Trial Outcomes & Findings for Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age (NCT NCT00467519)
NCT ID: NCT00467519
Last Updated: 2014-02-07
Results Overview
Seroprotection rate at level ≥ 0.1 IU/mL was defined as antibody concentrations ≥ 0.1 IU/mL. Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1045 participants
Primary outcome timeframe
Pre-dose and 30 days post-vaccination
Results posted on
2014-02-07
Participant Flow
Participants were enrolled from 13 April 2007 to 16 October 2009 in 42 clinical centers in the US and 1 clinical center in Canada.
A total of 1042 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Tdap Vaccine Group
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
|
DTaP Vaccine Group
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
|
|---|---|---|
|
Overall Study
STARTED
|
531
|
511
|
|
Overall Study
COMPLETED
|
517
|
488
|
|
Overall Study
NOT COMPLETED
|
14
|
23
|
Reasons for withdrawal
| Measure |
Tdap Vaccine Group
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
|
DTaP Vaccine Group
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
8
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
9
|
|
Overall Study
Withdrawal by Subject
|
4
|
10
|
Baseline Characteristics
Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age
Baseline characteristics by cohort
| Measure |
Tdap Vaccine Group
n=531 Participants
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
|
DTaP Vaccine Group
n=511 Participants
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
|
Total
n=1042 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
531 Participants
n=5 Participants
|
511 Participants
n=7 Participants
|
1042 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
4.45 Years
STANDARD_DEVIATION 0.48 • n=5 Participants
|
4.42 Years
STANDARD_DEVIATION 0.47 • n=7 Participants
|
4.44 Years
STANDARD_DEVIATION 0.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
275 Participants
n=5 Participants
|
244 Participants
n=7 Participants
|
519 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
256 Participants
n=5 Participants
|
267 Participants
n=7 Participants
|
523 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
522 participants
n=5 Participants
|
502 participants
n=7 Participants
|
1024 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 30 days post-vaccinationPopulation: Diphtheria and tetanus antibody analysis was in all enrolled and vaccinated participants in the per-protocol population.
Seroprotection rate at level ≥ 0.1 IU/mL was defined as antibody concentrations ≥ 0.1 IU/mL. Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Tdap Vaccine Group
n=442 Participants
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
|
DTaP Vaccine Group
n=426 Participants
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
|
|---|---|---|
|
Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level
Diphtheria (IU/mL), Pre-dose [n = 442, 425]
|
65 Percentage of Participants
|
69 Percentage of Participants
|
|
Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level
Diphtheria (IU/mL), Post-dose [n = 442, 426]
|
100 Percentage of Participants
|
100 Percentage of Participants
|
|
Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level
Tetanus (IU/mL), Pre-dose [n = 442, 426]
|
81 Percentage of Participants
|
85 Percentage of Participants
|
|
Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level
Tetanus (IU/mL), Post-dose [n = 442, 426]
|
100 Percentage of Participants
|
100 Percentage of Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 30 days post-vaccinationPopulation: Diphtheria and tetanus antibody analysis was in all enrolled and vaccinated participants in the per-protocol population.
Serothreshold rate at level ≥ 1.0 IU/mL was defined as antibody concentrations ≥ 1.0 IU/mL. Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Tdap Vaccine Group
n=442 Participants
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
|
DTaP Vaccine Group
n=426 Participants
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
|
|---|---|---|
|
Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL
Diphtheria (IU/mL), Pre-dose
|
4 Percentage of Participants
|
7 Percentage of Participants
|
|
Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL
Diphtheria (IU/mL), Post-dose
|
99 Percentage of Participants
|
100 Percentage of Participants
|
|
Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL
Tetanus (IU/mL), Pre-dose
|
11 Percentage of Participants
|
12 Percentage of Participants
|
|
Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL
Tetanus (IU/mL), Post-dose
|
97 Percentage of Participants
|
98 Percentage of Participants
|
PRIMARY outcome
Timeframe: 30 Days post-vaccinationPopulation: Pertussis antibody booster response analysis was in all enrolled and vaccinated participants in the per-protocol population.
Booster response was defined as post titer ≥ 0.4 IU/mL and pre-titer \< 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre titer ≥ 0.1 IU/mL but \< 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL Post-vaccination titers for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Tdap Vaccine Group
n=441 Participants
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
|
DTaP Vaccine Group
n=423 Participants
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
|
|---|---|---|
|
Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis
Pertussis Toxoid (EU/mL) [n = 401, 387]
|
88 Percentage of Participants
|
94 Percentage of Participants
|
|
Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis
Filamentous Haemagglutinin (EU/mL) [n = 432, 407]
|
92 Percentage of Participants
|
89 Percentage of Participants
|
|
Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis
Pertactin (EU/mL) [n = 441, 423]
|
92 Percentage of Participants
|
95 Percentage of Participants
|
|
Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis
Fimbriae types 2 and 3 (EU/mL) [n = 432, 418]
|
95 Percentage of Participants
|
94 Percentage of Participants
|
PRIMARY outcome
Timeframe: 30 Days post-vaccinationPopulation: Diphtheria and tetanus antibody booster response were analysed in all enrolled and vaccinated participants, per-protocol population.
Booster response was defined as post titer ≥ 0.4 IU/mL and pre titer \< 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre-titer ≥ 0.1 IU/mL but \< 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL. Post-vaccination titers for Diphtheria was determined by neutralization assay; tetanus titers was determined by an enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Tdap Vaccine Group
n=442 Participants
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
|
DTaP Vaccine Group
n=426 Participants
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
|
|---|---|---|
|
Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus
Diphtheria (IU/mL) [n = 442, 425]
|
99 Percentage of Participants
|
99 Percentage of Participants
|
|
Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus
Tetanus (IU/mL) [n = 442, 426]
|
98 Percentage of Participants
|
97 Percentage of Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 30 Days Post-vaccinationPopulation: Geometric mean titers were assessed in the per-protocol population.
Pre- and post-vaccination GMTs and their 95% confidence intervals for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Tdap Vaccine Group
n=442 Participants
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
|
DTaP Vaccine Group
n=426 Participants
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
|
|---|---|---|
|
Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis
Pertussis Toxoid, Pre-dose [n = 411, 390]
|
4.58 EU/mL
Interval 4.16 to 5.05
|
4.98 EU/mL
Interval 4.49 to 5.51
|
|
Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis
Pertussis Toxoid, Post-dose [n = 430, 423]
|
53.1 EU/mL
Interval 49.3 to 57.2
|
86.4 EU/mL
Interval 79.9 to 93.5
|
|
Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis
Filamentous Haemagglutinin, Pre-dose [n= 435, 408]
|
7.56 EU/mL
Interval 6.64 to 8.61
|
7.60 EU/mL
Interval 6.59 to 8.76
|
|
Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis
Filamentous Haemagglutinin, Post-dose [n=439, 424]
|
102 EU/mL
Interval 93.1 to 111.0
|
86.5 EU/mL
Interval 78.3 to 95.5
|
|
Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis
Pertactin, Pre-dose [n = 442, 424]
|
9.31 EU/mL
Interval 8.4 to 10.3
|
11.1 EU/mL
Interval 10.0 to 12.4
|
|
Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis
Pertactin, Post-dose [n = 441, 425]
|
121 EU/mL
Interval 109.0 to 134.0
|
173 EU/mL
Interval 155.0 to 193.0
|
|
Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis
Fimbriae types 2 and 3, Pre-dose [n = 434, 420]
|
23.8 EU/mL
Interval 21.0 to 27.0
|
24.4 EU/mL
Interval 21.4 to 27.7
|
|
Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis
Fimbriae types 2 and 3, Post-dose [n = 439, 424]
|
425 EU/mL
Interval 387.0 to 467.0
|
388 EU/mL
Interval 354.0 to 425.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 0 to 7 post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
Solicited Injection Site Reactions: Pain, erythema/redness, swelling, increased left limb circumference, and increased right limb circumference. Solicited Systemic Reactions: Fever (temperature), headache, malaise, and myalgia.
Outcome measures
| Measure |
Tdap Vaccine Group
n=531 Participants
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
|
DTaP Vaccine Group
n=511 Participants
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
|
|---|---|---|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Any Headache [n = 529, 495]
|
60 Participants
|
74 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Any Solicited Injection Site Reaction [n=529, 495]
|
455 Participants
|
451 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Any Pain [n = 529, 495]
|
318 Participants
|
334 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Grade 3 Pain (Incapacitating)
|
1 Participants
|
4 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Any Erythema [n = 529, 494]
|
140 Participants
|
201 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Grade 3 Erythema (> 50 mm)
|
17 Participants
|
65 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Any Swelling [n = 529, 493]
|
100 Participants
|
144 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Grade 3 Swelling (> 50 mm)
|
8 Participants
|
23 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Any Increased Left Limb Circumference [n=527, 494]
|
309 Participants
|
353 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Grade 3 Left Limb Circumference (> 40 mm increase)
|
1 Participants
|
5 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Any Increased Right Limb Circumference [n=527, 494
|
241 Participants
|
244 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Grade 3 Right Limb Circumerence (> 40 mm increase)
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Any Solicited System Reaction [n = 529, 495]
|
256 Participants
|
260 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Any Fever [n = 527, 493]
|
25 Participants
|
26 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Grade 3 Fever (> 39.5 °C)
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Grade 3 Headache (Prevents daily activities)
|
3 Participants
|
4 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Any Malaise [n = 529, 495]
|
143 Participants
|
150 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Grade 3 Malaise (Prevents daily activities)
|
5 Participants
|
7 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Any Myalgia [n = 529, 495]
|
185 Participants
|
196 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Grade 3 Myalgia (Prevents daily activities)
|
3 Participants
|
8 Participants
|
Adverse Events
Tdap Vaccine Group
Serious events: 4 serious events
Other events: 318 other events
Deaths: 0 deaths
DTaP Vaccine Group
Serious events: 5 serious events
Other events: 353 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tdap Vaccine Group
n=531 participants at risk
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
|
DTaP Vaccine Group
n=511 participants at risk
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/531 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
0.20%
1/511 • Number of events 1 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
|
Infections and infestations
Appendicitis
|
0.19%
1/531 • Number of events 1 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
0.00%
0/511 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
|
Infections and infestations
Pneumonia
|
0.19%
1/531 • Number of events 1 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
0.00%
0/511 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
|
Infections and infestations
Pyelonephritis
|
0.19%
1/531 • Number of events 1 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
0.00%
0/511 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.19%
1/531 • Number of events 1 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
0.59%
3/511 • Number of events 3 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/531 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
0.20%
1/511 • Number of events 1 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.19%
1/531 • Number of events 1 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
0.00%
0/511 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
Other adverse events
| Measure |
Tdap Vaccine Group
n=531 participants at risk
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
|
DTaP Vaccine Group
n=511 participants at risk
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
|
|---|---|---|
|
General disorders
Injection site Erythema
|
26.5%
140/529 • Number of events 140 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
40.7%
201/494 • Number of events 201 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
|
General disorders
Fever
|
4.7%
25/527 • Number of events 25 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
5.3%
26/493 • Number of events 26 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
|
General disorders
Increased left limb circumference
|
58.6%
309/527 • Number of events 309 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
71.5%
353/494 • Number of events 353 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
|
General disorders
Increased right limb circumference
|
45.7%
241/527 • Number of events 241 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
49.4%
244/494 • Number of events 244 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
|
General disorders
Injection site bruising
|
5.3%
28/531 • Number of events 31 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
7.8%
40/511 • Number of events 42 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
|
General disorders
Injection site induration
|
3.8%
20/531 • Number of events 21 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
5.5%
28/511 • Number of events 30 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
35.0%
185/529 • Number of events 185 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
39.6%
196/495 • Number of events 196 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
|
Nervous system disorders
Headache
|
11.3%
60/529 • Number of events 60 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
14.9%
74/495 • Number of events 74 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.0%
48/531 • Number of events 49 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
5.7%
29/511 • Number of events 31 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
|
General disorders
Solicited Injection Site Pain
|
60.1%
318/529 • Number of events 318 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
67.5%
334/495 • Number of events 334 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
|
General disorders
Solicited Injection Site Swelling
|
18.9%
100/529 • Number of events 100 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
29.2%
144/493 • Number of events 144 • Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
- Publication restrictions are in place
Restriction type: OTHER