Retrospective Survey of Safety of Fourth Dose Pentacel® in Children

• ClinicalTrials.gov Identifier: NCT00772369
• Recruitment Status: Completed
• First Posted: October 15, 2008
• Results First Posted: April 2, 2010
• Last Update Posted: February 14, 2014
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Conditions: Diphtheria; Pertussis; Haemophilus Infection; Tetanus; Polio
• Enrollment: 3214

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.

Arm/Group Title	Study Group
Arm/Group Description	Received 4th dose of the Pentacel® series before 2nd birthday
Period Title: Overall Study
Started	3214
Completed	3213
Not Completed	1
Reason Not Completed
Did not return record release form	1

Baseline Characteristics

Arm/Group Title		Study Group
Arm/Group Description		Received 4th dose of the Pentacel® series before 2nd birthday
Overall Number of Baseline Participants		3214
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3214 participants
	<=18 years	3214 100.0%
	Between 18 and 65 years	0 0.0%
	>=65 years	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Months
	Number Analyzed	3214 participants
		19.5 (1.45)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3214 participants
	Female	1538 47.9%
	Male	1676 52.1%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Canada	Number Analyzed	3214 participants
		3214

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series
Description	Positive response is a 'Yes' to any of the following questions: Has your child been admitted to a hospital?; 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?; Has your child developed a medical condition that required 3 or more office or emergency room visits for that condition?; 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

Outcome Measure Data

Analysis Population Description

Participants who completed the whole survey. Those who had confirmed data, or had data that did not require confirmation, or had unconfirmed data.

Arm/Group Title	Study Group
Arm/Group Description:	Received 4th dose of the Pentacel® series before 2nd birthday
Overall Number of Participants Analyzed	3213
Measure Type: Number; Unit of Measure: Particpants
Participants with no events reported	3023
Participants with events reported and confirmed	161
Events at 0 to 180 days after Dose 4	149
Events after Day 180 only	6
Events prior to Dose 4 only	6
Participants with events not confirmed	29

2. Primary Outcome

Title	Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine.
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Study Group
Arm/Group Description:	Received 4th dose of the Pentacel® series before 2nd birthday
Overall Number of Participants Analyzed	3184
Measure Type: Number; Unit of Measure: Participants
SAEs Occurring Post-dose 4 (Any)	80
SAEs Occurring Post-dose 4 (Related)	6
Red cell aplasia (Any)	1
Red cell aplasia (Related)	1
Vomiting nos (Any)	3
Vomiting nos (Related)	1
Difficulty in walking (Any)	1
Difficulty in walking (Related)	0
Pyrexia (Any)	2
Pyrexia (Related)	1
Hypersensitivity nos (Any)	1
Hypersensitivity nos (Related)	1
Bronchiolitis (Any)	3
Bronchiolitis (Related)	0
Bronchitis viral (Any)	1
Bronchitis viral (Related)	0
Bronchopneumonia nos (Any)	2
Bronchopneumonia nos (Related)	0
Cellulitis (Any)	1
Cellulitis (Related)	0
Croup infectious (Any)	8
Croup infectious (Related)	0
Gastroenteritis nos (Any)	6
Gastroenteritis nos (Related)	0
Gastroenteritis rotavirus (Any)	2
Gastroenteritis rotavirus (Related)	0
Gastroenteritis viral nos (Any)	2
Gastroenteritis viral nos (Related)	0
Herpes zoster (Any)	1
Herpes zoster (Related)	0
Kawasaki's disease (Any)	3
Kawasaki's disease (Related)	1
Lobar pneumonia nos (Any)	2
Lobar pneumonia nos (Related)	0
Localised infection (Any)	1
Localised infection (Related)	0
Periorbital cellulitis (Any)	1
Periorbital cellulitis (Related)	0
Pharyngitis (Any)	1
Pharyngitis (Related)	0
Pneumonia nos (Any)	7
Pneumonia nos (Related)	0
Pneumonia viral nos (Any)	1
Pneumonia viral nos (Related)	0
Tonsillitis viral nos (Any)	1
Tonsillitis viral nos (Related)	0
Upper respiratory tract infection nos (Any)	1
Upper respiratory tract infection nos (Related)	0
Urinary tract infection nos (Any)	1
Urinary tract infection nos (Related)	0
Viral infection nos (Any)	3
Viral infection nos (Related)	0
Femur fracture (Any)	1
Femur fracture (Related)	0
Hip dislocation (Any)	1
Hip dislocation (Related)	0
Diabetes mellitus nos (Any)	1
Diabetes mellitus nos (Related)	0
Acute lymphocytic leukaemia (Any)	1
Acute lymphocytic leukaemia (Related)	0
Autism (Any)	1
Autism (Related)	0
Convulsions nos (Any)	2
Convulsions nos (Related)	0
Febrile convulsion (Any)	13
Febrile convulsion (Related)	1
Breath holding (Any)	1
Breath holding (Related)	0
Balanitis nos (Any)	1
Balanitis nos (Related)	0
Asthma nos (Any)	8
Asthma nos (Related)	0
Bronchitis nos (Any)	1
Bronchitis nos (Related)	0
Pneumonia aspiration (Any)	1
Pneumonia aspiration (Related)	1
Wheezing (Any)	1
Wheezing (Related)	0

Adverse Events

Time Frame	Safety data were solicited through a retrospective survey within 6 months of the post-4th dose of Pentacel™ vaccine.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Study Group
Arm/Group Description	Received 4th dose of the Pentacel® series before 2nd birthday
All-Cause Mortality
	Study Group
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Study Group
	Affected / at Risk (%)	# Events
Total	93/3213 (2.89%)
Blood and lymphatic system disorders
Blood and lymphatic system disorders † 1	1/3213 (0.03%)	1
Gastrointestinal disorders
Gastrointestinal disorders † 1	6/3213 (0.19%)	7
General disorders
General disorders and administration site conditions † 1	4/3213 (0.12%)	4
Immune system disorders
Immune system disorders † 1	2/3213 (0.06%)	2
Infections and infestations
Infections and infestations † 1	52/3213 (1.62%)	52
Injury, poisoning and procedural complications
Injury, poisoning and procedural complication † 1	2/3213 (0.06%)	2
Metabolism and nutrition disorders
Metabolism and nutrition disorders † 1	2/3213 (0.06%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) † 1	1/3213 (0.03%)	1
Nervous system disorders
Nervous system disorders † 1	18/3213 (0.56%)	19
Psychiatric disorders
Psychiatric disorders † 1	2/3213 (0.06%)	3
Reproductive system and breast disorders
Reproductive system and breast disorders † 1	1/3213 (0.03%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders † 1	12/3213 (0.37%)	13
Surgical and medical procedures
Surgical and medical procedures † 1	1/3213 (0.03%)	2
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 6.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Study Group
	Affected / at Risk (%)	# Events
Total	0/3123 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

• Name/Title: Medical Director
• Organization: Sanofi Pasteur Inc.
• EMail: RegistryContactUs@sanofipasteur.com

• Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
• ClinicalTrials.gov Identifier: NCT00772369
• Other Study ID Numbers: M5A08
• First Submitted: October 13, 2008
• First Posted: October 15, 2008
• Results First Submitted: March 15, 2010
• Results First Posted: April 2, 2010
• Last Update Posted: February 14, 2014