Tetanus, Acellular Pertussis, Diphtheria
Conditions
Brief summary
The aims of this trial are to demonstrate the consistency of three manufacturing lots of GSK Biologicals' DTaP-IPV candidate vaccine in terms of immunogenicity and to evaluate the non-inferiority of GSK Biologicals' DTaP-IPV vaccine with respect to immunogenicity and safety compared to the control vaccines (separate injections of GSK Biologicals' DTaP vaccine \[Infanrix\] and Aventis Pasteur's IPV vaccine \[IPOL\]) when administered as a 5th dose of DTaP and a 4th dose of inactivated poliovirus vaccine in subjects 4 to 6 years of age. Vaccines will be co-administered with the second dose of M-M-RII, which is recommended at this age. Concomitant administration of a US-licensed influenza vaccine will be allowed according to seasonal availability of vaccine and at the discretion of the investigator.
Detailed description
* Investigational groups: 3, each receive one of 3 lots of DTaP-IPV vaccine. * Control: US-licensed DTaP (Infanrix) + US-licensed IPV (IPOL) vaccines administered in separate injections. * Two study visits one month apart for a subset of subjects (Safety and Immunogenicity subset) with a blood draw at each visit. All other subjects will have one visit. * A telephone contact 4-6 days after vaccination for all subjects, a telephone contact 31-38 days after vaccination for the Safety only subset and a telephone contact for all subjects during the extended safety follow-up phase (5 months following the active phase).
Interventions
BIOLOGICALSB213503 lot 1
SB213503 lot 1 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
BIOLOGICALSB213503 lot 2
SB213503 lot 2 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
BIOLOGICALSB213503 lot 3
SB213503 lot 3 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
BIOLOGICALInfanrix
Infanrix vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
BIOLOGICALIPOL
IPOL vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.
BIOLOGICALM-M-R II
M-M-R II vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
The study was conducted in an open manner except for the consistency lots of SB213503 vaccine that were double-blinded.
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female child between and including 4 and 6 years of age at the time of vaccination. * Free of obvious health problems as established by medical history and brief medical evaluation before entering into the study. * Received 4 doses of Infanrix and 3 doses of IPOL during the first 2 years of life. * Vaccination against measles, mumps, and rubella in the second year of life. * Subjects whom the investigator believed would comply with the requirements of the protocol. * Written informed consent obtained before study entry from the parent(s) or guardian(s) of the subject.
Exclusion criteria
* Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period. * History of previous or intercurrent diphtheria, tetanus, pertussis, polio, measles, mumps, or rubella disease, or of vaccination against these diseases given after the second year of life. * Known exposure to diphtheria, tetanus, pertussis, or polio, prior to vaccination. * Poliovirus vaccination with one or more doses of OPV vaccine. * Administration or planned administration of a vaccine not foreseen by the study protocol within 30 days of study vaccination and ending at Day 30. * Chronic administration or administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period ending at Day 30. * Administration of immunoglobulins and/or any blood products within three months prior to study vaccination or planned administration during the study period ending at Day 30. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection. * History of seizures or progressive neurological disorder, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy. * Major congenital defects or serious chronic illness. * Acute disease at the time of enrollment. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including allergic reactions to 2-phenoxyethanol, formaldehyde, neomycin, polymyxin B, streptomycin, gelatin, and/or latex. * History of anaphylactic reaction to egg proteins or previous doses of the vaccine(s). * Encephalopathy within 7 days of administration of previous dose of Infanrix. * Fever ≥ 40.5°C or 104.9°F (rectal temperature) (39.5°C or 103.1°F, oral/axillary) within 48 hours of previous dose of Infanrix not due to another identifiable cause. * Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of previous dose of Infanrix. * Persistent, severe, inconsolable screaming or crying lasting ≥ 3 hours which occurred within 48 hours of administration of previous dose of Infanrix. * Thrombocytopenia following a previous dose of M-M-RII or its component vaccines. * Inability to contact a parent/guardian of the subject by telephone. * Blood dyscrasias (including current thrombocytopenia), leukemia, lymphomas or other malignant neoplasms affecting the bone marrow or lymphatic systems. * Family history of congenital or hereditary immunodeficiency, unless the immune competence of the subject was demonstrated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentrations (GMCs) for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies in a Subset of Subjects | At Month 1 (i.e. one month after vaccination) | GMCs were measured by Enzyme-Linked Immunosorbent assay (ELISA), expressed in international units per milliliter (IU/mL). |
| Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects | At Month 1 (i.e. one month after vaccination) | GMCs were measured by Enzyme-Linked Immunosorbent assay (ELISA), expressed in ELISA units per milliliter (EL.U/mL). |
| Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects | At Month 1 (i.e. one month after vaccination) | GMTs were measured by Neutralization assay and expressed in titers. |
| Number of Subjects With Booster Response Against Diphtheria Toxoid (D) and Tetanus Toxoid (T) Antigens in a Subset of Subjects | At Month 1 (i.e. one month after vaccination) | Vaccine response defined as: For initially seronegative subjects \[pre-booster antibody concentration below (\<) cut-off of 0.1 international units per milliliter (IU/mL)\] with an increase of at least four times the cut-off one month after vaccination \[post-booster antibody concentration greater than or equal to (≥) 0.4 IU/mL\]. For initially seropositive subjects (pre-booster antibody concentration ≥ 0.1 IU/mL) with an increase of at least four times the pre-booster antibody concentration one month after vaccination. |
| Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | At Month 1 (i.e. one month after vaccination) | Vaccine response defined as: For initially seronegative subjects \[pre-booster antibody concentration below (\<) cut-off of 5 EL.U/mL\] with an increase of at least four times the cut-off one month after vaccination (post-booster antibody concentration ≥ 20 EL.U/mL). For initially seropositive subjects with pre-booster antibody concentration ≥ 5 EL.U/mL and \< 20 EL.U/mL with an increase of at least 4 times the pre-booster antibody concentration one month after vaccination. For initially seropositive subjects with pre-booster antibody concentration ≥ 20 EL.U/mL with an increase of at least 2 times the pre-booster antibody concentration one month after vaccination. |
| Number of Subjects With Circumferential Swelling at the Injection Site | Within 4 days (Day 0-3) after vaccination | Swelling (at the SB213503 & Infanrix injection sites) was categorized as an increase of \> or ≤ 30 mm in mid upper arm circumference compared to baseline measurement or with an increase in mid upper arm missing; extent of swelling \> or ≤ 50 % of upper arm length, or diameter of injection site missing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | At Month 1 (i.e. one month after vaccination) | Seroconversion was defined as a post-vaccination haemagglutination-inhibition (HI) titer of ≥ 1:40 in an initially HI antibody seronegative subject (pre-vaccination HI titer \< 1:10), or a ≥ 4 fold rise in HI titer in an initially HI antibody seropositive subject (pre-vaccination HI titer ≥ 1:10) The 3 flu strains assessed were H1N1, H3N2, and B. |
| Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | At Day 0 (i.e. before vaccination) and at Month 1 (i.e. one month after vaccination) | A seroprotected subject is defined as a vaccinated subject with anti-H1N1, anti-H3N2, and anti-B antibody titers greater than or equal to (≥) 1:40. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 4-day (Day 0-3) post-vaccination period | Assessed solicited local symptoms were pain, redness, and swelling (at the SB213503 & Infanrix vaccination sites). Any = any symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = redness/swelling spreading up to or beyond 50 mm diameter. |
| Number of Subjects With Any and Grade 3 Increase in the Mid-upper Arm Circumference at the Injection Site | During the 4-day (Day 0-3) post-vaccination period | Assessed specific symptom was increase in mid upper arm circumference (at the SB213503 & Infanrix injection sites). Any = any symptom regardless of intensity grade. Grade 3 increase in mid upper arm circumference = mid upper arm circumference greater than 30 mm. |
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens in a Subset of Subjects | At Month 1 (i.e. one month after vaccination) | A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | During the 15-day (Day 0-14) post-vaccination period | Solicited general symptoms specific to M-M-R II vaccination were fever \[≥ 37.5 degrees Celsius (°C)\], rash/exanthem, parotid/salivary gland swelling, and suspected signs of meningism including febrile convulsions . Any = any symptom regardless of intensity grade. Grade 3 = symptom that prevented normal everyday activity. Related = considered by the investigator to be related to the vaccine. Grade 3 fever = fever \>39°C. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within 31 days (Days 0-30) 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) | During the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]) | Serious adverse events (SAEs) that were assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. |
| Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits | During the extended safety follow-up phase (i.e. 5 months following the active phase [from Day 31 up to minimum 182 days post-vaccination]) | Among assessed chronic illness(es) were: autoimmune disorders, asthma, type I diabetes, and allergies. AEs leading to emergency room (ER) visits or to physician office visits that were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis, and gastroenteritis. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Day 0-3) post-vaccination period | Assessed solicited general symptoms were drowsiness, fever (orally) \[≥ 37.5 degrees Celsius (°C)\] and loss of appetite. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = considered by the investigator to be related to the vaccine. Grade 3 fever = fever \>39°C. |
| Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | At Month 1 (i.e. one month after vaccination) | A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody titers greater than or equal to 1:8. |
| Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | At Month 1 (i.e. one month after vaccination) | A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL). |
| Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to (≥) 1 IU/mL | At Month 1 (i.e. one month after vaccination) | The number of subjects with anti-D and anti-T antibody concentrations greater than or equal to (≥) 1 IU/mL is reported. |
| Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | At Month 1 (i.e. one month after vaccination) | Vaccine response defined as: For initially seronegative subjects (pre-booster antibody titer below cut-off of 1:8), an antibody titer ≥ 1:32 at one month after vaccination. For initially seropositive subjects (pre-booster antibody titer ≥1:8), an increase at least four times the pre-booster antibody titer at one month after vaccination. |
| Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | At Day 0 (i.e. before vaccination) and at Month 1 (i.e. one month after vaccination) | GMTs were measured by hemagglutination inhibition assay and expressed in titers. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 24 centers in the United States.
Pre-assignment details
All 4209 subjects enrolled in the study, received the study vaccination and were included in the Total vaccination cohort (TVC).
Participants by arm
| Arm | Count |
|---|---|
| SB213503 Lot 1 + M-M-R Group Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid. | 1,053 |
| SB213503 Lot 2 + M-M-R Group Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid. | 1,051 |
| SB213503 Lot 3 + M-M-R Group Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid. | 1,052 |
| Infanrix + IPOL + M-M-R Group Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid. | 1,053 |
| Total | 4,209 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 17 | 24 | 18 | 22 |
| Overall Study | Other | 0 | 0 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | SB213503 Lot 1 + M-M-R Group | SB213503 Lot 2 + M-M-R Group | SB213503 Lot 3 + M-M-R Group | Infanrix + IPOL + M-M-R Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 4.2 Years STANDARD_DEVIATION 0.38 | 4.2 Years STANDARD_DEVIATION 0.37 | 4.2 Years STANDARD_DEVIATION 0.37 | 4.2 Years STANDARD_DEVIATION 0.38 | 4.2 Years STANDARD_DEVIATION 0.37 |
| Race/Ethnicity, Customized Race American Hispanic | 208 Participants | 201 Participants | 188 Participants | 194 Participants | 791 Participants |
| Race/Ethnicity, Customized Race Arabic/North African | 9 Participants | 5 Participants | 6 Participants | 10 Participants | 30 Participants |
| Race/Ethnicity, Customized Race Black | 65 Participants | 74 Participants | 77 Participants | 77 Participants | 293 Participants |
| Race/Ethnicity, Customized Race East/South East Asian | 83 Participants | 95 Participants | 75 Participants | 103 Participants | 356 Participants |
| Race/Ethnicity, Customized Race Japanese | 3 Participants | 5 Participants | 3 Participants | 4 Participants | 15 Participants |
| Race/Ethnicity, Customized Race Not specified | 151 Participants | 132 Participants | 162 Participants | 158 Participants | 603 Participants |
| Race/Ethnicity, Customized Race South Asian | 45 Participants | 51 Participants | 55 Participants | 50 Participants | 201 Participants |
| Race/Ethnicity, Customized Race White/Caucasian | 489 Participants | 488 Participants | 486 Participants | 457 Participants | 1920 Participants |
| Sex: Female, Male Female | 526 Participants | 515 Participants | 533 Participants | 513 Participants | 2087 Participants |
| Sex: Female, Male Male | 527 Participants | 536 Participants | 519 Participants | 540 Participants | 2122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,053 | 0 / 1,051 | 0 / 1,052 | 0 / 1,053 |
| other Total, other adverse events | 797 / 1,053 | 783 / 1,051 | 814 / 1,052 | 804 / 1,053 |
| serious Total, serious adverse events | 4 / 1,053 | 7 / 1,051 | 1 / 1,052 | 4 / 1,053 |
Outcome results
Primary
Geometric Mean Concentrations (GMCs) for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies in a Subset of Subjects
GMCs were measured by Enzyme-Linked Immunosorbent assay (ELISA), expressed in international units per milliliter (IU/mL).
Time frame: At Month 1 (i.e. one month after vaccination)
Population: The anaylsis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies in a Subset of Subjects | Anti-D | 16.704 IU/mL |
| SB213503 Lot 1 + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies in a Subset of Subjects | Anti-T | 9.693 IU/mL |
| SB213503 Lot 2 + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies in a Subset of Subjects | Anti-T | 9.974 IU/mL |
| SB213503 Lot 2 + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies in a Subset of Subjects | Anti-D | 18.658 IU/mL |
| SB213503 Lot 3 + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies in a Subset of Subjects | Anti-D | 18.437 IU/mL |
| SB213503 Lot 3 + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies in a Subset of Subjects | Anti-T | 11.300 IU/mL |
| Infanrix + IPOL + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies in a Subset of Subjects | Anti-D | 18.112 IU/mL |
| Infanrix + IPOL + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies in a Subset of Subjects | Anti-T | 11.235 IU/mL |
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.871, 1.08]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.863, 1.07]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.89, 1.103]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.866, 1.097]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.78, 0.988]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.8, 1.014]ANCOVA
Primary
Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects
GMCs were measured by Enzyme-Linked Immunosorbent assay (ELISA), expressed in ELISA units per milliliter (EL.U/mL).
Time frame: At Month 1 (i.e. one month after vaccination)
Population: The anaylsis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects | Anti-PT | 66.9 EL.U/mL |
| SB213503 Lot 1 + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects | Anti-PRN | 617.4 EL.U/mL |
| SB213503 Lot 1 + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects | Anti-FHA | 809.1 EL.U/mL |
| SB213503 Lot 2 + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects | Anti-PT | 74.1 EL.U/mL |
| SB213503 Lot 2 + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects | Anti-PRN | 584.7 EL.U/mL |
| SB213503 Lot 2 + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects | Anti-FHA | 918.8 EL.U/mL |
| SB213503 Lot 3 + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects | Anti-FHA | 869.2 EL.U/mL |
| SB213503 Lot 3 + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects | Anti-PT | 71.4 EL.U/mL |
| SB213503 Lot 3 + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects | Anti-PRN | 594.2 EL.U/mL |
| Infanrix + IPOL + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects | Anti-PT | 80.4 EL.U/mL |
| Infanrix + IPOL + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects | Anti-PRN | 593.8 EL.U/mL |
| Infanrix + IPOL + M-M-R Group | Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects | Anti-FHA | 939.7 EL.U/mL |
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.828, 1.063]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.85, 1.091]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.906, 1.162]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.783, 0.976]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.849, 1.057]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.971, 1.209]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.867, 1.148]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.907, 1.2]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.909, 1.202]ANCOVA
Primary
Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects
GMTs were measured by Neutralization assay and expressed in titers.
Time frame: At Month 1 (i.e. one month after vaccination)
Population: The anaylsis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects | Anti-poliovirus 1 | 2095.0 Titers |
| SB213503 Lot 1 + M-M-R Group | Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects | Anti-poliovirus 3 | 3683.5 Titers |
| SB213503 Lot 1 + M-M-R Group | Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects | Anti-poliovirus 2 | 2345.4 Titers |
| SB213503 Lot 2 + M-M-R Group | Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects | Anti-poliovirus 1 | 2103.1 Titers |
| SB213503 Lot 2 + M-M-R Group | Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects | Anti-poliovirus 3 | 3400.7 Titers |
| SB213503 Lot 2 + M-M-R Group | Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects | Anti-poliovirus 2 | 2132.9 Titers |
| SB213503 Lot 3 + M-M-R Group | Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects | Anti-poliovirus 1 | 2129.2 Titers |
| SB213503 Lot 3 + M-M-R Group | Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects | Anti-poliovirus 2 | 2326.6 Titers |
| SB213503 Lot 3 + M-M-R Group | Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects | Anti-poliovirus 3 | 3603.8 Titers |
| Infanrix + IPOL + M-M-R Group | Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects | Anti-poliovirus 1 | 1683.1 Titers |
| Infanrix + IPOL + M-M-R Group | Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects | Anti-poliovirus 3 | 3367.8 Titers |
| Infanrix + IPOL + M-M-R Group | Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects | Anti-poliovirus 2 | 1802.0 Titers |
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.836, 1.181]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.831, 1.172]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.836, 1.18]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.951, 1.314]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.856, 1.183]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.765, 1.06]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.941, 1.314]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.876, 1.22]ANCOVA
Comparison: The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.787, 1.099]ANCOVA
Comparison: Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 1 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.68, 0.922]ANCOVA
Comparison: Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 2 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.696, 0.925]ANCOVA
Comparison: Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 3 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [0.811, 1.085]ANCOVA
Primary
Number of Subjects With Booster Response Against Diphtheria Toxoid (D) and Tetanus Toxoid (T) Antigens in a Subset of Subjects
Vaccine response defined as: For initially seronegative subjects \[pre-booster antibody concentration below (\<) cut-off of 0.1 international units per milliliter (IU/mL)\] with an increase of at least four times the cut-off one month after vaccination \[post-booster antibody concentration greater than or equal to (≥) 0.4 IU/mL\]. For initially seropositive subjects (pre-booster antibody concentration ≥ 0.1 IU/mL) with an increase of at least four times the pre-booster antibody concentration one month after vaccination.
Time frame: At Month 1 (i.e. one month after vaccination)
Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Booster Response Against Diphtheria Toxoid (D) and Tetanus Toxoid (T) Antigens in a Subset of Subjects | Anti-D, Total | 279 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Booster Response Against Diphtheria Toxoid (D) and Tetanus Toxoid (T) Antigens in a Subset of Subjects | Anti-T, Total | 266 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Booster Response Against Diphtheria Toxoid (D) and Tetanus Toxoid (T) Antigens in a Subset of Subjects | Anti-T, Total | 273 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Booster Response Against Diphtheria Toxoid (D) and Tetanus Toxoid (T) Antigens in a Subset of Subjects | Anti-D, Total | 280 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Booster Response Against Diphtheria Toxoid (D) and Tetanus Toxoid (T) Antigens in a Subset of Subjects | Anti-D, Total | 281 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Booster Response Against Diphtheria Toxoid (D) and Tetanus Toxoid (T) Antigens in a Subset of Subjects | Anti-T, Total | 277 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Booster Response Against Diphtheria Toxoid (D) and Tetanus Toxoid (T) Antigens in a Subset of Subjects | Anti-D, Total | 260 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Booster Response Against Diphtheria Toxoid (D) and Tetanus Toxoid (T) Antigens in a Subset of Subjects | Anti-T, Total | 245 Participants |
Comparison: Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of diphtheria toxoid (D) booster responses (i.e measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [-0.98, 1.21]
Comparison: Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of tetanus toxoid (T) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [-6.55, -0.09]
Primary
Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects
Vaccine response defined as: For initially seronegative subjects \[pre-booster antibody concentration below (\<) cut-off of 5 EL.U/mL\] with an increase of at least four times the cut-off one month after vaccination (post-booster antibody concentration ≥ 20 EL.U/mL). For initially seropositive subjects with pre-booster antibody concentration ≥ 5 EL.U/mL and \< 20 EL.U/mL with an increase of at least 4 times the pre-booster antibody concentration one month after vaccination. For initially seropositive subjects with pre-booster antibody concentration ≥ 20 EL.U/mL with an increase of at least 2 times the pre-booster antibody concentration one month after vaccination.
Time frame: At Month 1 (i.e. one month after vaccination)
Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-PT, Total | 251 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-PRN, Total | 270 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-FHA, Total | 265 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-PT, Total | 250 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-PRN, Total | 277 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-FHA, Total | 272 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-FHA, Total | 268 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-PT, Total | 257 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-PRN, Total | 279 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-PT, Total | 237 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-PRN, Total | 253 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-FHA, Total | 251 Participants |
Comparison: Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of pertussis toxoid (PT) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [-3.83, 3.71]
Comparison: Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of filamentous haemagglutinin (FHA) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [-2.5, 3.21]
Comparison: Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of pertactin (PRN) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.95% CI: [-3.79, 1.14]
Primary
Number of Subjects With Circumferential Swelling at the Injection Site
Swelling (at the SB213503 & Infanrix injection sites) was categorized as an increase of \> or ≤ 30 mm in mid upper arm circumference compared to baseline measurement or with an increase in mid upper arm missing; extent of swelling \> or ≤ 50 % of upper arm length, or diameter of injection site missing.
Time frame: Within 4 days (Day 0-3) after vaccination
Population: The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Increase in mid upper arm;swelling>50% of length | 0 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase≤30mm;diameter missing | 0 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Increase in mid upper arm;diameter missing | 0 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase≤30mm;swelling>50% of length | 9 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase>30mm;diameter missing | 2 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase>30mm;swelling≤50% of length | 10 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Increase in mid upper arm;swelling≤50% of length | 0 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase≤30mm;swelling≤50% of length | 62 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase>30mm;swelling>50% of length | 5 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase≤30mm;swelling≤50% of length | 42 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Increase in mid upper arm;swelling>50% of length | 0 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase≤30mm;diameter missing | 0 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase>30mm;swelling≤50% of length | 20 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase>30mm;swelling>50% of length | 10 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase>30mm;diameter missing | 0 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Increase in mid upper arm;diameter missing | 0 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Increase in mid upper arm;swelling≤50% of length | 2 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase≤30mm;swelling>50% of length | 10 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase≤30mm;swelling≤50% of length | 52 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase>30mm;swelling>50% of length | 5 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase>30mm;swelling≤50% of length | 23 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase>30mm;diameter missing | 1 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase≤30mm;swelling>50% of length | 12 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase≤30mm;diameter missing | 0 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Increase in mid upper arm;swelling>50% of length | 0 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Increase in mid upper arm;swelling≤50% of length | 0 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Increase in mid upper arm;diameter missing | 0 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Increase in mid upper arm;swelling>50% of length | 0 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase≤30mm;swelling>50% of length | 12 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase>30mm;diameter missing | 1 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Increase in mid upper arm;diameter missing | 0 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Increase in mid upper arm;swelling≤50% of length | 0 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase>30mm;swelling≤50% of length | 22 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase≤30mm;diameter missing | 0 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase≤30mm;swelling≤50% of length | 54 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Circumferential Swelling at the Injection Site | Circumference increase>30mm;swelling>50% of length | 11 Participants |
Comparison: Non-inferiority of the SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of the incidence of increased circumferential swelling at the SB213503 and Infanrix injection site, defined as an injection site swelling diameter that involves \> 50% of the length of the upper arm that also is associated with a \> 30 mm increase of the mid-upper arm circumference compared to the baseline measurement.95% CI: [-1.26, 0.16]
Secondary
Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects
GMTs were measured by hemagglutination inhibition assay and expressed in titers.
Time frame: At Day 0 (i.e. before vaccination) and at Month 1 (i.e. one month after vaccination)
Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received concomitant influenza vaccine and for whom immunogenicity data were available for the analyzed antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-B, Day 0 | 160.0 Titers |
| SB213503 Lot 1 + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-H1N1, Month 1 | 57.0 Titers |
| SB213503 Lot 1 + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-B, Month 1 | 1810.0 Titers |
| SB213503 Lot 1 + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-H3N2, Day 0 | 1280.0 Titers |
| SB213503 Lot 1 + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-H3N2, Month 1 | 1280.0 Titers |
| SB213503 Lot 1 + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-H1N1, Day 0 | 5.0 Titers |
| SB213503 Lot 2 + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-H3N2, Day 0 | 80.0 Titers |
| SB213503 Lot 2 + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-H1N1, Day 0 | 20.0 Titers |
| SB213503 Lot 2 + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-B, Day 0 | 10.0 Titers |
| SB213503 Lot 2 + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-H3N2, Month 1 | 493.6 Titers |
| SB213503 Lot 2 + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-B, Month 1 | 95.1 Titers |
| SB213503 Lot 2 + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-H1N1, Month 1 | 134.5 Titers |
| SB213503 Lot 3 + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-B, Month 1 | 28.3 Titers |
| SB213503 Lot 3 + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-H1N1, Month 1 | 20.0 Titers |
| SB213503 Lot 3 + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-H3N2, Month 1 | 113.1 Titers |
| SB213503 Lot 3 + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-H3N2, Day 0 | 80.0 Titers |
| SB213503 Lot 3 + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-H1N1, Day 0 | 20.0 Titers |
| SB213503 Lot 3 + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-B, Day 0 | 7.1 Titers |
| Infanrix + IPOL + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-B, Month 1 | 226.3 Titers |
| Infanrix + IPOL + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-H1N1, Day 0 | 56.6 Titers |
| Infanrix + IPOL + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-H1N1, Month 1 | 226.3 Titers |
| Infanrix + IPOL + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-H3N2, Day 0 | 134.5 Titers |
| Infanrix + IPOL + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-H3N2, Month 1 | 538.1 Titers |
| Infanrix + IPOL + M-M-R Group | Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects | Anti-B, Day 0 | 10.0 Titers |
Secondary
Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects
Seroconversion was defined as a post-vaccination haemagglutination-inhibition (HI) titer of ≥ 1:40 in an initially HI antibody seronegative subject (pre-vaccination HI titer \< 1:10), or a ≥ 4 fold rise in HI titer in an initially HI antibody seropositive subject (pre-vaccination HI titer ≥ 1:10) The 3 flu strains assessed were H1N1, H3N2, and B.
Time frame: At Month 1 (i.e. one month after vaccination)
Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received concomitant influenza vaccine and for whom immunogenicity data were available for the analyzed antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H1N1 | 1 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-B | 1 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H3N2 | 0 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H1N1 | 2 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-B | 3 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H3N2 | 2 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H3N2 | 0 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H1N1 | 0 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-B | 1 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H1N1 | 1 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-B | 2 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H3N2 | 1 Participants |
Secondary
Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL).
Time frame: At Month 1 (i.e. one month after vaccination)
Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-PT | 285 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-PRN | 285 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-FHA | 285 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-PT | 279 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-PRN | 281 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-FHA | 280 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-FHA | 285 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-PT | 283 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-PRN | 285 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-PT | 261 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-PRN | 261 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects | Anti-FHA | 261 Participants |
Secondary
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens in a Subset of Subjects
A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Time frame: At Month 1 (i.e. one month after vaccination)
Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens in a Subset of Subjects | Anti-D | 284 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens in a Subset of Subjects | Anti-T | 284 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens in a Subset of Subjects | Anti-T | 283 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens in a Subset of Subjects | Anti-D | 282 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens in a Subset of Subjects | Anti-D | 284 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens in a Subset of Subjects | Anti-T | 284 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens in a Subset of Subjects | Anti-D | 260 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens in a Subset of Subjects | Anti-T | 261 Participants |
Secondary
Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects
A seroprotected subject is defined as a vaccinated subject with anti-H1N1, anti-H3N2, and anti-B antibody titers greater than or equal to (≥) 1:40.
Time frame: At Day 0 (i.e. before vaccination) and at Month 1 (i.e. one month after vaccination)
Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received concomitant influenza vaccine and for whom immunogenicity data were available for the analyzed antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H1N1, Day 0 | 0 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H1N1, Month 1 | 1 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H3N2, Day 0 | 1 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H3N2, Month 1 | 1 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-B, Day 0 | 1 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-B, Month 1 | 1 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-B, Month 1 | 3 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H3N2, Month 1 | 4 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H1N1, Day 0 | 1 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H3N2, Day 0 | 2 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H1N1, Month 1 | 4 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-B, Day 0 | 1 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H1N1, Month 1 | 1 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H3N2, Day 0 | 1 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H3N2, Month 1 | 1 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-B, Month 1 | 1 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-B, Day 0 | 0 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H1N1, Day 0 | 1 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-B, Day 0 | 0 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-B, Month 1 | 2 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H1N1, Month 1 | 2 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H3N2, Month 1 | 2 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H1N1, Day 0 | 1 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects | Anti-H3N2, Day 0 | 2 Participants |
Secondary
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects
A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody titers greater than or equal to 1:8.
Time frame: At Month 1 (i.e. one month after vaccination)
Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 1 | 275 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 3 | 271 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 2 | 276 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 1 | 274 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 3 | 259 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 2 | 273 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 2 | 269 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 1 | 275 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 3 | 268 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 1 | 249 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 3 | 239 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 2 | 252 Participants |
Secondary
Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to (≥) 1 IU/mL
The number of subjects with anti-D and anti-T antibody concentrations greater than or equal to (≥) 1 IU/mL is reported.
Time frame: At Month 1 (i.e. one month after vaccination)
Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to (≥) 1 IU/mL | Anti-D | 284 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to (≥) 1 IU/mL | Anti-T | 281 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to (≥) 1 IU/mL | Anti-T | 282 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to (≥) 1 IU/mL | Anti-D | 282 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to (≥) 1 IU/mL | Anti-D | 284 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to (≥) 1 IU/mL | Anti-T | 281 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to (≥) 1 IU/mL | Anti-D | 260 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to (≥) 1 IU/mL | Anti-T | 261 Participants |
Secondary
Number of Subjects With Any and Grade 3 Increase in the Mid-upper Arm Circumference at the Injection Site
Assessed specific symptom was increase in mid upper arm circumference (at the SB213503 & Infanrix injection sites). Any = any symptom regardless of intensity grade. Grade 3 increase in mid upper arm circumference = mid upper arm circumference greater than 30 mm.
Time frame: During the 4-day (Day 0-3) post-vaccination period
Population: The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any and Grade 3 Increase in the Mid-upper Arm Circumference at the Injection Site | Increase in mid-upper arm circumference, Any | 368 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any and Grade 3 Increase in the Mid-upper Arm Circumference at the Injection Site | Increase in mid-upper arm circumference, Grade 3 | 16 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any and Grade 3 Increase in the Mid-upper Arm Circumference at the Injection Site | Increase in mid-upper arm circumference, Grade 3 | 29 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any and Grade 3 Increase in the Mid-upper Arm Circumference at the Injection Site | Increase in mid-upper arm circumference, Any | 374 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any and Grade 3 Increase in the Mid-upper Arm Circumference at the Injection Site | Increase in mid-upper arm circumference, Any | 393 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any and Grade 3 Increase in the Mid-upper Arm Circumference at the Injection Site | Increase in mid-upper arm circumference, Grade 3 | 29 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any and Grade 3 Increase in the Mid-upper Arm Circumference at the Injection Site | Increase in mid-upper arm circumference, Any | 397 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any and Grade 3 Increase in the Mid-upper Arm Circumference at the Injection Site | Increase in mid-upper arm circumference, Grade 3 | 33 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness, and swelling (at the SB213503 & Infanrix vaccination sites). Any = any symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = redness/swelling spreading up to or beyond 50 mm diameter.
Time frame: During the 4-day (Day 0-3) post-vaccination period
Population: The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any | 620 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3 | 19 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Any | 391 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Grade 3 | 187 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any | 295 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Grade 3 | 111 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Grade 3 | 95 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Grade 3 | 186 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any | 582 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Any | 399 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3 | 17 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any | 266 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3 | 13 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Any | 412 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Grade 3 | 194 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Grade 3 | 118 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any | 291 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any | 642 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any | 296 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Grade 3 | 122 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3 | 7 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Grade 3 | 213 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any | 601 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Any | 423 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever (orally) \[≥ 37.5 degrees Celsius (°C)\] and loss of appetite. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = considered by the investigator to be related to the vaccine. Grade 3 fever = fever \>39°C.
Time frame: During the 4-day (Day 0-3) post-vaccination period
Population: The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Loss of appetite, Any | 162 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Related | 154 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Loss of appetite, Related | 127 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), ≥ 37.5 °C | 167 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Drowsiness, Related | 153 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Drowsiness, Grade 3 | 9 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Loss of appetite, Grade 3 | 11 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), > 39.0 °C | 9 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Drowsiness, Any | 194 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), > 39.0 °C | 8 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Loss of appetite, Any | 160 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Related | 136 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Drowsiness, Grade 3 | 10 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Drowsiness, Any | 216 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Drowsiness, Related | 166 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Loss of appetite, Related | 117 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Loss of appetite, Grade 3 | 6 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), ≥ 37.5 °C | 154 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), > 39.0 °C | 16 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Drowsiness, Any | 185 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Drowsiness, Grade 3 | 7 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Drowsiness, Related | 148 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), ≥ 37.5 °C | 166 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Related | 143 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Loss of appetite, Any | 162 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Loss of appetite, Grade 3 | 7 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Loss of appetite, Related | 130 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Loss of appetite, Any | 166 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), ≥ 37.5 °C | 147 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Drowsiness, Related | 141 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Loss of appetite, Related | 125 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Loss of appetite, Grade 3 | 6 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Drowsiness, Grade 3 | 8 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Related | 128 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), > 39.0 °C | 11 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Drowsiness, Any | 181 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination
Solicited general symptoms specific to M-M-R II vaccination were fever \[≥ 37.5 degrees Celsius (°C)\], rash/exanthem, parotid/salivary gland swelling, and suspected signs of meningism including febrile convulsions . Any = any symptom regardless of intensity grade. Grade 3 = symptom that prevented normal everyday activity. Related = considered by the investigator to be related to the vaccine. Grade 3 fever = fever \>39°C.
Time frame: During the 15-day (Day 0-14) post-vaccination period
Population: The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Suspected signs of meningism, Any | 7 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Parotitis, Any | 1 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Non-administration site rash, Related | 5 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Non-administration site rash, Measles/Rubella-like | 5 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Rash site, Any | 34 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Fever (orally), > 39.0°C | 22 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Fever (orally), ≥ 37.5°C | 213 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Non-administration site rash, Grade 3 | 0 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Fever (orally), Related | 169 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Rash site, Any | 44 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Non-administration site rash, Measles/Rubella-like | 4 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Non-administration site rash, Grade 3 | 0 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Non-administration site rash, Related | 6 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Parotitis, Any | 3 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Suspected signs of meningism, Any | 5 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Fever (orally), ≥ 37.5°C | 215 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Fever (orally), > 39.0°C | 25 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Fever (orally), Related | 155 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Parotitis, Any | 2 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Non-administration site rash, Grade 3 | 0 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Rash site, Any | 21 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Suspected signs of meningism, Any | 4 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Fever (orally), Related | 159 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Fever (orally), ≥ 37.5°C | 218 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Non-administration site rash, Measles/Rubella-like | 4 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Fever (orally), > 39.0°C | 36 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Non-administration site rash, Related | 4 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Non-administration site rash, Grade 3 | 0 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Fever (orally), Related | 140 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Rash site, Any | 36 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Fever (orally), > 39.0°C | 23 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Suspected signs of meningism, Any | 5 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Non-administration site rash, Measles/Rubella-like | 6 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Parotitis, Any | 3 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Non-administration site rash, Related | 4 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination | Fever (orally), ≥ 37.5°C | 208 Participants |
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.
Time frame: Within 31 days (Days 0-30) post-vaccination period
Population: The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 321 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 317 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 326 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 307 Participants |
Secondary
Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects
Vaccine response defined as: For initially seronegative subjects (pre-booster antibody titer below cut-off of 1:8), an antibody titer ≥ 1:32 at one month after vaccination. For initially seropositive subjects (pre-booster antibody titer ≥1:8), an increase at least four times the pre-booster antibody titer at one month after vaccination.
Time frame: At Month 1 (i.e. one month after vaccination)
Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 1, Total | 264 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 3, Total | 259 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 2, Total | 271 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 1, Total | 257 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 3, Total | 245 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 2, Total | 252 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 2, Total | 258 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 1, Total | 264 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 3, Total | 256 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 1, Total | 231 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 3, Total | 220 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects | Anti-poliovirus type 2, Total | 234 Participants |
Secondary
Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits
Among assessed chronic illness(es) were: autoimmune disorders, asthma, type I diabetes, and allergies. AEs leading to emergency room (ER) visits or to physician office visits that were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis, and gastroenteritis.
Time frame: During the extended safety follow-up phase (i.e. 5 months following the active phase [from Day 31 up to minimum 182 days post-vaccination])
Population: The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all vaccinated subjects who had a follow-up contact during the ESFU period/who reported an unsolicited AE as specified in the protocol/onset of a chronic illness/SAE beyond Day 30, after the last vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits | Chronic illness | 6 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits | Physician's office visit | 20 Participants |
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits | Emergency room visit | 7 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits | Chronic illness | 6 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits | Physician's office visit | 22 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits | Emergency room visit | 7 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits | Emergency room visit | 10 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits | Chronic illness | 4 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits | Physician's office visit | 22 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits | Chronic illness | 5 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits | Physician's office visit | 19 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits | Emergency room visit | 8 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) that were assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time frame: During the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination])
Population: The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB213503 Lot 1 + M-M-R Group | Number of Subjects With Serious Adverse Events (SAEs) | 4 Participants |
| SB213503 Lot 2 + M-M-R Group | Number of Subjects With Serious Adverse Events (SAEs) | 7 Participants |
| SB213503 Lot 3 + M-M-R Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| Infanrix + IPOL + M-M-R Group | Number of Subjects With Serious Adverse Events (SAEs) | 4 Participants |