Influenza
Conditions
Keywords
H1N1, Influenza, Pandemic, GSK Bio's influenza vaccines GSK2340274A and GSK234072A
Brief summary
This study is designed to characterize the safety and immunogenicity of pandemic influenza (H1N1) candidate vaccines GSK2340274A and GSK234072A in children 3 to less than 10 years old.
Interventions
BIOLOGICALGSK Biologicals' GSK2340274A (two different formulations)
Intramuscular injection
BIOLOGICALGSK Biologicals' - GSK2340272A
Intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 9 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or pre-menarchal female children 3 to \< 10 years of age at the time of the study vaccination. Less than 10 years of age implies inclusion of children who have not reached their 10th birthday as of Day 0, the day of the study vaccine dose under this protocol. * Written informed consent obtained from the subject's parent/legally acceptable representative (LAR); written informed assent obtained from the subject if appropriate. * Good general health as established by medical history and clinical examination before entering into the study. * Subjects and/or parent(s)/LAR who the investigator believes can and will comply with the requirements of the protocol as documented by signature on the informed consent document (and, if appropriate, the informed assent document).
Exclusion criteria
* Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus. * Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine. * Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject or parent(s)/ LAR(s) unable/unlikely to provide accurate safety reports. * Presence of a temperature ≥ 38.0ºC by any route or method, or acute symptoms greater than mild severity on the scheduled date of vaccination. * Diagnosed with cancer, or treatment for cancer, within 3 years. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Receipt of systemic glucocorticoids within 1 month prior to study enrollment (day of study vaccination), or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed. * Receipt of any immunoglobulins and/or any blood products within 6 months of study enrollment or planned administration of any of these products during the study period. * Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible. * Administration of any licensed live-attenuated vaccine within 30 days before study vaccination or any licensed inactivated vaccine within 15 days before study vaccination. * Planned administration of any A/California H1N1v-like vaccine other than the study vaccine between Day 0 and the Day 21 phlebotomy. * Planned administration of any other vaccine not foreseen by the study protocol between Day 0 and Day 21. Routine childhood vaccinations are exempted if they cannot be delayed, but they must not be administered on the same day as the H1N1 vaccine candidate. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding study vaccination, or planned use during the study period. * Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. * Child in care (A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Strain | At Day 21 | Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer below (\<) 10 and a post-vaccination reciprocal titre greater than or equal to (≥) 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance. The CBER criterion was fulfilled if the lower 95% confidence interval (CI) for SCR was (\>) 40%. The CHMP criterion was fulfilled if the point estimate for SCR was \> 40%. |
| Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | At Day 0 | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was \> 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%. |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | At Day 21 | GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CHMP criterion was fulfilled if the point estimate for GMFR was \> 2.5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value | At Day 21 | The cut-off value for the humoral immune response in terms of vaccine H1N1 HI antibodies were egual to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. |
| HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain | At Day 21 | Titers are presented as geometric mean titers (GMTs), for the seropositivity cut-off value of ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain for children less than 6 years= cried when limb was moved/spontaneously painful. Grade 3 pain for children aged 6 to \< 10 years= pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)\]. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness= drowsiness that prevented normal activity. Grade 3 irritability= crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever \> 39.0 °C or \> 40.0 °C. Related= general symptom assessed by the investigator as causally related to the vaccination. This outcome measure refers to subjects aged 3 to 5 years. |
| Number of Subjects With Medically-attended Adverse Events (MAEs) | Up to day 21 | 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. Analysis of intensity and relationship to vaccination of MAEs was not performed. |
| Number of Seroconverted Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | At Day 182 | Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for SCR was \> 40%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SCR was \> 40%. |
| Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | Up to Day 21 | 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. |
| Number of Subjects With pIMDs | During the entire study period (Day 0 to Day 182) | 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. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | Within the 21-day (Days 0-20) post-vaccination period | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | Up to 21 days after vaccination | 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. |
| Number of Subjects With MAEs | During the entire study period (Day 0 to Day 182) | 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. Analysis of intensity and relationship to vaccination of MAEs was not performed. |
| Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | At Day 0 and Day 182 | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was \> 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%. |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | At Day 182 | GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CHMP criterion was fulfilled if the post-vaccination point estimate for SCF was \> 2.5. |
Countries
Philippines, Thailand
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| Arepanrix 1/2 Group Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm. | 76 |
| Pandemrix 1/2 Group Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm. | 75 |
| Arepanrix Group Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm. | 58 |
| Total | 209 |
Baseline characteristics
| Characteristic | Arepanrix 1/2 Group | Pandemrix 1/2 Group | Arepanrix Group | Total |
|---|---|---|---|---|
| Age, Continuous | 6 Years STANDARD_DEVIATION 2.03 | 6 Years STANDARD_DEVIATION 2.02 | 6 Years STANDARD_DEVIATION 2 | 6 Years STANDARD_DEVIATION 2.01 |
| Race/Ethnicity, Customized Asian-Central/South Asian heritage | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian-East Asian heritage | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian-South East Asian heritage | 76 Participants | 74 Participants | 57 Participants | 207 Participants |
| Sex: Female, Male Female | 30 Participants | 38 Participants | 27 Participants | 95 Participants |
| Sex: Female, Male Male | 46 Participants | 37 Participants | 31 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 75 | 0 / 58 |
| other Total, other adverse events | 52 / 76 | 52 / 75 | 35 / 58 |
| serious Total, serious adverse events | 1 / 76 | 0 / 75 | 1 / 58 |
Outcome results
Primary
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CHMP criterion was fulfilled if the point estimate for GMFR was \> 2.5.
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arepanrix 1/2 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 25.7 Fold increase |
| Pandemrix 1/2 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 27.1 Fold increase |
| Arepanrix Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 32.2 Fold increase |
Primary
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer below (\<) 10 and a post-vaccination reciprocal titre greater than or equal to (≥) 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance. The CBER criterion was fulfilled if the lower 95% confidence interval (CI) for SCR was (\>) 40%. The CHMP criterion was fulfilled if the point estimate for SCR was \> 40%.
Time frame: At Day 21
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 1/2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 75 Participants |
| Pandemrix 1/2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 74 Participants |
| Arepanrix Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 57 Participants |
Primary
Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was \> 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%.
Time frame: At Day 0
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 1/2 Group | Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 28 Participants |
| Pandemrix 1/2 Group | Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 24 Participants |
| Arepanrix Group | Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 18 Participants |
Primary
Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was \> 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%.
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjeects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 1/2 Group | Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 75 Participants |
| Pandemrix 1/2 Group | Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 74 Participants |
| Arepanrix Group | Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 57 Participants |
Secondary
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CHMP criterion was fulfilled if the post-vaccination point estimate for SCF was \> 2.5.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arepanrix 1/2 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 6.6 Fold increase |
| Pandemrix 1/2 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 8 Fold increase |
| Arepanrix Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 8.9 Fold increase |
Secondary
HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain
Titers are presented as geometric mean titers (GMTs), for the seropositivity cut-off value of ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arepanrix 1/2 Group | HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain | 448.6 Titers |
| Pandemrix 1/2 Group | HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain | 434.1 Titers |
| Arepanrix Group | HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain | 418.8 Titers |
Comparison: To demonstrate the immunological equivalence of HA antigen adjuvanted with AS03B manufactured in Quebec (Arepanrix™) and HA antigen adjuvanted with AS03B manufactured in Dresden (Pandemrix™), 21 days after vaccination.95% CI: [0.73, 1.26]
Secondary
HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain
Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arepanrix 1/2 Group | HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain | 117.4 Titers |
| Pandemrix 1/2 Group | HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain | 128.3 Titers |
| Arepanrix Group | HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain | 115.7 Titers |
Secondary
Number of Seroconverted Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for SCR was \> 40%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SCR was \> 40%.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 1/2 Group | Number of Seroconverted Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 46 Participants |
| Pandemrix 1/2 Group | Number of Seroconverted Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 53 Participants |
| Arepanrix Group | Number of Seroconverted Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 40 Participants |
Secondary
Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was \> 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%.
Time frame: At Day 0 and Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix 1/2 Group | Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | Flu A/CAL/7/09, Day 0 | 27 Participants |
| Arepanrix 1/2 Group | Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | Flu A/CAL/7/09, Day 182 | 55 Participants |
| Pandemrix 1/2 Group | Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | Flu A/CAL/7/09, Day 0 | 24 Participants |
| Pandemrix 1/2 Group | Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | Flu A/CAL/7/09, Day 182 | 63 Participants |
| Arepanrix Group | Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | Flu A/CAL/7/09, Day 0 | 18 Participants |
| Arepanrix Group | Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | Flu A/CAL/7/09, Day 182 | 46 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain for children less than 6 years= cried when limb was moved/spontaneously painful. Grade 3 pain for children aged 6 to \< 10 years= pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix 1/2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 41 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 3 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 0 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 1 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 41 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 5 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 1 Participants |
| Arepanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| Arepanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 0 Participants |
| Arepanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Arepanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Arepanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 23 Participants |
| Arepanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 1 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever \[defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)\]. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom= symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C, but ≤ 40.0 °C. Related= general symptom assessed by the investigator as causally related to the vaccination. This outcome measure refers to subjects aged 6 to 10 years.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects aged 6 to 10 years who received the study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain at other location | 5 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 0 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 1 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 4 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 7 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 0 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 4 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating | 1 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal | 1 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 1 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches | 0 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal | 2 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 1 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 1 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating | 2 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches | 6 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 1 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 4 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain at other location | 1 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating | 0 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain at other location | 1 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal | 0 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 1 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches | 1 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 9 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating | 1 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 2 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 3 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal | 1 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain at other location | 1 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain at other location | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain at other location | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches | 7 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches | 1 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 2 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain at other location | 4 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain at other location | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain at other location | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches | 5 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 2 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 4 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)\]. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness= drowsiness that prevented normal activity. Grade 3 irritability= crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever \> 39.0 °C or \> 40.0 °C. Related= general symptom assessed by the investigator as causally related to the vaccination. This outcome measure refers to subjects aged 3 to 5 years.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects aged 3 to 5 years who received the study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 1 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite | 1 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 1 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 0 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite | 6 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 0 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 2 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 1 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 2 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 0 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite | 1 Participants |
| Arepanrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 5 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite | 2 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 2 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 5 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 3 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 2 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 5 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 2 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite | 1 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 7 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite | 4 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 2 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite | 1 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 1 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 1 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 5 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 1 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 0 Participants |
Secondary
Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value
The cut-off value for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 1/2 Group | Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value | 72 Participants |
| Pandemrix 1/2 Group | Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value | 72 Participants |
| Arepanrix Group | Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value | 58 Participants |
Secondary
Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value
The cut-off value for the humoral immune response in terms of vaccine H1N1 HI antibodies were egual to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 1/2 Group | Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value | 76 Participants |
| Pandemrix 1/2 Group | Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value | 75 Participants |
| Arepanrix Group | Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value | 58 Participants |
Secondary
Number of Subjects With 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. Analysis of intensity and relationship to vaccination of MAEs was not performed.
Time frame: During the entire study period (Day 0 to Day 182)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 1/2 Group | Number of Subjects With MAEs | 29 Participants |
| Pandemrix 1/2 Group | Number of Subjects With MAEs | 29 Participants |
| Arepanrix Group | Number of Subjects With MAEs | 18 Participants |
Secondary
Number of Subjects With 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. Analysis of intensity and relationship to vaccination of MAEs was not performed.
Time frame: Up to day 21
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 1/2 Group | Number of Subjects With Medically-attended Adverse Events (MAEs) | 14 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Medically-attended Adverse Events (MAEs) | 9 Participants |
| Arepanrix Group | Number of Subjects With Medically-attended Adverse Events (MAEs) | 1 Participants |
Secondary
Number of Subjects With 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.
Time frame: During the entire study period (Day 0 to Day 182)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 1/2 Group | Number of Subjects With pIMDs | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With pIMDs | 0 Participants |
| Arepanrix Group | Number of Subjects With pIMDs | 0 Participants |
Secondary
Number of Subjects With 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.
Time frame: Up to Day 21
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 1/2 Group | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| Arepanrix Group | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
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.
Time frame: Up to 21 days after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 1/2 Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Arepanrix Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
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.
Time frame: During the entire study period (Day 0 to Day 182)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 1/2 Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Arepanrix Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Number of Subjects With 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.
Time frame: Within the 21-day (Days 0-20) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 1/2 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 22 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 21 Participants |
| Arepanrix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 5 Participants |
Secondary
Number of Subjects With 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.
Time frame: Within the 42-day (Days 0-41) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 1/2 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 28 Participants |
| Pandemrix 1/2 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 28 Participants |
| Arepanrix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 23 Participants |