Diphtheria, Pertussis, Tetanus
Conditions
Keywords
Diphtheria, Tetanus, Pertussis, ADACEL®, Tdap vaccine
Brief summary
The aim of the study is to assess the safety profile of ADACEL vaccine in a small number of participants in China. Primary objective: * To describe the safety in terms of occurrence of serious adverse reactions and grade 3 adverse reactions after administration of Sanofi Pasteur's Tdap vaccine (ADACEL) given as a single dose in 20 adults and 20 children. Secondary objective: * To describe the full reactogenicity profile after administration of sanofi pasteur's Tdap vaccine (ADACEL) given as a single dose in 20 adults and 20 children.
Detailed description
Participants will be enrolled sequentially into the study groups to receive one dose of ADACEL at Day 0 (Visit 1) and will be followed-up for 28-35 days.
Interventions
BIOLOGICALTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap
0.5 mL, Intramuscular (IM)
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Group 1: Aged 18 through 64 years on the day of inclusion Group 2: Aged 4 through 8 years on the day of inclusion * Informed consent form signed by the subject (Group 1) or by the parent(s) or legal representative (Group 2) * Subject (Group 1 and 2) and parent/legal representative (Group 2 only) able to attend all scheduled visits and to comply with all trial procedures * Group 1 only: For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) from at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination * Group 2 only: Written documentation of complete primary series and fourth dose of Diphtheria, Tetanus, Pertussis (DTP) vaccine as per China National Immunization Recommendations
Exclusion criteria
* Group 1 only: For a woman of child-bearing potential, known pregnancy or positive serum or urine pregnancy test * Group 1 only: Currently breast-feeding a child * Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination * Planned participation in another clinical trial during the present trial period * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine or to a vaccine containing any of the same substances * Chronic illness that, in the opinion of the Investigator, is at a stage that could interfere with trial conduct or completion * Group 1 only: Current alcohol abuse or drug addiction that may interfere with the ability to comply with trial procedures * Receipt or planned receipt of any vaccine in the 4 weeks preceding or following trial vaccination, except for influenza vaccination, which may be received at least two weeks before the study vaccine * Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C * History of diphtheria, tetanus, or pertussis infection (confirmed either clinically, serologically or microbiologically) * Previous fifth vaccination against pertussis disease and/or previous sixth vaccination against diphtheria and tetanus disease with either the trial vaccine or another vaccine (except Tetanus-prone wound management in Group 1) * Subject at high risk for diphtheria, tetanus, or pertussis infection during the trial, including persons who have exposure (e.g., member of a household with another infected member, travelers to or residents of areas where one of this disease is hyperendemic or epidemic, or microbiologists routinely working with one of these pathogens,) * Self-reported thrombocytopenia, bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination * Group 1 only: Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * History of contra-indication to vaccination with pertussis containing vaccine, including: * Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause * Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as immediate family members (i.e. husband, wife and their children, adopted or natural) of the employees or the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine | Day 0 up to Day 28 post-vaccination | Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling \>30 mm; Fever (temperature) \>39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Day 0 up to Day 7 post-vaccination | Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling \>30 mm; Fever (temperature) \>39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity. |
Countries
China
Participant flow
Recruitment details
The study participants were enrolled from 27 August 2013 through 08 October 2013 at 1 clinic center in China.
Pre-assignment details
A total of 40 participants who met all of the inclusion and none of the exclusion criteria were enrolled and vaccinated in this study.
Participants by arm
| Arm | Count |
|---|---|
| ADACEL™ Vaccine Group 1 Adults 18 to 64 years of age received a single booster dose of Tdap vaccine (ADACEL™) | 20 |
| ADACEL™ Vaccine Group 2 Children 4 to 8 years of age received a single booster dose of Tdap vaccine (ADACEL™) | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | ADACEL™ Vaccine Group 2 | ADACEL™ Vaccine Group 1 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 20 Participants | 0 Participants | 20 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 20 Participants | 20 Participants |
| Age, Continuous | 5.8 Years STANDARD_DEVIATION 1.1 | 44.2 Years STANDARD_DEVIATION 14.4 | 25.0 Years STANDARD_DEVIATION 21.9 |
| Region of Enrollment China | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Female | 14 Participants | 10 Participants | 24 Participants |
| Sex: Female, Male Male | 6 Participants | 10 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 20 | 9 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling \>30 mm; Fever (temperature) \>39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity.
Time frame: Day 0 up to Day 28 post-vaccination
Population: Serious adverse events and solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Injection site Pain | 0 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Injection site Erythema | 0 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Injection site Swelling | 0 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Fever | 0 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Headache | 0 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Malaise | 0 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Myalgia | 0 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine | Serious adverse events | 0 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine | Serious adverse events | 0 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Injection site Pain | 0 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Headache | 0 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Injection site Erythema | 3 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Myalgia | 0 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Injection site Swelling | 3 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Malaise | 0 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Fever | 0 Participants |
Secondary
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling \>30 mm; Fever (temperature) \>39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity.
Time frame: Day 0 up to Day 7 post-vaccination
Population: Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Myalgia | 0 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Injection site Pain | 0 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Injection site Erythema | 1 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Injection site Erythema | 0 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Injection site Swelling | 3 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Injection site Swelling | 0 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Fever | 0 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Fever | 0 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Headache | 1 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Headache | 0 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Malaise | 0 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Malaise | 0 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Myalgia | 1 Participants |
| ADACEL™ Vaccine Group 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Injection site Pain | 6 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Malaise | 0 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Injection site Pain | 9 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Fever | 0 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Injection site Pain | 0 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Malaise | 0 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Injection site Erythema | 9 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Headache | 1 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Injection site Erythema | 3 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Myalgia | 1 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Injection site Swelling | 9 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Myalgia | 0 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Injection site Swelling | 3 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Grade 3 Headache | 0 Participants |
| ADACEL™ Vaccine Group 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine | Fever | 3 Participants |