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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00635128
• Collaborator: (none)
• Enrollment: 415
• Locations: 38
• Arms: 2
• Actual Duration (Months): 5.2
• Patients Per Site: 10.9
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will be evaluated in terms of immunogenicity, safety and reactogenicity.

Condition or Disease	Intervention/Treatment	Phase
Poliomyelitis; Diphtheria; Tetanus; Acellular Pertussis	Biological: Boostrix-Polio	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 415 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Evaluation of GSK Biological's dTpa-IPV Booster Vaccine in Children and Adolescents, 5 Years After Previous dTpa-IPV Boosting.
• Actual Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Jul 8, 2008
• Actual Study Completion Date: Jul 8, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: Boostrix-Polio; A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.
Experimental: 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.	Biological: Boostrix-Polio; A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Any Grade 3 Solicited Local Symptoms [During the 4-day (Days 0-3) follow-up period after booster vaccination]

   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.

Secondary Outcome Measures

1. Number of Subjects With Any Solicited Local Symptoms [During the 4-day (Days 0-3) follow-up period after booster vaccination]

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

2. Number of Subjects With Any Solicited General Symptoms [During the 4-day (Days 0-3) follow-up period after booster vaccination]

   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.

3. Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids [Prior to (Month 0) and one month after (Month 1) booster vaccination]

   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.

4. Anti-D and Anti-T Antibody Concentrations [Prior to (Month 0) and one month after (Month 1) booster vaccination]

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

5. Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) [Prior to (Month 0) and one month after (Month 1) booster vaccination]

   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).

6. Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations [Prior to (Month 0) and one month after (Month 1) booster vaccination]

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

7. Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens [Prior to (Month 0) and one month after (Month 1) booster vaccination]

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

8. Anti-Polio 1, 2 and 3 Antibody Titers [Prior to (Month 0) and one month after (Month 1) booster vaccination]

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

9. Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN [One month after booster vaccination (At Month 1)]

   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).

10. Number of Subjects With Unsolicited Adverse Events (AEs) [During the 31-day (Days 0-30) follow-up period after booster vaccination]

    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.

11. Number of Subjects With Serious Adverse Events (SAEs) [During the entire booster period (Month 0 to Month 1)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years to 13 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.

• A male or female subject who received a booster vaccination with dTpa-IPV or dTpa + IPV in study 711866/001.

• Healthy subjects as established by medical history and clinical examination before entering into the study.

• Females of childbearing potential at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination.

• Written informed consent obtained from both parents/ guardians of the subject; assent from the subject himself/herself should also be requested whenever possible.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period.

• Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within six months prior to the booster dose.

• Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during study period.

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

• Previous booster vaccination against tetanus, diphtheria, pertussis, or poliomyelitis since the booster dose received in study 711866/001.

• History of diphtheria, tetanus, pertussis, or poliomyelitis diseases.

• Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

• Administration of immunoglobulin and/or any blood products within the three months preceding the booster dose or planned administration during the study period.

• Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.

• Occurrence of any of the following adverse events (AEs) after a previous administration of a DTP vaccine: hypersensitivity reaction to any component of the vaccine, encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine, fever ≥ 40°C within 48 hours of vaccination not due to another identifiable cause, collapse or shock-like state within 48 hours of vaccination

• Persistent, severe, inconsolable screaming or crying lasting >3 hours occurring within 48 hours of receipt of a previous dose of DTP vaccine convulsions with or without fever, occurring within 3 days of vaccination.

• Acute disease at the time of enrolment.

• Pregnant or lactating female.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Ettenheim	Baden-Wuerttemberg	Germany	77955
2	GSK Investigational Site	Kehl	Baden-Wuerttemberg	Germany	77694
3	GSK Investigational Site	Oberkirch	Baden-Wuerttemberg	Germany	77704
4	GSK Investigational Site	Offenburg	Baden-Wuerttemberg	Germany	77654
5	GSK Investigational Site	Cham	Bayern	Germany	93413
6	GSK Investigational Site	Kaufering	Bayern	Germany	86916
7	GSK Investigational Site	Landshut	Bayern	Germany	84032
8	GSK Investigational Site	Muenchen	Bayern	Germany	80939
9	GSK Investigational Site	Olching	Bayern	Germany	82140
10	GSK Investigational Site	Weilheim	Bayern	Germany	82362
11	GSK Investigational Site	Eschwege	Hessen	Germany	37269
12	GSK Investigational Site	Koenigstein	Hessen	Germany	61462
13	GSK Investigational Site	Salzgitter	Niedersachsen	Germany	38226
14	GSK Investigational Site	Wolfenbuettel	Niedersachsen	Germany	38302
15	GSK Investigational Site	Erkrath	Nordrhein-Westfalen	Germany	40699
16	GSK Investigational Site	Goch	Nordrhein-Westfalen	Germany	47574
17	GSK Investigational Site	Guetersloh	Nordrhein-Westfalen	Germany	33332
18	GSK Investigational Site	Heiligenhaus	Nordrhein-Westfalen	Germany	42579
19	GSK Investigational Site	Kleve-Materborn	Nordrhein-Westfalen	Germany	47533
20	GSK Investigational Site	Krefeld	Nordrhein-Westfalen	Germany	47798
21	GSK Investigational Site	Loehne	Nordrhein-Westfalen	Germany	32584
22	GSK Investigational Site	Muenster	Nordrhein-Westfalen	Germany	48159
23	GSK Investigational Site	Willich	Nordrhein-Westfalen	Germany	47877
24	GSK Investigational Site	Bad Kreuznach	Rheinland-Pfalz	Germany	55543
25	GSK Investigational Site	Frankenthal	Rheinland-Pfalz	Germany	67227
26	GSK Investigational Site	Mainz	Rheinland-Pfalz	Germany	55131
27	GSK Investigational Site	Trier	Rheinland-Pfalz	Germany	54294
28	GSK Investigational Site	Worms	Rheinland-Pfalz	Germany	67547
29	GSK Investigational Site	Worms	Rheinland-Pfalz	Germany	67549
30	GSK Investigational Site	Dresden	Sachsen	Germany	01169
31	GSK Investigational Site	Dresden	Sachsen	Germany	01307
32	GSK Investigational Site	Brunsbuettel	Schleswig-Holstein	Germany	25541
33	GSK Investigational Site	Flensburg	Schleswig-Holstein	Germany	24937
34	GSK Investigational Site	Flensburg	Schleswig-Holstein	Germany	24939
35	GSK Investigational Site	Flensburg	Schleswig-Holstein	Germany	24943
36	GSK Investigational Site	Berlin		Germany	12627
37	GSK Investigational Site	Berlin		Germany	13355
38	GSK Investigational Site	Berlin		Germany	13507

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

• Knuf M et al. The repeated administration of a reduced antigen content diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine (dTpa-IPV; BoostrixTM IPV) in adolescents. Abstract presented at IDSA. Philadelphia, USA, 29 October- 1 November 2009.
• Knuf M, Baine Y, Bianco V, Boutriau D, Miller JM. Antibody persistence and immune memory 15 months after priming with an investigational tetravalent meningococcal tetanus toxoid conjugate vaccine (MenACWY-TT) in toddlers and young children. Hum Vaccin Immunother. 2012 Jul;8(7):866-72. doi: 10.4161/hv.20229. Epub 2012 Apr 9.
• Mertsola J et al. The safety of repeated administration of Boostrix™, a reduced-antigen-content dTpa booster. Abstract presented at Excellence In Paediatrics (EIP). Florence, Italy, 3-6 December 2009.
• Mertsola J et al. The safety of repeated administration of reduced-antigen-content dTpa boosters. Abstract presented at WSPID-6th World Congress. Buenos Aires, Argentina, 19-22 November 2009.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00635128
• Other Study ID Numbers: 110947
• First Posted: Mar 13, 2008
• Last Update Posted: Jun 6, 2018
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Diphtheria; vaccine; DTP; Poliomyelitis; Pertussis; Booster; Tetanus
• Additional relevant MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis

Study Results

Participant Flow

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

Arm/Group Title	Boostrix-Polio Group	Boostrix + IPV Mérieux Group
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	351	64
COMPLETED	351	64
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Boostrix-Polio Group	Boostrix + IPV Mérieux Group	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	351	64	415
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	11.4 (0.97)	11.3 (0.72)	11.38 (0.94)
Sex: Female, Male (Count of Participants)
Female	169 48.1%	32 50%	201 48.4%
Male	182 51.9%	32 50%	214 51.6%
Race/Ethnicity, Customized (Count of Participants)
White-Caucasian/European heritage	347 98.9%	63 98.4%	410 98.8%
White-Arabic/North African heritage	4 1.1%	0 0%	4 1%
Not specified	0 0%	1 1.6%	1 0.2%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Any Grade 3 Solicited Local Symptoms
Description	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.
Time Frame	During the 4-day (Days 0-3) follow-up period after booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix-Polio Group	Boostrix + IPV Mérieux Group
Arm/Group Description	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.	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.
Measure Participants	351	64
Grade 3 Pain	14 4%	3 4.7%
Grade 3 Redness (mm)	14 4%	5 7.8%
Grade 3 Swelling (mm)	10 2.8%	5 7.8%

2. Secondary Outcome

Title	Number of Subjects With Any Solicited Local Symptoms
Description	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time Frame	During the 4-day (Days 0-3) follow-up period after booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix-Polio Group	Boostrix + IPV Mérieux Group
Arm/Group Description	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.	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.
Measure Participants	351	64
Any Pain	257 73.2%	45 70.3%
Any Redness	169 48.1%	26 40.6%
Any Swelling	141 40.2%	22 34.4%

3. Secondary Outcome

Title	Number of Subjects With Any Solicited General Symptoms
Description	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.
Time Frame	During the 4-day (Days 0-3) follow-up period after booster vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Boostrix-Polio Group	Boostrix + IPV Mérieux Group
Arm/Group Description	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.	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.
Measure Participants	351	63
Any Fatigue	87 24.8%	14 21.9%
Any Gastrointestinal	41 11.7%	4 6.3%
Any Headache	76 21.7%	12 18.8%
Any Temperature	14 4%	0 0%

4. Secondary Outcome

Title	Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids
Description	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.
Time Frame	Prior to (Month 0) and one month after (Month 1) booster vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Boostrix-Polio Group	Boostrix + IPV Mérieux Group
Arm/Group Description	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.	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.
Measure Participants	336	62
Anti-D ≥ 0.1 IU/mL, M0	298 84.9%	53 82.8%
Anti-D ≥ 0.1 IU/mL, M1	336 95.7%	62 96.9%
Anti-D ≥ 1 IU/mL, M0	91 25.9%	13 20.3%
Anti-D ≥ 1 IU/mL, M1	308 87.7%	55 85.9%
Anti-T ≥ 0.1 IU/mL, M0	330 94%	61 95.3%
Anti-T ≥ 0.1 IU/mL, M1	336 95.7%	62 96.9%
Anti-T ≥ 1 IU/mL, M0	181 51.6%	35 54.7%
Anti-T ≥ 1 IU/mL, M1	335 95.4%	61 95.3%

5. Secondary Outcome

Title	Anti-D and Anti-T Antibody Concentrations
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Time Frame	Prior to (Month 0) and one month after (Month 1) booster vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Boostrix-Polio Group	Boostrix + IPV Mérieux Group
Arm/Group Description	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.	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.
Measure Participants	336	62
Anti-D, M0	0.51	0.446
Anti-D, M1	4.784	4.153
Anti-T, M0	1.197	1.067
Anti-T, M1	11.81	9.518

6. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Description	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).
Time Frame	Prior to (Month 0) and one month after (Month 1) booster vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Boostrix-Polio Group	Boostrix + IPV Mérieux Group
Arm/Group Description	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.	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.
Measure Participants	336	62
Anti-PT, M0	134 38.2%	21 32.8%
Anti-PT, M1	334 95.2%	59 92.2%
Anti-FHA, M0	332 94.6%	60 93.8%
Anti-FHA, M1	336 95.7%	61 95.3%
Anti-PRN, M0	325 92.6%	57 89.1%
Anti-PRN, M1	336 95.7%	62 96.9%

7. Secondary Outcome

Title	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Description	Antibodies concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time Frame	Prior to (Month 0) and one month after (Month 1) booster vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Boostrix-Polio Group	Boostrix + IPV Mérieux Group
Arm/Group Description	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.	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.
Measure Participants	336	62
Anti-PT, M0	5.2	4.5
Anti-PT, M1	41.6	32
Anti-FHA, M0	69.8	70.1
Anti-FHA, M1	662.7	733.9
Anti-PRN, M0	46.8	41.1
Anti-PRN, M1	570.8	460.4

8. Secondary Outcome

Title	Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens
Description	A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ the value of 8.
Time Frame	Prior to (Month 0) and one month after (Month 1) booster vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Boostrix-Polio Group	Boostrix + IPV Mérieux Group
Arm/Group Description	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.	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.
Measure Participants	335	62
Anti-polio 1, M0	329 93.7%	60 93.8%
Anti-polio 1, M1	335 95.4%	62 96.9%
Anti-polio 2, M0	333 94.9%	62 96.9%
Anti-polio 2, M1	335 95.4%	62 96.9%
Anti-polio 3, M0	324 92.3%	60 93.8%
Anti-polio 3, M1	333 94.9%	62 96.9%

9. Secondary Outcome

Title	Anti-Polio 1, 2 and 3 Antibody Titers
Description	Antibody titers were presented as geometric mean titers (GMTs).
Time Frame	Prior to (Month 0) and one month after (Month 1) booster vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Boostrix-Polio Group	Boostrix + IPV Mérieux Group
Arm/Group Description	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.	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.
Measure Participants	335	62
Anti-polio 1, M0	138.7	128.9
Anti-polio 1, M1	1359.6	1088.9
Anti-polio 2, M0	166.3	179.2
Anti-polio 2, M1	1629.4	1309.5
Anti-polio 3, M0	117.2	118.4
Anti-polio 3, M1	1882.4	1712.5

10. Secondary Outcome

Title	Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN
Description	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).
Time Frame	One month after booster vaccination (At Month 1)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Boostrix-Polio Group	Boostrix + IPV Mérieux Group
Arm/Group Description	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.	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.
Measure Participants	335	62
Anti-PT	308 87.7%	56 87.5%
Anti-FHA	311 88.6%	56 87.5%
Anti-PRN	319 90.9%	61 95.3%

11. Secondary Outcome

Title	Number of Subjects With Unsolicited Adverse Events (AEs)
Description	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.
Time Frame	During the 31-day (Days 0-30) follow-up period after booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix-Polio Group	Boostrix + IPV Mérieux Group
Arm/Group Description	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.	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.
Measure Participants	351	64
Count of Participants [Participants]	47 13.4%	17 26.6%

12. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	During the entire booster period (Month 0 to Month 1)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix-Polio Group	Boostrix + IPV Mérieux Group
Arm/Group Description	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.	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.
Measure Participants	351	64
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	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).
Arm/Group Title	Boostrix-Polio Group		Boostrix + IPV Mérieux Group
Arm/Group Description	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.		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.
All Cause Mortality
	Boostrix-Polio Group		Boostrix + IPV Mérieux Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/351 (0%)		0/64 (0%)
Serious Adverse Events
	Boostrix-Polio Group		Boostrix + IPV Mérieux Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/351 (0%)		0/64 (0%)
Other (Not Including Serious) Adverse Events
	Boostrix-Polio Group		Boostrix + IPV Mérieux Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	281/351 (80.1%)		51/64 (79.7%)
General disorders
Pain	257/351 (73.2%)		45/64 (70.3%)
Redness (mm)	169/351 (48.1%)		26/64 (40.6%)
Swelling (mm)	141/351 (40.2%)		22/64 (34.4%)
Fatigue	87/351 (24.8%)		14/63 (22.2%)
Gastrointestinal symptoms	41/351 (11.7%)		4/63 (6.3%)
Headache	76/351 (21.7%)		12/63 (19%)

Limitations/Caveats

[Not Specified]

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.