| Primary | Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens | Booster response was defined as: For initially seronegative subjects [i.e. pre-vaccination concentration below (<) cut-off value of 0.1 international units per milliliter (IU/mL)] antibody concentrations at least four times the assay cut-off [post vaccination concentration greater than or equal to (≥) 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 booster vaccination concentration. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Count of Participants | | Participants | | At Month 1, one month after the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
| | | Title | Denominators | Categories |
|---|
| Anti-D | - ParticipantsOG000177
- ParticipantsOG00190
| |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Non-inferiority in terms of booster response to D | Standardized asymptotic | | | | Percentage difference | 0.56 | | | 2-Sided | 95 | -3.55 | 3.14 | | | | | Non-Inferiority | To assess the Non-inferiority of the Boostrix Polio Group compared to the Repevax Group in terms of booster response to diphtheria, standardized asymptotic 95% CI for the groups'difference [Repevax Group minus Boostrix Polio Group] was computed. Non-inferiority criterion: Upper limit of the 95% CI of the groups' difference in booster response rate ≤10%. |
|
| Primary | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Month 1, one month after the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
|
| Primary | Anti-Polio Virus Type 1, 2 and 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 1, one month after the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
|
| Secondary | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | A seroprotected subject was defined a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per millilitre (IU/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Count of Participants | | Participants | | Before (Month 0) and one month after (Month 1) the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
|
| Secondary | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | A seropositive subject for anti-PT, anti-FHA and anti-PRN was a subject whose antibody concentration was ≥ 5 EL.U/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Count of Participants | | Participants | | Before (Month 0) and one month after (Month 1) the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
|
| Secondary | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | A seroprotected subject was defined as a subject with anti-polio type 1, 2 and 3 antibody titres ≥ the value of 8. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Count of Participants | | Participants | | Before (Month 0) and one month after (Month 1) the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
|
| Secondary | Number of Seropositive Subjects for Anti-measles Antibody | A seropositive subject was defined as a subject with anti-measles antibody titers ≥ 150 mIU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Count of Participants | | Participants | | Before (Month 0) and one month after (Month 1) the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
|
| Secondary | Number of Seropositive Subjects for Anti-mumps Antibody | A seropositive subject was defined as a subject with anti-mumps antibody titers ≥ 231 U/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Count of Participants | | Participants | | Before (Month 0) and one month after (Month 1) the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
|
| Secondary | Number of Seropositive Subjects for Anti-rubella Antibody | A seropositive subject was defined as a subject with anti-rubella antibody titers ≥ 4 IU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Count of Participants | | Participants | | Before (Month 0) and one month after (Month 1) the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
|
| Secondary | Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Before (Month 0) and one month after (Month 1) the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
|
| Secondary | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Month 0, before the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
|
| Secondary | Anti-mumps Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in U/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | U/mL | | Before (Month 0) and one month after (Month 1) the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
|
| Secondary | Anti-measles Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | Before (Month 0) and one month after (Month 1) the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
|
| Secondary | Anti-rubella Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Before (Month 0) and one month after (Month 1) the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
|
| Secondary | Anti-Polio Type 1, 2 and 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 0, before the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
|
| Secondary | Number of Subjects With a Booster Response to PT, FHA and PRN Antigens | Booster response was defined as: For initially seronegative subjects (pre-vaccination concentration < 5 EL.U/mL), antibody concentrations at least four times the assay 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 booster 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 booster vaccination concentration. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Count of Participants | | Participants | | At Month 1, one month after the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 |
|
| Secondary | Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens | Booster response defined as: For initially seronegative subjects, antibody titers at least four times the cut-off (post-vaccination titer ≥ 32); For initially seropositive subjects, an increase in antibody titers of at least four times the Pre booster vaccination titer. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Count of Participants | | Participants | | At Month 1, one month after the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
|
| Secondary | Number of Seroconverted Subjects for Anti-measles | Seroconversion for anti-measles was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative [with antibody concentrations ≥ 150 milli-international units per millilitre (mIU/mL)]. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Count of Participants | | Participants | | Before (Month 0) and one month after (Month 1) the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
|
| Secondary | Number of Seroconverted Subjects for Anti-mumps | Seroconversion for anti-mumps was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative [with antibody concentrations ≥ 231 units per millilitre (U/mL)]. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Count of Participants | | Participants | | Before (Month 0) and one month after (Month 1) the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right 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 subjects with at least one vaccine administration documented, who had their symptoms sheet filled in and 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 |
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| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
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| Secondary | Number of Subjects With Any Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite 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 subjects with at least one vaccine administration documented, who had their symptoms sheet filled in and 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 |
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| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
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| 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 subjects with at least one vaccine administration documented and 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 |
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| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | |
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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 subjects with at least one vaccine administration documented and for whom data were available. | Posted | | Count of Participants | | Participants | | During the entire study period (From Day 0 to Month 1) | | | | ID | Title | Description |
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| OG000 | Boostrix Polio Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | | OG001 | Repevax Group | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
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