Download PDF

Clinical Trial Results:
A phase IV, open, non-randomized, multicentre study to assess the reactogenicity and immunogenicity of a booster dose of GSK Biologicals’ combined reduced-antigen-content diphtheria, tetanus and acellular pertussis vaccine dTpa (Boostrix) when administered in healthy adult subjects, after previous booster vaccination with dTpa in study 263855/029 (dTpa-029).

Summary
EudraCT number	2009-016012-21
Trial protocol	BE
Global end of trial date	08 May 2012

Results information
Results version number	v3(current)
This version publication date	16 Sep 2018
First version publication date	21 May 2015
Other versions	v1 , v2
Version creation reason	Correction of full data set Minor corrections of the full study results.

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

113055

ISRCTN number

US NCT number

NCT01147900

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline Biologicals

Sponsor organisation address

Rue de l’Institut 89, Rixensart, Belgium,

Public contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, SKClinicalSupportHD@gsk.com

Scientific contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, SKClinicalSupportHD@gsk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

28 Nov 2012

Is this the analysis of the primary completion data?

Yes

Primary completion date

08 May 2012

Global end of trial reached?

Yes

Global end of trial date

08 May 2012

Was the trial ended prematurely?

Main objective of the trial

•To assess the persistence of anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, and anti-PRN antibodies 8.5 and 10 years after the previous booster dose in study 263855/029 (dTpa-029). •To assess the immunogenicity of the administered dTpa vaccine in terms of antibody response to all vaccine antigens, one month after a second booster vaccination in subjects who will receive: - the Boostrix-REF vaccine and have previously received the same vaccine. - the Boostrix-US vaccine and have previously received the same vaccine. - the Boostrix-REF vaccine and have previously received the Boostrix-INV vaccine.

Protection of trial subjects

All subjects were supervised for after vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.

Background therapy

Evidence for comparator

Actual start date of recruitment

15 Jun 2010

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 180

Worldwide total number of subjects

180

EEA total number of subjects

180

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

180

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Subjects consisted of those previously vaccinated & boosted in GSK263855/029 study and contacted for participation in this booster (BST) study. Duration of this study was about 19 months, from Year 8.5 (8.5 years post BST in GSK263855/029 study) to one month post BST in this study (Year 10 [10 years post BST in GSK263855/029 study] + one month).

Screening details

At Year 8.5, a total of 180 subjects (out of the 478 planned) were enrolled: 54, 60 and 66 subjects in the Boostrix-REF, Boostrix-US, and Boostrix-INV groups, respectively. At Year 10, a total of 177 subjects (out of the 180 planned) were enrolled: 55, 60 and 62 in the Boostrix-REF, Boostrix-US, and Boostrix-INV groups, respectively.

Period 1 title

At Year 8.5

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Boostrix-US Group

Arm description

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Arm type

Experimental

Investigational medicinal product name

Boostrix-US formulation

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular, single dose

Boostrix-INV Group

Arm description

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Arm type

Experimental

Investigational medicinal product name

Boostrix- investigational formulation

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular, single dose

Boostrix-REF Group

Arm description

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Arm type

Experimental

Investigational medicinal product name

Boostrix-reference formulation

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular, single dose

Number of subjects in period 1	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Started	54	60	66
Completed	54	60	66

Period 2 title

At Year 10

Is this the baseline period?

Yes ^[1]

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Boostrix-US Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Boostrix-US formulation

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular, single dose

Boostrix-INV Group

Arm description

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Arm type

Experimental

Investigational medicinal product name

Boostrix- investigational formulation

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular, single dose

Boostrix-REF Group

Arm description

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Arm type

Experimental

Investigational medicinal product name

Boostrix- reference formulation

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular, single dose

Notes
[1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
Justification: More subjects were enrolled in the second period for Boostrix-US Group, therefore it was considered the baseline period.

Number of subjects in period 2 ^[2] ^[3]	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Started	55	60	62
Completed	55	59	62
Not completed	0	1	0
Lost to follow-up	-	1	-

Notes
[2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: The worldwide number of enrolled subjects was based on the first period, while the number of subjects reported to be in the baseline periods was based on the second period.
[3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.

Baseline characteristics

Top of page

Reporting group title

Boostrix-US Group

Reporting group description

Reporting group title

Boostrix-INV Group

Reporting group description

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Reporting group title

Boostrix-REF Group

Reporting group description

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Reporting group values	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group	Total
Number of subjects	55	60	62	177
Age categorical
Units: Subjects
In utero				0
Preterm newborn infants (gestational age < 37 wks)				0
Newborns (0-27 days)				0
Infants and toddlers (28 days-23 months)				0
Children (2-11 years)				0
Adolescents (12-17 years)				0
Adults (18-64 years)				0
From 65-84 years				0
85 years and over				0
Age continuous
The baseline measure data correspond to Year 10.
Units: years
geometric mean (standard deviation)	23.5 ± 1.44	23.4 ± 1.21	23.3 ± 1.17	-
Gender categorical
The baseline measure data correspond to Year 10.
Units: Subjects
Female	29	31	36	96
Male	26	29	26	81

End points

Top of page

Reporting group title

Boostrix-US Group

Reporting group description

Reporting group title

Boostrix-INV Group

Reporting group description

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Reporting group title

Boostrix-REF Group

Reporting group description

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Reporting group title

Boostrix-US Group

Reporting group description

Reporting group title

Boostrix-INV Group

Reporting group description

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Reporting group title

Boostrix-REF Group

Reporting group description

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Primary: Number of seroprotected subjects against diphtheria and tetanus

Top of page

End point title

Number of seroprotected subjects against diphtheria and tetanus ^[1]

End point description

A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).

End point type

Primary

End point timeframe

At Year 8.5

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.

End point values	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Number of subjects analysed	54	59	65
Units: Subjects
Anti-D	53	59	65
Anti-T	54	59	65

No statistical analyses for this end point

Primary: Concentrations for anti-D and anti-T antibodies.

Top of page

End point title

Concentrations for anti-D and anti-T antibodies. ^[2]

End point description

Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.

End point type

Primary

End point timeframe

At Year 8.5

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.

End point values	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Number of subjects analysed	54	59	65
Units: IU/mL
geometric mean (confidence interval 95%)
Anti-D	0.912 (0.728 to 1.141)	1.205 (0.984 to 1.474)	0.872 (0.711 to 1.068)
Anti-T	1.889 (1.585 to 2.251)	1.991 (1.674 to 2.368)	1.846 (1.604 to 2.123)

No statistical analyses for this end point

Primary: Number of seroprotected subjects against diphtheria and tetanus.

Top of page

End point title

Number of seroprotected subjects against diphtheria and tetanus. ^[3]

End point description

A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).

End point type

Primary

End point timeframe

At Year 10

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.

End point values	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Number of subjects analysed	54	60	61
Units: Subjects
Anti-D	53	60	61
Anti-T	54	60	61

No statistical analyses for this end point

Primary: Concentrations for anti-D and anti-T antibodies.

Top of page

End point title

Concentrations for anti-D and anti-T antibodies. ^[4]

End point description

Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.

End point type

Primary

End point timeframe

At Year 10

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.

End point values	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Number of subjects analysed	54	60	61
Units: IU/mL
geometric mean (confidence interval 95%)
Anti-D	0.767 (0.6 to 0.982)	1.099 (0.882 to 1.37)	0.681 (0.55 to 0.844)
Anti-T	2.008 (1.65 to 2.444)	2.009 (1.701 to 2.372)	1.76 (1.518 to 2.041)

No statistical analyses for this end point

Primary: Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-pertactin (anti-PRN) and anti-filamentous haemagglutinin (anti-FHA) antibodies.

Top of page

End point title

Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-pertactin (anti-PRN) and anti-filamentous haemagglutinin (anti-FHA) antibodies. ^[5]

End point description

A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

End point type

Primary

End point timeframe

At Year 8.5

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.

End point values	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Number of subjects analysed	54	59	65
Units: Subjects
Anti-PT [N=54;59;65]	42	48	60
Anti-FHA [N=54;59;62]	54	59	62
Anti-PRN [N=54;59;65]	54	59	65

No statistical analyses for this end point

Primary: Concentrations for anti-PT, anti-PRN and anti-FHA antibodies.

Top of page

End point title

Concentrations for anti-PT, anti-PRN and anti-FHA antibodies. ^[6]

End point description

Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL for all antibodies assessed.

End point type

Primary

End point timeframe

At Year 8.5

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.

End point values	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Number of subjects analysed	54	59	65
Units: EL.U/mL
geometric mean (confidence interval 95%)
Anti-PT [N=54;59;65]	10.933 (7.979 to 14.98)	13.372 (10.139 to 17.634)	18.034 (13.812 to 23.545)
Anti-FHA [N=54;59;62]	72.653 (57.904 to 91.158)	96.144 (75.613 to 122.25)	102.604 (85.687 to 122.861)
Anti-PRN [N=54;59;65]	161.349 (121.75 to 213.827)	179.027 (136.303 to 235.144)	134.616 (106.266 to 170.528)

No statistical analyses for this end point

Primary: Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN antibodies.

Top of page

End point title

Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN antibodies. ^[7]

End point description

A seropositive subject for anti-PT/anti-FHA/anti-PRN antibodies was defined as a vaccinated subject who had anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

End point type

Primary

End point timeframe

At Year 10

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.

End point values	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Number of subjects analysed	54	60	60
Units: Subjects
Anti-PT [N=52;59;59]	44	49	51
Anti-PRN [N=54;60;60]	54	60	60
Anti-FHA [N=54;60;60]	54	60	60

No statistical analyses for this end point

Primary: Concentrations for anti-PT, anti-FHA and anti-PRN antibodies.

Top of page

End point title

Concentrations for anti-PT, anti-FHA and anti-PRN antibodies. ^[8]

End point description

Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.

End point type

Primary

End point timeframe

At Year 10

Notes
[8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.

End point values	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Number of subjects analysed	54	60	60
Units: EL.U/mL
geometric mean (confidence interval 95%)
Anti-PT [N=52;59;59]	11.627 (8.863 to 15.252)	13.987 (10.874 to 17.991)	15.728 (11.76 to 21.034)
Anti-PRN [N=54;60;60]	131.814 (98.531 to 176.34)	158.239 (120.864 to 207.171)	115.209 (91.288 to 145.398)
Anti-FHA [N=54;60;60]	75.574 (61.018 to 93.603)	98.182 (77.166 to 124.921)	98.441 (82.71 to 117.165)

No statistical analyses for this end point

Primary: Number of seroprotected subjects against diphtheria and tetanus

Top of page

End point title

Number of seroprotected subjects against diphtheria and tetanus ^[9]

End point description

End point type

Primary

End point timeframe

At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.

End point values	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Number of subjects analysed	54	59	60
Units: Subjects
Anti-D, PRE	53	59	60
Anti-D, POST	54	59	60
Anti-T, PRE	54	59	60
Anti-T, POST	54	59	60

No statistical analyses for this end point

Primary: Concentrations for anti-D and anti-T antibodies.

Top of page

End point title

Concentrations for anti-D and anti-T antibodies. ^[10]

End point description

Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.

End point type

Primary

End point timeframe

At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)

Notes
[10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.

End point values	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Number of subjects analysed	54	59	60
Units: IU/mL
geometric mean (confidence interval 95%)
Anti-D, PRE	0.767 (0.6 to 0.982)	1.094 (0.874 to 1.368)	0.686 (0.552 to 0.853)
Anti-D, POST	4.251 (3.646 to 4.957)	5.226 (4.353 to 6.275)	4.15 (3.543 to 4.862)
Anti-T, PRE	2.008 (1.65 to 2.444)	1.987 (1.68 to 2.35)	1.752 (1.508 to 2.037)
Anti-T, POST	7.581 (6.523 to 8.809)	8.456 (7.294 to 9.802)	8.792 (7.582 to 10.195)

No statistical analyses for this end point

Primary: Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN antibodies.

Top of page

End point title

Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN antibodies. ^[11]

End point description

End point type

Primary

End point timeframe

At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.

End point values	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Number of subjects analysed	54	59	60
Units: Subjects
Anti-PT, PRE [N=52;58;58]	44	48	50
Anti-PT, POST [N=54;59;60]	54	59	60
Anti-PRN, PRE [N=54;59;59]	54	59	59
Anti-PRN, POST [N=53;59;60]	53	59	60
Anti-FHA, PRE [N=54;59;59]	54	59	59
Anti-FHA, POST [N=53;59;60]	53	59	60

No statistical analyses for this end point

Primary: Concentrations for anti-PT, anti-FHA and anti-PRN antibodies.

Top of page

End point title

Concentrations for anti-PT, anti-FHA and anti-PRN antibodies. ^[12]

End point description

Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.

End point type

Primary

End point timeframe

At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)

Notes
[12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.

End point values	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Number of subjects analysed	54	59	60
Units: EL.U/mL
geometric mean (confidence interval 95%)
Anti-PT, PRE [N=52;58;58]	11.627 (8.863 to 15.252)	14.193 (11.003 to 18.306)	15.65 (11.643 to 21.035)
Anti-PT, POST [N=54;59;60]	82.478 (66.951 to 101.606)	108.094 (87.703 to 133.227)	123.964 (103.458 to 148.533)
Anti-PRN, PRE [N=54;59;59]	131.814 (98.531 to 176.34)	161.903 (123.574 to 212.12)	114.226 (90.201 to 144.652)
Anti-PRN, POST [N=53;59;60]	445.751 (372.77 to 533.02)	448.475 (383.748 to 524.12)	448.839 (379.488 to 530.863)
Anti-FHA, PRE [N=54;59;59]	75.574 (61.018 to 93.603)	96.098 (75.507 to 122.305)	97.698 (81.891 to 116.555)
Anti-FHA, POST [N=53;59;60]	503.532 (426.524 to 594.444)	592.177 (516.831 to 678.507)	558.648 (489.266 to 637.869)

No statistical analyses for this end point

Primary: Number of booster responders to pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN) antigens.

Top of page

End point title

Number of booster responders to pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN) antigens. ^[13]

End point description

A booster responder to PT/PRN antigens was defined as either a vaccinated subject seronegative at analysis baseline (Year 10) with anti-PT/anti-PRN antibody concentration greater than or equal to (≥) 5 EL.U/mL at one month post Year 10 booster vaccination, or as a vaccinated subject seropositive at analysis baseline (Year 10) and with anti-PT/anti-PRN antibody concentration with at least a 2-fold increase at one month post Year 10 booster vaccination. A seronegative/seropositive subject was defined as a vaccinated subject with anti-PT/anti-PRN antibody concentration ≥/< 5 EL.U/mL.

End point type

Primary

End point timeframe

At 1 month post Year 10 booster vaccination

Notes
[13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.

End point values	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Number of subjects analysed	46	52	52
Units: Subjects
Booster responses to anti-PT [N=44;51;51]	44	51	48
Booster responses to anti-PRN [N=45;52;52]	23	29	35
Booster responses to anti-FHA [N=46;52;50]	43	47	48

No statistical analyses for this end point

Secondary: Number of subjects with any solicited local symptoms.

Top of page

End point title

Number of subjects with any solicited local symptoms.

End point description

Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.

End point type

Secondary

End point timeframe

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

End point values	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Number of subjects analysed	55	59	62
Units: Subjects
Any Pain	50	55	54
Any Redness	23	23	21
Any Swelling	21	20	19

No statistical analyses for this end point

Secondary: Number of subjects with any solicited general symptoms.

Top of page

End point title

Number of subjects with any solicited general symptoms.

End point description

Assessed solicited general symptoms were fatigue, gastrointestinal, headache and fever [defined as axillary temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade and relationship to vaccination.

End point type

Secondary

End point timeframe

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

End point values	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Number of subjects analysed	54	59	62
Units: Subjects
Any Fatigue	17	20	22
Any Gastrointestinal Symptoms	10	9	13
Any Headache	13	19	13
Any Fever	1	1	1

No statistical analyses for this end point

Secondary: Number of subjects with any unsolicited adverse events (AEs).

Top of page

End point title

Number of subjects with any unsolicited adverse events (AEs).

End point description

An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.

End point type

Secondary

End point timeframe

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

End point values	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Number of subjects analysed	55	60	62
Units: Subjects
Subjects with any unsolicited AE(s)	22	16	21

No statistical analyses for this end point

Secondary: Number of subjects with any serious adverse events (SAEs).

Top of page

End point title

Number of subjects with any serious adverse events (SAEs).

End point description

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject..

End point type

Secondary

End point timeframe

At Year 8.5

End point values	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Number of subjects analysed	54	60	66
Units: Subjects
Subjects with any SAE(s)	0	0	0

No statistical analyses for this end point

Secondary: Number of subjects with any serious adverse events (SAEs).

Top of page

End point title

Number of subjects with any serious adverse events (SAEs).

End point description

End point type

Secondary

End point timeframe

From Year 8.5 up to study end (one month post Year 10 booster vaccination)

End point values	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Number of subjects analysed	55	60	62
Units: Subjects
Subjects with any SAE(s)	0	0	0

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days post Year 10 booster vaccination; Solicited symptoms: During the 4 days post Year 10 booster vaccination.

Adverse event reporting additional description

Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, & Year 10 for the other groups.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

15.1

Reporting group title

Boostrix-US Group

Reporting group description

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Reporting group title

Boostrix-INV Group

Reporting group description

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Reporting group title

Boostrix-REF Group

Reporting group description

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Serious adverse events	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 55 (0.00%)	0 / 60 (0.00%)	0 / 62 (0.00%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Total subjects affected by non serious adverse events
subjects affected / exposed	53 / 55 (96.36%)	58 / 60 (96.67%)	58 / 62 (93.55%)
Nervous system disorders
Headache (AE)
alternative assessment type: Non-systematic
subjects affected / exposed	5 / 55 (9.09%)	1 / 60 (1.67%)	3 / 62 (4.84%)
occurrences all number	5	1	3
General disorders and administration site conditions
Pain
subjects affected / exposed ^[1]	50 / 55 (90.91%)	55 / 59 (93.22%)	54 / 62 (87.10%)
occurrences all number	50	55	54
Redness
subjects affected / exposed ^[2]	23 / 55 (41.82%)	23 / 59 (38.98%)	21 / 62 (33.87%)
occurrences all number	23	23	21
Swelling
subjects affected / exposed ^[3]	21 / 55 (38.18%)	20 / 59 (33.90%)	19 / 62 (30.65%)
occurrences all number	21	20	19
Fatigue
subjects affected / exposed ^[4]	17 / 54 (31.48%)	20 / 59 (33.90%)	22 / 62 (35.48%)
occurrences all number	17	20	22
Gastrointestinal symptoms
subjects affected / exposed ^[5]	10 / 54 (18.52%)	9 / 59 (15.25%)	13 / 62 (20.97%)
occurrences all number	10	9	13
Headache (General Symptom)
subjects affected / exposed ^[6]	13 / 54 (24.07%)	19 / 59 (32.20%)	13 / 62 (20.97%)
occurrences all number	13	19	13
Infections and infestations
Nasopharyngitis
alternative assessment type: Non-systematic
subjects affected / exposed	6 / 55 (10.91%)	1 / 60 (1.67%)	4 / 62 (6.45%)
occurrences all number	6	1	4

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This solicited local symptom was only collected from subjects with their symptom sheets completed.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This solicited local symptom was only collected from subjects with their symptom sheets completed.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This solicited local symptom was only collected from subjects with their symptom sheets completed.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This solicited general symptom was only collected from subjects with their symptom sheets completed.
[5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This solicited general symptom was only collected from subjects with their symptom sheets completed.
[6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This solicited general symptom was only collected from subjects with their symptom sheets completed.

More information

Top of page

Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of seroprotected subjects against diphtheria and tetanus

Primary: Number of seroprotected subjects against diphtheria and tetanus

Primary: Concentrations for anti-D and anti-T antibodies.

Primary: Concentrations for anti-D and anti-T antibodies.

Primary: Number of seroprotected subjects against diphtheria and tetanus.

Primary: Number of seroprotected subjects against diphtheria and tetanus.

Primary: Concentrations for anti-D and anti-T antibodies.

Primary: Concentrations for anti-D and anti-T antibodies.

Primary: Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-pertactin (anti-PRN) and anti-filamentous haemagglutinin (anti-FHA) antibodies.

Primary: Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-pertactin (anti-PRN) and anti-filamentous haemagglutinin (anti-FHA) antibodies.

Primary: Concentrations for anti-PT, anti-PRN and anti-FHA antibodies.

Primary: Concentrations for anti-PT, anti-PRN and anti-FHA antibodies.

Primary: Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN antibodies.

Primary: Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN antibodies.

Primary: Concentrations for anti-PT, anti-FHA and anti-PRN antibodies.

Primary: Concentrations for anti-PT, anti-FHA and anti-PRN antibodies.

Primary: Number of seroprotected subjects against diphtheria and tetanus

Primary: Number of seroprotected subjects against diphtheria and tetanus

Primary: Concentrations for anti-D and anti-T antibodies.

Primary: Concentrations for anti-D and anti-T antibodies.

Primary: Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN antibodies.

Primary: Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN antibodies.

Primary: Concentrations for anti-PT, anti-FHA and anti-PRN antibodies.

Primary: Concentrations for anti-PT, anti-FHA and anti-PRN antibodies.

Primary: Number of booster responders to pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN) antigens.

Primary: Number of booster responders to pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN) antigens.

Secondary: Number of subjects with any solicited local symptoms.

Secondary: Number of subjects with any solicited local symptoms.

Secondary: Number of subjects with any solicited general symptoms.

Secondary: Number of subjects with any solicited general symptoms.

Secondary: Number of subjects with any unsolicited adverse events (AEs).

Secondary: Number of subjects with any unsolicited adverse events (AEs).

Secondary: Number of subjects with any serious adverse events (SAEs).

Secondary: Number of subjects with any serious adverse events (SAEs).

Secondary: Number of subjects with any serious adverse events (SAEs).

Secondary: Number of subjects with any serious adverse events (SAEs).

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information