Trial Outcomes & Findings for Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine (NCT NCT00304265)
NCT ID: NCT00304265
Last Updated: 2016-04-14
Results Overview
Solicited injection site reactions: Pain, Erythema, Swelling, and Arm circumference. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
215 participants
Primary outcome timeframe
Days 0 to 14 Post-vaccination
Results posted on
2016-04-14
Participant Flow
Participants were enrolled from February 2006 to July 2006 at 17 clinical sites in Germany.
A total of 214 participants who met the inclusion and exclusion criteria were enrolled and vaccinated. One over aged participant was also vaccinated and included in the safety analysis.
Participant milestones
| Measure |
6th Dose Pertussis Vaccine Group
Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
|
5th Dose Pertussis Vaccine Group
Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
98
|
|
Overall Study
COMPLETED
|
117
|
98
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine
Baseline characteristics by cohort
| Measure |
6th Dose Pertussis Vaccine Group
n=117 Participants
Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
|
5th Dose Pertussis Vaccine Group
n=98 Participants
Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
117 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
215 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
|
12.3 Years
FULL_RANGE 0 • n=5 Participants
|
12.6 Years
FULL_RANGE 0 • n=7 Participants
|
12.4 Years
FULL_RANGE 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
117 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 0 to 14 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, Swelling, and Arm circumference. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Outcome measures
| Measure |
6th Dose Pertussis Vaccine Group
n=117 Participants
Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
|
5th Dose Pertussis Vaccine Group
n=97 Participants
Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
|
|---|---|---|
|
Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
Fever
|
5 Participants
|
15 Participants
|
|
Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
Any Headache
|
40 Participants
|
50 Participants
|
|
Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
Any Myalgia
|
69 Participants
|
73 Participants
|
|
Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
Grade 3 Myalgia (Prevents Daily Activity)
|
5 Participants
|
10 Participants
|
|
Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
Any Local Reactions After Vaccination
|
89 Participants
|
87 Participants
|
|
Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
Any Pain
|
85 Participants
|
87 Participants
|
|
Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
Grade 3 Pain (Incapacitating)
|
7 Participants
|
8 Participants
|
|
Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
Any Erythema
|
19 Participants
|
27 Participants
|
|
Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
Grade 3 Erythema (> 5.0 cm)
|
10 Participants
|
10 Participants
|
|
Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
Any Swelling
|
24 Participants
|
17 Participants
|
|
Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
Grade 3 Swelling (> 5.0 cm)
|
6 Participants
|
8 Participants
|
|
Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
Any Increase in Arm Circumference
|
8 Participants
|
11 Participants
|
|
Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
Grade 3 Increase in Arm Circumference (> 5.0 cm)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
Any Systemic Reactions After Vaccination
|
85 Participants
|
84 Participants
|
|
Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
Grade 3 Headache (Prevents Daily Activities)
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
Any Malaise
|
40 Participants
|
44 Participants
|
|
Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
Grade 3 Malaise (Prevents Daily Activities)
|
2 Participants
|
2 Participants
|
Adverse Events
6th Dose Pertussis Vaccine Group
Serious events: 0 serious events
Other events: 89 other events
Deaths: 0 deaths
5th Dose Pertussis Vaccine Group
Serious events: 0 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
6th Dose Pertussis Vaccine Group
n=117 participants at risk
Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
|
5th Dose Pertussis Vaccine Group
n=97 participants at risk；n=98 participants at risk
Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
|
|---|---|---|
|
General disorders
Injection site pain
|
76.1%
89/117 • Adverse event data were collected for 28 days post-vaccination.
|
89.7%
87/97 • Adverse event data were collected for 28 days post-vaccination.
|
|
General disorders
Injection site erythema
|
16.2%
19/117 • Adverse event data were collected for 28 days post-vaccination.
|
27.8%
27/97 • Adverse event data were collected for 28 days post-vaccination.
|
|
General disorders
Injection site swelling
|
20.5%
24/117 • Adverse event data were collected for 28 days post-vaccination.
|
17.5%
17/97 • Adverse event data were collected for 28 days post-vaccination.
|
|
Nervous system disorders
Headache
|
34.2%
40/117 • Adverse event data were collected for 28 days post-vaccination.
|
51.5%
50/97 • Adverse event data were collected for 28 days post-vaccination.
|
|
General disorders
Malaise
|
34.2%
40/117 • Adverse event data were collected for 28 days post-vaccination.
|
45.4%
44/97 • Adverse event data were collected for 28 days post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
59.0%
69/117 • Adverse event data were collected for 28 days post-vaccination.
|
75.3%
73/97 • Adverse event data were collected for 28 days post-vaccination.
|
|
General disorders
Pyrexia
|
4.3%
5/117 • Adverse event data were collected for 28 days post-vaccination.
|
15.5%
15/97 • Adverse event data were collected for 28 days 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