Persistence Study of GSK Biologicals' Tdap Vaccine 1, 3, 5 and 9 Years Following Administration as an Initial Single Dose in Healthy Young Adults and to Evaluate the Immunogenicity and Safety of Boostrix as a Second Dose of Tdap, When Administered at Year 9

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00489970
• Collaborator: (none)
• Enrollment: 1,954
• Locations: 37
• Arms: 3
• Actual Duration (Months): 105
• Patients Per Site: 52.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the persistence of antibodies against all the vaccine antigens 1, 3, 5 and 9 years after an initial vaccination with Tdap, and also to assess immunogenicity and safety of another dose of Boostrix, administered in this study.

This protocol posting deals with objectives and outcome measures of the extension phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00346073).

Condition or Disease	Intervention/Treatment	Phase
Acellular Pertussis; Tetanus; Diphtheria	Procedure: Taking of blood samples; Biological: Boostrix; Biological: Adacel	Phase 3

Detailed Description

Subjects were previously vaccinated with either Boostrix or a control Tdap vaccine (Sanofi Pasteurs' Adacel) in study NCT00346073. Only subjects who were part of the primary study will be invited to participate in this study. All subjects will receive a single dose of Boostrix at Visit 6 (Day 0) and subjects will be observed till Visit 7 (Day 30) for safety in terms of solicited adverse events (during 4 days post vaccination), unsolicited adverse events (during 31 days post vaccination) and serious adverse event (during the trial period). A blood sample will be collected from all subjects before vaccination (Visit 6) and one month after vaccination (Visit 7) for antibodies estimation.

This summary has been updated following Protocol amendment 1 dated 09 November 2010, amendment 2 dated 18 February 2014, and amendment 3 dated 10 December 2014. The protocol was amended first due to the following reasons:

1. The maximum window period allowed for the return of subjects for the Year 5 and Year 10 follow-up visits (Visit 5 and Visit 6) was extended from ± 5 weeks to ± 8 weeks.

2. The contact details for reporting of SAEs were clarified.

3. Text pertaining to the reporting of spontaneous abortion was removed from the protocol.

4. The number of attempts to contact subjects who did not return for scheduled persistence visits was clarified.

The main purpose of protocol amendment 2 is to evaluate the immunogenicity and safety of Boostrix as a second dose of Tdap vaccine when administered 8 years after an initial dose of Tdap. The Year 10 time point for evaluation of persistence has been cancelled because it is no longer feasible to conduct after a second dose of Tdap vaccine has been administered at Year 8.

The purpose of amendment 3 is to add co-primary objective to demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix group and Adacel group) is non-inferior to the immune response elicited by a first dose of Tdap vaccine (Control group), with respect to booster response against diphtheria, tetanus and pertussis (PT, FHA and PRN) antigens, one month following vaccination according to CBER's input. Accordingly, the study start has been pushed to Year 9 and this is reflected throughout the document.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1954 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Persistence Study of GSK Biologicals' Tdap Vaccine (776423), 1, 3, 5 and 9 Years Following Administration as a Single Dose in NCT00346073 Study and to Evaluate the Immunogenicity and Safety of Boostrix as a Second Dose of Tdap, When Administered at Year 9
• Actual Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Boostrix Group Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Procedure: Taking of blood samples; No treatment is planned to be given in this study. Blood samples will be collected at the following time points: 1 year, 3 years, 5 years and 9 years after the dose of vaccination.; Biological: Boostrix; A single dose of Boostrix was administered in the primary study (NCT00346073). No treatment was given in this study.
Active Comparator: Adacel Group Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Procedure: Taking of blood samples; No treatment is planned to be given in this study. Blood samples will be collected at the following time points: 1 year, 3 years, 5 years and 9 years after the dose of vaccination.; Biological: Boostrix; A single dose of Boostrix was administered in the primary study (NCT00346073). No treatment was given in this study.; Biological: Adacel; A single dose of Adacel was administered in the primary study (NCT00346073). No treatment was given in this study.
Active Comparator: Control group Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.	Biological: Boostrix; A single dose of Boostrix was administered in the primary study (NCT00346073). No treatment was given in this study.

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Greater Than or Equal to (≥) Protocol Specified Cut-off [At year 1 after the vaccination in primary study (NCT00346073)]

   Anti-D cut-off was defined as ≥ 0.1 International Units per milliliter (IU/mL) determined with Enzyme-linked Immunosorbent Assay (ELISA)

2. Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off [At year 3 after the vaccination in primary study (NCT00346073)]

   Anti-D cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA

3. Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off [At year 5 after the vaccination in primary study (NCT00346073)]

   Anti-D cut-off was defined as ≥ 0.1IU/mL as assessed by ELISA.

4. Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off [At Year 9, one month before the booster vaccination.]

   Anti-D cut-off was defined as ≥ to 0.1IU/mL as assessed by ELISA.

5. Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations ≥ Protocol Specified Cut-off [At year 1 after the vaccination in primary study (NCT00346073)]

   Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.

6. Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off [At year 3 after the vaccination in primary study (NCT00346073)]

   Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.

7. Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off [At year 5 after the vaccination in primary study (NCT00346073)]

   Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.

8. Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off [At Year 9, one month before the booster vaccination.]

   Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.

9. Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL [At Year 9, one month after the booster vaccination.]

   Number of subjects with anti-D and anti-T concentrations ≥ 0.1 IU/mL and 1 IU/mL were tabulated

10. Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations [At Year 9, one month before booster vaccination]

    Anti-PT, anti-FHA and anti-PRN antibody concentrations were measured by ELISA, tabulated as GMCs and expressed in IU/mL.

11. Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations [At Year 9, one month after the booster vaccination]

    Anti-PT, anti-FHA and anti-PRN antibody concentrations were measured by ELISA, tabulated as GMCs and expressed in IU/mL.

12. Booster Response to D and T Antigens [At Year 9, one month after the booster vaccination.]

    A booster response was defined as: for initially seronegative subjects (S-) (pre-vaccination concentration below cut-off: < 0.1 IU/mL) antibody concentrations at least four times the cut-off (post vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (S+) (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration; Total = subjects either seropositive or seronegative.

13. Booster Response to PT, FHA and PRN Antigens [At Year 9, one month after the booster vaccination.]

    Booster response was defined as: for subjects with pre-vaccination antibody concentration < 5 EL.U/mL (S-): antibody concentration ≥ 20 EL.U/mL; for subjects with pre-vaccination antibody concentration ≥ 5 EL.U/mL and < 20 EL.U/mL (S+, <4*cut-off): antibody concentration at least four times the pre-vaccination concentration; for subjects with pre-vaccination antibody concentration ≥ 20 EL.U/mL (S+, ≥4*cut-off): antibody concentration at least two times the pre-vaccination concentration; Total = subjects either seropositive or seronegative

Secondary Outcome Measures

1. Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)]

   The cut-off for anti-PT concentrations was defined as ≥ 5 ELISA units per mililiter (EL.U/mL).

2. Number of Subjects With Anti-PT Antibody Concentrations Equal to or Above Protocol Specified Cut-off [At Year 9, one month before(pre booster) and after the booster vaccination(post booster)]

   The cut-off for anti-PT concentrations was defined as equal to or greater than 2.693 IU/mL.

3. Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off [At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)]

   The cut-off for anti-FHA concentrations was defined as equal to or greater than 5 EL.U/mL.

4. Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off [At Year 9, one month before(pre booster) and after the booster vaccination(post booster)]

   The cut-off for anti-FHA concentrations was defined as equal to or greater than 2.046 IU/mL

5. Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off [At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)]

   The cut-off for anti-PRN concentrations was defined as equal to or greater than 5 EL.U/mL.

6. Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off [At Year 9, one month before(pre booster) and after the booster vaccination(post booster)]

   The cut-off for anti-PRN concentrations was defined as equal to or greater than 2.187 IU/mL.

7. Anti-D Antibody Concentration [At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)]

   Anti-D antibody concentration is expressed as geometric mean concentration (GMC) in IU/mL.

8. Anti-D Antibody Concentration [At Year 9, one month before(pre booster) and after the booster vaccination(post booster)]

   Anti-D antibody concentration is expressed as GMC in IU/mL.

9. Anti-T Antibody Concentration [At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)]

   Anti-T antibody concentration is expressed as GMC in IU/mL.

10. Anti-T Antibody Concentration [At Year 9, one month before(pre booster) and after the booster vaccination(post booster)]

    Anti-T antibody concentration is expressed as GMC in IU/mL.

11. Anti-PT Antibody Concentration [At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)]

    Anti-PT antibody concentration is expressed as GMC in EL.U/mL.

12. Anti-PT Antibody Concentration [At Year 9, one month before(pre booster) and after the booster vaccination(post booster)]

    Anti-PT antibody concentration was expressed as GMC in IU/mL.

13. Anti-FHA Antibody Concentration [At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)]

    Anti-FHA antibody concentration is expressed as GMC in IU/mL

14. Anti-FHA Antibody Concentration [At Year 9, one month before(pre booster) and after the booster vaccination(post booster)]

    Anti-FHA antibody concentration was expressed as GMC in IU/mL.

15. Anti-PRN Antibody Concentration [At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)]

    Anti-PRN antibody concentration is expressed as GMC in IU/mL

16. Anti-PRN Antibody Concentration [At Year 9, one month before(pre booster) and after the booster vaccination(post booster)]

    Anti-PRN antibody concentration is expressed as GMC in IU/mL.

17. Alternative Booster Response to Anti-D and Anti-T Antigens [At Year 9, one month after booster vaccination]

    Alternative Booster response to D and T antigens is defined as: - For subjects with pre-booster antibody concentration below 0.1 IU/mL: antibody concentrations at least four times the 0.1IU/ML, one month after vaccination, and - For subjects with pre-booster antibody concentration ≥0.1 IU/mL and <1.0 IU/mL: antibody concentrations of at least four times the pre-booster antibody concentration, one month after vaccination. - For subjects with pre-booster antibody concentration ≥1.0 IU/mL and <6.0 IU/mL: antibody concentrations of at least two times the pre-booster antibody concentration, one month after vaccination. - Subjects with pre-booster antibody concentration ≥6.0 IU/mL are not evaluable for booster response. S- = Antibody concentration < 0.1 IU/mL S+ = Antibody concentration ≥ 0.1 IU/mL Total = subjects either seropositive or seronegative

18. Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens [At Year 9, one month after booster vaccination]

    Alternative Booster response to PT, FHA and PRN antigens is defined as: - For subjects with pre-booster antibody concentration below the assay cut off: antibody concentrations at least four times the assay cut off one month after vaccination, and - For subjects with pre-booster antibody concentration ≥ assay cut off and < 60 IU/mL: antibody concentration increase of at least 30 IU/mL from the pre-booster antibody concentration, one month after vaccination. - For subjects with pre-booster antibody concentration ≥ 60 IU/mL : at least 1.5 fold increase of antibody concentration from the pre-booster antibody concentration, one month after vaccination. S- = seronegative subjects (antibody concentration below assay cut off for anti-PT, anti-FHA, anti-PRN) S+ = seropositive subjects (antibody concentration below assay cut off for anti-PT, anti-FHA, anti-PRN) Total = subjects either seropositive or seronegative

19. Seroprotection Status for Anti-D Antibody Concentration [At Year 9, one month before(pre booster) and after the booster vaccination(post booster)]

    Seroprotection status for anti-D antibody concentration < 0.1 IU/mL were tested for neutralizing antibodies using a VERO-cell neutralization assay. Seroprotection rate is defined as the percentage of subjects with antibody concentrations greater than or equal (≥) the seroprotection cut-off value defined for that antibody.

20. Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 [During the 4-day (Days 0-3) post vaccination period.]

    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 50 millimeters (mm)

21. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 [During the 4-day (Days 0-3) post vaccination period.]

    The solicited general symptoms assessed were Fatigue, Gastrointestinal symptoms (including nausea, vomiting, diarrhea and abdominal pain), Headache and Fever [defined as temperature of ≥100.4 degrees Fahrenheit (F) by any route]. Any = Occurrence of any general symptom regardless of its intensity grade or relationship to vaccination; Grade 3 Symptom = Symptom that prevented normal activity; Grade 3 Fever > 104.0 degrees F.

22. Number of Subjects With Any Large Injection Site Reaction - Year 9 [During the 4-day (Days 0-3) follow-up period after vaccination.]

    Large injection site reaction = a swelling with a diameter > 100 mm, noticeable diffuse swelling or noticeable increase in limb circumference.

23. Number of Subjects With Any Unsolicited Adverse Events (AEs) - Year 9 [During the 31-day (Days 0-30) post-vaccination period.]

    An unsolicited AE covers any untoward medical oc-currence 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.

24. Number of Subjects With Serious Adverse Events (SAEs) - Year 9 [During the 31-day (Days 0-30) post-vaccination period]

    SAEs assessed 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: 28 Years to 73 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Persistence follow-up phase up to Year 9 time point:

The following criteria are applicable to subjects who refuse vaccination at Year 8 time point:

All subjects who received study vaccination (Boostrix or Adacel) in study NCT00346073 will be considered eligible to participate in this study.

Written informed consent must be obtained from the subject prior to each study time point.

Vaccination phase at Year 9 applicable for subjects in Boostrix and Adacel groups only:

The following criterion is applicable to subjects willing to consent to vaccination at Year 9 time point in the Boostrix and Adacel groups:

• All subjects who received study vaccination (Boostrix or Adacel) in study NCT00346073 will be considered eligible to participate in this study.

Vaccination phase at Year 9 applicable for subjects in the Control group only:

The following criterion is applicable to subjects willing to consent to vaccination at Year 9 time point in the Control group only:

• Subjects within the age range of 28-73 years will be considered eligible to participate in this study in the Control group.

Vaccination phase at Year 9 applicable for ALL subjects (Control, Boostrix and Adacel groups):

The following criteria are applicable to subjects willing to consent to vaccination at Year 9 time point in the Boostrix, Adacel and Control groups:

All subjects must satisfy the following criteria at study entry at Year 9 time point:

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).

Written informed consent obtained from the subject for vaccination at Year 9 time point.

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

• Female subjects of non-childbearing potential may be enrolled in the study.

• Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.

• Female subjects of child bearing potential may be enrolled in the study, if the subject

• has practiced adequate contraception for 30 days prior to vaccination, and

• has a negative pregnancy test on the day of vaccination, and

• has agreed to continue adequate contraception for 1 month after completion of the vaccine dose

Exclusion Criteria:

The following criteria should be checked at the time of Year 9 vaccination time point. If any criteria is applicable, the subject must not be vaccinated in the study:

For subjects in Boostrix and Adacel groups:

• Administration of Tdap vaccine since the last dose received in the study NCT00346073.

For subjects in the Control group:

• Administration of Tdap (Boostrix or Adacel) vaccine at any time prior to the administration of Boostrix vaccine in this study.

For ALL subjects (Control, Boostrix and Adacel groups):

Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period, 31 days (Day 0-30).

• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to Visit 6 (pre-vacc). Inhaled and topical steroids are allowed.

• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of vaccine, with the exception of inactivated Influenza vaccine which is allowed throughout the study period, 31 days (Day 0-30).

-- 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 vaccine/product.

• Hypersensitivity to latex.

• History of diphtheria, tetanus or pertussis diseases.

• Severe allergic reaction (e.g. anaphylaxis) after previous administration of any tetanus toxoid, diphtheria toxoid, or pertussis-antigen containing vaccines, or any component of Boostrix.

• History of any neurological disorders or seizures.

• Encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) of unknown etiology occurring within seven days following previous vaccination with pertussis-containing vaccine.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

• Acute disease and/or fever at the time of enrolment.

• Fever is defined as temperature ≥ 100.4°F by any route. The preferred route for recording temperature in this study will be oral.

• Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.

• Administration of immunoglobulins and/or any blood products within three months preceding the dose of study vaccine or planned administration during the study period, 31 days (Day 0-30).

Administration of any tetanus or diphtheria containing vaccine or any registered or investigational vaccine utilizing a diphtheria toxoid or tetanus toxoid carrier within 5 years prior to the administration of Boostrix vaccine in this study.

• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.

• Pregnant or lactating female.

• Female planning to become pregnant or planning to discontinue contraceptive precautions during the 31 day (Day 0-30) follow-up period post-vaccination.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Huntsville	Alabama	United States	35802
2	GSK Investigational Site	Chandler	Arizona	United States	85224
3	GSK Investigational Site	Mesa	Arizona	United States	85203
4	GSK Investigational Site	Mesa	Arizona	United States	85213
5	GSK Investigational Site	Phoenix	Arizona	United States	85014
6	GSK Investigational Site	Tempe	Arizona	United States	85283
7	GSK Investigational Site	Little Rock	Arkansas	United States	72205
8	GSK Investigational Site	San Diego	California	United States	92103-6204
9	GSK Investigational Site	San Diego	California	United States	92108
10	GSK Investigational Site	Colorado Springs	Colorado	United States	80909
11	GSK Investigational Site	Pueblo	Colorado	United States	81001
12	GSK Investigational Site	Washington	District of Columbia	United States	20006
13	GSK Investigational Site	Melbourne	Florida	United States	32935
14	GSK Investigational Site	Miami	Florida	United States	33143
15	GSK Investigational Site	Pembroke Pines	Florida	United States	33024
16	GSK Investigational Site	Boise	Idaho	United States	83704
17	GSK Investigational Site	Peoria	Illinois	United States	61602
18	GSK Investigational Site	South Bend	Indiana	United States	46601
19	GSK Investigational Site	Bardstown	Kentucky	United States	40004
20	GSK Investigational Site	Richland	Michigan	United States	49083
21	GSK Investigational Site	Saint Louis	Missouri	United States	63141
22	GSK Investigational Site	North Platte	Nebraska	United States	69101
23	GSK Investigational Site	Raleigh	North Carolina	United States	27609
24	GSK Investigational Site	Tabor City	North Carolina	United States	28463
25	GSK Investigational Site	Winston-Salem	North Carolina	United States	27103
26	GSK Investigational Site	Oklahoma City	Oklahoma	United States	73112
27	GSK Investigational Site	Erie	Pennsylvania	United States	16505
28	GSK Investigational Site	Grove City	Pennsylvania	United States	16127
29	GSK Investigational Site	Johnstown	Pennsylvania	United States	15904
30	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15241
31	GSK Investigational Site	Charleston	South Carolina	United States	29412
32	GSK Investigational Site	Bristol	Tennessee	United States	37620
33	GSK Investigational Site	Houston	Texas	United States	77024
34	GSK Investigational Site	Salt Lake City	Utah	United States	84109
35	GSK Investigational Site	Salt Lake City	Utah	United States	84121
36	GSK Investigational Site	West Jordan	Utah	United States	84088
37	GSK Investigational Site	Norfolk	Virginia	United States	23507

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• IPD for this study will be made available via the Clinical Study Data Request site.
• Redacted with child studies & included

Publications

• Brandon D, Kimmel M, Kuriyakose SO, Kostanyan L, Mesaros N. Antibody persistence and safety and immunogenicity of a second booster dose nine years after a first booster vaccination with a reduced antigen diphtheria-tetanus-acellular pertussis vaccine (Tdap) in adults. Vaccine. 2018 Oct 8;36(42):6325-6333. doi: 10.1016/j.vaccine.2018.08.051. Epub 2018 Sep 7. Erratum in: Vaccine. 2020 Mar 10;38(12):2746-2747.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00489970
• Other Study ID Numbers: 110080; 110082; 110084; 110086
• First Posted: Jun 22, 2007
• Last Update Posted: May 1, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Persistence; immunogenicity
• Additional relevant MeSH terms: Diphtheria

Study Results

Participant Flow

Recruitment Details	A total of 1592 participants were enrolled in the study at Year 1 (in the Boostrix and Adacel groups). As per advice from the Centre for Biologics and Research Evaluation (CBER), an additional treatment group acting as control was also added at Year 9, therefore the total number of subjects analyzed was 1592 (Year 1) + 362 (Year 9) = 1954.
Pre-assignment Detail	Subjects who received a single dose of Boostrix or Adacel vaccines, in the primary study (NCT00346073) were included in this study.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Period Title: Persistence Year 1
STARTED	1069	523	0
COMPLETED	1069	523	0
NOT COMPLETED	0	0	0
Period Title: Persistence Year 1
STARTED	1019	486	0
COMPLETED	1019	486	0
NOT COMPLETED	0	0	0
Period Title: Persistence Year 1
STARTED	856	401	0
COMPLETED	856	401	0
NOT COMPLETED	0	0	0
Period Title: Persistence Year 1
STARTED	309	138	362
COMPLETED	306	136	357
NOT COMPLETED	3	2	5

Baseline Characteristics

Arm/Group Title	Boostrix Group	Adacel Group	Control Group	Total
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.	Total of all reporting groups
Overall Participants	1069	523	362	1954
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.7 (13.39)	42.5 (13.27)	52.0 (13.6)	42.0 (13.35)
Sex: Female, Male (Count of Participants)
Female	680 63.6%	357 68.3%	196 54.1%	1233 63.1%
Male	389 36.4%	166 31.7%	166 45.9%	721 36.9%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Greater Than or Equal to (≥) Protocol Specified Cut-off
Description	Anti-D cut-off was defined as ≥ 0.1 International Units per milliliter (IU/mL) determined with Enzyme-linked Immunosorbent Assay (ELISA)
Time Frame	At year 1 after the vaccination in primary study (NCT00346073)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

Arm/Group Title	Boostrix Group	Adacel Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
Measure Participants	1010	504
Count of Participants [Participants]	967 90.5%	489 93.5%

2. Primary Outcome

Title	Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off
Description	Anti-D cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA
Time Frame	At year 3 after the vaccination in primary study (NCT00346073)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

Arm/Group Title	Boostrix Group	Adacel Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
Measure Participants	934	449
Count of Participants [Participants]	857 80.2%	425 81.3%

3. Primary Outcome

Title	Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off
Description	Anti-D cut-off was defined as ≥ 0.1IU/mL as assessed by ELISA.
Time Frame	At year 5 after the vaccination in primary study (NCT00346073)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

Arm/Group Title	Boostrix Group	Adacel Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
Measure Participants	789	372
Count of Participants [Participants]	735 68.8%	359 68.6%

4. Primary Outcome

Title	Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off
Description	Anti-D cut-off was defined as ≥ to 0.1IU/mL as assessed by ELISA.
Time Frame	At Year 9, one month before the booster vaccination.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

Arm/Group Title	Boostrix Group	Adacel Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
Measure Participants	269	118
Count of Participants [Participants]	245 22.9%	113 21.6%

5. Primary Outcome

Title	Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations ≥ Protocol Specified Cut-off
Description	Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.
Time Frame	At year 1 after the vaccination in primary study (NCT00346073)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

Arm/Group Title	Boostrix Group	Adacel Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
Measure Participants	1014	506
Count of Participants [Participants]	1000 93.5%	504 96.4%

6. Primary Outcome

Title	Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off
Description	Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.
Time Frame	At year 3 after the vaccination in primary study (NCT00346073)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

Arm/Group Title	Boostrix Group	Adacel Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
Measure Participants	937	442
Count of Participants [Participants]	899 84.1%	440 84.1%

7. Primary Outcome

Title	Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off
Description	Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.
Time Frame	At year 5 after the vaccination in primary study (NCT00346073)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

Arm/Group Title	Boostrix Group	Adacel Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
Measure Participants	788	372
Count of Participants [Participants]	772 72.2%	370 70.7%

8. Primary Outcome

Title	Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off
Description	Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.
Time Frame	At Year 9, one month before the booster vaccination.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

Arm/Group Title	Boostrix Group	Adacel Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
Measure Participants	268	120
Count of Participants [Participants]	263 24.6%	120 22.9%

9. Primary Outcome

Title	Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL
Description	Number of subjects with anti-D and anti-T concentrations ≥ 0.1 IU/mL and 1 IU/mL were tabulated
Time Frame	At Year 9, one month after the booster vaccination.

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	269	120	363
Anti-D, ≥ 0.1 IU/ML	245 22.9%	113 21.6%	265 73.2%
Anti-T, ≥ 0.1 IU/ML	263 24.6%	120 22.9%	304 84%
Anti-D, ≥ 1 IU/ML	114 10.7%	54 10.3%	92 25.4%
Anti-T, ≥ 1 IU/ML	211 19.7%	101 19.3%	231 63.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Boostrix Group, Control Group
	Comments	To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against diphtheria antigen, one month following vaccination.
	Type of Statistical Test	Non-Inferiority
	Comments	One month after vaccination, the lower limit of the 97.5% confidence interval (CI) for the difference between groups in the seroprotection rate [a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	1.41
	Confidence Interval	(2-Sided) 97.5%; -1.16 to 4.17
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Boostrix Group, Control Group
	Comments	To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against tetanus antigen, one month following vaccination.
	Type of Statistical Test	Non-Inferiority
	Comments	One month after vaccination, the lower limit of the 97.5% confidence interval (CI) for the difference between groups in the seroprotection rate [a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	0.31
	Confidence Interval	(2-Sided) 97.5%; -1.52 to 2.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Adacel Group, Control Group
	Comments	To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against diphtheria antigen, one month following vaccination.
	Type of Statistical Test	Non-Inferiority
	Comments	One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the seroprotection rate [a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	1.32
	Confidence Interval	(2-Sided) 97.5%; -3.41 to 4.15
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Adacel Group, Control Group
	Comments	To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against tetanus antigen, one month following vaccination.
	Type of Statistical Test	Non-Inferiority
	Comments	One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the seroprotection rate [a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	0.31
	Confidence Interval	(2-Sided) 97.5%; -3.69 to 2.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.

10. Primary Outcome

Title	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Description	Anti-PT, anti-FHA and anti-PRN antibody concentrations were measured by ELISA, tabulated as GMCs and expressed in IU/mL.
Time Frame	At Year 9, one month before booster vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	271	120	327
Anti-PT	8.2	7.8	5.4
Anti-FHA	42.2	28.4	23.6
Anti-PRN	63.8	64.7	17.8

11. Primary Outcome

Title	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Description	Anti-PT, anti-FHA and anti-PRN antibody concentrations were measured by ELISA, tabulated as GMCs and expressed in IU/mL.
Time Frame	At Year 9, one month after the booster vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Total Vaccinated Cohort (TVC) at Year 9 which included all subjects with a study vaccine administration dose documented: a safety analysis based on the TVC included all vaccinated subjects, an immunogenicity analysis based on the TVC included all vaccinated subjects for whom immunogenicity results were available.

Arm/Group Title	Boostrix Group	Adacel Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the nondominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap] (GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423) divided by Infanrix Group in APV-039 who included subjects who received 3 consecutive doses of Infanrix.
Measure Participants	271	121
ANTI-PT	64.1	70.4
ANTI-FHA	247.9	254.6
ANTI-PRN	405.4	511.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Boostrix Group, Adacel Group
	Comments	To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PT one month following vaccination
	Type of Statistical Test	Non-Inferiority
	Comments	One month after vaccination, the lower limits of the 97.5% CIs for the anti-PT GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC ratio
	Estimated Value	1.53
	Confidence Interval	(2-Sided) 97.5%; 1.31 to 1.79
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Boostrix Group, Adacel Group
	Comments	To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-FHA one month following vaccination
	Type of Statistical Test	Non-Inferiority
	Comments	One month after vaccination, the lower limits of the 97.5% CIs for the anti-FHA GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC ratio
	Estimated Value	5.27
	Confidence Interval	(2-Sided) 97.5%; 4.62 to 6.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Boostrix Group, Adacel Group
	Comments	To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PRN one month following vaccination
	Type of Statistical Test	Non-Inferiority
	Comments	One month after vaccination, the lower limits of the 97.5% CIs for the anti-PRN GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC ratio
	Estimated Value	3.62
	Confidence Interval	(2-Sided) 97.5%; 3.07 to 4.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Boostrix Group, Adacel Group
	Comments	To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PT one month following vaccination
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	One month after vaccination, the lower limits of the 97.5% CIs for the anti-PT GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC ratio
	Estimated Value	1.64
	Confidence Interval	() 97.5%; 1.33 to 2.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Boostrix Group, Adacel Group
	Comments	To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-FHA one month following vaccination
	Type of Statistical Test	Non-Inferiority
	Comments	One month after vaccination, the lower limits of the 97.5% CIs for the anti-FHA GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC ratio
	Estimated Value	5.27
	Confidence Interval	(2-Sided) 97.5%; 4.37 to 6.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Boostrix Group, Adacel Group
	Comments	To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PRN one month following vaccination
	Type of Statistical Test	Non-Inferiority
	Comments	One month after vaccination, the lower limits of the 97.5% CIs for the anti-PRN GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC ratio
	Estimated Value	4.47
	Confidence Interval	(2-Sided) 97.5%; 3.58 to 5.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Primary Outcome

Title	Booster Response to D and T Antigens
Description	A booster response was defined as: for initially seronegative subjects (S-) (pre-vaccination concentration below cut-off: < 0.1 IU/mL) antibody concentrations at least four times the cut-off (post vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (S+) (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration; Total = subjects either seropositive or seronegative.
Time Frame	At Year 9, one month after the booster vaccination.

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	269	120	324
Anti-D, S-	16 1.5%	3 0.6%	35 9.7%
Anti-D, S+	153 14.3%	68 13%	187 51.7%
Anti-D, Total	169 15.8%	71 13.6%	222 61.3%
Anti-T, S-	5 0.5%	18 3.4%
Anti-T, S+	121 11.3%	44 8.4%	139 38.4%
Anti-T, Total	126 11.8%	44 8.4%	157 43.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Boostrix Group, Control Group
	Comments	To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against diphtheria antigen, one month following vaccination.
	Type of Statistical Test	Non-Inferiority
	Comments	One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in booster response rate
	Estimated Value	-5.91
	Confidence Interval	(2-Sided) 97.5%; -14.67 to 2.85
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Boostrix Group, Control Group
	Comments	To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against tetanus antigen, one month following vaccination.
	Type of Statistical Test	Non-Inferiority
	Comments	One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in booster response rate
	Estimated Value	-1.44
	Confidence Interval	(2-Sided) 97.5%; -10.63 to 7.79
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Adacel Group, Control Group
	Comments	To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against diphtheria antigen, one month following vaccination.
	Type of Statistical Test	Non-Inferiority
	Comments	One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in booster response rate
	Estimated Value	-8.56
	Confidence Interval	(2-Sided) 97.5%; -20.33 to 2.73
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Adacel Group, Control Group
	Comments	To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against tetanus antigen, one month following vaccination.
	Type of Statistical Test	Non-Inferiority
	Comments	One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in booster response rate
	Estimated Value	-11.79
	Confidence Interval	(2-Sided) 97.5%; -22.98 to 0.15
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.

13. Primary Outcome

Title	Booster Response to PT, FHA and PRN Antigens
Description	Booster response was defined as: for subjects with pre-vaccination antibody concentration < 5 EL.U/mL (S-): antibody concentration ≥ 20 EL.U/mL; for subjects with pre-vaccination antibody concentration ≥ 5 EL.U/mL and < 20 EL.U/mL (S+, <4*cut-off): antibody concentration at least four times the pre-vaccination concentration; for subjects with pre-vaccination antibody concentration ≥ 20 EL.U/mL (S+, ≥4*cut-off): antibody concentration at least two times the pre-vaccination concentration; Total = subjects either seropositive or seronegative
Time Frame	At Year 9, one month after the booster vaccination.

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	271	120	327
Anti-PT, S-	34 3.2%	10 1.9%	101 27.9%
Anti-PT, S+, < 4*cut-off	106 9.9%	53 10.1%	94 26%
Anti-PT, S+, ≥ 4*cut-off	95 8.9%	43 8.2%	97 26.8%
Anti-PT, Total	235 22%	106 20.3%	292 80.7%
Anti-FHA, S-	1 0.1%	5 1%
Anti-FHA, S+, < 4*cut-off	16 1.5%	9 1.7%	70 19.3%
Anti-FHA, S+, ≥ 4*cut-off	216 20.2%	106 20.3%	228 63%
Anti-FHA, Total	232 21.7%	116 22.2%	303 83.7%
Anti-PRN, S-	4 0.4%	1 0.2%	31 8.6%
Anti-PRN, S+, < 4*cut-off	27 2.5%	10 1.9%	75 20.7%
Anti-PRN, S+, ≥ 4*cut-off	179 16.7%	87 16.6%	175 48.3%
Anti-PRN, Total	210 19.6%	98 18.7%	281 77.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Boostrix Group, Control Group
	Comments	To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PT antigen, one month following vaccination.
	Type of Statistical Test	Non-Inferiority
	Comments	One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)] against PT antigen was greater than or equal to -10% (clinical limit for non-inferiority).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in booster response rate
	Estimated Value	-2.85
	Confidence Interval	(2-Sided) 97.5%; -9.09 to 3.08
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Boostrix Group, Control Group
	Comments	To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against FHA antigen, one month following vaccination.
	Type of Statistical Test	Non-Inferiority
	Comments	One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)] against FHA antigen was greater than or equal to -10% (clinical limit for non-inferiority).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in booster response rate
	Estimated Value	-7.05
	Confidence Interval	(2-Sided) 97.5%; -13.16 to -1.40
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Boostrix Group, Control Group
	Comments	To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PRN antigen, one month following vaccination.
	Type of Statistical Test	Non-Inferiority
	Comments	One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)] against PRN antigen was greater than or equal to -10% (clinical limit for non-inferiority).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in booster response rate
	Estimated Value	-10.32
	Confidence Interval	(2-Sided) 97.5%; -17.50 to -3.38
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Adacel Group, Control Group
	Comments	To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PT antigen, one month following vaccination.
	Type of Statistical Test	Non-Inferiority
	Comments	One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)] against PT antigen was greater than or equal to -10% (clinical limit for non-inferiority).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in booster response rate
	Estimated Value	-1.24
	Confidence Interval	(2-Sided) 97.5%; -10.03 to 5.57
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Adacel Group, Control Group
	Comments	To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against FHA antigen, one month following vaccination.
	Type of Statistical Test	Non-Inferiority
	Comments	One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)] against FHA antigen was greater than or equal to -10% (clinical limit for non-inferiority).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in booster response rate
	Estimated Value	4.01
	Confidence Interval	(2-Sided) 97.5%; -2.38 to 8.66
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Adacel Group, Control Group
	Comments	To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PRN antigen, one month following vaccination.
	Type of Statistical Test	Non-Inferiority
	Comments	One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)] against PRN antigen was greater than or equal to -10% (clinical limit for non-inferiority).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in booster response
	Estimated Value	-4.76
	Confidence Interval	(2-Sided) 97.5%; -14.53 to 3.18
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.

14. Secondary Outcome

Title	Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Description	The cut-off for anti-PT concentrations was defined as ≥ 5 ELISA units per mililiter (EL.U/mL).
Time Frame	At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

Arm/Group Title	Boostrix Group	Adacel Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
Measure Participants	1013	506
Year 1	917 85.8%	435 83.2%
Year 3	751 70.3%	316 60.4%
Year 5	670 62.7%	285 54.5%

15. Secondary Outcome

Title	Number of Subjects With Anti-PT Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Description	The cut-off for anti-PT concentrations was defined as equal to or greater than 2.693 IU/mL.
Time Frame	At Year 9, one month before(pre booster) and after the booster vaccination(post booster)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	271	121	327
Pre-booster	230 21.5%	106 20.3%	209 57.7%
Post-booster	268 25.1%	120 22.9%	322 89%

16. Secondary Outcome

Title	Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Description	The cut-off for anti-FHA concentrations was defined as equal to or greater than 5 EL.U/mL.
Time Frame	At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

Arm/Group Title	Boostrix Group	Adacel Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
Measure Participants	1014	502
Year 1	1012 94.7%	501 95.8%
Year 3	913 85.4%	437 83.6%
Year 5	788 73.7%	368 70.4%

17. Secondary Outcome

Title	Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Description	The cut-off for anti-FHA concentrations was defined as equal to or greater than 2.046 IU/mL
Time Frame	At Year 9, one month before(pre booster) and after the booster vaccination(post booster)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	271	121	327
Pre-booster	271 25.4%	119 22.8%	322 89%
Post-booster	271 25.4%	121 23.1%	327 90.3%

18. Secondary Outcome

Title	Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Description	The cut-off for anti-PRN concentrations was defined as equal to or greater than 5 EL.U/mL.
Time Frame	At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

Arm/Group Title	Boostrix Group	Adacel Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
Measure Participants	1011	501
Year 1	971 90.8%	489 93.5%
Year 3	862 80.6%	426 81.5%
Year 5	755 70.6%	362 69.2%

19. Secondary Outcome

Title	Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Description	The cut-off for anti-PRN concentrations was defined as equal to or greater than 2.187 IU/mL.
Time Frame	At Year 9, one month before(pre booster) and after the booster vaccination(post booster)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	271	121	326
Pre-booster	267 25%	117 22.4%	284 78.5%
Post-booster	271 25.4%	121 23.1%	326 90.1%

20. Secondary Outcome

Title	Anti-D Antibody Concentration
Description	Anti-D antibody concentration is expressed as geometric mean concentration (GMC) in IU/mL.
Time Frame	At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

Arm/Group Title	Boostrix Group	Adacel Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
Measure Participants	1010	504
Year 1	1.4	1.4
Year 3	0.9	1.0
Year 5	0.8	0.9

21. Secondary Outcome

Title	Anti-D Antibody Concentration
Description	Anti-D antibody concentration is expressed as GMC in IU/mL.
Time Frame	At Year 9, one month before(pre booster) and after the booster vaccination(post booster)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	271	121	326
Pre-booster	0.7	0.8	0.4
Post-booster	4.1	4.7	4.0

22. Secondary Outcome

Title	Anti-T Antibody Concentration
Description	Anti-T antibody concentration is expressed as GMC in IU/mL.
Time Frame	At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

Arm/Group Title	Boostrix Group	Adacel Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
Measure Participants	1014	506
Year 1	3.4	4.4
Year 3	2.2	2.9
Year 5	2.0	2.5

23. Secondary Outcome

Title	Anti-T Antibody Concentration
Description	Anti-T antibody concentration is expressed as GMC in IU/mL.
Time Frame	At Year 9, one month before(pre booster) and after the booster vaccination(post booster)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	271	121	327
Pre-booster	1.8	2.3	1.5
Post-booster	8.4	8.6	8.8

24. Secondary Outcome

Title	Anti-PT Antibody Concentration
Description	Anti-PT antibody concentration is expressed as GMC in EL.U/mL.
Time Frame	At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

Arm/Group Title	Boostrix Group	Adacel Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
Measure Participants	1013	506
Year 1	22.4	15.6
Year 3	14.1	10.0
Year 5	14.6	11.6

25. Secondary Outcome

Title	Anti-PT Antibody Concentration
Description	Anti-PT antibody concentration was expressed as GMC in IU/mL.
Time Frame	At Year 9, one month before(pre booster) and after the booster vaccination(post booster)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	271	121	327
Pre-booster	8.2	7.8	5.4
Post-booster	64.1	70.4	66.2

26. Secondary Outcome

Title	Anti-FHA Antibody Concentration
Description	Anti-FHA antibody concentration is expressed as GMC in IU/mL
Time Frame	At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

Arm/Group Title	Boostrix Group	Adacel Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
Measure Participants	1014	502
Year 1	190.1	118.8
Year 3	114.1	81.8
Year 5	110.0	80.8

27. Secondary Outcome

Title	Anti-FHA Antibody Concentration
Description	Anti-FHA antibody concentration was expressed as GMC in IU/mL.
Time Frame	At Year 9, one month before(pre booster) and after the booster vaccination(post booster)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	271	121	327
Pre-booster	42.2	28.4	23.6
Post-booster	247.9	254.6	373.6

28. Secondary Outcome

Title	Anti-PRN Antibody Concentration
Description	Anti-PRN antibody concentration is expressed as GMC in IU/mL
Time Frame	At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

Arm/Group Title	Boostrix Group	Adacel Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
Measure Participants	1011	501
Year 1	152.2	132.5
Year 3	82.5	70.6
Year 5	85.3	77.4

29. Secondary Outcome

Title	Anti-PRN Antibody Concentration
Description	Anti-PRN antibody concentration is expressed as GMC in IU/mL.
Time Frame	At Year 9, one month before(pre booster) and after the booster vaccination(post booster)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	271	121	326
Pre-booster	63.8	64.7	17.8
Post-booster	405.4	511.8	336.4

30. Secondary Outcome

Title	Alternative Booster Response to Anti-D and Anti-T Antigens
Description	Alternative Booster response to D and T antigens is defined as: - For subjects with pre-booster antibody concentration below 0.1 IU/mL: antibody concentrations at least four times the 0.1IU/ML, one month after vaccination, and - For subjects with pre-booster antibody concentration ≥0.1 IU/mL and <1.0 IU/mL: antibody concentrations of at least four times the pre-booster antibody concentration, one month after vaccination. - For subjects with pre-booster antibody concentration ≥1.0 IU/mL and <6.0 IU/mL: antibody concentrations of at least two times the pre-booster antibody concentration, one month after vaccination. - Subjects with pre-booster antibody concentration ≥6.0 IU/mL are not evaluable for booster response. S- = Antibody concentration < 0.1 IU/mL S+ = Antibody concentration ≥ 0.1 IU/mL Total = subjects either seropositive or seronegative
Time Frame	At Year 9, one month after booster vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	259	115	311
ANTI-D, S-	16 1.5%	3 0.6%	35 9.7%
ANTI-D, S+ (<1 IU/ML)	103 9.6%	45 8.6%	148 40.9%
ANTI-D, S+ (≥1 IU/ML)	84 7.9%	40 7.6%	65 18%
ANTI-D, Total	203 19%	88 16.8%	248 68.5%
ANTI-T, S-	5 0.5%	18 3.4%
ANTI-T, S+ (<1 IU/ML)	46 4.3%	14 2.7%	65 18%
ANTI-T, S+ (≥1 IU/ML)	151 14.1%	74 14.1%	159 43.9%
ANTI-T, Total	202 18.9%	88 16.8%	242 66.9%

31. Secondary Outcome

Title	Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens
Description	Alternative Booster response to PT, FHA and PRN antigens is defined as: - For subjects with pre-booster antibody concentration below the assay cut off: antibody concentrations at least four times the assay cut off one month after vaccination, and - For subjects with pre-booster antibody concentration ≥ assay cut off and < 60 IU/mL: antibody concentration increase of at least 30 IU/mL from the pre-booster antibody concentration, one month after vaccination. - For subjects with pre-booster antibody concentration ≥ 60 IU/mL : at least 1.5 fold increase of antibody concentration from the pre-booster antibody concentration, one month after vaccination. S- = seronegative subjects (antibody concentration below assay cut off for anti-PT, anti-FHA, anti-PRN) S+ = seropositive subjects (antibody concentration below assay cut off for anti-PT, anti-FHA, anti-PRN) Total = subjects either seropositive or seronegative
Time Frame	At Year 9, one month after booster vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	271	120	327
ANTI-FHA, S-	1 0.1%	5 1%
ANTI-FHA, ≥ assay Cut-off and < 60 IU/mL	171 16%	91 17.4%	241 66.6%
ANTI-FHA, ≥ 60 IU/mL	82 7.7%	27 5.2%	64 17.7%
ANTI-FHA, Total	253 23.7%	119 22.8%	310 85.6%
ANTI-PRN, S-	4 0.4%	1 0.2%	31 8.6%
ANTI-PRN, ≥ assay Cut-off and < 60 IU/mL	115 10.8%	52 9.9%	185 51.1%
ANTI-PRN, ≥ 60 IU/mL	111 10.4%	53 10.1%	62 17.1%
ANTI-PRN, Total	230 21.5%	106 20.3%	278 76.8%
ANTI-PT, S-	34 3.2%	10 1.9%	101 27.9%
ANTI-PT, ≥ assay Cut-off and < 60 IU/mL	169 15.8%	83 15.9%	166 45.9%
ANTI-PT, ≥ 60 IU/mL	7 0.7%	3 0.6%	10 2.8%
ANTI-PT, Total	210 19.6%	96 18.4%	277 76.5%

32. Secondary Outcome

Title	Seroprotection Status for Anti-D Antibody Concentration
Description	Seroprotection status for anti-D antibody concentration < 0.1 IU/mL were tested for neutralizing antibodies using a VERO-cell neutralization assay. Seroprotection rate is defined as the percentage of subjects with antibody concentrations greater than or equal (≥) the seroprotection cut-off value defined for that antibody.
Time Frame	At Year 9, one month before(pre booster) and after the booster vaccination(post booster)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	271	121	326
Pre-booster	8.3	40.0	27.6
Post-booster	50.0	0.0	14.3

33. Secondary Outcome

Title	Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9
Description	Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 50 millimeters (mm)
Time Frame	During the 4-day (Days 0-3) post vaccination period.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9 and had their diary cards completed.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	306	137	358
Any Pain	180 16.8%	84 16.1%	132 36.5%
Grade 3 Pain	3 0.3%	1 0.2%	4 1.1%
Any Redness	74 6.9%	32 6.1%	53 14.6%
Grade 3 Redness	5 0.5%	2 0.4%	0 0%
Any Swelling	57 5.3%	26 5%	41 11.3%
Grade 3 Swelling	4 0.4%	2 0.4%	2 0.6%

34. Secondary Outcome

Title	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9
Description	The solicited general symptoms assessed were Fatigue, Gastrointestinal symptoms (including nausea, vomiting, diarrhea and abdominal pain), Headache and Fever [defined as temperature of ≥100.4 degrees Fahrenheit (F) by any route]. Any = Occurrence of any general symptom regardless of its intensity grade or relationship to vaccination; Grade 3 Symptom = Symptom that prevented normal activity; Grade 3 Fever > 104.0 degrees F.
Time Frame	During the 4-day (Days 0-3) post vaccination period.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9 and had their diary cards completed.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	306	137	358
Any Fatigue	71 6.6%	23 4.4%	51 14.1%
Grade 3 Fatigue	3 0.3%	1 0.2%	0 0%
Any Gastrointestinal symptoms	27 2.5%	4 0.8%	29 8%
Grade 3 Gastrointestinal symptoms	0 0%	0 0%	0 0%
Any Headache	52 4.9%	25 4.8%	53 14.6%
Grade 3 Headache	0 0%	1 0.2%	1 0.3%
Any Fever	2 0.2%	0 0%	2 0.6%
Grade 3 Fever	0 0%	0 0%	0 0%

35. Secondary Outcome

Title	Number of Subjects With Any Large Injection Site Reaction - Year 9
Description	Large injection site reaction = a swelling with a diameter > 100 mm, noticeable diffuse swelling or noticeable increase in limb circumference.
Time Frame	During the 4-day (Days 0-3) follow-up period after vaccination.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	309	138	362
Count of Participants [Participants]	0 0%	0 0%	0 0%

36. Secondary Outcome

Title	Number of Subjects With Any Unsolicited Adverse Events (AEs) - Year 9
Description	An unsolicited AE covers any untoward medical oc-currence 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.
Time Frame	During the 31-day (Days 0-30) post-vaccination period.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	309	138	362
Count of Participants [Participants]	42 3.9%	23 4.4%	37 10.2%

37. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs) - Year 9
Description	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	During the 31-day (Days 0-30) post-vaccination period

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9.

Arm/Group Title	Boostrix Group	Adacel Group	Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).	Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Measure Participants	309	138	362
Count of Participants [Participants]	0 0%	0 0%	1 0.3%

Adverse Events

Time Frame	Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Adverse Event Reporting Description	Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
Arm/Group Title	Boostrix Group		Adacel Group		Control Group
Arm/Group Description	Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).		Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).		Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
All Cause Mortality
	Boostrix Group		Adacel Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/309 (0%)		0/138 (0%)		0/362 (0%)
Serious Adverse Events
	Boostrix Group		Adacel Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/309 (0%)		0/138 (0%)		1/362 (0.3%)
Nervous system disorders
Seizure	0/309 (0%)		0/138 (0%)		1/362 (0.3%)
Other (Not Including Serious) Adverse Events
	Boostrix Group		Adacel Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	213/309 (68.9%)		95/138 (68.8%)		172/362 (47.5%)
Gastrointestinal disorders
Gastrointestinal disorder	28/309 (9.1%)	28	4/138 (2.9%)	4	29/362 (8%)	29
General disorders
Fatigue	71/309 (23%)	72	23/138 (16.7%)	23	51/362 (14.1%)	51
Pain	181/309 (58.6%)	183	84/138 (60.9%)	84	132/362 (36.5%)	132
Swelling	57/309 (18.4%)	57	26/138 (18.8%)	26	41/362 (11.3%)	41
Nervous system disorders
Headache	53/309 (17.2%)	54	28/138 (20.3%)	29	57/362 (15.7%)	58
Skin and subcutaneous tissue disorders
Erythema	74/309 (23.9%)	74	32/138 (23.2%)	32	53/362 (14.6%)	53

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.