,2.187 IU/mL for anti-PRN | Before the first dose of Infanrix hexa |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, anti-FHA and anti-PRN antibody concentrations were expressed as GMCs and measured in IU/mL. | Before the first dose of Infanrix hexa |
| Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in IU/mL. | 1 month after the last dose of the primary vaccination |
| Anti-Polio Type 1, 2 and 3 Antibody Titers | Anti-Polio type 1, 2 and 3 antibody titers were expressed as geometric mean titers (GMT). | 1 month after the last dose of the primary vaccination |
| Anti-HBs Antibody Concentrations | Anti-HBs antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in mIU/mL. | 1 month after the last dose of the primary vaccination |
| Anti-PRP Antibody Concentrations | Anti-PRP antibody concentrations were expressed as GMCs and measured in µg/mL. | 1 month after the last dose of the primary vaccination |
| Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-PT, anti-FHA, anti-PRN antibody concentrations were expressed as GMCs and measured in IU/mL. | 1 month after the last dose of the primary vaccination |
| Anti-pneumococcal Antibody Concentrations | Assessed anti-pneumococcal serotypes were (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F), expressed as GMCs and measured in µg/mL. | 1 month after the last dose of the primary vaccination |
| Number of Subjects With Anti-PT, Anti-FHA, Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off. | A seropositive subject is a subject whose antibody concentration is ≥ the assay cut-off defined. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA,2.187 IU/mL for anti-PRN | 1 month after the last dose of the primary vaccination |
| Number of Subjects With Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Solicited local symptoms were assessed by each and across dose. | During the 4-day (Day 0-Day 3) follow-up period after each vaccination |
| Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and fever [defined as axillary route temperature ≥ 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Solicited general symptoms were assessed by each and across dose. | During the 4-day (Day 0-Day 3) follow-up period after each vaccination |
| Number of Subjects With Unsolicited Adverse Events | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | During the 31-day (days 0-30) follow-up period after each vaccination |
| Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. | From Day 0, prior to vaccination until the study end, at Month 3 or 5 (depending on vaccination schedule of the country) |
| Calgary |
| Alberta |
| T3B 6A8 |
| Canada |
| GSK Investigational Site | Halifax | Nova Scotia | B3K 6R8 | Canada |
| GSK Investigational Site | Montreal | Quebec | H3T 1C5 | Canada |
| GSK Investigational Site | Brno | 613 00 | Czechia |
| GSK Investigational Site | Hradec Králové | 500 02 | Czechia |
| GSK Investigational Site | Ostrava - Vitkovice | 703 84 | Czechia |
| GSK Investigational Site | Prague | 140 59 | Czechia |
| GSK Investigational Site | Prague | 14700 | Czechia |
| GSK Investigational Site | Kokkola | 67100 | Finland |
| GSK Investigational Site | Oulu | 90220 | Finland |
| GSK Investigational Site | Seinäjoki | 60100 | Finland |
| GSK Investigational Site | Tampere | 33100 | Finland |
| GSK Investigational Site | Turku | 20520 | Finland |
| GSK Investigational Site | Milan | Lombardy | 20122 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20142 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20154 | Italy |
| GSK Investigational Site | Novara | Piedmont | 28100 | Italy |
| GSK Investigational Site | Turin | Piedmont | 10126 | Italy |
| GSK Investigational Site | Málaga | Andalusia | 29004 | Spain |
| GSK Investigational Site | Antequera/Málaga | 29200 | Spain |
| GSK Investigational Site | Aravaca | 28023 | Spain |
| GSK Investigational Site | Burgos | 09006 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Madrid | 28050 | Spain |
| GSK Investigational Site | Majadahonda (Madrid) | 28222 | Spain |
| GSK Investigational Site | Móstoles | 28938 | Spain |
| GSK Investigational Site | Santiago de Compostela | 15706 | Spain |
| GSK Investigational Site | Seville | 41014 | Spain |
| FG001 |
| Control Group |
Infants born to mothers belonging to the Control group in study NCT02377349 [DTPA (BOOSTRIX)-047], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | dTpa Group | Infants born to mothers belonging to the Boostrix Group in study NCT02377349 [DTPA (BOOSTRIX)-047] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule. |
| BG001 | Control Group | Infants born to mothers belonging to the Control group in study NCT02377349 [DTPA (BOOSTRIX)-047], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule. |
| 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at Dose 1 | Mean | Standard Deviation | Weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | 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 Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens | Vaccine response to the PT, FHA and PRN antigens, is defined as the appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations lower than (<) the cut-off value of the assay), or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations greater than or equal to (≥) the cut-off value of the assay). Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, 2.187 IU/mL for anti-PRN. | The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the Totally vaccinated cohort (TVC) who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component | Posted | Count of Participants | Participants | 1 month after the last dose of the primary vaccination |
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| Primary | Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off | A seroprotected subject is a subject whose antibody concentration/titre was ≥ the level defining clinical protection, of 0.1 International Units per milliliter (IU/mL). | The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component. | Posted | Count of Participants | Participants | 1 month after the last dose of the primary vaccination |
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| Primary | Number of Seroprotected Subjects With Anti Hepatitis B (Anti-HBs) Antibody Concentration Above or Equal to the Assay Cut-off | A seroprotected subject is a subject whose antibody concentration/titre was ≥ to the level defining clinical protection, of 10 micro International Units per milliliter (mIU/mL). | The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component. | Posted | Count of Participants | Participants | 1 month after the last dose of the primary vaccination |
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| Primary | Number of Seroprotected Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentration Above or Equal to 8 | A seroprotected subject is a subject whose antibody titre was ≥ the level defining clinical protection, of 8 ED50. | The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component. | Posted | Count of Participants | Participants | 1 month after the last dose of the primary vaccination |
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| Primary | Number of Seroprotected Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Above or Equal to the Assay Cut-off | A seroprotected subject is a subject whose antibody concentration/titre was ≥ the level defining clinical protection, of 0.15 micrograms per milliliter (µg/mL). | The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component. | Posted | Count of Participants | Participants | 1 month after the last dose of the primary vaccination |
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| Secondary | Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off. | A seroprotected subject is a subject whose antibody concentration was ≥ the level defining clinical protection, of 0.1 IU/mL. | The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component. | Posted | Count of Participants | Participants | Before the first dose of Infanrix hexa |
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| Secondary | Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in IU/mL. | The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Before the first dose of Infanrix hexa |
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| Secondary | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off. | A seropositive subject is a subject whose antibody concentration is ≥ the assay cut-off defined. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA,2.187 IU/mL for anti-PRN | The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component. | Posted | Count of Participants | Participants | Before the first dose of Infanrix hexa |
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| Secondary | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, anti-FHA and anti-PRN antibody concentrations were expressed as GMCs and measured in IU/mL. | The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component. | Posted | Geometric Mean | 95% Confidence Interval | IU/ml | Before the first dose of Infanrix hexa |
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| Secondary | Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in IU/mL. | The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component. | Posted | Geometric Mean | 95% Confidence Interval | IU/ml | 1 month after the last dose of the primary vaccination |
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| Secondary | Anti-Polio Type 1, 2 and 3 Antibody Titers | Anti-Polio type 1, 2 and 3 antibody titers were expressed as geometric mean titers (GMT). | The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 1 month after the last dose of the primary vaccination |
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| Secondary | Anti-HBs Antibody Concentrations | Anti-HBs antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in mIU/mL. | The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component. | Posted | Geometric Mean | 95% Confidence Interval | mIU/ml | 1 month after the last dose of the primary vaccination |
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| Secondary | Anti-PRP Antibody Concentrations | Anti-PRP antibody concentrations were expressed as GMCs and measured in µg/mL. | The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | 1 month after the last dose of the primary vaccination |
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| Secondary | Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-PT, anti-FHA, anti-PRN antibody concentrations were expressed as GMCs and measured in IU/mL. | The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 1 month after the last dose of the primary vaccination |
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| Secondary | Anti-pneumococcal Antibody Concentrations | Assessed anti-pneumococcal serotypes were (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F), expressed as GMCs and measured in µg/mL. | The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | 1 month after the last dose of the primary vaccination |
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| Secondary | Number of Subjects With Anti-PT, Anti-FHA, Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off. | A seropositive subject is a subject whose antibody concentration is ≥ the assay cut-off defined. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA,2.187 IU/mL for anti-PRN | The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component. | Posted | Count of Participants | Participants | 1 month after the last dose of the primary vaccination |
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| Secondary | Number of Subjects With Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Solicited local symptoms were assessed by each and across dose. | The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and for those with at least 1 vaccine administration documented. | Posted | Count of Participants | Participants | During the 4-day (Day 0-Day 3) follow-up period after each vaccination |
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| Secondary | Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and fever [defined as axillary route temperature ≥ 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Solicited general symptoms were assessed by each and across dose. | The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and for those with at least 1 vaccine administration documented. | Posted | Count of Participants | Participants | During the 4-day (Day 0-Day 3) follow-up period after each vaccination |
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| Secondary | Number of Subjects With Unsolicited Adverse Events | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and for those with at least 1 vaccine administration documented. | Posted | Count of Participants | Participants | During the 31-day (days 0-30) follow-up period after each vaccination |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. | The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and for those with at least 1 vaccine administration documented. | Posted | Count of Participants | Participants | From Day 0, prior to vaccination until the study end, at Month 3 or 5 (depending on vaccination schedule of the country) |
|
Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
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 | dTpa Group | Infants born to mothers belonging to the Boostrix Group in study NCT02377349 [DTPA (BOOSTRIX)-047] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule. | 0 | 296 | 7 | 296 | 292 | 296 |
| EG001 | Control Group | Infants born to mothers belonging to the Control group in study NCT02377349 [DTPA (BOOSTRIX)-047], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule. | 0 | 305 | 17 | 305 | 294 | 305 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congenital cytomegalovirus infection | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Craniosynostosis | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Cryptorchism | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Dandy-walker syndrome | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Ear malformation | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Microcephaly | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Intestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Milk allergy | Immune system disorders | Systematic Assessment |
| ||
| Bacterial infection | Infections and infestations | Systematic Assessment |
| ||
| Bronchiolitis | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Candida infection | Infections and infestations | Systematic Assessment |
| ||
| Conjunctivitis | Infections and infestations | Systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Systematic Assessment |
| ||
| Respiratory syncytial virus bronchiolitis | Infections and infestations | Systematic Assessment |
| ||
| Superinfection bacterial | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Viral infection | Infections and infestations | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Femur fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Skull fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Skull fractured base | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Altered state of consciousness | Nervous system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Congenital torticollis | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Phimosis | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Dacryostenosis acquired | Eye disorders | Systematic Assessment |
| ||
| Eye discharge | Eye disorders | Systematic Assessment |
| ||
| Eye irritation | Eye disorders | Systematic Assessment |
| ||
| Eye swelling | Eye disorders | Systematic Assessment |
| ||
| Pupils unequal | Eye disorders | Systematic Assessment |
| ||
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abnormal faeces | Gastrointestinal disorders | Systematic Assessment |
| ||
| Change of bowel habit | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Enteritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastric disorder | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gingival pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haematochezia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Infantile colic | Gastrointestinal disorders | Systematic Assessment |
| ||
| Infrequent bowel movements | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mucous stools | Gastrointestinal disorders | Systematic Assessment |
| ||
| Odynophagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oral mucosal erythema | Gastrointestinal disorders | Systematic Assessment |
| ||
| Regurgitation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Sandifer's syndrome | Gastrointestinal disorders | Systematic Assessment |
| ||
| Teething | Gastrointestinal disorders | Systematic Assessment |
| ||
| Toothache | Gastrointestinal disorders | Systematic Assessment |
| ||
| Umbilical hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Influenza like illness | General disorders | Systematic Assessment |
| ||
| Injection site bruising | General disorders | Systematic Assessment |
| ||
| Injection site induration | General disorders | Systematic Assessment |
| ||
| Injection site mass | General disorders | Systematic Assessment |
| ||
| Injection site nodule | General disorders | Systematic Assessment |
| ||
| Injection site swelling | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Thirst | General disorders | Systematic Assessment |
| ||
| Vaccination site erythema | General disorders | Systematic Assessment |
| ||
| Vaccination site pain | General disorders | Systematic Assessment |
| ||
| Vaccination site swelling | General disorders | Systematic Assessment |
| ||
| Vessel puncture site bruise | General disorders | Systematic Assessment |
| ||
| Milk allergy | Immune system disorders | Systematic Assessment |
| ||
| Adenoiditis | Infections and infestations | Systematic Assessment |
| ||
| Bronchiolitis | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Campylobacter gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Candida infection | Infections and infestations | Systematic Assessment |
| ||
| Candida nappy rash | Infections and infestations | Systematic Assessment |
| ||
| Conjunctivitis | Infections and infestations | Systematic Assessment |
| ||
| Croup infectious | Infections and infestations | Systematic Assessment |
| ||
| Ear infection | Infections and infestations | Systematic Assessment |
| ||
| Enterovirus infection | Infections and infestations | Systematic Assessment |
| ||
| Erythema infectiosum | Infections and infestations | Systematic Assessment |
| ||
| Exanthema subitum | Infections and infestations | Systematic Assessment |
| ||
| Eye infection | Infections and infestations | Systematic Assessment |
| ||
| Fungal skin infection | Infections and infestations | Systematic Assessment |
| ||
| Furuncle | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis viral | Infections and infestations | Systematic Assessment |
| ||
| Hand-foot-and-mouth disease | Infections and infestations | Systematic Assessment |
| ||
| Impetigo | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Laryngitis | Infections and infestations | Systematic Assessment |
| ||
| Nail infection | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Oral candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Oral fungal infection | Infections and infestations | Systematic Assessment |
| ||
| Otitis media | Infections and infestations | Systematic Assessment |
| ||
| Otitis media acute | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Pharyngotonsillitis | 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 |
| ||
| Tonsillitis | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Varicella | Infections and infestations | Systematic Assessment |
| ||
| Varicella zoster virus infection | Infections and infestations | Systematic Assessment |
| ||
| Viral infection | Infections and infestations | Systematic Assessment |
| ||
| Viral rash | Infections and infestations | Systematic Assessment |
| ||
| Viral upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Arthropod bite | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Bite | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Foreign body in gastrointestinal tract | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Head injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Thermal burn | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vaccination complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Body temperature increased | Investigations | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Head deformity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Positional plagiocephaly | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Posture abnormal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Torticollis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Infantile haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Aphonia | Nervous system disorders | Systematic Assessment |
| ||
| External hydrocephalus | Nervous system disorders | Systematic Assessment |
| ||
| Epiphysiolysis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Emotional distress | Psychiatric disorders | Systematic Assessment |
| ||
| Irritability | Psychiatric disorders | Systematic Assessment |
| ||
| Genital labial adhesions | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Choking | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Acne | 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 diaper | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Erythema | 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 macular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pallor | Vascular disorders | Systematic Assessment |
| ||
| Peripheral coldness | Vascular disorders | Systematic Assessment |
| ||
| Injection site erythema | General disorders | Systematic Assessment |
| ||
| Injection site pain | General disorders | Systematic Assessment |
| ||
| Irritability postvaccinal | General disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system 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 | Jul 16, 2018 | Mar 7, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013742 | Tetanus |
| D011051 | Poliomyelitis |
| D004165 | Diphtheria |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
Not provided
Not provided
Not provided
| Male |
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| Asian - East Asian Heritage |
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| Asian - South East Asian Heritage |
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| White - Arabic / North African Heritage |
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| White - Caucasian / European Heritage |
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| Mixed origin |
|
| anti-FHA antibody |
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| anti-PRN antibody |
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