Diphtheria, Pertussis, Tetanus
Conditions
Keywords
Diphtheria, Tetanus, Pertussis, Adacel®
Brief summary
The objective of this study is to describe the safety of Adacel® vaccination in adults subjects in Vietnam. This study is conducted in accordance with Vietnamese regulation in support to Adacel® registration. Primary objective: To monitor the adverse effects of the vaccine ADACEL® from day 0 to day 30 after immunization.
Detailed description
Participants will receive a single dose of Adacel® vaccine and will be followed closely during 30 minutes post-vaccination period; a home visit will be made daily during 7 days following vaccination in order to monitor safety. An additional visit will be conducted 30 days post-vaccination to collect safety information.
Interventions
BIOLOGICALAdacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
: * Male or female (not pregnant) from 18-45 years of age. * Healthy, with no current illnesses. * Have not been immunized against diphtheria, pertussis and tetanus in the past 5 years. * Women of childbearing age will agree to use birth control during the study. * In good health, as verified by the following criteria: Heart rate, blood pressure, temperature and health history. * Able to understand and comply with requirements of the study. * A voluntary consent form is required before participating in the study.
Exclusion criteria
: * History of allergy to any ingredient in the vaccine. * A positive pregnancy test (for women of childbearing age) or women who are breastfeeding. * Compromised immune system due to treatment of a progressive disease. * Currently on oral or injected steroids, inhaled high-dosage steroids or other immunodeficiency or toxic drugs. * History of taking Immunoglobulin or other products during the 3 months prior to participating in the study. * Received other vaccines during the 4 months prior to participating in the study. * Has an acute or chronic condition that affects safety (including but not limited to: chronic liver disease, some kidney pathologies, progressive or unstabilized nerve disorders, diabetes and organ transplants). * Experienced a severe adverse event after receiving ADACEL® vaccine. * History of acute illness with temperatures over 37.5ºC during the week before receiving the vaccine. * Human immunodeficiency virus (HIV) infection. * History of alcohol or drug addiction during the past 5 years. * Plans to travel outside of the study area between shots and visits. * History of Guillain-Barré syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Days 0-7 Post-vaccination | Solicited injection site reactions: Pain, itchiness, erythema (redness), and swelling. Solicited systemic reactions: Headache, body ache and muscle weakness, tiredness, chill, nausea, vomiting, rash, itchiness, anorexia, sore and swollen joints, diarrhea, lymph node swelling, and fever (temperature). |
Countries
Vietnam
Participant flow
Recruitment details
Participants were enrolled from 06 to 13 December 2009 in 1 medical center in Vietnam.
Pre-assignment details
A total of 30 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and evaluated.
Participants by arm
| Arm | Count |
|---|---|
| ADACEL® Vaccine Group All participants received a single dose of ADACEL® vaccine on Day 0. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | ADACEL® Vaccine Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 35.1 Years STANDARD_DEVIATION 5.82 |
| Region of Enrollment Vietnam | 30 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Solicited injection site reactions: Pain, itchiness, erythema (redness), and swelling. Solicited systemic reactions: Headache, body ache and muscle weakness, tiredness, chill, nausea, vomiting, rash, itchiness, anorexia, sore and swollen joints, diarrhea, lymph node swelling, and fever (temperature).
Time frame: Days 0-7 Post-vaccination
Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Any Solicited Injection Site Reaction | 27 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Any Injection Site Pain | 27 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Grade 3 Inj. site pain (hindered daily activities) | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Any Itchiness | 1 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Grade 3 Itchiness (hindered daily activities) | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Any Erythema | 1 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Grade 3 Erythema (hindered daily activities) | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Grade 3 Swelling (hindered daily activities) | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Any Vomiting | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Grade 3 Vomiting (hinders daily activities) | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Any Anorexia | 1 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Grade 3 Anorexia (hinders daily activities) | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Any Sore and Swollen Joints | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Gr 3 Sore and Swollen Joints (hinders activities) | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Any Diarrhea | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Grade 3 Diarrhea (hinders daily activities) | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Any Lymph Node Swelling | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Any Swelling | 1 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Any Solicited Systemic Reaction | 5 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Any Headache | 2 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Grade 3 Headache (hindered daily activities) | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Any Body Ache or Muscle Weakness | 1 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Grade 3 Body Ache or Muscle Weakness | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Any Tiredness | 4 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Grade 3 Tiredness (hinders daily activities) | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Any Chills | 1 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Grade 3 Chills (hinders daily activities) | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Any Nausea | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Grade 3 Nausea (hinders daily activities) | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Any Rash | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Grade 3 Rash (hinders daily activities) | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Any Itchiness | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Grade 3 Itchiness (hinders daily activities) | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Grade 3 Lymph Node Swelling (hinders activities) | 0 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Any Fever | 1 Participants |
| ADACEL® Vaccine Group | Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine | Grade Fever (hinders daily activities) | 0 Participants |