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Clinical Trial Results:
Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (SP0173) in Healthy Adolescents, Adults, and Older Adults

Summary
EudraCT number	2018-003838-32
Trial protocol	Outside EU/EEA
Global end of trial date	21 Feb 2017

Results information
Results version number	v1(current)
This version publication date	30 May 2019
First version publication date	30 May 2019
Other versions

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

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Trial information

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Sponsor protocol code

ADC01

ISRCTN number

US NCT number

NCT02587520

WHO universal trial number (UTN)

U1111-1161-3027

Sponsor organisation name

Sanofi Pasteur Inc.

Sponsor organisation address

1 Discovery Drive, Swiftwater, United States, 18370

Public contact

Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com

Scientific contact

Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.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?

Yes

Analysis stage

Final

Date of interim/final analysis

23 May 2017

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

21 Feb 2017

Was the trial ended prematurely?

Main objective of the trial

To describe the safety profile of each SP0173 investigational formulations. To describe the immunogenicity of each SP0173 investigational formulations.

Protection of trial subjects

Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate adverse reactions.

Background therapy

Evidence for comparator

Actual start date of recruitment

22 Oct 2015

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 1363

Worldwide total number of subjects

1363

EEA total number of subjects

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)

383

Adolescents (12-17 years)

Adults (18-64 years)

455

From 65 to 84 years

449

85 years and over

Subject disposition

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Recruitment details

Study subjects were enrolled in 20 centers in the Unites States (US) from 22 October 2015 to 15 August 2016.

Screening details

A total of 1363 subjects were randomized in a 1:1:1 ratio to 1 of the 6 formulation study groups. Randomization was stratified by age (adolescents: age 10–18 years, adults: age 19–64 years, older adults: age >= 65 years).

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Adolescents: SP0173 Formulation 1

Arm description

Healthy subjects aged 10–18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.

Arm type

Experimental

Investigational medicinal product name

SP0173

Investigational medicinal product code

Other name

Tdap: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 milliliter (mL), intramuscular, single dose on Day 0.

Adolescents: SP0173 Formulation 2

Arm description

Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

Arm type

Experimental

Investigational medicinal product name

SP0173

Investigational medicinal product code

Other name

Tdap

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, single dose on Day 0.

Adolescents: SP0173 Formulation 3

Arm description

Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

Arm type

Experimental

Investigational medicinal product name

SP0173

Investigational medicinal product code

Other name

Tdap

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, single dose on Day 0.

Adolescents: SP0173 Formulation 4

Arm description

Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

Arm type

Experimental

Investigational medicinal product name

SP0173

Investigational medicinal product code

Other name

Tdap

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, single dose on Day 0.

Adolescents: Adacel®

Arm description

Healthy subjects aged 10–18 years received Adacel®.

Arm type

Active comparator

Investigational medicinal product name

Adacel®

Investigational medicinal product code

Other name

Tdap

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, single dose on Day 0.

Adolescents: Boostrix®

Arm description

Healthy subjects aged 10–18 years received Boostrix®.

Arm type

Active comparator

Investigational medicinal product name

Boostrix®

Investigational medicinal product code

Other name

Tdap

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, single dose on Day 0.

Adults: SP0173 Formulation 1

Arm description

Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

Arm type

Experimental

Investigational medicinal product name

SP0173

Investigational medicinal product code

Other name

Tdap

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, single dose on Day 0.

Adults: SP0173 Formulation 2

Arm description

Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

Arm type

Experimental

Investigational medicinal product name

SP0173

Investigational medicinal product code

Other name

Tdap

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, single dose on Day 0.

Adults: SP0173 Formulation 3

Arm description

Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

Arm type

Experimental

Investigational medicinal product name

SP0173

Investigational medicinal product code

Other name

Tdap

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, single dose on Day 0.

Adults: SP0173 Formulation 4

Arm description

Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

Arm type

Experimental

Investigational medicinal product name

SP0173

Investigational medicinal product code

Other name

Tdap

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, single dose on Day 0.

Adults: Adacel®

Arm description

Healthy subjects aged 19–64 years received Adacel®.

Arm type

Active comparator

Investigational medicinal product name

Adacel®

Investigational medicinal product code

Other name

Tdap

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, single dose on Day 0.

Adults: Boostrix®

Arm description

Healthy subjects aged 19–64 years received Boostrix®.

Arm type

Active comparator

Investigational medicinal product name

Boostrix®

Investigational medicinal product code

Other name

Tdap

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, single dose on Day 0.

Older Adults: SP0173 Formulation 1

Arm description

Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

Arm type

Experimental

Investigational medicinal product name

SP0173

Investigational medicinal product code

Other name

Tdap

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, single dose on Day 0.

Older Adults: SP0173 Formulation 2

Arm description

Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

Arm type

Experimental

Investigational medicinal product name

SP0173

Investigational medicinal product code

Other name

Tdap

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, single dose on Day 0.

Older Adults: SP0173 Formulation 3

Arm description

Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

Arm type

Experimental

Investigational medicinal product name

SP0173

Investigational medicinal product code

Other name

Tdap

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, single dose on Day 0.

Older Adults: SP0173 Formulation 4

Arm description

Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

Arm type

Experimental

Investigational medicinal product name

SP0173

Investigational medicinal product code

Other name

Tdap

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, single dose on Day 0.

Older Adults: Adacel®

Arm description

Healthy subjects aged >= 65 years received Adacel®.

Arm type

Active comparator

Investigational medicinal product name

Adacel®

Investigational medicinal product code

Other name

Tdap

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, single dose on Day 0.

Older Adults: Boostrix®

Arm description

Healthy subjects aged >= 65 years received Boostrix®.

Arm type

Active comparator

Investigational medicinal product name

Boostrix®

Investigational medicinal product code

Other name

Tdap

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, single dose on Day 0.

Number of subjects in period 1	Adolescents: SP0173 Formulation 1	Adolescents: SP0173 Formulation 2	Adolescents: SP0173 Formulation 3	Adolescents: SP0173 Formulation 4	Adolescents: Adacel®	Adolescents: Boostrix®	Adults: SP0173 Formulation 1	Adults: SP0173 Formulation 2	Adults: SP0173 Formulation 3	Adults: SP0173 Formulation 4	Adults: Adacel®	Adults: Boostrix®	Older Adults: SP0173 Formulation 1	Older Adults: SP0173 Formulation 2	Older Adults: SP0173 Formulation 3	Older Adults: SP0173 Formulation 4	Older Adults: Adacel®	Older Adults: Boostrix®
Started	80	71	78	79	75	75	76	73	76	76	76	73	77	74	78	72	76	78
Completed	78	69	77	74	75	72	73	71	73	71	73	69	77	73	78	72	76	78
Not completed	2	2	1	5	0	3	3	2	3	5	3	4	0	1	0	0	0	0
Consent withdrawn by subject	-	-	1	1	-	1	1	-	-	-	-	-	-	1	-	-	-	-
Adverse event	-	-	-	-	-	-	-	-	-	-	-	1	-	-	-	-	-	-
Lost to follow-up	-	2	-	2	-	1	1	1	-	2	2	1	-	-	-	-	-	-
Protocol deviation	2	-	-	2	-	1	1	1	3	3	1	2	-	-	-	-	-	-

Baseline characteristics

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Reporting group title

Adolescents: SP0173 Formulation 1

Reporting group description

Healthy subjects aged 10–18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.

Reporting group title

Adolescents: SP0173 Formulation 2

Reporting group description

Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adolescents: SP0173 Formulation 3

Reporting group description

Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adolescents: SP0173 Formulation 4

Reporting group description

Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adolescents: Adacel®

Reporting group description

Healthy subjects aged 10–18 years received Adacel®.

Reporting group title

Adolescents: Boostrix®

Reporting group description

Healthy subjects aged 10–18 years received Boostrix®.

Reporting group title

Adults: SP0173 Formulation 1

Reporting group description

Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adults: SP0173 Formulation 2

Reporting group description

Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adults: SP0173 Formulation 3

Reporting group description

Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adults: SP0173 Formulation 4

Reporting group description

Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adults: Adacel®

Reporting group description

Healthy subjects aged 19–64 years received Adacel®.

Reporting group title

Adults: Boostrix®

Reporting group description

Healthy subjects aged 19–64 years received Boostrix®.

Reporting group title

Older Adults: SP0173 Formulation 1

Reporting group description

Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Older Adults: SP0173 Formulation 2

Reporting group description

Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Older Adults: SP0173 Formulation 3

Reporting group description

Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Older Adults: SP0173 Formulation 4

Reporting group description

Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Older Adults: Adacel®

Reporting group description

Healthy subjects aged >= 65 years received Adacel®.

Reporting group title

Older Adults: Boostrix®

Reporting group description

Healthy subjects aged >= 65 years received Boostrix®.

Reporting group values	Adolescents: SP0173 Formulation 1	Adolescents: SP0173 Formulation 2	Adolescents: SP0173 Formulation 3	Adolescents: SP0173 Formulation 4	Adolescents: Adacel®	Adolescents: Boostrix®	Adults: SP0173 Formulation 1	Adults: SP0173 Formulation 2	Adults: SP0173 Formulation 3	Adults: SP0173 Formulation 4	Adults: Adacel®	Adults: Boostrix®	Older Adults: SP0173 Formulation 1	Older Adults: SP0173 Formulation 2	Older Adults: SP0173 Formulation 3	Older Adults: SP0173 Formulation 4	Older Adults: Adacel®	Older Adults: Boostrix®	Total
Number of subjects	80	71	78	79	75	75	76	73	76	76	76	73	77	74	78	72	76	78	1363
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	10.8 ± 1.3	11.0 ± 1.3	11.1 ± 1.6	10.8 ± 1.4	10.8 ± 1.5	11.1 ± 1.6	42.5 ± 12.5	41.2 ± 12.1	40.1 ± 12.8	42.1 ± 13.0	41.3 ± 12.7	42.5 ± 13.2	71.3 ± 5.4	71.8 ± 5.4	70.9 ± 4.8	70.8 ± 5.1	70.9 ± 5.0	71.3 ± 4.8	-
Gender categorical
Units: Subjects
Female	41	33	35	37	39	40	43	46	38	39	44	36	37	38	51	38	46	45	726
Male	39	38	43	42	36	35	33	27	38	37	32	37	40	36	27	34	30	33	637
Race
Units: Subjects
White	71	60	71	72	63	65	48	51	46	53	52	51	69	64	70	66	69	68	1109
Asian	0	0	1	0	2	2	2	1	4	1	0	1	0	0	0	1	1	0	16
Black or African American	7	9	2	4	8	4	23	18	24	18	23	19	7	8	8	5	6	10	203
American Indian or Alaska Native	0	1	0	0	0	0	1	1	0	3	0	1	0	1	0	0	0	0	8
Native Hawaiian or other Pacific Islander	0	0	1	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	3
Mixed origin	2	1	3	2	2	4	2	1	2	1	1	1	1	1	0	0	0	0	24
Missing	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Ethnicity
Units: Subjects
Hispanic or Latino	4	2	3	4	4	6	17	19	8	11	15	10	11	12	13	15	12	13	179
Not Hispanic or Latino	76	69	75	75	71	69	59	54	68	65	61	63	64	59	64	55	63	61	1171
Missing	0	0	0	0	0	0	0	0	0	0	0	0	2	3	1	2	1	4	13

End points

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Reporting group title

Adolescents: SP0173 Formulation 1

Reporting group description

Healthy subjects aged 10–18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.

Reporting group title

Adolescents: SP0173 Formulation 2

Reporting group description

Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adolescents: SP0173 Formulation 3

Reporting group description

Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adolescents: SP0173 Formulation 4

Reporting group description

Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adolescents: Adacel®

Reporting group description

Healthy subjects aged 10–18 years received Adacel®.

Reporting group title

Adolescents: Boostrix®

Reporting group description

Healthy subjects aged 10–18 years received Boostrix®.

Reporting group title

Adults: SP0173 Formulation 1

Reporting group description

Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adults: SP0173 Formulation 2

Reporting group description

Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adults: SP0173 Formulation 3

Reporting group description

Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adults: SP0173 Formulation 4

Reporting group description

Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adults: Adacel®

Reporting group description

Healthy subjects aged 19–64 years received Adacel®.

Reporting group title

Adults: Boostrix®

Reporting group description

Healthy subjects aged 19–64 years received Boostrix®.

Reporting group title

Older Adults: SP0173 Formulation 1

Reporting group description

Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Older Adults: SP0173 Formulation 2

Reporting group description

Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Older Adults: SP0173 Formulation 3

Reporting group description

Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Older Adults: SP0173 Formulation 4

Reporting group description

Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Older Adults: Adacel®

Reporting group description

Healthy subjects aged >= 65 years received Adacel®.

Reporting group title

Older Adults: Boostrix®

Reporting group description

Healthy subjects aged >= 65 years received Boostrix®.

Primary: Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10–18 Years

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End point title

Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10–18 Years ^[1] ^[2]

End point description

A solicited reaction is an adverse event (AE) that is prelisted in the electronic Case Report Form (eCRF) & considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed & reported under the conditions (nature & onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling & solicited systemic reactions: Fever, Headache, Malaise, Myalgia. Percentages of subjects with at least one solicited injection site reactions & systemic reactions were reported. Safety analysis set that was defined as those subjects who had received study vaccine. All subjects had their safety analyzed according to the vaccine they actually received. Here, "n"= number of subjects with available data for this endpoint.

End point type

Primary

End point timeframe

Within 7 days after vaccination

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: As the endpoint is descriptive in nature, no statistical hypothesis was tested.
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Arms applicable for this endpoint are reported.

End point values	Adolescents: SP0173 Formulation 1	Adolescents: SP0173 Formulation 2	Adolescents: SP0173 Formulation 3	Adolescents: SP0173 Formulation 4	Adolescents: Adacel®	Adolescents: Boostrix®
Number of subjects analysed	79	71	77	77	75	75
Units: percentage of subjects
number (not applicable)
Pain (n= 78, 69, 77, 74, 75, 73)	75.6	73.9	64.9	66.2	78.7	65.8
Erythema (n= 78, 69, 77, 74, 75, 73)	11.5	5.8	13.0	1.4	5.3	2.7
Swelling (n= 78, 69, 77, 74, 75, 73)	9.0	5.8	10.4	0.0	1.3	5.5
Upper limb edema (n= 77, 69, 77, 74, 74, 73)	58.4	59.4	63.6	62.2	64.9	45.2
Extensive limb swelling (n= 79, 71, 77, 75, 75)	0.0	0.0	0.0	0.0	0.0	0.0
Fever (n= 77, 69, 77, 74, 75, 73)	1.3	0.0	1.3	0.0	0.0	1.4
Headache (n= 78, 69, 77, 74, 75, 73)	26.9	20.3	24.7	33.8	26.7	37.0
Malaise (n= 78, 69, 77, 74, 75, 73)	17.9	24.6	18.2	24.3	16.0	23.3
Myalgia (n= 78, 69, 77, 74, 75, 73)	53.8	50.7	49.4	56.8	69.3	52.1

No statistical analyses for this end point

Primary: Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19–64 Years

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End point title

Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19–64 Years ^[3] ^[4]

End point description

A solicited reaction is an AE that is prelisted in the eCRF and considered to be related to vaccination. A solicited reaction is therefore an ADR observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Percentages of subjects with at least one solicited injection site reactions and systemic reactions were reported. Analysis was performed on safety analysis set. Here, "n"= number of subjects with available data for this endpoint.

End point type

Primary

End point timeframe

Within 7 days after vaccination

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: As the endpoint is descriptive in nature, no statistical hypothesis was tested.
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Arms applicable for this endpoint are reported.

End point values	Adults: SP0173 Formulation 1	Adults: SP0173 Formulation 2	Adults: SP0173 Formulation 3	Adults: SP0173 Formulation 4	Adults: Adacel®	Adults: Boostrix®
Number of subjects analysed	76	73	76	76	76	72
Units: percentage of subjects
number (not applicable)
Pain (n= 73, 70, 73, 71, 72, 68)	52.1	48.6	67.1	59.2	68.1	51.5
Erythema (n= 73, 70, 73, 71, 72, 68)	2.7	1.4	2.7	0.0	6.9	2.9
Swelling (n= 73, 70, 73, 71, 72, 68)	1.4	4.3	5.5	1.4	4.2	1.5
Upper limb edema (n= 71, 67, 72, 69, 71, 67)	39.4	55.2	56.9	53.6	49.3	46.3
Extensive limb swelling (n= 76, 73, 76, 76, 76, 72	0.0	0.0	0.0	0.0	1.3	0.0
Fever (n= 71, 68, 72, 70, 71, 68)	0.0	0.0	0.0	0.0	2.8	1.5
Headache (n= 73, 71, 73, 71, 72, 68)	21.9	15.5	26.0	26.8	26.4	27.9
Malaise (n= 73, 71, 73, 71, 72, 68)	24.7	12.7	21.9	26.8	31.9	22.1
Myalgia (n= 73, 71, 73, 71, 72, 68)	43.8	40.8	47.9	50.7	54.2	41.2

No statistical analyses for this end point

Primary: Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >= 65 Years

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End point title

Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >= 65 Years ^[5] ^[6]

End point description

End point type

Primary

End point timeframe

Within 7 days after vaccination

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: As the endpoint is descriptive in nature, no statistical hypothesis was tested.
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Arms applicable for this endpoint are reported.

End point values	Older Adults: SP0173 Formulation 1	Older Adults: SP0173 Formulation 2	Older Adults: SP0173 Formulation 3	Older Adults: SP0173 Formulation 4	Older Adults: Adacel®	Older Adults: Boostrix®
Number of subjects analysed	77	73	78	72	76	78
Units: percentage of subjects
number (not applicable)
Pain (77, 73, 78, 72, 75, 78)	27.3	46.6	43.6	47.2	37.3	32.1
Erythema (77, 73, 78, 72, 75, 78)	0.0	1.4	2.6	2.8	4.0	1.3
Swelling (77, 73, 78, 72, 75, 78)	1.3	8.2	7.7	2.8	1.3	2.6
Upper limb edema (75, 70, 75, 71, 72, 74)	50.7	61.4	48.0	53.5	44.4	54.1
Extensive limb swelling (77, 73, 78, 72, 76, 78)	0.0	0.0	0.0	0.0	0.0	0.0
Fever (76, 72, 77, 71, 72, 74)	0.0	1.4	0.0	0.0	0.0	0.0
Headache (77, 73, 78, 72, 74, 77)	7.8	13.7	25.6	16.7	14.9	18.2
Malaise (77, 73, 77, 72, 74, 77)	7.8	16.4	18.2	12.5	10.8	7.8
Myalgia (77, 73, 77, 72, 74, 77)	15.6	28.8	39.0	31.9	31.1	22.1

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Non-serious adverse events (AEs) were collected from Day 0 to Day 7 (solicited reactions) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.

Adverse event reporting additional description

A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e.,solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the Safety Analysis Set.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

18.0

Reporting group title

Adolescents: SP0173 Formulation 1

Reporting group description

Healthy subjects aged 10–18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.

Reporting group title

Adolescents: SP0173 Formulation 2

Reporting group description

Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adolescents: SP0173 Formulation 3

Reporting group description

Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adolescents: SP0173 Formulation 4

Reporting group description

Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adolescents: Adacel®

Reporting group description

Healthy subjects aged 10–18 years received Adacel®.

Reporting group title

Adolescents: Boostrix®

Reporting group description

Healthy subjects aged 10–18 years received Boostrix®.

Reporting group title

Adults: SP0173 Formulation 1

Reporting group description

Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adults: SP0173 Formulation 2

Reporting group description

Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adults: SP0173 Formulation 3

Reporting group description

Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adults: SP0173 Formulation 4

Reporting group description

Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Adults: Adacel®

Reporting group description

Healthy subjects aged 19–64 years received Adacel®.

Reporting group title

Adults: Boostrix®

Reporting group description

Healthy subjects aged 19–64 years received Boostrix®.

Reporting group title

Older Adults: SP0173 Formulation 1

Reporting group description

Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Older Adults: SP0173 Formulation 2

Reporting group description

Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Older Adults: SP0173 Formulation 3

Reporting group description

Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Older Adults: SP0173 Formulation 4

Reporting group description

Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

Reporting group title

Older Adults: Adacel®

Reporting group description

Healthy subjects aged >= 65 years received Adacel®.

Reporting group title

Older Adults: Boostrix®

Reporting group description

Healthy subjects aged >= 65 years received Boostrix®.

Adolescents: SP0173 Formulation 1

Adolescents: SP0173 Formulation 2

Adolescents: SP0173 Formulation 3

Adolescents: SP0173 Formulation 4

Adolescents: Adacel®

Adolescents: Boostrix®

Adults: SP0173 Formulation 1

Adults: SP0173 Formulation 2

Adults: SP0173 Formulation 3

Adults: SP0173 Formulation 4

Adults: Adacel®

Adults: Boostrix®

Older Adults: SP0173 Formulation 1

Older Adults: SP0173 Formulation 2

Older Adults: SP0173 Formulation 3

Older Adults: SP0173 Formulation 4

Older Adults: Adacel®

Older Adults: Boostrix®

Total subjects affected by serious adverse events

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

1 / 77 (1.30%)

0 / 75 (0.00%)

1 / 76 (1.32%)

1 / 73 (1.37%)

1 / 76 (1.32%)

0 / 76 (0.00%)

2 / 72 (2.78%)

0 / 77 (0.00%)

3 / 73 (4.11%)

4 / 78 (5.13%)

1 / 72 (1.39%)

2 / 76 (2.63%)

2 / 78 (2.56%)

number of deaths (all causes)

number of deaths resulting from adverse events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast Cancer Recurrent

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

0 / 75 (0.00%)

0 / 76 (0.00%)

0 / 73 (0.00%)

0 / 76 (0.00%)

0 / 72 (0.00%)

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 78 (0.00%)

0 / 72 (0.00%)

0 / 76 (0.00%)

1 / 78 (1.28%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Humerus Fracture

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

0 / 75 (0.00%)

0 / 76 (0.00%)

0 / 73 (0.00%)

0 / 76 (0.00%)

0 / 72 (0.00%)

0 / 77 (0.00%)

1 / 73 (1.37%)

0 / 78 (0.00%)

0 / 72 (0.00%)

0 / 76 (0.00%)

0 / 78 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Laceration

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

1 / 77 (1.30%)

0 / 75 (0.00%)

0 / 76 (0.00%)

0 / 73 (0.00%)

0 / 76 (0.00%)

0 / 72 (0.00%)

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 78 (0.00%)

0 / 72 (0.00%)

0 / 76 (0.00%)

0 / 78 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

Aortic Stenosis

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

0 / 75 (0.00%)

0 / 76 (0.00%)

0 / 73 (0.00%)

0 / 76 (0.00%)

0 / 72 (0.00%)

0 / 77 (0.00%)

1 / 73 (1.37%)

0 / 78 (0.00%)

0 / 72 (0.00%)

0 / 76 (0.00%)

0 / 78 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Cardiac Failure Congestive

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

0 / 75 (0.00%)

0 / 76 (0.00%)

0 / 73 (0.00%)

0 / 76 (0.00%)

0 / 72 (0.00%)

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 78 (0.00%)

0 / 72 (0.00%)

1 / 76 (1.32%)

0 / 78 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Coronary Artery Disease

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

0 / 75 (0.00%)

0 / 76 (0.00%)

0 / 73 (0.00%)

0 / 76 (0.00%)

0 / 72 (0.00%)

0 / 77 (0.00%)

1 / 73 (1.37%)

0 / 78 (0.00%)

0 / 72 (0.00%)

0 / 76 (0.00%)

0 / 78 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ventricular Fibrillation

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

0 / 75 (0.00%)

0 / 76 (0.00%)

0 / 73 (0.00%)

0 / 76 (0.00%)

1 / 72 (1.39%)

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 78 (0.00%)

0 / 72 (0.00%)

0 / 76 (0.00%)

0 / 78 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Nervous system disorders

Embolic Cerebral Infarction

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

0 / 75 (0.00%)

0 / 76 (0.00%)

0 / 73 (0.00%)

0 / 76 (0.00%)

0 / 72 (0.00%)

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 78 (0.00%)

0 / 72 (0.00%)

1 / 76 (1.32%)

0 / 78 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Transient Ischaemic Attack

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

0 / 75 (0.00%)

0 / 76 (0.00%)

0 / 73 (0.00%)

0 / 76 (0.00%)

0 / 72 (0.00%)

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 78 (0.00%)

1 / 72 (1.39%)

0 / 76 (0.00%)

0 / 78 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

Device Dislocation

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

0 / 75 (0.00%)

0 / 76 (0.00%)

0 / 73 (0.00%)

0 / 76 (0.00%)

0 / 72 (0.00%)

0 / 77 (0.00%)

0 / 73 (0.00%)

1 / 78 (1.28%)

0 / 72 (0.00%)

0 / 76 (0.00%)

0 / 78 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Drug Withdrawal Syndrome

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

0 / 75 (0.00%)

0 / 76 (0.00%)

0 / 73 (0.00%)

0 / 76 (0.00%)

0 / 72 (0.00%)

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 78 (0.00%)

0 / 72 (0.00%)

0 / 76 (0.00%)

1 / 78 (1.28%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Non-Cardiac Chest Pain

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

0 / 75 (0.00%)

0 / 76 (0.00%)

0 / 73 (0.00%)

0 / 76 (0.00%)

0 / 72 (0.00%)

0 / 77 (0.00%)

0 / 73 (0.00%)

1 / 78 (1.28%)

0 / 72 (0.00%)

0 / 76 (0.00%)

0 / 78 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Immune system disorders

Drug Hypersensitivity

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

0 / 75 (0.00%)

0 / 76 (0.00%)

0 / 73 (0.00%)

0 / 76 (0.00%)

0 / 72 (0.00%)

0 / 77 (0.00%)

0 / 73 (0.00%)

1 / 78 (1.28%)

0 / 72 (0.00%)

0 / 76 (0.00%)

0 / 78 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

Asthma

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

0 / 75 (0.00%)

0 / 76 (0.00%)

1 / 73 (1.37%)

0 / 76 (0.00%)

0 / 72 (0.00%)

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 78 (0.00%)

0 / 72 (0.00%)

0 / 76 (0.00%)

0 / 78 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Chronic Obstructive Pulmonary Disease

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

0 / 75 (0.00%)

1 / 76 (1.32%)

0 / 73 (0.00%)

0 / 76 (0.00%)

0 / 72 (0.00%)

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 78 (0.00%)

0 / 72 (0.00%)

0 / 76 (0.00%)

0 / 78 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

Acute Kidney Injury

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

0 / 75 (0.00%)

0 / 76 (0.00%)

0 / 73 (0.00%)

0 / 76 (0.00%)

0 / 72 (0.00%)

0 / 77 (0.00%)

0 / 73 (0.00%)

1 / 78 (1.28%)

0 / 72 (0.00%)

0 / 76 (0.00%)

0 / 78 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Psychiatric disorders

Post-Traumatic Stress Disorder

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

0 / 75 (0.00%)

0 / 76 (0.00%)

0 / 73 (0.00%)

0 / 76 (0.00%)

1 / 72 (1.39%)

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 78 (0.00%)

0 / 72 (0.00%)

0 / 76 (0.00%)

0 / 78 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Appendicitis Perforated

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

0 / 75 (0.00%)

0 / 76 (0.00%)

0 / 73 (0.00%)

1 / 76 (1.32%)

0 / 76 (0.00%)

0 / 72 (0.00%)

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 78 (0.00%)

0 / 72 (0.00%)

0 / 76 (0.00%)

0 / 78 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia

subjects affected / exposed

0 / 79 (0.00%)

0 / 71 (0.00%)

0 / 77 (0.00%)

0 / 75 (0.00%)

0 / 76 (0.00%)

0 / 73 (0.00%)

0 / 76 (0.00%)

1 / 76 (1.32%)

0 / 76 (0.00%)

0 / 72 (0.00%)

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 78 (0.00%)

0 / 72 (0.00%)

0 / 76 (0.00%)

0 / 78 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

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

Non-serious adverse events	Adolescents: SP0173 Formulation 1	Adolescents: SP0173 Formulation 2	Adolescents: SP0173 Formulation 3	Adolescents: SP0173 Formulation 4	Adolescents: Adacel®	Adolescents: Boostrix®	Adults: SP0173 Formulation 1	Adults: SP0173 Formulation 2	Adults: SP0173 Formulation 3	Adults: SP0173 Formulation 4	Adults: Adacel®	Adults: Boostrix®	Older Adults: SP0173 Formulation 1	Older Adults: SP0173 Formulation 2	Older Adults: SP0173 Formulation 3	Older Adults: SP0173 Formulation 4	Older Adults: Adacel®	Older Adults: Boostrix®
Total subjects affected by non serious adverse events
subjects affected / exposed	71 / 79 (89.87%)	64 / 71 (90.14%)	67 / 77 (87.01%)	68 / 77 (88.31%)	71 / 75 (94.67%)	66 / 75 (88.00%)	52 / 76 (68.42%)	53 / 73 (72.60%)	67 / 76 (88.16%)	54 / 76 (71.05%)	62 / 76 (81.58%)	50 / 72 (69.44%)	53 / 77 (68.83%)	60 / 73 (82.19%)	58 / 78 (74.36%)	53 / 72 (73.61%)	49 / 76 (64.47%)	56 / 78 (71.79%)
Nervous system disorders
Headache
subjects affected / exposed	23 / 79 (29.11%)	15 / 71 (21.13%)	19 / 77 (24.68%)	25 / 77 (32.47%)	22 / 75 (29.33%)	29 / 75 (38.67%)	16 / 76 (21.05%)	11 / 73 (15.07%)	19 / 76 (25.00%)	19 / 76 (25.00%)	19 / 76 (25.00%)	19 / 72 (26.39%)	6 / 77 (7.79%)	10 / 73 (13.70%)	20 / 78 (25.64%)	12 / 72 (16.67%)	11 / 76 (14.47%)	14 / 78 (17.95%)
occurrences all number	25	15	21	26	22	30	16	11	19	19	19	21	6	10	20	12	11	15
General disorders and administration site conditions
Change In Limb Circumference
subjects affected / exposed	45 / 79 (56.96%)	41 / 71 (57.75%)	49 / 77 (63.64%)	46 / 77 (59.74%)	48 / 75 (64.00%)	33 / 75 (44.00%)	28 / 76 (36.84%)	37 / 73 (50.68%)	41 / 76 (53.95%)	37 / 76 (48.68%)	35 / 76 (46.05%)	31 / 72 (43.06%)	38 / 77 (49.35%)	43 / 73 (58.90%)	36 / 78 (46.15%)	38 / 72 (52.78%)	32 / 76 (42.11%)	40 / 78 (51.28%)
occurrences all number	45	41	49	46	48	33	28	37	41	37	35	31	38	43	36	38	32	40
Injection Site Erythema
subjects affected / exposed	9 / 79 (11.39%)	4 / 71 (5.63%)	10 / 77 (12.99%)	1 / 77 (1.30%)	4 / 75 (5.33%)	2 / 75 (2.67%)	2 / 76 (2.63%)	1 / 73 (1.37%)	2 / 76 (2.63%)	0 / 76 (0.00%)	5 / 76 (6.58%)	2 / 72 (2.78%)	0 / 77 (0.00%)	1 / 73 (1.37%)	2 / 78 (2.56%)	2 / 72 (2.78%)	3 / 76 (3.95%)	1 / 78 (1.28%)
occurrences all number	9	4	10	1	4	2	2	1	2	0	5	2	0	1	2	2	3	1
Injection Site Pain
subjects affected / exposed	59 / 79 (74.68%)	51 / 71 (71.83%)	50 / 77 (64.94%)	49 / 77 (63.64%)	59 / 75 (78.67%)	48 / 75 (64.00%)	38 / 76 (50.00%)	34 / 73 (46.58%)	49 / 76 (64.47%)	42 / 76 (55.26%)	49 / 76 (64.47%)	35 / 72 (48.61%)	22 / 77 (28.57%)	34 / 73 (46.58%)	34 / 78 (43.59%)	34 / 72 (47.22%)	28 / 76 (36.84%)	25 / 78 (32.05%)
occurrences all number	59	51	50	49	59	48	38	34	49	42	49	35	22	34	34	34	28	25
Injection Site Swelling
subjects affected / exposed	7 / 79 (8.86%)	4 / 71 (5.63%)	8 / 77 (10.39%)	0 / 77 (0.00%)	1 / 75 (1.33%)	4 / 75 (5.33%)	1 / 76 (1.32%)	3 / 73 (4.11%)	4 / 76 (5.26%)	1 / 76 (1.32%)	3 / 76 (3.95%)	1 / 72 (1.39%)	1 / 77 (1.30%)	6 / 73 (8.22%)	6 / 78 (7.69%)	2 / 72 (2.78%)	1 / 76 (1.32%)	2 / 78 (2.56%)
occurrences all number	7	4	8	0	1	4	1	3	4	1	3	1	1	6	6	2	1	2
Malaise
subjects affected / exposed	14 / 79 (17.72%)	17 / 71 (23.94%)	14 / 77 (18.18%)	18 / 77 (23.38%)	12 / 75 (16.00%)	17 / 75 (22.67%)	18 / 76 (23.68%)	9 / 73 (12.33%)	16 / 76 (21.05%)	19 / 76 (25.00%)	23 / 76 (30.26%)	15 / 72 (20.83%)	6 / 77 (7.79%)	12 / 73 (16.44%)	14 / 78 (17.95%)	9 / 72 (12.50%)	8 / 76 (10.53%)	6 / 78 (7.69%)
occurrences all number	14	17	14	18	12	17	18	9	16	19	23	15	6	12	14	9	8	6
Gastrointestinal disorders
Abdominal Pain
subjects affected / exposed	3 / 79 (3.80%)	3 / 71 (4.23%)	4 / 77 (5.19%)	1 / 77 (1.30%)	3 / 75 (4.00%)	1 / 75 (1.33%)	0 / 76 (0.00%)	0 / 73 (0.00%)	0 / 76 (0.00%)	0 / 76 (0.00%)	0 / 76 (0.00%)	0 / 72 (0.00%)	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 78 (0.00%)	0 / 72 (0.00%)	0 / 76 (0.00%)	0 / 78 (0.00%)
occurrences all number	3	3	4	1	3	1	0	0	0	0	0	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	1 / 79 (1.27%)	4 / 71 (5.63%)	4 / 77 (5.19%)	3 / 77 (3.90%)	2 / 75 (2.67%)	0 / 75 (0.00%)	0 / 76 (0.00%)	1 / 73 (1.37%)	2 / 76 (2.63%)	1 / 76 (1.32%)	2 / 76 (2.63%)	1 / 72 (1.39%)	0 / 77 (0.00%)	0 / 73 (0.00%)	2 / 78 (2.56%)	1 / 72 (1.39%)	0 / 76 (0.00%)	2 / 78 (2.56%)
occurrences all number	1	4	4	3	3	0	0	1	2	1	2	1	0	0	2	1	0	2
Oropharyngeal Pain
subjects affected / exposed	2 / 79 (2.53%)	5 / 71 (7.04%)	2 / 77 (2.60%)	2 / 77 (2.60%)	4 / 75 (5.33%)	0 / 75 (0.00%)	1 / 76 (1.32%)	2 / 73 (2.74%)	4 / 76 (5.26%)	1 / 76 (1.32%)	0 / 76 (0.00%)	2 / 72 (2.78%)	0 / 77 (0.00%)	0 / 73 (0.00%)	1 / 78 (1.28%)	0 / 72 (0.00%)	0 / 76 (0.00%)	0 / 78 (0.00%)
occurrences all number	2	5	2	2	5	0	1	2	5	1	0	2	0	0	1	0	0	0
Musculoskeletal and connective tissue disorders
Myalgia
subjects affected / exposed	42 / 79 (53.16%)	35 / 71 (49.30%)	38 / 77 (49.35%)	42 / 77 (54.55%)	52 / 75 (69.33%)	38 / 75 (50.67%)	32 / 76 (42.11%)	29 / 73 (39.73%)	35 / 76 (46.05%)	36 / 76 (47.37%)	39 / 76 (51.32%)	28 / 72 (38.89%)	12 / 77 (15.58%)	21 / 73 (28.77%)	31 / 78 (39.74%)	23 / 72 (31.94%)	23 / 76 (30.26%)	18 / 78 (23.08%)
occurrences all number	42	35	38	42	52	38	32	29	35	36	39	28	12	21	31	23	23	18
Infections and infestations
Pharyngitis
subjects affected / exposed	3 / 79 (3.80%)	7 / 71 (9.86%)	3 / 77 (3.90%)	5 / 77 (6.49%)	3 / 75 (4.00%)	2 / 75 (2.67%)	0 / 76 (0.00%)	0 / 73 (0.00%)	0 / 76 (0.00%)	0 / 76 (0.00%)	0 / 76 (0.00%)	0 / 72 (0.00%)	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 78 (0.00%)	0 / 72 (0.00%)	0 / 76 (0.00%)	0 / 78 (0.00%)
occurrences all number	3	10	3	5	5	2	0	0	0	0	0	0	0	0	0	0	0	0
Pharyngitis Streptococcal
subjects affected / exposed	5 / 79 (6.33%)	4 / 71 (5.63%)	5 / 77 (6.49%)	5 / 77 (6.49%)	2 / 75 (2.67%)	4 / 75 (5.33%)	0 / 76 (0.00%)	1 / 73 (1.37%)	1 / 76 (1.32%)	0 / 76 (0.00%)	1 / 76 (1.32%)	0 / 72 (0.00%)	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 78 (0.00%)	0 / 72 (0.00%)	0 / 76 (0.00%)	0 / 78 (0.00%)
occurrences all number	5	4	7	5	2	5	0	1	1	0	1	0	0	0	0	0	0	0
Viral Pharyngitis
subjects affected / exposed	3 / 79 (3.80%)	4 / 71 (5.63%)	2 / 77 (2.60%)	2 / 77 (2.60%)	0 / 75 (0.00%)	1 / 75 (1.33%)	0 / 76 (0.00%)	0 / 73 (0.00%)	0 / 76 (0.00%)	0 / 76 (0.00%)	0 / 76 (0.00%)	0 / 72 (0.00%)	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 78 (0.00%)	0 / 72 (0.00%)	0 / 76 (0.00%)	0 / 78 (0.00%)
occurrences all number	3	4	3	2	0	1	0	0	0	0	0	0	0	0	0	0	0	0

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Were there any global substantial amendments to the protocol? Yes

29 Sep 2015

Following amendments were made: - To add an unscheduled visit for subjects who presented a Grade 3 solicited adverse event. - To include a 6-month follow-up after vaccination.

13 May 2016

Amendment 2.0 was to adjust the number of sites were the trial was going to be conducted. - To clarify that sites should follow state law with regard to the age of majority for consent. - The definition of Category 2 concomitant medication was also revised such that allergy hyposensitization therapy and topical analgesics were not to be recorded as Category 2.

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

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Clinical trials

Clinical Trial Results:
Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (SP0173) in Healthy Adolescents, Adults, and Older Adults

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10–18 Years

Primary: Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10–18 Years

Primary: Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19–64 Years

Primary: Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19–64 Years

Primary: Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >= 65 Years

Primary: Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >= 65 Years

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Austria
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Outside EU/EEA

Clinical trials

Clinical Trial Results: Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (SP0173) in Healthy Adolescents, Adults, and Older Adults

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10–18 Years

Primary: Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10–18 Years

Primary: Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19–64 Years

Primary: Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19–64 Years

Primary: Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >= 65 Years

Primary: Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >= 65 Years

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (SP0173) in Healthy Adolescents, Adults, and Older Adults