Trial Outcomes & Findings for Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine (NCT NCT00635128)

NCT ID: NCT00635128

Last Updated: 2018-06-06

Results Overview

Assessed solicited local symptoms were pain, redness and swelling. Grade 3 Pain: Pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 415 participants
• Primary outcome timeframe: During the 4-day (Days 0-3) follow-up period after booster vaccination
• Results posted on: 2018-06-06

Participant Flow

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participant milestones

Measure	Boostrix-Polio Group Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.	Boostrix + IPV Mérieux Group Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Study STARTED	351	64
Overall Study COMPLETED	351	64
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine

Baseline characteristics by cohort

Measure	Boostrix-Polio Group n=351 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.	Boostrix + IPV Mérieux Group n=64 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.	Total n=415 Participants Total of all reporting groups
Age, Continuous	11.4 Years STANDARD_DEVIATION 0.97 • n=5 Participants	11.3 Years STANDARD_DEVIATION 0.72 • n=7 Participants	11.38 Years STANDARD_DEVIATION 0.94 • n=5 Participants
Sex: Female, Male Female	169 Participants n=5 Participants	32 Participants n=7 Participants	201 Participants n=5 Participants
Sex: Female, Male Male	182 Participants n=5 Participants	32 Participants n=7 Participants	214 Participants n=5 Participants
Race/Ethnicity, Customized White-Caucasian/European heritage	347 Participants n=5 Participants	63 Participants n=7 Participants	410 Participants n=5 Participants
Race/Ethnicity, Customized White-Arabic/North African heritage	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Not specified	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the 4-day (Days 0-3) follow-up period after booster vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Assessed solicited local symptoms were pain, redness and swelling. Grade 3 Pain: Pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

Outcome measures

Measure	Boostrix-Polio Group n=351 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.	Boostrix + IPV Mérieux Group n=64 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Any Grade 3 Solicited Local Symptoms Grade 3 Pain	14 Participants	3 Participants
Number of Subjects With Any Grade 3 Solicited Local Symptoms Grade 3 Redness (mm)	14 Participants	5 Participants
Number of Subjects With Any Grade 3 Solicited Local Symptoms Grade 3 Swelling (mm)	10 Participants	5 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) follow-up period after booster vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Measure	Boostrix-Polio Group n=351 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.	Boostrix + IPV Mérieux Group n=64 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Any Solicited Local Symptoms Any Swelling	141 Participants	22 Participants
Number of Subjects With Any Solicited Local Symptoms Any Pain	257 Participants	45 Participants
Number of Subjects With Any Solicited Local Symptoms Any Redness	169 Participants	26 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) follow-up period after booster vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and who had the symptoms sheet filled in.

Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.

Outcome measures

Measure	Boostrix-Polio Group n=351 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.	Boostrix + IPV Mérieux Group n=63 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Any Solicited General Symptoms Any Fatigue	87 Participants	14 Participants
Number of Subjects With Any Solicited General Symptoms Any Gastrointestinal	41 Participants	4 Participants
Number of Subjects With Any Solicited General Symptoms Any Headache	76 Participants	12 Participants
Number of Subjects With Any Solicited General Symptoms Any Temperature	14 Participants	0 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after (Month 1) booster vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

Anti-D and anti-T antibody concnetration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL have been assessed by enzyme-linked immunosorbent assay (ELISA). Pre-vaccination sera with ELISA concentrations < 0.1 IU/mL were tested for neutralising antibodies using a Vero-cell neutralisation assay with a 0.016 IU/mL cut-off.

Outcome measures

Measure	Boostrix-Polio Group n=336 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.	Boostrix + IPV Mérieux Group n=62 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids Anti-D ≥ 1 IU/mL, M0	91 Participants	13 Participants
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids Anti-T ≥ 0.1 IU/mL, M0	330 Participants	61 Participants
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids Anti-T ≥ 0.1 IU/mL, M1	336 Participants	62 Participants
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids Anti-T ≥ 1 IU/mL, M0	181 Participants	35 Participants
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids Anti-D ≥ 0.1 IU/mL, M0	298 Participants	53 Participants
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids Anti-D ≥ 0.1 IU/mL, M1	336 Participants	62 Participants
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids Anti-D ≥ 1 IU/mL, M1	308 Participants	55 Participants
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids Anti-T ≥ 1 IU/mL, M1	335 Participants	61 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after (Month 1) booster vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

Outcome measures

Measure	Boostrix-Polio Group n=336 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.	Boostrix + IPV Mérieux Group n=62 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Anti-D and Anti-T Antibody Concentrations Anti-D, M1	4.784 IU/mL Interval 4.302 to 5.32	4.153 IU/mL Interval 3.089 to 5.585
Anti-D and Anti-T Antibody Concentrations Anti-T, M0	1.197 IU/mL Interval 1.045 to 1.37	1.067 IU/mL Interval 0.797 to 1.429
Anti-D and Anti-T Antibody Concentrations Anti-T, M1	11.81 IU/mL Interval 11.011 to 12.667	9.518 IU/mL Interval 7.879 to 11.498
Anti-D and Anti-T Antibody Concentrations Anti-D, M0	0.51 IU/mL Interval 0.429 to 0.608	0.446 IU/mL Interval 0.305 to 0.651

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after (Month 1) booster vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milliliter (EL.U/ml).

Outcome measures

Measure	Boostrix-Polio Group n=336 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.	Boostrix + IPV Mérieux Group n=62 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PT, M0	134 Participants	21 Participants
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PT, M1	334 Participants	59 Participants
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-FHA, M0	332 Participants	60 Participants
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-FHA, M1	336 Participants	61 Participants
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PRN, M0	325 Participants	57 Participants
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PRN, M1	336 Participants	62 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after (Month 1) booster vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

Antibodies concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

Outcome measures

Measure	Boostrix-Polio Group n=336 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.	Boostrix + IPV Mérieux Group n=62 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT, M0	5.2 EL.U/mL Interval 4.7 to 5.9	4.5 EL.U/mL Interval 3.6 to 5.6
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT, M1	41.6 EL.U/mL Interval 38.1 to 45.3	32 EL.U/mL Interval 24.5 to 41.9
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA, M0	69.8 EL.U/mL Interval 62.1 to 78.4	70.1 EL.U/mL Interval 52.5 to 93.5
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA, M1	662.7 EL.U/mL Interval 613.2 to 716.1	733.9 EL.U/mL Interval 610.4 to 882.5
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN, M0	46.8 EL.U/mL Interval 41.5 to 52.8	41.1 EL.U/mL Interval 30.0 to 56.2
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN, M1	570.8 EL.U/mL Interval 527.4 to 617.7	460.4 EL.U/mL Interval 353.3 to 600.0

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after (Month 1) booster vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ the value of 8.

Outcome measures

Measure	Boostrix-Polio Group n=335 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.	Boostrix + IPV Mérieux Group n=62 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens Anti-polio 2, M1	335 Participants	62 Participants
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens Anti-polio 3, M0	324 Participants	60 Participants
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens Anti-polio 1, M0	329 Participants	60 Participants
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens Anti-polio 1, M1	335 Participants	62 Participants
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens Anti-polio 2, M0	333 Participants	62 Participants
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens Anti-polio 3, M1	333 Participants	62 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after (Month 1) booster vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

Antibody titers were presented as geometric mean titers (GMTs).

Outcome measures

Measure	Boostrix-Polio Group n=335 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.	Boostrix + IPV Mérieux Group n=62 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Anti-Polio 1, 2 and 3 Antibody Titers Anti-polio 1, M0	138.7 Titers Interval 123.0 to 156.4	128.9 Titers Interval 96.1 to 172.7
Anti-Polio 1, 2 and 3 Antibody Titers Anti-polio 1, M1	1359.6 Titers Interval 1213.4 to 1523.3	1088.9 Titers Interval 866.5 to 1368.4
Anti-Polio 1, 2 and 3 Antibody Titers Anti-polio 2, M0	166.3 Titers Interval 149.5 to 185.0	179.2 Titers Interval 142.9 to 224.7
Anti-Polio 1, 2 and 3 Antibody Titers Anti-polio 2, M1	1629.4 Titers Interval 1475.2 to 1799.7	1309.5 Titers Interval 1035.2 to 1656.3
Anti-Polio 1, 2 and 3 Antibody Titers Anti-polio 3, M0	117.2 Titers Interval 102.8 to 133.5	118.4 Titers Interval 83.4 to 168.0
Anti-Polio 1, 2 and 3 Antibody Titers Anti-polio 3, M1	1882.4 Titers Interval 1687.9 to 2099.3	1712.5 Titers Interval 1329.2 to 2206.3

SECONDARY outcome

Timeframe: One month after booster vaccination (At Month 1)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

Booster vaccine response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL).

Outcome measures

Measure	Boostrix-Polio Group n=335 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.	Boostrix + IPV Mérieux Group n=62 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN Anti-PT	308 Participants	56 Participants
Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN Anti-FHA	311 Participants	56 Participants
Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN Anti-PRN	319 Participants	61 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) follow-up period after booster vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

AEs results are presented for all subjects. 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.

Outcome measures

Measure	Boostrix-Polio Group n=351 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.	Boostrix + IPV Mérieux Group n=64 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Unsolicited Adverse Events (AEs)	47 Participants	17 Participants

SECONDARY outcome

Timeframe: During the entire booster period (Month 0 to Month 1)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Measure	Boostrix-Polio Group n=351 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.	Boostrix + IPV Mérieux Group n=64 Participants Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Serious Adverse Events (SAEs)	0 Participants	0 Participants

Adverse Events

Boostrix-Polio Group

Serious events: 0 serious events

Other events: 281 other events

Deaths: 0 deaths

Boostrix + IPV Mérieux Group

Serious events: 0 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Boostrix-Polio Group n=351 participants at risk Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.	Boostrix + IPV Mérieux Group n=64 participants at risk Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
General disorders Pain	73.2% 257/351 • Solicited local/general symptoms during the 4-day (Days 0-3) post-booster period; AEs during the 31-day (Days 0-30) post-booster period; SAEs following booster vaccination (up to Month 1).	70.3% 45/64 • Solicited local/general symptoms during the 4-day (Days 0-3) post-booster period; AEs during the 31-day (Days 0-30) post-booster period; SAEs following booster vaccination (up to Month 1).
General disorders Redness (mm)	48.1% 169/351 • Solicited local/general symptoms during the 4-day (Days 0-3) post-booster period; AEs during the 31-day (Days 0-30) post-booster period; SAEs following booster vaccination (up to Month 1).	40.6% 26/64 • Solicited local/general symptoms during the 4-day (Days 0-3) post-booster period; AEs during the 31-day (Days 0-30) post-booster period; SAEs following booster vaccination (up to Month 1).
General disorders Swelling (mm)	40.2% 141/351 • Solicited local/general symptoms during the 4-day (Days 0-3) post-booster period; AEs during the 31-day (Days 0-30) post-booster period; SAEs following booster vaccination (up to Month 1).	34.4% 22/64 • Solicited local/general symptoms during the 4-day (Days 0-3) post-booster period; AEs during the 31-day (Days 0-30) post-booster period; SAEs following booster vaccination (up to Month 1).
General disorders Fatigue	24.8% 87/351 • Solicited local/general symptoms during the 4-day (Days 0-3) post-booster period; AEs during the 31-day (Days 0-30) post-booster period; SAEs following booster vaccination (up to Month 1).	22.2% 14/63 • Solicited local/general symptoms during the 4-day (Days 0-3) post-booster period; AEs during the 31-day (Days 0-30) post-booster period; SAEs following booster vaccination (up to Month 1).
General disorders Gastrointestinal symptoms	11.7% 41/351 • Solicited local/general symptoms during the 4-day (Days 0-3) post-booster period; AEs during the 31-day (Days 0-30) post-booster period; SAEs following booster vaccination (up to Month 1).	6.3% 4/63 • Solicited local/general symptoms during the 4-day (Days 0-3) post-booster period; AEs during the 31-day (Days 0-30) post-booster period; SAEs following booster vaccination (up to Month 1).
General disorders Headache	21.7% 76/351 • Solicited local/general symptoms during the 4-day (Days 0-3) post-booster period; AEs during the 31-day (Days 0-30) post-booster period; SAEs following booster vaccination (up to Month 1).	19.0% 12/63 • Solicited local/general symptoms during the 4-day (Days 0-3) post-booster period; AEs during the 31-day (Days 0-30) post-booster period; SAEs following booster vaccination (up to Month 1).

Additional Information

GSK Response Center

GlaxoSmithKline

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Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER