| Primary | Number of Subjects With Any Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Grade 3 Pain: Pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) follow-up period after booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix-Polio Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | Boostrix + IPV Mérieux Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. |
| | | Title | Denominators | Categories |
|---|
| Grade 3 Pain | | | | Grade 3 Redness (mm) | | |
| |
| Secondary | Number of Subjects With Any Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) follow-up period after booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix-Polio Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | Boostrix + IPV Mérieux Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. |
| |
| Secondary | Number of Subjects With Any Solicited General Symptoms | Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and who had the symptoms sheet filled in. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) follow-up period after booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix-Polio Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | Boostrix + IPV Mérieux Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. |
| |
| Secondary | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids | Anti-D and anti-T antibody concnetration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL have been assessed by enzyme-linked immunosorbent assay (ELISA). Pre-vaccination sera with ELISA concentrations < 0.1 IU/mL were tested for neutralising antibodies using a Vero-cell neutralisation assay with a 0.016 IU/mL cut-off. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | | Count of Participants | | Participants | | Prior to (Month 0) and one month after (Month 1) booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix-Polio Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | Boostrix + IPV Mérieux Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Secondary | Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrixâ„¢-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Prior to (Month 0) and one month after (Month 1) booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix-Polio Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | Boostrix + IPV Mérieux Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. |
| |
| Secondary | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milliliter (EL.U/ml). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | | Count of Participants | | Participants | | Prior to (Month 0) and one month after (Month 1) booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix-Polio Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | Boostrix + IPV Mérieux Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Secondary | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Antibodies concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrixâ„¢-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | Prior to (Month 0) and one month after (Month 1) booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix-Polio Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | Boostrix + IPV Mérieux Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. |
| |
| Secondary | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ the value of 8. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | | Count of Participants | | Participants | | Prior to (Month 0) and one month after (Month 1) booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix-Polio Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | Boostrix + IPV Mérieux Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. |
| |
| Secondary | Anti-Polio 1, 2 and 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrixâ„¢-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior to (Month 0) and one month after (Month 1) booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix-Polio Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | Boostrix + IPV Mérieux Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. |
| |
| Secondary | Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Booster vaccine response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrixâ„¢-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | | Count of Participants | | Participants | | One month after booster vaccination (At Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix-Polio Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | Boostrix + IPV Mérieux Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) | AEs results are presented for all subjects. 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 was 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, which included all vaccinated subjects for whom data were available. | Posted | | Count of Participants | | Participants | | During the 31-day (Days 0-30) follow-up period after booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix-Polio Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | Boostrix + IPV Mérieux Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | | Count of Participants | | Participants | | During the entire booster period (Month 0 to Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix-Polio Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | Boostrix + IPV Mérieux Group | Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. |
| |