Diphtheria, Haemophilus Infection, Pertussis, Polio, Tetanus
Conditions
Keywords
Pertussis, Whooping cough, Diphtheria, Tetanus, Haemophilus influenzae, Poliovirus Types 1, 2, and 3.
Brief summary
The purpose of this survey is to collect selected safety data. Primary Objective: To collect selected safety data at 6 months following the 4th dose of the Pentacel® series.
Detailed description
This is a retrospective survey to collect selected safety data at 6 months following the 4th dose of Pentacel® in children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel® series before their 2nd birthday.
Interventions
None listed
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Months to 24 Months
Healthy volunteers
Yes
Inclusion criteria
* Children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel® series before their 2nd birthday. * Written Informed Consent and Telephone consent from the parent(s) or guardian(s). * Able to comply with the survey procedures.
Exclusion criteria
* Fourth dose of the Pentacel® series received on or after the child's 2nd birthday.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series | 6 months post 4th dose vaccination | Positive response is a 'Yes' to any of the following questions: 1. Has your child been admitted to a hospital? 2. Has your child experienced an illness that made you fear for his/her life (life-threatening episode) that required attendance to the Emergency Room or a Physician's office? 3. Has your child developed a medical condition that required 3 or more office or emergency room visits for that condition? 4. Has your child been diagnosed by a physician as having: Low blood count or low platelet count? Swelling or redness of the joints? Asthma? Diabetes? Autism? |
| Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | 6 Months post 4th dose vaccination | SAE: any untoward medical occurrence with the following outcomes: * death, * a life-threatening adverse drug experience (as confirmed by the investigators), * inpatient hospitalization or prolongation of existing hospitalization, * a persistent or significant disability/incapacity, or * a congenital anomaly/birth defect. Medical conditions that required 3 or more office or emergency room visits, and diagnosis by a physician of low blood cell count or low platelet count, swelling or redness of the joints, asthma, diabetes, or autism were also solicited. (MedDRA Version 6.0) |
Countries
Canada
Participant flow
Recruitment details
Telephone contact for this study was from 20 September 2003 to 30 April 2004.
Pre-assignment details
A total of 3214 participants that met the inclusion and exclusion criteria were enrolled in this survey. One participant did not return a record release form and twenty-nine (29) others were also excluded from the Primary Analysis Population because their safety data could not be confirmed.
Participants by arm
| Arm | Count |
|---|---|
| Study Group Received 4th dose of the Pentacel® series before 2nd birthday | 3,214 |
| Total | 3,214 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not return record release form | 1 |
Baseline characteristics
| Characteristic | Study Group |
|---|---|
| Age, Categorical <=18 years | 3214 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 19.5 Months STANDARD_DEVIATION 1.45 |
| Region of Enrollment Canada | 3214 participants |
| Sex: Female, Male Female | 1538 Participants |
| Sex: Female, Male Male | 1676 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3,123 |
| serious Total, serious adverse events | 93 / 3,213 |
Outcome results
Primary
Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine.
SAE: any untoward medical occurrence with the following outcomes: * death, * a life-threatening adverse drug experience (as confirmed by the investigators), * inpatient hospitalization or prolongation of existing hospitalization, * a persistent or significant disability/incapacity, or * a congenital anomaly/birth defect. Medical conditions that required 3 or more office or emergency room visits, and diagnosis by a physician of low blood cell count or low platelet count, swelling or redness of the joints, asthma, diabetes, or autism were also solicited. (MedDRA Version 6.0)
Time frame: 6 Months post 4th dose vaccination
Population: Response to questionnaire that were confirmed by the primary care physician's office were analyzed, Primary Analysis Population. Unconfirmed safety data form 29 participants were excluded from the primary analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | SAEs Occurring Post-dose 4 (Any) | 80 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | SAEs Occurring Post-dose 4 (Related) | 6 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Red cell aplasia (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Red cell aplasia (Related) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Vomiting nos (Any) | 3 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Vomiting nos (Related) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Difficulty in walking (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Difficulty in walking (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Pyrexia (Any) | 2 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Pyrexia (Related) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Hypersensitivity nos (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Hypersensitivity nos (Related) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Bronchiolitis (Any) | 3 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Bronchiolitis (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Bronchitis viral (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Bronchitis viral (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Bronchopneumonia nos (Any) | 2 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Bronchopneumonia nos (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Cellulitis (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Cellulitis (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Croup infectious (Any) | 8 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Croup infectious (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Gastroenteritis nos (Any) | 6 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Breath holding (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Pneumonia aspiration (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Periorbital cellulitis (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Pharyngitis (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Pharyngitis (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Pneumonia nos (Any) | 7 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Pneumonia nos (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Pneumonia viral nos (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Pneumonia viral nos (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Tonsillitis viral nos (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Tonsillitis viral nos (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Upper respiratory tract infection nos (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Upper respiratory tract infection nos (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Urinary tract infection nos (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Urinary tract infection nos (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Viral infection nos (Any) | 3 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Viral infection nos (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Femur fracture (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Femur fracture (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Hip dislocation (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Hip dislocation (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Diabetes mellitus nos (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Diabetes mellitus nos (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Acute lymphocytic leukaemia (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Acute lymphocytic leukaemia (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Autism (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Autism (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Convulsions nos (Any) | 2 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Convulsions nos (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Febrile convulsion (Any) | 13 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Febrile convulsion (Related) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Breath holding (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Balanitis nos (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Balanitis nos (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Asthma nos (Any) | 8 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Asthma nos (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Bronchitis nos (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Bronchitis nos (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Pneumonia aspiration (Related) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Wheezing (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Wheezing (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Gastroenteritis nos (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Gastroenteritis rotavirus (Any) | 2 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Gastroenteritis rotavirus (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Gastroenteritis viral nos (Any) | 2 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Gastroenteritis viral nos (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Herpes zoster (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Herpes zoster (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Kawasaki's disease (Any) | 3 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Kawasaki's disease (Related) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Lobar pneumonia nos (Any) | 2 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Lobar pneumonia nos (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Localised infection (Any) | 1 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Localised infection (Related) | 0 Participants |
| Study Group | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | Periorbital cellulitis (Any) | 1 Participants |
Primary
Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series
Positive response is a 'Yes' to any of the following questions: 1. Has your child been admitted to a hospital? 2. Has your child experienced an illness that made you fear for his/her life (life-threatening episode) that required attendance to the Emergency Room or a Physician's office? 3. Has your child developed a medical condition that required 3 or more office or emergency room visits for that condition? 4. Has your child been diagnosed by a physician as having: Low blood count or low platelet count? Swelling or redness of the joints? Asthma? Diabetes? Autism?
Time frame: 6 months post 4th dose vaccination
Population: Participants who completed the whole survey. Those who had confirmed data, or had data that did not require confirmation, or had unconfirmed data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group | Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series | Participants with no events reported | 3023 Particpants |
| Study Group | Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series | Participants with events reported and confirmed | 161 Particpants |
| Study Group | Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series | Events at 0 to 180 days after Dose 4 | 149 Particpants |
| Study Group | Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series | Events after Day 180 only | 6 Particpants |
| Study Group | Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series | Events prior to Dose 4 only | 6 Particpants |
| Study Group | Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series | Participants with events not confirmed | 29 Particpants |