Diphtheria, Pertussis, Tetanus
Conditions
Keywords
ADACEL™, Tetanus, Diphteria, Acellular pertussis
Brief summary
To assess the immunogenicity profile of ADACEL™, Tetanus and Diphtheria Toxoids Adsorbed combined with Component Pertussis Vaccine (TdcP Vaccine) one month after administration. To describe the safety profile of ADACEL™ (TdcP Vaccine) when given as a fifth dose.
Interventions
BIOLOGICALDiphteria, tetanus, and Acellular Pertussis vaccine
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged from 6 to 8 years on the day of inclusion * Informed consent form (ICF) signed by parent(s)/legal representative * Able to attend all scheduled visits and to comply with all trial procedures * Written documentation of complete primary series and fourth dose of Diphtheria, Tetanus toxoids and whole cell Pertussis vaccine (DTP) * Parent(s)/legal representative present or fully completed pre-inclusion medical questionnaire
Exclusion criteria
* Participation in another clinical trial in the 4 weeks preceding the trial vaccination * Planned participation in another clinical trial during the present trial period * 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 * Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances with specific focus on subjects who had, after previous administration of DTP or diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine, one of the following adverse events 1. encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose 2. temperature of \> 40.5 °C within 48 hours not due to another identifiable cause 3. collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours 4. persistent, inconsolable crying lasting \> 3 hours, occurring within 48 hours 5. seizure with or without fever occurring within 3 days * Chronic illness at a stage that could interfere with trial conduct or completion. * Blood or blood-derived products received in the past 3 months * Any vaccination in the 4 weeks preceding the trial vaccination (except Oral Poliomyelitis Vaccine \[OPV\]) * Any vaccination planned during the present trial period (except OPV) * History of diphtheria and/or tetanus and/or pertussis infection (confirmed either clinically, serologically or microbiologically) * Previous fifth vaccination against diphtheria and/or tetanus and/or pertussis infection with the trial vaccine or another vaccine * Clinical or serological evidence of systemic illness including Hepatitis B, C or Human Immunodeficiency Virus (HIV) * Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination * History of/current seizures * Febrile illness (axillary temperature ≥ 37.4 °C) or acute illness on the day of inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination | Day 0 and Day 28 Post-vaccination | Immunogenicity profile of ADACEL™ (TdcP vaccine) antibody (anti-diphtheria, anti-tetanus, and anti-pertussis) responses at Day 0 and Day 28 Post-vaccination. |
| Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination | Day 0 and Day 28 post-vaccination | GMTs and 95% confidence intervals of anti-diphtheria, anti-tetanus, and anti-pertussis toxoids responses at Day 0 and Day 28 Post-vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination | Within 8 days of vaccination | The percentage of participants reporting solicited injection site and systemic reactions within 8 days after vaccination with ADACEL™ (TdcP vaccine) when given as a fifth dose |
Countries
Taiwan
Participant flow
Recruitment details
Study participants were enrolled from 01 November through 07 December 2005 in 1 medical clinic in Taiwan
Pre-assignment details
A total of 115 participants that met the inclusion and exclusion criteria were recruited for the study; 112 were vaccinated and included in the final analysis and this report.
Participants by arm
| Arm | Count |
|---|---|
| ADACEL™ Group Participants received 1 dose of ADACEL™ (TdcP vaccine) | 112 |
| Total | 112 |
Baseline characteristics
| Characteristic | ADACEL™ Group |
|---|---|
| Age, Categorical <=18 years | 112 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 6.8 years STANDARD_DEVIATION 0.3 |
| Region of Enrollment Taiwan | 112 participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 112 |
| serious Total, serious adverse events | 0 / 112 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination
GMTs and 95% confidence intervals of anti-diphtheria, anti-tetanus, and anti-pertussis toxoids responses at Day 0 and Day 28 Post-vaccination.
Time frame: Day 0 and Day 28 post-vaccination
Population: Geometric Mean Titers were evaluated in the per-protocol immunogenicity population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ADACEL™ Group | Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination | Anti-diphtheria - Day 28 | 4.87 Titers |
| ADACEL™ Group | Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination | Anti-tetanus - Day 0 | 0.386 Titers |
| ADACEL™ Group | Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination | Anti-tetanus - Day 28 | 18.8 Titers |
| ADACEL™ Group | Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination | Anti-pertussis toxoid - Day 0 | 9.5 Titers |
| ADACEL™ Group | Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination | Anti-pertussis toxoid - Day 28 | 189 Titers |
| ADACEL™ Group | Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination | Anti-Filamentous Haemagglutinin - Day 0 | 16.7 Titers |
| ADACEL™ Group | Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination | Anti-Filamentous Haemagglutinin - Day 28 | 234 Titers |
| ADACEL™ Group | Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination | Anti-Fimbriae Types 2 and 3 - Day 0 | 31.2 Titers |
| ADACEL™ Group | Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination | Anti-Pertactin - Day 28 | 312 Titers |
| ADACEL™ Group | Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination | Anti-diphtheria - Day 0 | 0.120 Titers |
| ADACEL™ Group | Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination | Anti-Fimbriae Types 2 and 3 - Day 28 | 940 Titers |
| ADACEL™ Group | Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination | Anti-Pertactin - Day 0 | 8.89 Titers |
Primary
Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination
Immunogenicity profile of ADACEL™ (TdcP vaccine) antibody (anti-diphtheria, anti-tetanus, and anti-pertussis) responses at Day 0 and Day 28 Post-vaccination.
Time frame: Day 0 and Day 28 Post-vaccination
Population: Seroprotection to each vaccine antigen was evaluated in the per-protocol immunogenicity population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ADACEL™ Group | Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination | Anti-diphtheria (≥ 0.1 IU/mL, Day 28) | 99 Percentage of participants |
| ADACEL™ Group | Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination | Anti-tetanus (≥ 0.01 IU/mL, Day 0) | 100 Percentage of participants |
| ADACEL™ Group | Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination | Anti-tetanus (≥ 0.01 IU/mL, Day 28) | 100 Percentage of participants |
| ADACEL™ Group | Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination | Anti-tetanus (≥ 0.1 IU/mL, Day 0) | 90 Percentage of participants |
| ADACEL™ Group | Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination | Anti-tetanus (≥ 0.1 IU/mL, Day 28) | 100 Percentage of participants |
| ADACEL™ Group | Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination | Anti-pertussis toxoid (≥4-fold rise, Day 28) | 88 Percentage of participants |
| ADACEL™ Group | Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination | Anti-Filamentous Haemagglutinin ≥4-fold rise Day28 | 88 Percentage of participants |
| ADACEL™ Group | Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination | Anti-diphtheria (≥ 0.01 IU/mL, Day 0) | 95 Percentage of participants |
| ADACEL™ Group | Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination | Anti-diphtheria (≥ 0.01 IU/mL, Day 28) | 99 Percentage of participants |
| ADACEL™ Group | Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination | Anti-diphtheria (≥ 0.1 IU/mL, Day 0) | 55 Percentage of participants |
| ADACEL™ Group | Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination | Anti-Fimbriae Types 2 & 3 (≥4-fold rise, Day 28) | 87 Percentage of participants |
| ADACEL™ Group | Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination | Anti-Pertactin (≥4-fold rise, Day 28) | 99 Percentage of participants |
Secondary
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination
The percentage of participants reporting solicited injection site and systemic reactions within 8 days after vaccination with ADACEL™ (TdcP vaccine) when given as a fifth dose
Time frame: Within 8 days of vaccination
Population: Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ADACEL™ Group | Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination | Any solicited injection site reaction | 67 Percentage of Participants |
| ADACEL™ Group | Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination | Any Injection site pain | 59 Percentage of Participants |
| ADACEL™ Group | Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination | Gd3 Injection site pain(inj limb movement reduced) | 4 Percentage of Participants |
| ADACEL™ Group | Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination | Any Injection site erythema | 33 Percentage of Participants |
| ADACEL™ Group | Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination | Grade 3 Injection site erythema (≥ 5 cm) | 6 Percentage of Participants |
| ADACEL™ Group | Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination | Any solicited systemic reaction | 58 Percentage of Participants |
| ADACEL™ Group | Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination | Any Fever | 10 Percentage of Participants |
| ADACEL™ Group | Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination | Grade 3 Fever (≥ 39.0 °C) | 0 Percentage of Participants |
| ADACEL™ Group | Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination | Grade 3 Malaise (prevents daily activities) | 0 Percentage of Participants |
| ADACEL™ Group | Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination | Any Injection site swelling | 37 Percentage of Participants |
| ADACEL™ Group | Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination | Grade 3 Injection site swelling (≥ 5 cm) | 5 Percentage of Participants |
| ADACEL™ Group | Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination | Any Headache | 17 Percentage of Participants |
| ADACEL™ Group | Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination | Grade 3 Headache (prevents daily activities) | 1 Percentage of Participants |
| ADACEL™ Group | Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination | Any Malaise | 31 Percentage of Participants |
| ADACEL™ Group | Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination | Any Myalgia | 53 Percentage of Participants |
| ADACEL™ Group | Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination | Grade 3 Myalgia (prevents daily activities) | 1 Percentage of Participants |