Trial Outcomes & Findings for Retrospective Survey of Safety of Fourth Dose Pentacel® in Children (NCT NCT00772369)
NCT ID: NCT00772369
Last Updated: 2014-02-14
Results Overview
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?
Recruitment status
COMPLETED
Target enrollment
3214 participants
Primary outcome timeframe
6 months post 4th dose vaccination
Results posted on
2014-02-14
Participant Flow
Telephone contact for this study was from 20 September 2003 to 30 April 2004.
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.
Participant milestones
| Measure |
Study Group
Received 4th dose of the Pentacel® series before 2nd birthday
|
|---|---|
|
Overall Study
STARTED
|
3214
|
|
Overall Study
COMPLETED
|
3213
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Study Group
Received 4th dose of the Pentacel® series before 2nd birthday
|
|---|---|
|
Overall Study
Did not return record release form
|
1
|
Baseline Characteristics
Retrospective Survey of Safety of Fourth Dose Pentacel® in Children
Baseline characteristics by cohort
| Measure |
Study Group
n=3214 Participants
Received 4th dose of the Pentacel® series before 2nd birthday
|
|---|---|
|
Age, Categorical
<=18 years
|
3214 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
|
19.5 Months
STANDARD_DEVIATION 1.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1538 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1676 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3214 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post 4th dose vaccinationPopulation: Participants who completed the whole survey. Those who had confirmed data, or had data that did not require confirmation, or had unconfirmed data.
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?
Outcome measures
| Measure |
Study Group
n=3213 Participants
Received 4th dose of the Pentacel® series before 2nd birthday
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: 6 Months post 4th dose vaccinationPopulation: 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.
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)
Outcome measures
| Measure |
Study Group
n=3184 Participants
Received 4th dose of the Pentacel® series before 2nd birthday
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
Adverse Events
Study Group
Serious events: 93 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Group
n=3123 participants at risk；n=3213 participants at risk
Received 4th dose of the Pentacel® series before 2nd birthday
|
|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
0.03%
1/3213 • Number of events 1 • Safety data were solicited through a retrospective survey within 6 months of the post-4th dose of Pentacel™ vaccine.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
0.19%
6/3213 • Number of events 7 • Safety data were solicited through a retrospective survey within 6 months of the post-4th dose of Pentacel™ vaccine.
|
|
General disorders
General disorders and administration site conditions
|
0.12%
4/3213 • Number of events 4 • Safety data were solicited through a retrospective survey within 6 months of the post-4th dose of Pentacel™ vaccine.
|
|
Immune system disorders
Immune system disorders
|
0.06%
2/3213 • Number of events 2 • Safety data were solicited through a retrospective survey within 6 months of the post-4th dose of Pentacel™ vaccine.
|
|
Infections and infestations
Infections and infestations
|
1.6%
52/3213 • Number of events 52 • Safety data were solicited through a retrospective survey within 6 months of the post-4th dose of Pentacel™ vaccine.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complication
|
0.06%
2/3213 • Number of events 2 • Safety data were solicited through a retrospective survey within 6 months of the post-4th dose of Pentacel™ vaccine.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
0.06%
2/3213 • Number of events 2 • Safety data were solicited through a retrospective survey within 6 months of the post-4th dose of Pentacel™ vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
0.03%
1/3213 • Number of events 1 • Safety data were solicited through a retrospective survey within 6 months of the post-4th dose of Pentacel™ vaccine.
|
|
Nervous system disorders
Nervous system disorders
|
0.56%
18/3213 • Number of events 19 • Safety data were solicited through a retrospective survey within 6 months of the post-4th dose of Pentacel™ vaccine.
|
|
Psychiatric disorders
Psychiatric disorders
|
0.06%
2/3213 • Number of events 3 • Safety data were solicited through a retrospective survey within 6 months of the post-4th dose of Pentacel™ vaccine.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
0.03%
1/3213 • Number of events 1 • Safety data were solicited through a retrospective survey within 6 months of the post-4th dose of Pentacel™ vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
0.37%
12/3213 • Number of events 13 • Safety data were solicited through a retrospective survey within 6 months of the post-4th dose of Pentacel™ vaccine.
|
|
Surgical and medical procedures
Surgical and medical procedures
|
0.03%
1/3213 • Number of events 2 • Safety data were solicited through a retrospective survey within 6 months of the post-4th dose of Pentacel™ vaccine.
|
Other adverse events
Adverse event data not reported
Additional Information
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