Trial Outcomes & Findings for Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX® (NCT NCT00319553)

NCT ID: NCT00319553

Last Updated: 2012-10-05

Results Overview

Solicited injection site reactions: Pain, Erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 reaction definitions: Pain = Incapacitating, unable to perform usual activities; Erythema and swelling = ≥ 5 cm; Fever = temperature ≥ 39.1°C or ≥ 102.3°F; Headache, Malaise, and Myalgia = Prevents daily activities.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

647 participants

Primary outcome timeframe

Day 0 to 7 post-vaccination

Results posted on

2012-10-05

Participant Flow

Participants were enrolled from 09 May 2006 to 02 October 2006 in 12 clinical centers in the US.

A total of 647 participants who met the inclusion and exclusion criteria were enrolled, 644 were vaccinated and included in the analysis.

Participant milestones

Participant milestones
Measure	Adacel® Vaccine Group	Boostrix® Vaccine Group
Overall Study STARTED	323	321
Overall Study COMPLETED	319	317
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Adacel® Vaccine Group	Boostrix® Vaccine Group
Overall Study Protocol Violation	1	2
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adacel® Vaccine Group n=323 Participants	Boostrix® Vaccine Group n=321 Participants	Total n=644 Participants Total of all reporting groups
Age, Categorical <=18 years	291 Participants n=5 Participants	291 Participants n=7 Participants	582 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	30 Participants n=7 Participants	62 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	14.5 years STANDARD_DEVIATION 2.33 • n=5 Participants	14.7 years STANDARD_DEVIATION 2.33 • n=7 Participants	14.6 years STANDARD_DEVIATION 2.33 • n=5 Participants
Sex: Female, Male Female	154 Participants n=5 Participants	150 Participants n=7 Participants	304 Participants n=5 Participants
Sex: Female, Male Male	169 Participants n=5 Participants	171 Participants n=7 Participants	340 Participants n=5 Participants
Region of Enrollment United States	323 participants n=5 Participants	321 participants n=7 Participants	644 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 to 7 post-vaccination

Population: Solicited injection site and Systemic reactions were analyzed in the intent-to-treat safety population

Outcome measures

Outcome measures
Measure	Adacel® Vaccine Group n=320 Participants	Boostrix® Vaccine Group n=317 Participants
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® Any solicited injection site reaction	273 Participants	257 Participants
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® Grade 3 solicited injection site reaction	5 Participants	4 Participants
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® Any solicited injection site Pain	270 Participants	247 Participants
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® Grade 3 solicited inj. site Pain (Incapacitating)	2 Participants	3 Participants
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® Any solicited injection site Erythema	75 Participants	67 Participants
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® Grade 3 solicited injection site Erythema (≥ 5 cm)	2 Participants	1 Participants
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® Any solicited injection site Swelling	61 Participants	44 Participants
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® Grade 3 solicited injection site Swelling (≥ 5 cm)	2 Participants	1 Participants
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® Any solicited systemic reaction	216 Participants	205 Participants
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® Grade 3 solicited systemic reaction	9 Participants	9 Participants
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® Any solicited Fever	18 Participants	9 Participants
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® Grade 3 solicited Fever (≥ 39.1°C or ≥ 102.3°F)	1 Participants	0 Participants
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® Any solicited Headache	136 Participants	108 Participants
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® Gr 3 solicited Headache: Prevents daily activities	3 Participants	4 Participants
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® Any solicited Malaise	91 Participants	78 Participants
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® Gr 3 solicited Malaise: Prevents daily activities	8 Participants	6 Participants
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® Any solicited Myalgia	167 Participants	166 Participants
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® Gr 3 solicited Myalgia: Prevents daily activities	1 Participants	3 Participants

PRIMARY outcome

Timeframe: Day 0 and 28 days post-vaccination

Population: Tetanus antitoxin concentrations were analyzed in the per-protocol population.

Outcome measures

Outcome measures
Measure	Adacel® Vaccine Group n=305 Participants	Boostrix® Vaccine Group n=304 Participants
Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. Tetanus IgG antitoxin ≥0.1 IU/mL :pre-vaccination	99 Percentage of Participants	98 Percentage of Participants
Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. Tetanus IgG antitoxin ≥0.1 IU/mL :28 days post-vac	100 Percentage of Participants	100 Percentage of Participants

PRIMARY outcome

Timeframe: Day 0 and 28 days post-vaccination

Population: Diphtheria antitoxin concentrations were analyzed in the per-protocol population

Outcome measures

Outcome measures
Measure	Adacel® Vaccine Group n=305 Participants	Boostrix® Vaccine Group n=304 Participants
Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. Diphtheria IgG antitoxin ≥0.1 IU/mL : pre-vacc	92 Percentage of Participants	93 Percentage of Participants
Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. Diphtheria IgG antitoxin ≥0.1 IU/mL: 28 D post-vac	100 Percentage of Participants	100 Percentage of Participants

PRIMARY outcome

Timeframe: Day 0 and 28 days post-vaccination

Population: Geometric mean concentration of antibody to the pertussis antigens were analyzed in the per-protocol population

Outcome measures

Outcome measures
Measure	Adacel® Vaccine Group n=305 Participants	Boostrix® Vaccine Group n=304 Participants
Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. Anti-pertussis toxoid IgG: pre-vaccination	14.4 EU/mL Interval 12.5 to 16.6	13.5 EU/mL Interval 11.6 to 15.8
Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. Anti-filamentous hemagglutinin IgG:pre-vaccination	26.1 EU/mL Interval 22.7 to 30.0	28.2 EU/mL Interval 24.5 to 32.4
Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. Anti-pertactin IgG: pre-vaccination	12.4 EU/mL Interval 10.6 to 14.6	13.1 EU/mL Interval 11.2 to 15.5
Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. Anti-fimbriae types 2 and 3 IgG: pre-vaccination	13.9 EU/mL Interval 12.0 to 16.2	14.5 EU/mL Interval 12.2 to 17.2
Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. Anti-pertussis toxoid IgG: post-vaccination	86.7 EU/mL Interval 78.8 to 95.4	135.9 EU/mL Interval 122.9 to 150.2
Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. Anti-filamentous hemagglutinin IgG post-vaccinat.	240.7 EU/mL Interval 217.7 to 266.1	402.9 EU/mL Interval 365.5 to 444.2
Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. Anti-pertactin IgG: post-vaccination	322.7 EU/mL Interval 279.7 to 372.4	463.3 EU/mL Interval 395.4 to 542.9
Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. Anti-fimbriae types 2 and 3 IgG: post-vaccination	1203 EU/mL Interval 1004.0 to 1442.0	26.6 EU/mL Interval 22.2 to 31.8

Adverse Events

Adacel® Vaccine Group

Serious events: 0 serious events

Other events: 273 other events

Deaths: 0 deaths

Boostrix® Vaccine Group

Serious events: 0 serious events

Other events: 257 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Adacel® Vaccine Group n=320 participants at risk；n=323 participants at risk	Boostrix® Vaccine Group n=317 participants at risk；n=321 participants at risk
General disorders Solicited injection site Pain	84.4% 270/320 • Adverse events data were collected from the day of vaccination up to 1 month post-vaccination.	81.1% 257/317 • Adverse events data were collected from the day of vaccination up to 1 month post-vaccination.
General disorders Solicited injection site Erythema	23.4% 75/320 • Adverse events data were collected from the day of vaccination up to 1 month post-vaccination.	21.2% 67/316 • Adverse events data were collected from the day of vaccination up to 1 month post-vaccination.
General disorders Solicited injection site Swelling	19.1% 61/320 • Adverse events data were collected from the day of vaccination up to 1 month post-vaccination.	13.9% 44/316 • Adverse events data were collected from the day of vaccination up to 1 month post-vaccination.
General disorders Solicited Fever	5.6% 18/320 • Adverse events data were collected from the day of vaccination up to 1 month post-vaccination.	2.8% 9/316 • Adverse events data were collected from the day of vaccination up to 1 month post-vaccination.
Nervous system disorders Solicited Headache	42.5% 136/320 • Adverse events data were collected from the day of vaccination up to 1 month post-vaccination.	34.1% 108/317 • Adverse events data were collected from the day of vaccination up to 1 month post-vaccination.
General disorders Solicited Malaise	28.4% 91/320 • Adverse events data were collected from the day of vaccination up to 1 month post-vaccination.	24.6% 78/317 • Adverse events data were collected from the day of vaccination up to 1 month post-vaccination.
Musculoskeletal and connective tissue disorders Solicited Myalgia	52.2% 167/320 • Adverse events data were collected from the day of vaccination up to 1 month post-vaccination.	52.4% 166/317 • Adverse events data were collected from the day of vaccination up to 1 month post-vaccination.

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: [email protected]

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