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Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00148941
Collaborator
(none)
4,209
Enrollment
24
Locations
4
Arms
22.9
Actual Duration (Months)
175.4
Patients Per Site
7.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: SB213503 lot 1
  • Biological: SB213503 lot 2
  • Biological: SB213503 lot 3
  • Biological: Infanrix
  • Biological: IPOL
  • Biological: M-M-R II
 Phase 3

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
4209 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
The study was conducted in an open manner except for the consistency lots of SB213503 vaccine that were double-blinded.
Primary Purpose:
Prevention
Official Title:
Safety, Immunogenicity and Consistency of 3 Manufacturing Lots of DTaP-IPV Vaccine Versus Separate Injections of GSK Biologicals' DTaP + Aventis Pasteur's IPV Administered as Booster Doses to Healthy Children 4-6 Years, Each Co-administered With Merck's MMR Vaccine
Actual Study Start Date :
Jan 6, 2005
Actual Primary Completion Date :
Nov 1, 2006
Actual Study Completion Date :
Dec 4, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Biological: SB213503 lot 1
SB213503 lot 1 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
Other Names:
  • GSK Biologicals combined diphteria, tetanus, acellular pertussis and inactivated poliovirus lot 1 vaccine

    • Biological: M-M-R II
    M-M-R II vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.
    Other Names:
  • Merck and Company licensed combined measles-mumps-rubella vaccine

    		•
    Experimental: 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.

    Biological: SB213503 lot 2
    SB213503 lot 2 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
    Other Names:
  • GSK Biologicals combined diphteria, tetanus, acellular pertussis and inactivated poliovirus lot 2 vaccine

    • Biological: M-M-R II
    M-M-R II vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.
    Other Names:
  • Merck and Company licensed combined measles-mumps-rubella vaccine

    		•
    Experimental: 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.

    Biological: SB213503 lot 3
    SB213503 lot 3 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
    Other Names:
  • GSK Biologicals combined diphteria, tetanus, acellular pertussis and inactivated poliovirus lot 3 vaccine

    • Biological: M-M-R II
    M-M-R II vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.
    Other Names:
  • Merck and Company licensed combined measles-mumps-rubella vaccine

    		•
    Active Comparator: 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.

    Biological: Infanrix
    Infanrix vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
    Other Names:
  • GSK Biologicals combined diphteria, tetanus, acellular pertussis vaccine

    • Biological: IPOL
    IPOL vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.
    Other Names:
  • Aventis Pasteur inactivated poliovirus vaccine

    • Biological: M-M-R II
    M-M-R II vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.
    Other Names:
  • Merck and Company licensed combined measles-mumps-rubella vaccine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. 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).

    3. 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.

    4. 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.

    5. 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.

    6. 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 Outcome Measures

    1. 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).

    2. 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.

    3. 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).

    4. 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.

    5. 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.

    6. 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.

    7. 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.

    8. 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.

    9. 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.

    10. 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.

    11. 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.

    12. 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.

    13. 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.

    14. 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.

    15. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 6 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GSK Investigational Site Little Rock Arkansas United States 72205
    2 GSK Investigational Site Antioch California United States 94509
    3 GSK Investigational Site Daly City California United States 94015
    4 GSK Investigational Site Fairfield California United States 94533
    5 GSK Investigational Site Fremont California United States 94538
    6 GSK Investigational Site Fresno California United States 93726
    7 GSK Investigational Site Hayward California United States 94545
    8 GSK Investigational Site Oakland California United States 94611
    9 GSK Investigational Site Pleasanton California United States 94588
    10 GSK Investigational Site Redwood City California United States 94063
    11 GSK Investigational Site Richmond California United States 94801
    12 GSK Investigational Site Roseville California United States 95661
    13 GSK Investigational Site Sacramento California United States 95823
    14 GSK Investigational Site Sacramento California United States 95825
    15 GSK Investigational Site San Francisco California United States 94115
    16 GSK Investigational Site San Jose California United States 95119
    17 GSK Investigational Site San Ramon California United States 94583
    18 GSK Investigational Site Santa Clara California United States 95051
    19 GSK Investigational Site Santa Rosa California United States 95403
    20 GSK Investigational Site Vacaville California United States 95688
    21 GSK Investigational Site Vallejo California United States 94589
    22 GSK Investigational Site Walnut Creek California United States 94596
    23 GSK Investigational Site Columbus Ohio United States 43214
    24 GSK Investigational Site Mechanicsville Virginia United States 23111

    Sponsors and Collaborators

    • GlaxoSmithKline

    Investigators

    • Study Director: GSK Clinical Trials, GlaxoSmithKline

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT00148941
    Other Study ID Numbers:
    • 213503/048
    First Posted:
    Sep 8, 2005
    Last Update Posted:
    Feb 5, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Diphtheria
    Vaccines

    Study Results

    Participant Flow

    Recruitment Details This study was conducted at 24 centers in the United States.
    Pre-assignment Detail All 4209 subjects enrolled in the study, received the study vaccination and were included in the Total vaccination cohort (TVC).
    Arm/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Period Title: Overall Study
    STARTED 1053 1051 1052 1053
    COMPLETED 1035 1027 1032 1029
    NOT COMPLETED 18 24 20 24

    Baseline Characteristics

    Arm/Group Title 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
    Arm/Group Description 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. 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. 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. 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. Total of all reporting groups
    Overall Participants 1053 1051 1052 1053 4209
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    4.2
    (0.38)
    4.2
    (0.37)
    4.2
    (0.37)
    4.2
    (0.38)
    4.2
    (0.37)
    Sex: Female, Male (Count of Participants)
    Female
    526
    50%
    515
    49%
    533
    50.7%
    513
    48.7%
    2087
    49.6%
    Male
    527
    50%
    536
    51%
    519
    49.3%
    540
    51.3%
    2122
    50.4%
    Race/Ethnicity, Customized (Count of Participants)
    Black
    65
    6.2%
    74
    7%
    77
    7.3%
    77
    7.3%
    293
    7%
    White/Caucasian
    489
    46.4%
    488
    46.4%
    486
    46.2%
    457
    43.4%
    1920
    45.6%
    Arabic/North African
    9
    0.9%
    5
    0.5%
    6
    0.6%
    10
    0.9%
    30
    0.7%
    East/South East Asian
    83
    7.9%
    95
    9%
    75
    7.1%
    103
    9.8%
    356
    8.5%
    South Asian
    45
    4.3%
    51
    4.9%
    55
    5.2%
    50
    4.7%
    201
    4.8%
    American Hispanic
    208
    19.8%
    201
    19.1%
    188
    17.9%
    194
    18.4%
    791
    18.8%
    Japanese
    3
    0.3%
    5
    0.5%
    3
    0.3%
    4
    0.4%
    15
    0.4%
    Not specified
    151
    14.3%
    132
    12.6%
    162
    15.4%
    158
    15%
    603
    14.3%

    Outcome Measures

    1. Primary Outcome
    Title Geometric Mean Concentrations (GMCs) for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies in a Subset of Subjects
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    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/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 284 283 284 261
    Anti-D
    16.704
    18.658
    18.437
    18.112
    Anti-T
    9.693
    9.974
    11.300
    11.235
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 1 + M-M-R Group, SB213503 Lot 2 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% confidence intervals (CIs) for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMC ratio
    Estimated Value 0.970
    Confidence Interval (2-Sided) 95%
    0.871 to 1.080
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 1 + M-M-R Group, SB213503 Lot 3 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMC ratio
    Estimated Value 0.961
    Confidence Interval (2-Sided) 95%
    0.863 to 1.070
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 2 + M-M-R Group, SB213503 Lot 3 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMC ratio
    Estimated Value 0.991
    Confidence Interval (2-Sided) 95%
    0.890 to 1.103
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 1 + M-M-R Group, SB213503 Lot 2 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMC ratio
    Estimated Value 0.975
    Confidence Interval (2-Sided) 95%
    0.866 to 1.097
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 1 + M-M-R Group, SB213503 Lot 3 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMC ratio
    Estimated Value 0.878
    Confidence Interval (2-Sided) 95%
    0.780 to 0.988
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 2 + M-M-R Group, SB213503 Lot 3 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMC ratio
    Estimated Value 0.901
    Confidence Interval (2-Sided) 95%
    0.800 to 1.014
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title 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
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    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/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 285 281 285 261
    Anti-PT
    66.9
    74.1
    71.4
    80.4
    Anti-FHA
    809.1
    918.8
    869.2
    939.7
    Anti-PRN
    617.4
    584.7
    594.2
    593.8
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 1 + M-M-R Group, SB213503 Lot 2 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMC ratio
    Estimated Value 0.938
    Confidence Interval (2-Sided) 95%
    0.828 to 1.063
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 1 + M-M-R Group, SB213503 Lot 3 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMC ratio
    Estimated Value 0.963
    Confidence Interval (2-Sided) 95%
    0.850 to 1.091
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 2 + M-M-R Group, SB213503 Lot 3 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMC ratio
    Estimated Value 1.026
    Confidence Interval (2-Sided) 95%
    0.906 to 1.162
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 1 + M-M-R Group, SB213503 Lot 2 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMC ratio
    Estimated Value 0.874
    Confidence Interval (2-Sided) 95%
    0.783 to 0.976
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 1 + M-M-R Group, SB213503 Lot 3 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMC ratio
    Estimated Value 0.947
    Confidence Interval (2-Sided) 95%
    0.849 to 1.057
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 2 + M-M-R Group, SB213503 Lot 3 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMC ratio
    Estimated Value 1.084
    Confidence Interval (2-Sided) 95%
    0.971 to 1.209
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 1 + M-M-R Group, SB213503 Lot 2 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMC ratio
    Estimated Value 0.998
    Confidence Interval (2-Sided) 95%
    0.867 to 1.148
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 1 + M-M-R Group, SB213503 Lot 3 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMC ratio
    Estimated Value 1.043
    Confidence Interval (2-Sided) 95%
    0.907 to 1.200
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 2 + M-M-R Group, SB213503 Lot 3 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMC ratio
    Estimated Value 1.045
    Confidence Interval (2-Sided) 95%
    0.909 to 1.202
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Primary Outcome
    Title Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects
    Description GMTs were measured by Neutralization assay and expressed in titers.
    Time Frame At Month 1 (i.e. one month after vaccination)

    Outcome Measure Data

    Analysis Population Description
    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/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 276 274 276 252
    Anti-poliovirus 1
    2095.0
    2103.1
    2129.2
    1683.1
    Anti-poliovirus 2
    2345.4
    2132.9
    2326.6
    1802.0
    Anti-poliovirus 3
    3683.5
    3400.7
    3603.8
    3367.8
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 1 + M-M-R Group, SB213503 Lot 2 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ratio
    Estimated Value 0.994
    Confidence Interval (2-Sided) 95%
    0.836 to 1.181
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 1 + M-M-R Group, SB213503 Lot 3 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ratio
    Estimated Value 0.987
    Confidence Interval (2-Sided) 95%
    0.831 to 1.172
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 2 + M-M-R Group, SB213503 Lot 3 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ratio
    Estimated Value 0.993
    Confidence Interval (2-Sided) 95%
    0.836 to 1.180
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 1 + M-M-R Group, SB213503 Lot 2 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ratio
    Estimated Value 1.118
    Confidence Interval (2-Sided) 95%
    0.951 to 1.314
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 1 + M-M-R Group, SB213503 Lot 3 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ratio
    Estimated Value 1.006
    Confidence Interval (2-Sided) 95%
    0.856 to 1.183
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 2 + M-M-R Group, SB213503 Lot 3 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5] for Anti-poliovirus type 2.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ratio
    Estimated Value 0.900
    Confidence Interval (2-Sided) 95%
    0.765 to 1.060
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 1 + M-M-R Group, SB213503 Lot 2 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ratio
    Estimated Value 1.112
    Confidence Interval (2-Sided) 95%
    0.941 to 1.314
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 1 + M-M-R Group, SB213503 Lot 3 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ratio
    Estimated Value 1.034
    Confidence Interval (2-Sided) 95%
    0.876 to 1.220
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection SB213503 Lot 2 + M-M-R Group, SB213503 Lot 3 + M-M-R Group
    Comments 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.
    Type of Statistical Test Equivalence
    Comments Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ratio
    Estimated Value 0.930
    Confidence Interval (2-Sided) 95%
    0.787 to 1.099
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection 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
    Comments 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.
    Type of Statistical Test Non-Inferiority
    Comments The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ration
    Estimated Value 0.792
    Confidence Interval (2-Sided) 95%
    0.680 to 0.922
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Other Statistical Analysis SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection 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
    Comments 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.
    Type of Statistical Test Non-Inferiority
    Comments The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ratio
    Estimated Value 0.802
    Confidence Interval (2-Sided) 95%
    0.696 to 0.925
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Other Statistical Analysis SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection 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
    Comments 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.
    Type of Statistical Test Non-Inferiority
    Comments The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ratio
    Estimated Value 0.938
    Confidence Interval (2-Sided) 95%
    0.811 to 1.085
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Other Statistical Analysis SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
    4. Primary Outcome
    Title Number of Subjects With Booster Response Against Diphtheria Toxoid (D) and Tetanus Toxoid (T) Antigens in a Subset of Subjects
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    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/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 280 283 282 261
    Anti-D, Total
    279
    26.5%
    280
    26.6%
    281
    26.7%
    260
    24.7%
    Anti-T, Total
    266
    25.3%
    273
    26%
    277
    26.3%
    245
    23.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 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
    Comments 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.
    Type of Statistical Test Non-Inferiority
    Comments The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference between groups
    Estimated Value 0.47
    Confidence Interval (2-Sided) 95%
    -0.98 to 1.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Other Statistical Analysis SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 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
    Comments 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.
    Type of Statistical Test Non-Inferiority
    Comments The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference between groups
    Estimated Value -2.81
    Confidence Interval (2-Sided) 95%
    -6.55 to -0.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Other Statistical Analysis SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
    5. Primary Outcome
    Title Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    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/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 281 281 284 261
    Anti-PT, Total
    251
    23.8%
    250
    23.8%
    257
    24.4%
    237
    22.5%
    Anti-FHA, Total
    265
    25.2%
    272
    25.9%
    268
    25.5%
    251
    23.8%
    Anti-PRN, Total
    270
    25.6%
    277
    26.4%
    279
    26.5%
    253
    24%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 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
    Comments 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.
    Type of Statistical Test Non-Inferiority
    Comments The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference between groups
    Estimated Value 0.36
    Confidence Interval (2-Sided) 95%
    -3.83 to 3.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Other Statistical Analysis SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 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
    Comments 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.
    Type of Statistical Test Non-Inferiority
    Comments The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference between groups
    Estimated Value 0.79
    Confidence Interval (2-Sided) 95%
    -2.50 to 3.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Other Statistical Analysis SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 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
    Comments 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.
    Type of Statistical Test Non-Inferiority
    Comments The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference between groups
    Estimated Value -0.82
    Confidence Interval (2-Sided) 95%
    -3.79 to 1.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Other Statistical Analysis SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
    6. Primary Outcome
    Title Number of Subjects With Circumferential Swelling at the Injection Site
    Description 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

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
    Arm/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 1053 1051 1052 1053
    Circumference increase>30mm;swelling>50% of length
    5
    0.5%
    10
    1%
    5
    0.5%
    11
    1%
    Circumference increase>30mm;swelling≤50% of length
    10
    0.9%
    20
    1.9%
    23
    2.2%
    22
    2.1%
    Circumference increase>30mm;diameter missing
    2
    0.2%
    0
    0%
    1
    0.1%
    1
    0.1%
    Circumference increase≤30mm;swelling>50% of length
    9
    0.9%
    10
    1%
    12
    1.1%
    12
    1.1%
    Circumference increase≤30mm;swelling≤50% of length
    62
    5.9%
    42
    4%
    52
    4.9%
    54
    5.1%
    Circumference increase≤30mm;diameter missing
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Increase in mid upper arm;swelling>50% of length
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Increase in mid upper arm;swelling≤50% of length
    0
    0%
    2
    0.2%
    0
    0%
    0
    0%
    Increase in mid upper arm;diameter missing
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 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
    Comments 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.
    Type of Statistical Test Non-Inferiority
    Comments Non-inferiority objective was considered demonstrated, when the upper limit of the 95% CI for the difference between groups (SB213503 + M-M-R Group = pooled lot 1, 2 & 3 groups minus Infanrix + IPOL + M-M-R Group) in percentage of subjects reporting increased circumferential swelling was equal or less than 2%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage
    Estimated Value -0.41
    Confidence Interval (2-Sided) 95%
    -1.26 to 0.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Other Statistical Analysis SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
    7. Secondary Outcome
    Title Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens in a Subset of Subjects
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    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/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 284 283 284 261
    Anti-D
    284
    27%
    282
    26.8%
    284
    27%
    260
    24.7%
    Anti-T
    284
    27%
    283
    26.9%
    284
    27%
    261
    24.8%
    8. Secondary Outcome
    Title Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    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/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 276 274 276 252
    Anti-poliovirus type 1
    275
    26.1%
    274
    26.1%
    275
    26.1%
    249
    23.6%
    Anti-poliovirus type 2
    276
    26.2%
    273
    26%
    269
    25.6%
    252
    23.9%
    Anti-poliovirus type 3
    271
    25.7%
    259
    24.6%
    268
    25.5%
    239
    22.7%
    9. Secondary Outcome
    Title Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    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/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 285 281 285 261
    Anti-PT
    285
    27.1%
    279
    26.5%
    283
    26.9%
    261
    24.8%
    Anti-FHA
    285
    27.1%
    280
    26.6%
    285
    27.1%
    261
    24.8%
    Anti-PRN
    285
    27.1%
    281
    26.7%
    285
    27.1%
    261
    24.8%
    10. Secondary Outcome
    Title Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to (≥) 1 IU/mL
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    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/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 284 283 284 261
    Anti-D
    284
    27%
    282
    26.8%
    284
    27%
    260
    24.7%
    Anti-T
    281
    26.7%
    282
    26.8%
    281
    26.7%
    261
    24.8%
    11. Secondary Outcome
    Title Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    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/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 274 268 273 252
    Anti-poliovirus type 1, Total
    264
    25.1%
    257
    24.5%
    264
    25.1%
    231
    21.9%
    Anti-poliovirus type 2, Total
    271
    25.7%
    252
    24%
    258
    24.5%
    234
    22.2%
    Anti-poliovirus type 3, Total
    259
    24.6%
    245
    23.3%
    256
    24.3%
    220
    20.9%
    12. Secondary Outcome
    Title Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    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/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 1 4 2 2
    Anti-H1N1, Day 0
    5.0
    20.0
    20.0
    56.6
    Anti-H1N1, Month 1
    57.0
    134.5
    20.0
    226.3
    Anti-H3N2, Day 0
    1280.0
    80.0
    80.0
    134.5
    Anti-H3N2, Month 1
    1280.0
    493.6
    113.1
    538.1
    Anti-B, Day 0
    160.0
    10.0
    7.1
    10.0
    Anti-B, Month 1
    1810.0
    95.1
    28.3
    226.3
    13. Secondary Outcome
    Title Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    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/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 1 3 2 2
    Anti-H1N1
    1
    0.1%
    2
    0.2%
    0
    0%
    1
    0.1%
    Anti-H3N2
    0
    0%
    2
    0.2%
    0
    0%
    1
    0.1%
    Anti-B
    1
    0.1%
    3
    0.3%
    1
    0.1%
    2
    0.2%
    14. Secondary Outcome
    Title Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    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/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 1 4 2 2
    Anti-H1N1, Day 0
    0
    0%
    1
    0.1%
    1
    0.1%
    1
    0.1%
    Anti-H1N1, Month 1
    1
    0.1%
    4
    0.4%
    1
    0.1%
    2
    0.2%
    Anti-H3N2, Day 0
    1
    0.1%
    2
    0.2%
    1
    0.1%
    2
    0.2%
    Anti-H3N2, Month 1
    1
    0.1%
    4
    0.4%
    1
    0.1%
    2
    0.2%
    Anti-B, Day 0
    1
    0.1%
    1
    0.1%
    0
    0%
    0
    0%
    Anti-B, Month 1
    1
    0.1%
    3
    0.3%
    1
    0.1%
    2
    0.2%
    15. Secondary Outcome
    Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 1046 1039 1043 1043
    Pain, Any
    620
    58.9%
    582
    55.4%
    642
    61%
    601
    57.1%
    Pain, Grade 3
    19
    1.8%
    17
    1.6%
    13
    1.2%
    7
    0.7%
    Redness, Any
    391
    37.1%
    399
    38%
    412
    39.2%
    423
    40.2%
    Redness, Grade 3
    187
    17.8%
    186
    17.7%
    194
    18.4%
    213
    20.2%
    Swelling, Any
    295
    28%
    266
    25.3%
    291
    27.7%
    296
    28.1%
    Swelling, Grade 3
    111
    10.5%
    95
    9%
    118
    11.2%
    122
    11.6%
    16. Secondary Outcome
    Title Number of Subjects With Any and Grade 3 Increase in the Mid-upper Arm Circumference at the Injection Site
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 1046 1039 1043 1043
    Increase in mid-upper arm circumference, Any
    368
    34.9%
    374
    35.6%
    393
    37.4%
    397
    37.7%
    Increase in mid-upper arm circumference, Grade 3
    16
    1.5%
    29
    2.8%
    29
    2.8%
    33
    3.1%
    17. Secondary Outcome
    Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 1044 1037 1040 1036
    Drowsiness, Any
    194
    18.4%
    216
    20.6%
    185
    17.6%
    181
    17.2%
    Drowsiness, Grade 3
    9
    0.9%
    10
    1%
    7
    0.7%
    8
    0.8%
    Drowsiness, Related
    153
    14.5%
    166
    15.8%
    148
    14.1%
    141
    13.4%
    Fever (orally), ≥ 37.5 °C
    167
    15.9%
    154
    14.7%
    166
    15.8%
    147
    14%
    Fever (orally), > 39.0 °C
    9
    0.9%
    8
    0.8%
    16
    1.5%
    11
    1%
    Fever (orally), Related
    154
    14.6%
    136
    12.9%
    143
    13.6%
    128
    12.2%
    Loss of appetite, Any
    162
    15.4%
    160
    15.2%
    162
    15.4%
    166
    15.8%
    Loss of appetite, Grade 3
    11
    1%
    6
    0.6%
    7
    0.7%
    6
    0.6%
    Loss of appetite, Related
    127
    12.1%
    117
    11.1%
    130
    12.4%
    125
    11.9%
    18. Secondary Outcome
    Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 1044 1037 1040 1036
    Rash site, Any
    34
    3.2%
    44
    4.2%
    21
    2%
    36
    3.4%
    Non-administration site rash, Measles/Rubella-like
    5
    0.5%
    4
    0.4%
    4
    0.4%
    6
    0.6%
    Non-administration site rash, Grade 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Non-administration site rash, Related
    5
    0.5%
    6
    0.6%
    4
    0.4%
    4
    0.4%
    Parotitis, Any
    1
    0.1%
    3
    0.3%
    2
    0.2%
    3
    0.3%
    Suspected signs of meningism, Any
    7
    0.7%
    5
    0.5%
    4
    0.4%
    5
    0.5%
    Fever (orally), ≥ 37.5°C
    213
    20.2%
    215
    20.5%
    218
    20.7%
    208
    19.8%
    Fever (orally), > 39.0°C
    22
    2.1%
    25
    2.4%
    36
    3.4%
    23
    2.2%
    Fever (orally), Related
    169
    16%
    155
    14.7%
    159
    15.1%
    140
    13.3%
    19. Secondary Outcome
    Title Number of Subjects With Any Unsolicited Adverse Events (AEs)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
    Arm/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 1053 1051 1052 1053
    Count of Participants [Participants]
    321
    30.5%
    317
    30.2%
    326
    31%
    307
    29.2%
    20. Secondary Outcome
    Title Number of Subjects With Serious Adverse Events (SAEs)
    Description 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])

    Outcome Measure Data

    Analysis Population Description
    The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
    Arm/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 1053 1051 1052 1053
    Count of Participants [Participants]
    4
    0.4%
    7
    0.7%
    1
    0.1%
    4
    0.4%
    21. Secondary Outcome
    Title Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits
    Description 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])

    Outcome Measure Data

    Analysis Population Description
    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/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 1028 1019 1024 1022
    Chronic illness
    6
    0.6%
    6
    0.6%
    4
    0.4%
    5
    0.5%
    Emergency room visit
    7
    0.7%
    7
    0.7%
    10
    1%
    8
    0.8%
    Physician's office visit
    20
    1.9%
    22
    2.1%
    22
    2.1%
    19
    1.8%

    Adverse Events

    Time Frame Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
    Adverse Event Reporting Description
    Arm/Group Title 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
    Arm/Group Description 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. 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. 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. 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.
    All Cause Mortality
    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
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/1053 (0%) 0/1051 (0%) 0/1052 (0%) 0/1053 (0%)
    Serious Adverse Events
    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
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/1053 (0.4%) 7/1051 (0.7%) 1/1052 (0.1%) 4/1053 (0.4%)
    Eye disorders
    Optic atrophy 0/1053 (0%) 0 1/1051 (0.1%) 1 0/1052 (0%) 0 0/1053 (0%) 0
    Gastrointestinal disorders
    Appendicitis perforated 0/1053 (0%) 0 0/1051 (0%) 0 0/1052 (0%) 0 1/1053 (0.1%) 1
    Constipation 0/1053 (0%) 0 0/1051 (0%) 0 0/1052 (0%) 0 1/1053 (0.1%) 1
    Gastritis 1/1053 (0.1%) 1 0/1051 (0%) 0 0/1052 (0%) 0 0/1053 (0%) 0
    Infections and infestations
    Pneumonia 1/1053 (0.1%) 1 0/1051 (0%) 0 0/1052 (0%) 0 1/1053 (0.1%) 1
    Viral infection 1/1053 (0.1%) 1 0/1051 (0%) 0 0/1052 (0%) 0 1/1053 (0.1%) 1
    Cellulitis 0/1053 (0%) 0 1/1051 (0.1%) 1 0/1052 (0%) 0 0/1053 (0%) 0
    Gastroenteritis 0/1053 (0%) 0 0/1051 (0%) 0 1/1052 (0.1%) 1 0/1053 (0%) 0
    Pneumonia necrotizing 1/1053 (0.1%) 1 0/1051 (0%) 0 0/1052 (0%) 0 0/1053 (0%) 0
    Subcutaneous abscess 0/1053 (0%) 0 1/1051 (0.1%) 1 0/1052 (0%) 0 0/1053 (0%) 0
    Metabolism and nutrition disorders
    Dehydration 1/1053 (0.1%) 1 2/1051 (0.2%) 2 1/1052 (0.1%) 1 1/1053 (0.1%) 1
    Hypernatraemia 0/1053 (0%) 0 1/1051 (0.1%) 1 0/1052 (0%) 0 0/1053 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Burkitt's lymphoma 0/1053 (0%) 0 1/1051 (0.1%) 1 0/1052 (0%) 0 0/1053 (0%) 0
    Nervous system disorders
    Cerebrovascular accident 0/1053 (0%) 0 1/1051 (0.1%) 1 0/1052 (0%) 0 0/1053 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Asthma 0/1053 (0%) 0 1/1051 (0.1%) 1 0/1052 (0%) 0 0/1053 (0%) 0
    Other (Not Including Serious) Adverse Events
    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
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 797/1053 (75.7%) 783/1051 (74.5%) 814/1052 (77.4%) 804/1053 (76.4%)
    General disorders
    Pain 620/1053 (58.9%) 622 583/1051 (55.5%) 584 642/1052 (61%) 642 601/1053 (57.1%) 604
    Pyrexia 227/1053 (21.6%) 229 228/1051 (21.7%) 232 234/1052 (22.2%) 241 233/1053 (22.1%) 236
    Swelling 295/1053 (28%) 295 266/1051 (25.3%) 266 292/1052 (27.8%) 292 298/1053 (28.3%) 298
    Infections and infestations
    Upper respiratory tract infection 54/1053 (5.1%) 56 57/1051 (5.4%) 59 71/1052 (6.7%) 71 60/1053 (5.7%) 63
    Metabolism and nutrition disorders
    Decreased appetite 162/1053 (15.4%) 162 160/1051 (15.2%) 160 162/1052 (15.4%) 162 166/1053 (15.8%) 166
    Nervous system disorders
    Somnolence 194/1053 (18.4%) 194 217/1051 (20.6%) 217 185/1052 (17.6%) 185 181/1053 (17.2%) 181
    Skin and subcutaneous tissue disorders
    Erythema 391/1053 (37.1%) 392 400/1051 (38.1%) 400 412/1052 (39.2%) 412 424/1053 (40.3%) 424

    Limitations/Caveats

    None reported.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

    Results Point of Contact

    Name/Title GSK Response Center
    Organization GlaxoSmithKline
    Phone 866-435-7343
    Email GSKClinicalSupportHD@gsk.com
    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT00148941
    Other Study ID Numbers:
    • 213503/048
    First Posted:
    Sep 8, 2005
    Last Update Posted:
    Feb 5, 2020
    Last Verified:
    Jan 1, 2020