Trial Outcomes & Findings for Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents (NCT NCT01689324)

Results Overview

Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

43 participants

Primary outcome timeframe

Day 28 post-vaccination

Results posted on

2014-02-21

Participant Flow

The study participants were enrolled from 12 September through 14 October 2012 in 3 clinic centers in Japan.

A total of 43 participants that met all the inclusion criteria but none of the exclusion criteria were enrolled and vaccinated in the study.

Participant milestones

Participant milestones
Measure	Study Group Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Overall Study STARTED	43
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Group n=43 Participants Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Age, Categorical <=18 years	43 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	11.4 Years STANDARD_DEVIATION 0.5 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment Japan	43 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 28 post-vaccination

Population: Seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set

Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination.

Outcome measures

Outcome measures
Measure	Study Group n=43 Participants Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL® Diphtheria	100 Percentage of Participants
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL® Tetanus	100 Percentage of Participants

PRIMARY outcome

Timeframe: Day 28 post-vaccination

Population: Booster response to diphtheria and tetanus antigens were determined in the Immunology Analysis Set

Diphtheria booster response was defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration \> 2.56 IU/mL. Tetanus booster response was defined as a ≥ 4-fold rise in pre- to post- vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration \> 2.7 IU/mL.

Outcome measures

Outcome measures
Measure	Study Group n=43 Participants Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL® Diphtheria	98 Percentage of Participants
Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL® Tetanus	100 Percentage of Participants

PRIMARY outcome

Timeframe: Day 28 post-vaccination

Population: Booster response to pertussis antigens were determined in the Immunology Analysis Set

Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but \< 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)

Outcome measures

Outcome measures
Measure	Study Group n=43 Participants Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL® Pertussis toxoid	63 Percentage of Participants
Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL® Filamentous hemagglutinin	88 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 pre-vaccination

Population: Pre-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set

Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL.

Outcome measures

Outcome measures
Measure	Study Group n=43 Participants Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination With ADACEL® Diphtheria	63 Percentage of Participants
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination With ADACEL® Tetanus	91 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (pre-vaccination) and day 28 post-vaccination

Population: Pre- and post-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set.

Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.01 IU/mL.

Outcome measures

Outcome measures
Measure	Study Group n=43 Participants Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL® Diphtheria (Pre-vaccination)	100 Percentage of Participants
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL® Diphtheria (Post-vaccination)	100 Percentage of Participants
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL® Tetanus (Pre-vaccination)	100 Percentage of Participants
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL® Tetanus (Post-vaccination)	100 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (pre-vaccination) and day 28 post-vaccination

Population: Pre- and post-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set

Seroprotection was defined as the percentage of participants with antibody concentration of ≥1.0 IU/mL.

Outcome measures

Outcome measures
Measure	Study Group n=43 Participants Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL® Diphtheria (Pre-vaccination)	12 Percentage of Participants
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL® Diphtheria (Post-vaccination)	100 Percentage of Participants
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL® Tetanus (Pre-vaccination)	30 Percentage of Participants
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL® Tetanus (Post-vaccination)	100 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccination

Population: Pre and post vaccination geometric mean concentrations to Diphtheria and Tetanus antigens were determined in the Immunology Analysis Set

Outcome measures

Outcome measures
Measure	Study Group n=43 Participants Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL® Diphtheria (Pre-vaccination)	0.22 Titers Interval 0.14 to 0.35
Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL® Diphtheria (Post-vaccination)	8.58 Titers Interval 6.76 to 10.88
Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL® Tetanus (Pre-vaccination)	0.46 Titers Interval 0.33 to 0.64
Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL® Tetanus (Post-vaccination)	37.80 Titers Interval 30.16 to 47.38

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccination

Population: Pre and post vaccination geometric mean concentrations to pertussis antibodies were determined in the Immunology Analysis Set

Outcome measures

Outcome measures
Measure	Study Group n=43 Participants Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL® Pertussis toxoid (pre-vaccination)	12.21 Titers Interval 7.82 to 19.05
Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL® Pertussis toxoid (post-vaccination)	46.92 Titers Interval 33.65 to 65.42
Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL® Filamentous hemagglutinin (pre-vaccination)	34.79 Titers Interval 23.47 to 51.57
Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL® Filamentous hemagglutinin (post-vaccination)	204.00 Titers Interval 164.26 to 253.36
Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL® Pertactin (pre-vaccination)	10.64 Titers Interval 6.28 to 18.03
Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL® Pertactin (post-vaccination)	272.82 Titers Interval 197.63 to 376.62
Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL® Fimbriae types 2 and 3 (pre-vaccination)	7.78 Titers Interval 5.42 to 11.17
Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL® Fimbriae types 2 and 3 (post-vaccination)	748.28 Titers Interval 443.23 to 1263.27

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 28 post-vaccination

Population: Booster response to pertussis antigens were determined in the Immunology Analysis Set

Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but \< 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)

Outcome measures

Outcome measures
Measure	Study Group n=43 Participants Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Percentage of Participants With Booster Response to Pertussis Antigens, Pertactin and Fimbriae Following Vaccination With ADACEL® Pertactin	93 Percentage of Participants
Percentage of Participants With Booster Response to Pertussis Antigens, Pertactin and Fimbriae Following Vaccination With ADACEL® Fimbriae Types 2 and 3	98 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 up to Day 7 post-vaccination

Population: Solicited injection site and systemic reactions were assessed in the Safety Analysis Set

Solicited injection-site reactions: Pain, Redness, and Swelling. Grade 3: Pain, Significant, prevents daily activity; Redness and Swelling, \>100 mm. Solicited systemic reactions: Fever (Temperature); Headache, Malaise, and Myalgia. Grade 3: Fever, ≥ 39°C; Headache, Malaise and Myalgia, Significant, prevents daily activity.

Outcome measures

Outcome measures
Measure	Study Group n=43 Participants Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL® Solicited injection site Pain	37 Participants
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL® Grade 3 solicited injection site Pain	0 Participants
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL® Solicited injection site Erythema	9 Participants
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL® Grade 3 solicited injection site Erythema	0 Participants
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL® Solicited injection site Swelling	12 Participants
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL® Grade 3 solicited injection site Swelling	1 Participants
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL® Fever	9 Participants
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL® Grade 3 Fever	1 Participants
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL® Headache	8 Participants
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL® Grade 3 Headache	0 Participants
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL® Malaise	11 Participants
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL® Grade 3 Malaise	0 Participants
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL® Myalgia	17 Participants
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL® Grade 3 Myalgia	0 Participants

Adverse Events

Study Group

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Study Group n=43 participants at risk Participants received a single booster dose of Tdap vaccine on Day 0.
General disorders Solicited injection site Pain	86.0% 37/43 • Number of events 37 • Adverse event data were collected from Day 0 (post-vaccination) up to 1 month post-vaccination
General disorders Solicited injection site Erythema	20.9% 9/43 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to 1 month post-vaccination
General disorders Solicited injection site Swelling	27.9% 12/43 • Number of events 12 • Adverse event data were collected from Day 0 (post-vaccination) up to 1 month post-vaccination
General disorders Fever	20.9% 9/43 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to 1 month post-vaccination
General disorders Malaise	25.6% 11/43 • Number of events 11 • Adverse event data were collected from Day 0 (post-vaccination) up to 1 month post-vaccination
General disorders Myalgia	39.5% 17/43 • Number of events 17 • Adverse event data were collected from Day 0 (post-vaccination) up to 1 month post-vaccination
Infections and infestations Nasopharyngitis	16.3% 7/43 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to 1 month post-vaccination
Nervous system disorders Headache	18.6% 8/43 • Number of events 8 • Adverse event data were collected from Day 0 (post-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