Diphtheria, Pertussis, Tetanus, Whooping Cough
Conditions
Keywords
Tetanus, Diphtheria, Pertussis, SP0173, Tdap vaccine
Brief summary
This was a dose and formulation ranging study to assess the safety and immunogenicity of SP0173 in healthy adolescents, adults, and older adults in the United States (US). Primary Objective * To describe the safety profile of each SP0173 investigational formulation. Observational Objective: * To describe the immunogenicity of each SP0173 investigational formulation.
Detailed description
All participants received a single dose of vaccine, and were assessed for immunogenicity at baseline (pre-vaccination) and at 30 days post-vaccination. They were also monitored for safety from day of vaccination up to Day 180 post-vaccination.
Interventions
BIOLOGICALTetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1
0.5 milliliter (mL), Intramuscular
BIOLOGICALTetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2
0.5 mL, Intramuscular
BIOLOGICALTetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
0.5 mL, Intramuscular
BIOLOGICALTetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4
0.5 mL, Intramuscular
BIOLOGICALLicensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed
0.5 mL, Intramuscular
BIOLOGICALLicensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged 10 to 18 years, 19 to 64 years, or \>= 65 years on the day of inclusion. * Informed consent form had been signed and dated by the participant, or assent form had been signed and dated by the participant and informed consent form had been signed and dated by the parent/guardian * Participant or participant and parent/guardian able to attend all scheduled visits and to comply with all study procedures.
Exclusion criteria
* Participant was pregnant, or lactating, or of childbearing potential, (to be considered of non-childbearing potential, a female must be premenarche or post-menopausal for at least 1 year) surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. * Participation at the time of study enrollment or planned participation during the present study period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. * Received any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine between Visit 1 and Visit 2. * Known or suspected receipt of a tetanus toxoid, reduced diphtheria toxoid, and Acellular pertussis (Tdap) vaccine or Tdap-containing vaccine at any point in time, or receipt of a tetanus and diphtheria containing vaccine in the preceding 5 years. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy. * History of diphtheria, tetanus, or pertussis infection (confirmed either serologically or microbiologically). * Known or suspected systemic hypersensitivity to any of the vaccine components or history of life-threatening reaction to the study vaccine or a vaccine containing the same substances. * Laboratory-confirmed / self-reported thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. * History of encephalopathy (e.g., coma, decreased level of consciousness, or prolonged seizures) not attributable to another identifiable cause within 7 days of administration of a previous dose of diphtheria and tetanus toxoids and pertussis (DTP), or diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Current alcohol abuse or drug addiction. * Chronic illness that was at a stage where it might interfere with trial conduct or completion. * Moderate or severe acute illness/infection on the day of vaccination or febrile illness (temperature \>= 100.4°F). * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Within 7 days after vaccination | A solicited reaction (SR) is an adverse event (AE) that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. An SR is therefore an adverse drug reaction (ADR) observed and 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 and solicited systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported. |
| Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Within 7 days after vaccination | An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR 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. Number of participants with at least one solicited injection site reactions and systemic reactions were reported. |
| Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Within 7 days after vaccination | An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR 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. Number of participants with at least one solicited injection site reactions and systemic reactions were reported. |
Countries
United States
Participant flow
Recruitment details
Study participants were enrolled in 20 centers in the Unites States (US) from 22 October 2015 to 15 August 2016.
Pre-assignment details
A total of 1363 participants 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, and older adults: age greater than equal to \[\>=\] 65 years).
Participants by arm
| Arm | Count |
|---|---|
| Adolescents: SP0173 Formulation 1 Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine. | 80 |
| Adolescents: SP0173 Formulation 2 Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. | 71 |
| Adolescents: SP0173 Formulation 3 Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. | 78 |
| Adolescents: SP0173 Formulation 4 Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. | 79 |
| Adolescents: Adacel® Healthy participants aged 10-18 years received Adacel®. | 75 |
| Adolescents: Boostrix® Healthy participants aged 10-18 years received Boostrix®. | 75 |
| Adults: SP0173 Formulation 1 Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. | 76 |
| Adults: SP0173 Formulation 2 Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. | 73 |
| Adults: SP0173 Formulation 3 Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. | 76 |
| Adults: SP0173 Formulation 4 Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. | 76 |
| Adults: Adacel® Healthy participants aged 19-64 years received Adacel®. | 76 |
| Adults: Boostrix® Healthy participants aged 19-64 years received Boostrix®. | 73 |
| Older Adults: SP0173 Formulation 1 Healthy participants aged \>=65 years received a single dose of the SP0173 Tdap vaccine. | 77 |
| Older Adults: SP0173 Formulation 2 Healthy participants aged \>=65 years received a single dose of the SP0173 Tdap vaccine. | 74 |
| Older Adults: SP0173 Formulation 3 Healthy subjects aged \>=65 years received a single dose of the SP0173 Tdap vaccine. | 78 |
| Older Adults: SP0173 Formulation 4 Healthy subjects aged \>= 65 years received a single dose of the SP0173 Tdap vaccine. | 72 |
| Older Adults: Adacel® Healthy participants aged \>=65 years received Adacel®. | 76 |
| Older Adults: Boostrix® Healthy participants aged \>=65 years received Boostrix®. | 78 |
| Total | 1,363 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 | 0 | 2 | 0 | 1 | 1 | 1 | 0 | 2 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 2 | 0 | 0 | 2 | 0 | 1 | 1 | 1 | 3 | 3 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 10.8 years STANDARD_DEVIATION 1.3 | 11.0 years STANDARD_DEVIATION 1.3 | 11.1 years STANDARD_DEVIATION 1.6 | 10.8 years STANDARD_DEVIATION 1.4 | 10.8 years STANDARD_DEVIATION 1.5 | 11.1 years STANDARD_DEVIATION 1.6 | 42.5 years STANDARD_DEVIATION 12.5 | 41.2 years STANDARD_DEVIATION 12.1 | 40.1 years STANDARD_DEVIATION 12.8 | 42.1 years STANDARD_DEVIATION 13 | 41.3 years STANDARD_DEVIATION 12.7 | 42.5 years STANDARD_DEVIATION 13.2 | 71.3 years STANDARD_DEVIATION 5.4 | 71.8 years STANDARD_DEVIATION 5.4 | 70.9 years STANDARD_DEVIATION 4.8 | 70.8 years STANDARD_DEVIATION 5.1 | 70.9 years STANDARD_DEVIATION 5 | 71.3 years STANDARD_DEVIATION 4.8 | 41.2 years STANDARD_DEVIATION 25.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 3 Participants | 4 Participants | 4 Participants | 6 Participants | 17 Participants | 19 Participants | 8 Participants | 11 Participants | 15 Participants | 10 Participants | 11 Participants | 12 Participants | 13 Participants | 15 Participants | 12 Participants | 13 Participants | 179 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 76 Participants | 69 Participants | 75 Participants | 75 Participants | 71 Participants | 69 Participants | 59 Participants | 54 Participants | 68 Participants | 65 Participants | 61 Participants | 63 Participants | 64 Participants | 59 Participants | 64 Participants | 55 Participants | 63 Participants | 61 Participants | 1171 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants | 1 Participants | 2 Participants | 1 Participants | 4 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 4 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 9 Participants | 2 Participants | 4 Participants | 8 Participants | 4 Participants | 23 Participants | 18 Participants | 24 Participants | 18 Participants | 23 Participants | 19 Participants | 7 Participants | 8 Participants | 8 Participants | 5 Participants | 6 Participants | 10 Participants | 203 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 4 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 24 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 71 Participants | 60 Participants | 71 Participants | 72 Participants | 63 Participants | 65 Participants | 48 Participants | 51 Participants | 46 Participants | 53 Participants | 52 Participants | 51 Participants | 69 Participants | 64 Participants | 70 Participants | 66 Participants | 69 Participants | 68 Participants | 1109 Participants |
| Sex: Female, Male Female | 41 Participants | 33 Participants | 35 Participants | 37 Participants | 39 Participants | 40 Participants | 43 Participants | 46 Participants | 38 Participants | 39 Participants | 44 Participants | 36 Participants | 37 Participants | 38 Participants | 51 Participants | 38 Participants | 46 Participants | 45 Participants | 726 Participants |
| Sex: Female, Male Male | 39 Participants | 38 Participants | 43 Participants | 42 Participants | 36 Participants | 35 Participants | 33 Participants | 27 Participants | 38 Participants | 37 Participants | 32 Participants | 37 Participants | 40 Participants | 36 Participants | 27 Participants | 34 Participants | 30 Participants | 33 Participants | 637 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 0 / 71 | 0 / 77 | 0 / 77 | 0 / 75 | 0 / 75 | 0 / 76 | 0 / 73 | 0 / 76 | 0 / 76 | 0 / 76 | 1 / 72 | 0 / 77 | 0 / 73 | 0 / 78 | 0 / 72 | 0 / 76 | 0 / 78 |
| other Total, other adverse events | 71 / 79 | 64 / 71 | 67 / 77 | 68 / 77 | 71 / 75 | 66 / 75 | 52 / 76 | 53 / 73 | 67 / 76 | 54 / 76 | 62 / 76 | 50 / 72 | 53 / 77 | 60 / 73 | 58 / 78 | 53 / 72 | 49 / 76 | 56 / 78 |
| serious Total, serious adverse events | 0 / 79 | 0 / 71 | 0 / 77 | 1 / 77 | 0 / 75 | 0 / 75 | 1 / 76 | 1 / 73 | 1 / 76 | 1 / 76 | 0 / 76 | 2 / 72 | 0 / 77 | 3 / 73 | 4 / 78 | 1 / 72 | 2 / 76 | 2 / 78 |
Outcome results
Primary
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years
A solicited reaction (SR) is an adverse event (AE) that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. An SR is therefore an adverse drug reaction (ADR) observed and 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 and solicited systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.
Time frame: Within 7 days after vaccination
Population: Safety analysis set that was defined as those participants who had received study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Here, number analyzed= number of participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Malaise | 14 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Myalgia | 42 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Injection site swelling | 7 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Fever | 1 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Headache | 21 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Extensive limb swelling | 0 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Injection site erythema | 9 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Injection site pain | 59 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Upper limb edema | 45 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Myalgia | 35 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Fever | 0 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Injection site erythema | 4 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Injection site swelling | 4 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Injection site pain | 51 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Malaise | 17 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Upper limb edema | 41 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Headache | 14 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Extensive limb swelling | 0 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Injection site erythema | 10 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Fever | 1 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Upper limb edema | 49 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Malaise | 14 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Myalgia | 38 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Injection site swelling | 8 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Headache | 19 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Extensive limb swelling | 0 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Injection site pain | 50 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Fever | 0 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Injection site pain | 49 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Injection site erythema | 1 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Injection site swelling | 0 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Upper limb edema | 46 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Extensive limb swelling | 0 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Headache | 25 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Malaise | 18 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Myalgia | 42 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Extensive limb swelling | 0 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Upper limb edema | 48 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Headache | 20 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Injection site swelling | 1 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Myalgia | 52 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Malaise | 12 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Injection site erythema | 4 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Injection site pain | 59 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Fever | 0 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Injection site pain | 48 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Upper limb edema | 33 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Fever | 1 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Myalgia | 38 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Malaise | 17 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Headache | 27 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Injection site swelling | 4 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Extensive limb swelling | 0 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years | Injection site erythema | 2 Participants |
Primary
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years
An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR 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. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.
Time frame: Within 7 days after vaccination
Population: Analysis was performed on safety analysis set. Here, number analyzed=number of participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Malaise | 18 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Myalgia | 32 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Injection site swelling | 1 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Fever | 0 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Headache | 16 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Extensive limb swelling | 0 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Injection site erythema | 2 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Injection site pain | 38 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Upper limb edema | 28 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Myalgia | 29 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Fever | 0 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Injection site erythema | 1 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Injection site swelling | 3 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Injection site pain | 34 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Malaise | 9 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Upper limb edema | 37 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Headache | 11 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Extensive limb swelling | 0 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Injection site erythema | 2 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Fever | 0 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Upper limb edema | 41 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Malaise | 16 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Myalgia | 35 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Injection site swelling | 4 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Headache | 19 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Extensive limb swelling | 0 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Injection site pain | 49 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Fever | 0 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Injection site pain | 42 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Injection site erythema | 0 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Injection site swelling | 1 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Upper limb edema | 37 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Extensive limb swelling | 0 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Headache | 19 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Malaise | 19 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Myalgia | 36 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Extensive limb swelling | 1 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Upper limb edema | 35 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Headache | 19 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Injection site swelling | 3 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Myalgia | 39 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Malaise | 23 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Injection site erythema | 5 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Injection site pain | 49 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Fever | 2 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Injection site pain | 35 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Upper limb edema | 31 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Fever | 1 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Myalgia | 28 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Malaise | 15 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Headache | 19 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Injection site swelling | 1 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Extensive limb swelling | 0 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years | Injection site erythema | 2 Participants |
Primary
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years
An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR 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. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.
Time frame: Within 7 days after vaccination
Population: Analysis was performed on safety analysis set. Here, number analyzed=number of participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Extensive limb swelling | 0 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Injection site pain | 21 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Myalgia | 12 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Malaise | 6 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Upper limb edema | 38 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Fever | 0 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Injection site swelling | 1 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Headache | 6 Participants |
| Adolescents: SP0173 Formulation 1 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Injection site erythema | 0 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Fever | 1 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Myalgia | 21 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Malaise | 12 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Headache | 10 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Injection site swelling | 6 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Injection site erythema | 1 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Upper limb edema | 43 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Injection site pain | 34 Participants |
| Adolescents: SP0173 Formulation 2 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Extensive limb swelling | 0 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Injection site erythema | 2 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Injection site swelling | 6 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Fever | 0 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Extensive limb swelling | 0 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Injection site pain | 34 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Malaise | 14 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Myalgia | 30 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Headache | 20 Participants |
| Adolescents: SP0173 Formulation 3 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Upper limb edema | 36 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Extensive limb swelling | 0 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Injection site pain | 34 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Malaise | 9 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Injection site swelling | 2 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Upper limb edema | 38 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Myalgia | 23 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Injection site erythema | 2 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Fever | 0 Participants |
| Adolescents: SP0173 Formulation 4 | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Headache | 12 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Headache | 11 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Injection site erythema | 3 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Fever | 0 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Extensive limb swelling | 0 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Malaise | 8 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Upper limb edema | 32 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Injection site swelling | 1 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Injection site pain | 28 Participants |
| Adolescents: Adacel® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Myalgia | 23 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Injection site pain | 25 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Injection site erythema | 1 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Injection site swelling | 2 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Upper limb edema | 40 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Extensive limb swelling | 0 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Fever | 0 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Headache | 14 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Malaise | 6 Participants |
| Adolescents: Boostrix® | Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years | Myalgia | 17 Participants |