| Primary | Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). The reference cut-off value was greater than or equal to (≥) 0.1 IU/mL. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and 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 | | At Month 1, one month post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polioâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Boostrix Polioâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | | OG001 | Tetravac Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravacâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Tetravacâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
| | | Title | Denominators | Categories |
|---|
| Anti-D | | | Title | Measurements |
|---|
| - OG0009.207(8.057 to 10.522)
- OG00121.393(19.165 to 23.88)
|
| | Anti-T | | |
| |
| Primary | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Antibody titers were presented as geometric mean titers (GMTs) for the assay cut-off ≥ the value of 8. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and 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 | | At Month 1, one month post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polioâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Boostrix Polioâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | | OG001 | Tetravac Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravacâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Tetravacâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
|
| Primary | Number of Seroprotected Subjects Against Polio Types 1, 2 and 3 | A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titers ≥ the value of 8. Antibody titers have been assessed by neutralization assay. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | | Count of Participants | | Participants | | At Month 1, one month post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polioâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Boostrix Polioâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | | OG001 | Tetravac Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravacâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Tetravacâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
|
| Primary | Number of Seropositive Subjects for Anti-D and Anti-T Antibodies | A seropositive subject was defined as a subject with anti-D and anti-T concentrations ≥ 0.1 IU/mL. Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | | Count of Participants | | Participants | | At Month 1, one month post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polioâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Boostrix Polioâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | | OG001 | Tetravac Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravacâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Tetravacâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
|
| Secondary | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | A seroprotected subject was defined as a subject with anti-D and anti-T concentrations ≥ 1.0 IU/mL. Antibody concentrations have been assessed by ELISA. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | | Count of Participants | | Participants | | At Month 1, one month post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polioâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Boostrix Polioâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | | OG001 | Tetravac Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravacâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Tetravacâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
|
| Secondary | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations, expressed in ELISA units per milliliter (EL.U/mL). The reference cut-off value was ≥ 5 EL.U/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and 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 | | At Month 1, one month post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polioâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Boostrix Polioâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | | OG001 | Tetravac Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravacâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Tetravacâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
|
| Secondary | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies | A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN concentrations ≥ 5.0 IU/mL. Antibody concentrations have been assessed by ELISA. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | | Count of Participants | | Participants | | At Month 1, one month post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polioâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Boostrix Polioâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | | OG001 | Tetravac Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravacâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Tetravacâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
|
| Secondary | Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella | Seropositivity was defined as: subjects with antibody concentrations ≥ 150 milli-international units per milliliter (mIU/mL), ≥ 231 units per milliliter (U/mL), ≥ 4 international units per milliliter (IU/mL) and ≥ 50 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella antibodies, respectively. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | | Count of Participants | | Participants | | At Month 1, one month post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polioâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Boostrix Polioâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | | OG001 | Tetravac Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravacâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Tetravacâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
|
| Secondary | Anti-measles and Anti-varicella Antibody Concentrations | Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in mIU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and 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 | mIU/mL | | At Month 1, one month post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polioâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Boostrix Polioâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | | OG001 | Tetravac Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravacâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Tetravacâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
|
| Secondary | Anti-mumps Antibody Concentrations | Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in U/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and 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 | U/mL | | At Month 1, one month post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polioâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Boostrix Polioâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | | OG001 | Tetravac Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravacâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Tetravacâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
|
| Secondary | Anti-rubella Antibody Concentrations | Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in IU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and 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 | | At Month 1, one month post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polioâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Boostrix Polioâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | | OG001 | Tetravac Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravacâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Tetravacâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
|
| Secondary | Number of Subjects With Booster Responses to Anti-D and Anti-T | Booster responses to anti-D and anti-T were defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 0.1 IU/mL), antibody concentrations at least four times the assay cut-off (post-vaccination concentration ≥ 0.4 IU/mL). For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL), an increase in antibody concentrations of at least four times the pre-vaccination concentration. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | | Count of Participants | | Participants | | At Month 1, one month post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polioâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Boostrix Polioâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | | OG001 | Tetravac Group | |
|
| Secondary | Number of Subjects With Booster Responses to Anti-polio Type 1, 2 and 3 | Booster response to the poliovirus antigens was defined as: For initially seronegative subjects (pre-vaccination antibody titre < cut-off of 8), antibody titre ≥ 32. For initially seropositive subjects (pre-vaccination antibody titres ≥ 8), an increase in antibody titres of at least four times the pre-vaccination titre. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | | Count of Participants | | Participants | | At Month 1, one month post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polioâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Boostrix Polioâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | | OG001 | Tetravac Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravacâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Tetravacâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
|
| Secondary | Number of Subjects With Booster Responses to Anti-PT, Anti-FHA and Anti-PRN | Booster response to the PT, FHA and PRN antigens was defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 5 EL.U/mL), antibody concentrations at least four times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL). For initially seropositive subjects with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL, an increase in antibody concentrations of at least four times the pre-vaccination concentration. For initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL, an increase in antibody concentrations of at least two times the pre-vaccination concentration. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | | Count of Participants | | Participants | | At Month 1, one month post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polioâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Boostrix Polioâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
|
| Secondary | Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella | Seroconversion for anti-measles, anti-mumps, anti-rubella and anti-varicella was defined as the appearance of antibodies after vaccination in subjects who were seronegative before vaccination. There were no seronegative subjects for anti-rubella antibodies, prior to vaccination. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | | Count of Participants | | Participants | | At Month 1, one month post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polioâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Boostrix Polioâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | | OG001 | Tetravac Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravacâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Tetravacâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
|
| 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. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-vaccination period | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polioâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Boostrix Polioâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | | OG001 | Tetravac Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravacâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Tetravacâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper 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. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-vaccination period | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polioâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Boostrix Polioâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | | OG001 | Tetravac Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravacâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Tetravacâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
|
| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 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. | Posted | | Count of Participants | | Participants | | During the 31-day (Days 0-30) post-vaccination period | | | | ID | Title | Description |
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| OG000 | Boostrix Polio Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polioâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Boostrix Polioâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | | OG001 | Tetravac Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravacâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Tetravacâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed 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. | Posted | | Count of Participants | | Participants | | During the whole study period (from Month 0 to Month 1) | | | | ID | Title | Description |
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| OG000 | Boostrix Polio Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polioâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Boostrix Polioâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | | OG001 | Tetravac Group | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrixâ„¢ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravacâ„¢ vaccine co-administered with a single dose of Priorix Tetraâ„¢ vaccine at Day 0. Tetravacâ„¢ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetraâ„¢ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
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