Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Previously Boosted Young Adults

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01738477
• Collaborator: (none)
• Enrollment: 165
• Locations: 20
• Arms: 2
• Actual Duration (Months): 14
• Patients Per Site: 8.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this follow-up study is to evaluate the persistence of antibodies against all the vaccine antigens 10 years after booster vaccination with either Tdap or Td, 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 = NCT00109330).

Condition or Disease	Intervention/Treatment	Phase
Tetanus; Acellular Pertussis; Diphtheria	Biological: Boostrix	Phase 3

Detailed Description

Subjects were previously vaccinated with either Boostrix or a control Td vaccine in study NCT00109330. 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 1 (Day 0) and subjects will be observed till Visit 2 (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 1) and one month after vaccination (Visit 2) for antibodies estimation.

This summary has been updated following Protocol amendment 2 dated 03 October 2013. The protocol is being amended to facilitate enrolment by:

• • Extending the window period for re-vaccination from ± 6 months to ± 300 days from the Year 10 time point.
• • Extending the recruitment period from 6 months to 14 months. The format of non-inferiority criterion of the first co-primary objective has been updated to keep it aligned with the format of non-inferiority criterion of the second co-primary objective.

Study Design

• Study Type: Interventional
• Actual Enrollment: 165 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Evaluation of Immunogenicity and Safety of GSK Biologicals' Tdap Booster Vaccine (Boostrix™) in Young Adults, Administered 10 Years After Previous Tdap Boosting
• Actual Study Start Date: Jan 31, 2013
• Actual Primary Completion Date: Apr 2, 2014
• Actual Study Completion Date: Apr 2, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Boostrix Group 2 Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.	Biological: Boostrix; Single dose intramuscular administration.
Active Comparator: Boostrix Group 1 Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Biological: Boostrix; Single dose intramuscular administration.

Outcome Measures

Primary Outcome Measures

1. Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T). [At Month 1]

   A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)

2. Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN). [At Month 1]

   Concentrations were expressed in geometric mean concentrations (GMCs).

Secondary Outcome Measures

1. Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T). [At Month 0]

   A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)

2. Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off. [At Month 0 and Month 1]

   The cut-off of the assay was ≥ 1.0 IU/mL.

3. Anti-D and Anti-T Antibody Concentrations. [At Month 0 and Month 1]

   Concentrations were expressed as GMCs.

4. Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN). [At Month 0]

   Concentrations were expressed in geometric mean concentrations (GMCs).

5. Number of Subjects With a Booster Response to Anti-D and Anti-T. [At Month 1]

   Booster response to anti-D and anti-T antigens was defined as: for initially seronegative subjects with pre-booster antibody concentration below 0.1 IU/mL, an increase of at least four times 0.1 IU/mL one month after vaccination, for initially seropositive subjects with pre-booster antibody concentration ≥ 0.1 IU/mL, an increase of at least four times the pre-booster antibody concentration one month after vaccination.

6. Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN. [At Month 1.]

   Booster response to pertussis antigens was defined as: for initially seronegative subjects (pre-booster antibody concentration below the assay cut-off) with an increase of at least four times the assay cut-off one month after vaccination; for initially seropositive subjects with anti-body concentration < four times the assay cut-off with an increase of at least four times the pre-booster antibody concentration one month after vaccination; for initially seropositive subjects with anti-body concentration ≥ four times the assay cut-off with an increase of at least two times the pre-booster antibody concentration one month after vaccination.

7. Number of Subjects With Solicited Local Symptoms. [During the 4 days (Day 0 - 3) follow-up period after vaccination.]

   The solicited local symptoms assessed were Pain, Redness and Swelling. Any = any solicited local symptom regardless of intensity.

8. Number of Subjects With Solicited General Symptoms. [During the 4 days (Day 0 - 3) follow-up period after vaccination.]

   The solicited local symptoms assessed were Fatigue, Gastrointestinal, Headache and Fever. Any = any solicited general symptom regardless of intensity.

9. Number of Subjects With Unsolicited Adverse Events (AEs). [During the 31 days (Day 0 - 30) after vaccination.]

   An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

10. Number of Subjects With Serious Adverse Events (SAEs). [From Day 0 to 31 days post-vaccination.]

    SAEs assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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 visit).

• Subjects who have received a dose of Tdap or Td vaccines 10 years (+/-300 days) back, in study NCT00109330.

• Written informed consent obtained from the subject.

• 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 childbearing 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 during the entire treatment period and for 1 month after completion of the vaccine dose.

Exclusion Criteria:

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

• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose . For corticosteroids, this will mean prednisone (≥ 20 mg/day (for adult subjects), or equivalent. 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 31 days after the dose of vaccine, with the exception of Influenza vaccine which is allowed throughout the study period.

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

• Previous vaccination against diphtheria, tetanus or pertussis since the last dose received in the Study NCT00109330.

• History of diphtheria, tetanus or pertussis diseases following the receipt of booster dose in the Study NCT00109330.

• 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.

• Hypersensitivity to latex.

• Encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) of unknown etiology occurring within 7 days following previous vaccination with pertussis-containing vaccine.

• History of any neurological disorders or seizures.

• 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 ≥ 99.5°F for oral, axillary or tympanic route, or ≥ 100.4°F for rectal 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 the 3 months preceding the booster dose of study vaccine or planned administration during the study period.

• Pregnant or lactating female.

• Female planning to become pregnant or planning to discontinue contraceptive precautions up to 1 month post-vaccination.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Mesa	Arizona	United States	85213
2	GSK Investigational Site	Tempe	Arizona	United States	85283
3	GSK Investigational Site	Jonesboro	Arkansas	United States	72401
4	GSK Investigational Site	Fullerton	California	United States	92835
5	GSK Investigational Site	Rolling Hills Estates	California	United States	90274
6	GSK Investigational Site	Golden	Colorado	United States	80401
7	GSK Investigational Site	Norwich	Connecticut	United States	06360
8	GSK Investigational Site	Jacksonville	Florida	United States	32209
9	GSK Investigational Site	Chicago	Illinois	United States	60614
10	GSK Investigational Site	Bardstown	Kentucky	United States	40004
11	GSK Investigational Site	Woburn	Massachusetts	United States	01801
12	GSK Investigational Site	Omaha	Nebraska	United States	68131
13	GSK Investigational Site	East Setauket	New York	United States	11733
14	GSK Investigational Site	Cleveland	Ohio	United States	44109
15	GSK Investigational Site	Cleveland	Ohio	United States	44121
16	GSK Investigational Site	Erie	Pennsylvania	United States	16505
17	GSK Investigational Site	Upper Saint Clair	Pennsylvania	United States	15241
18	GSK Investigational Site	Houston	Texas	United States	77030
19	GSK Investigational Site	Salt Lake City	Utah	United States	84109
20	GSK Investigational Site	South Jordan	Utah	United States	84095

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01738477
• Other Study ID Numbers: 116570
• First Posted: Nov 30, 2012
• Last Update Posted: Jun 6, 2018
• Last Verified: May 1, 2018

• Keywords provided by GlaxoSmithKline: Booster; Tdap; Immunogenicity; Repeat dose; Safety; BoostrixTM; Persistence
• Additional relevant MeSH terms: Diphtheria

Study Results

Participant Flow

Arm/Group Title	Boostrix Group 1	Boostrix Group 2
Arm/Group Description	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Period Title: Overall Study
STARTED	37	128
COMPLETED	36	124
NOT COMPLETED	1	4

Baseline Characteristics

Arm/Group Title	Boostrix Group 1	Boostrix Group 2	Total
Arm/Group Description	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.	Total of all reporting groups
Overall Participants	37	128	165
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	23.3 (2.4)	23.5 (2.1)	23.5 (2.1)
Sex: Female, Male (Count of Participants)
Female	18 48.6%	57 44.5%	75 45.5%
Male	19 51.4%	71 55.5%	90 54.5%
Race/Ethnicity, Customized (Count of Participants)
Black	1 2.7%	6 4.7%	7 4.2%
Oriental	0 0%	1 0.8%	1 0.6%
Other	5 13.5%	7 5.5%	12 7.3%
White/caucasian	31 83.8%	114 89.1%	145 87.9%

Outcome Measures

1. Primary Outcome

Title	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).
Description	A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)
Time Frame	At Month 1

Outcome Measure Data

Analysis Population Description

The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.

Arm/Group Title	Boostrix Group 1	Boostrix Group 2
Arm/Group Description	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Measure Participants	35	115
Anti-D	35 94.6%	115 89.8%
Anti-T	35 94.6%	115 89.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Boostrix Group 1, Boostrix Group 2
	Comments	Non-inferiority in terms of seroprotection rates to diphtheria.
	Type of Statistical Test	Non-Inferiority
	Comments	To assess the non-inferiority of the second dose of Boostrix (Boostrix 2 Group) minus first dose of Boostrix (Boostrix 1 Group) for anti-diphtheria. Objective of non-inferiority was considered to be met if the lower limit (LL) of the 95% confidence interval (CI) was greater than, or equal to -10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0
	Confidence Interval	() 95%; -3.25 to 9.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Boostrix Group 1, Boostrix Group 2
	Comments	Non-inferiority in terms of seroprotection rates to tetanus.
	Type of Statistical Test	Non-Inferiority
	Comments	To assess the non-inferiority of the second dose of Boostrix (Boostrix 2 Group) minus first dose of Boostrix (Boostrix 1 Group) for anti-tetanus. Objective of non-inferiority was considered to be met if the LL of the 95% CI was above -10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0
	Confidence Interval	() 95%; -3.25 to 9.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN).
Description	Concentrations were expressed in geometric mean concentrations (GMCs).
Time Frame	At Month 1

Outcome Measure Data

Analysis Population Description

The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.

Arm/Group Title	Boostrix Group 1	Boostrix Group 2
Arm/Group Description	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Measure Participants	35	115
anti-PT	66.2	87.3
anti-FHA	336.2	290.5
anti-PRN	425.5	463.3

3. Secondary Outcome

Title	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).
Description	A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)
Time Frame	At Month 0

Outcome Measure Data

Analysis Population Description

The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.

Arm/Group Title	Boostrix Group 1	Boostrix Group 2
Arm/Group Description	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Measure Participants	35	115
Anti-D	35 94.6%	115 89.8%
Anti-T	35 94.6%	115 89.8%

4. Secondary Outcome

Title	Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off.
Description	The cut-off of the assay was ≥ 1.0 IU/mL.
Time Frame	At Month 0 and Month 1

Outcome Measure Data

Analysis Population Description

The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.

Arm/Group Title	Boostrix Group 1	Boostrix Group 2
Arm/Group Description	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Measure Participants	35	115
Anti-D at Month 0	23 62.2%	70 54.7%
Anti-D at Month 1	34 91.9%	115 89.8%
Anti-T at Month 0	27 73%	86 67.2%
Anti-T at Month 1	35 94.6%	115 89.8%

5. Secondary Outcome

Title	Anti-D and Anti-T Antibody Concentrations.
Description	Concentrations were expressed as GMCs.
Time Frame	At Month 0 and Month 1

Outcome Measure Data

Analysis Population Description

The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.

Arm/Group Title	Boostrix Group 1	Boostrix Group 2
Arm/Group Description	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Measure Participants	35	115
Anti-D at Month 0	1.6	1.6
Anti-D at Month 1	6.8	6.0
Anti-T at Month 0	1.8	1.8
Anti-T at Month 1	9.9	9.7

6. Secondary Outcome

Title	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN).
Description	Concentrations were expressed in geometric mean concentrations (GMCs).
Time Frame	At Month 0

Outcome Measure Data

Analysis Population Description

The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.

Arm/Group Title	Boostrix Group 1	Boostrix Group 2
Arm/Group Description	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Measure Participants	35	115
anti-PT	5.3	9.9
anti-FHA	21.7	36.9
anti-PRN	27.8	71.6

7. Secondary Outcome

Title	Number of Subjects With a Booster Response to Anti-D and Anti-T.
Description	Booster response to anti-D and anti-T antigens was defined as: for initially seronegative subjects with pre-booster antibody concentration below 0.1 IU/mL, an increase of at least four times 0.1 IU/mL one month after vaccination, for initially seropositive subjects with pre-booster antibody concentration ≥ 0.1 IU/mL, an increase of at least four times the pre-booster antibody concentration one month after vaccination.
Time Frame	At Month 1

Outcome Measure Data

Analysis Population Description

The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.

Arm/Group Title	Boostrix Group 1	Boostrix Group 2
Arm/Group Description	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Measure Participants	35	115
Anti-D	14 37.8%	47 36.7%
Anti-T	21 56.8%	64 50%

8. Secondary Outcome

Title	Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN.
Description	Booster response to pertussis antigens was defined as: for initially seronegative subjects (pre-booster antibody concentration below the assay cut-off) with an increase of at least four times the assay cut-off one month after vaccination; for initially seropositive subjects with anti-body concentration < four times the assay cut-off with an increase of at least four times the pre-booster antibody concentration one month after vaccination; for initially seropositive subjects with anti-body concentration ≥ four times the assay cut-off with an increase of at least two times the pre-booster antibody concentration one month after vaccination.
Time Frame	At Month 1.

Outcome Measure Data

Analysis Population Description

The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.

Arm/Group Title	Boostrix Group 1	Boostrix Group 2
Arm/Group Description	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Measure Participants	35	115
Anti-PT	33 89.2%	106 82.8%
Anti-FHA	34 91.9%	104 81.3%
Anti-PRN	29 78.4%	79 61.7%

9. Secondary Outcome

Title	Number of Subjects With Solicited Local Symptoms.
Description	The solicited local symptoms assessed were Pain, Redness and Swelling. Any = any solicited local symptom regardless of intensity.
Time Frame	During the 4 days (Day 0 - 3) follow-up period after vaccination.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented and the symptom sheet filled-in.

Arm/Group Title	Boostrix Group 1	Boostrix Group 2
Arm/Group Description	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix™ in this study.	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix™ in this study.
Measure Participants	36	125
Any Pain	21 56.8%	97 75.8%
Any Redness	15 40.5%	47 36.7%
Any Swelling	7 18.9%	30 23.4%

10. Secondary Outcome

Title	Number of Subjects With Solicited General Symptoms.
Description	The solicited local symptoms assessed were Fatigue, Gastrointestinal, Headache and Fever. Any = any solicited general symptom regardless of intensity.
Time Frame	During the 4 days (Day 0 - 3) follow-up period after vaccination.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented and the symptom sheet filled-in.

Arm/Group Title	Boostrix Group 1	Boostrix Group 2
Arm/Group Description	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix™ in this study.	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix™ in this study.
Measure Participants	36	125
Any Fatigue	8 21.6%	38 29.7%
Any Gastrointestinal Symptoms	1 2.7%	11 8.6%
Any Headache	8 21.6%	40 31.3%
Any Fever	1 2.7%	3 2.3%

11. Secondary Outcome

Title	Number of Subjects With Unsolicited Adverse Events (AEs).
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Time Frame	During the 31 days (Day 0 - 30) after vaccination.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented.

Arm/Group Title	Boostrix Group 1	Boostrix Group 2
Arm/Group Description	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix™ in this study.	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix™ in this study.
Measure Participants	37	128
Count of Participants [Participants]	10 27%	33 25.8%

12. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs).
Description	SAEs assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame	From Day 0 to 31 days post-vaccination.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented.

Arm/Group Title	Boostrix Group 1	Boostrix Group 2
Arm/Group Description	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix™ in this study.	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix™ in this study.
Measure Participants	37	128
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	Solicited local/general symptoms: during the 4-days (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 31-day (Days 0-30) post-vaccination period; SAE(s): from Month 0 to Month 1.
Arm/Group Title	Boostrix Group 1		Boostrix Group 2
Arm/Group Description	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.		Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
All Cause Mortality
	Boostrix Group 1		Boostrix Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/128 (0%)
Serious Adverse Events
	Boostrix Group 1		Boostrix Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/128 (0%)
Other (Not Including Serious) Adverse Events
	Boostrix Group 1		Boostrix Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/37 (81.1%)		107/128 (83.6%)
Gastrointestinal disorders
Gastrointestinal disorder	1/37 (2.7%)	1	11/128 (8.6%)	11
General disorders
Fatigue	8/37 (21.6%)	8	38/128 (29.7%)	38
Pain	21/37 (56.8%)	21	97/128 (75.8%)	97
Swelling	7/37 (18.9%)	7	30/128 (23.4%)	30
Musculoskeletal and connective tissue disorders
Myalgia	2/37 (5.4%)	2	1/128 (0.8%)	1
Nervous system disorders
Headache	11/37 (29.7%)	15	46/128 (35.9%)	56
Reproductive system and breast disorders
Dysmenorrhoea	2/37 (5.4%)	2	2/128 (1.6%)	2
Skin and subcutaneous tissue disorders
Erythema	15/37 (40.5%)	15	47/128 (36.7%)	47

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.