| Primary | Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (<) 10 and a post-vaccination reciprocal HI titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | At Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG002 | GSK2340273A/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG003 | GSK2340273A/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
| | Units | Counts |
|---|
| Participants | - OG00063
- OG00155
- OG00258
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00060
- OG00153
- OG00245
- OG003
|
|
| |
| Primary | Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Primary | Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Primary | Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Primary | Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Primary | Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis | A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus. | The analysis was performed on the Total Vaccinated Cohort at Day 21, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Primary | Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis | A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus. | The analysis was performed on the Total Vaccinated Cohort at Day 21, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | At Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Primary | Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis | A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Primary | Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis | A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Primary | Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis | A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Primary | Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis | A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Primary | Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - First Analysis | A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Primary | Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis | A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Primary | Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - Second Analysis | A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Primary | Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis | A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Primary | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis | SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Fold change | | At Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Primary | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis | SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Fold change | | At Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Primary | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis | SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Fold change | | At Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Primary | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis | SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Fold change | | At Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Primary | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis | SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Fold change | | At Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Seropositive Subjects for HI Antibodies - Preliminary Analysis | A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | At Day 0 (PRE) and at Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Seropositive Subjects for HI Antibodies - First Analysis | A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 0 (PRE) and at Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Seropositive Subjects for HI Antibodies - Second Analysis | A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 0 (PRE) and at Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Seropositive Subjects for HI Antibodies - First Analysis | A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 0 (PRE) and at Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Seropositive Subjects for HI Antibodies - Second Analysis | A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 0 (PRE) and at Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Seropositive Subjects for HI Antibodies | A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 0 (PRE) and at Day 182 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis | Titers are presented as geometric mean titers (GMTs) and measured in titers. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Day 0 (PRE) and at Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis | Titers are presented as geometric mean titers (GMTs) and measured in titers. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Day 0 (PRE) and at Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis | Titers are presented as geometric mean titers (GMTs) and measured in titers. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Day 0 (PRE) and at Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis | Titers are presented as geometric mean titers (GMTs) and measured in titers. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Day 0 (PRE) and at Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis | Titers are presented as geometric mean titers (GMTs) and measured in titers. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Day 0 (PRE) and at Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain | Titers are presented as geometric mean titers (GMTs) and measured in titers. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Day 0 (PRE) and at Day 182 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (<) 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 182 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain | A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 0 (PRE) and at Day 182 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain | SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Fold change | | At Day 182 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain | A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8. The vaccine strain assessed was Flu A/Neth/602/09 H1N1. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 0 (PRE) and at Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain | Titers are presented as geometric mean titers (GMTs) and measured in titers. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Day 0 (PRE) and at Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain | A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8. The vaccine strain assessed was Flu A/Neth/602/09 H1N1. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 0 (PRE) and at Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain | Titers are presented as geometric mean titers (GMTs) and measured in titers. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Day 0 (PRE) and at Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations | Vaccine responses are defined as the incidence rate of vaccinated subjects with at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination. The vaccine strain assessed was Flu A/Neth/602/09 H1N1. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 0 (PRE) and at Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations | Vaccine response was defined as at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination. The vaccine strain assessed was Flu A/Neth/602/09. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Day 0 (PRE) and at Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Preliminary Analysis | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 6M-5Y Group | Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F1 6Y-9Y Group | Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 6M-5Y Group | Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F1 6Y-9Y Group | Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 6M-35M Group | Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F1 3Y-5Y Group | Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 6M-5Y Group | Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 6M-5Y Group | Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating, temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 6Y-9Y Group | Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 6Y-9Y Group | Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 6M-5Y Group | Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 6M-5Y Group | Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, and shivering, sweating, temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (° C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 6Y-9Y Group | Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 6Y-9Y Group | |
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| Secondary | Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 6M-35M Group | Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F1 3Y-5Y Group | Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 6Y-9Y Group | Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 6Y-9Y Group | |
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| Secondary | Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis | Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | At Day 0 (PRE), at Day 7 and at Day 21 | | | | ID | Title | Description |
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| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis | Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | At Day 0 (PRE), at Day 7 and at Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Subjects With Haematological Laboratory Abnormalities - First Analysis | Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | At Day 0 (PRE), at Day 7, at Day 21 and at Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis | Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | At Day 0 (PRE), at Day 7, at Day 21 and at Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis | Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC], Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | At Day 0 (PRE), at Day 7 and at Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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| Secondary | Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis | Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | At Day 0 (PRE), at Day 7, at Day 21 and at Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Secondary | Number of Subjects With Haematological Laboratory Abnormalities | Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | At Day 182 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Secondary | Number of Subjects With Biochemical Laboratory Abnormalities | Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | At Day 182 | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) - Preliminary Analysis | 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 who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | Within 21 days (Days 0-20) post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) - First Analysis | 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 who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | Within 42 days (Days 0-41) post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) - Second Analysis | 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 who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | Within 41 days (Days 0-40) post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| 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 who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | Within 84 days (Days 0-83) post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Secondary | Number of Subjects With Any Medically-attended Adverse Events (MAEs) - Preliminary Analysis | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | Within 21 days (Days 0-20) post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Secondary | Number of Subjects With Any Medically-attended Adverse Events (MAEs) - First Analysis | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | Within 41 days (Days 0-40) post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Secondary | Number of Subjects With Any Medically-attended Adverse Events (MAEs) - Second Analysis | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | Within 42 days (Days 0-41) post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Secondary | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | Within 182 days (Days 0-181) post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Secondary | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | Throughout the entire study period (Day 0 - Day 385) | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Secondary | Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Preliminary Analysis | Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | Within 21 days (Days 0-20) post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Secondary | Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - First Analysis | Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | Within 42 days (Days 0-41) post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Secondary | Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Second Analysis | Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | Within 42 days (Days 0-41) post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Secondary | Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) | Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | Within 182 days (Days 0-181) post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Secondary | Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) | Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | Throughout the entire study period (Day 0 - Day 385) | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) - Preliminary Analysis | 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 who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | Within 21 days (Days 0-20) post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) - First Analysis | 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 who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | Within 42 days (Days 0-41) post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) - Second Analysis | 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 who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | Within 42 days (Day 0-41) post vaccination | | | | ID | Title | Description |
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| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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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 who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | Within 182 days (Days 0-181) post vaccination | | | | ID | Title | Description |
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| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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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 who received at least 1 study vaccination. | Posted | | Count of Participants | | Participants | | Throughout the entire study period (Day 0 - Day 385) | | | | ID | Title | Description |
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| OG000 | Arepanrix/F1 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). | | OG001 | Arepanrix/F2 Group | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrixâ„¢-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
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