Safety and Immune Response of Different Pediatric Combination Vaccines.

• Sponsor: Sanofi Pasteur, a Sanofi Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00255047
• Collaborator: (none)
• Enrollment: 2,167
• Locations: 36
• Arms: 4
• Duration (Months): 39
• Patients Per Site: 60.2
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.

Condition or Disease	Intervention/Treatment	Phase
Diphtheria; Polio; Pertussis	Biological: DAPTACEL®. (DTaP), IPOL®., and ActHIB®.; Biological: Pentacel®: DTaP-IPV/Hib combined; Biological: DTaP-IPV and ActHIB®; Biological: Pentacel®: DTaP-IPV/Hib combined	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 2167 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Comparative Immunogenicity of Different Multivalent Component Pertussis Vaccine Formulations Based on a 5 Component Acellular Pertussis Vaccine in Infants and Toddlers
• Study Start Date: Nov 1, 2005
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Group 1: DAPTACEL®, ActHIB®, and IPOL® Participants will receive 3 doses of DAPTACEL®, ActHIB®, and IPOL® at Months 2, 4, and 6, respectively	Biological: DAPTACEL®. (DTaP), IPOL®., and ActHIB®.; 0.5 mL, Intramuscular; Other Names: DAPTACEL® IPOL® ActHIB®
Experimental: Study Group 2: Pentacel® Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively	Biological: Pentacel®: DTaP-IPV/Hib combined; 0.5 mL, Intramuscular; Other Names: Pentacel®
Experimental: Study Group 3: DTaP-IPV and ActHIB® Participants will receive 3 doses of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively	Biological: DTaP-IPV and ActHIB®; 0.5 mL, Intramuscular; Other Names: ActHIB®
Experimental: Study Group 4: Pentacel® Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively	Biological: Pentacel®: DTaP-IPV/Hib combined; 0.5 mL, Intramuscular; Other Names: Pentacel®

Outcome Measures

Primary Outcome Measures

1. Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. [30 Days post-dose 3 vaccination]

   Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer > LLOQ; or a pre-dose 1 titer > LLOQ and post-dose 3 titer ≥ pre-dose 1 titer.

2. Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) [30 Days post-dose 3 vaccination]

3. Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. [30 Days post-dose 3 vaccination.]

Other Outcome Measures

1. Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 [7 days post-vaccination 3]

   Solicited injection site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (body temperature), Vomiting, Abnormal crying, Lethargy, Appetite decreased, Irritability, and Rash.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 42 Days to 89 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Aged ≥ 42 days and ≤ 89 days on the day of inclusion

• Born at full term of pregnancy (≥ 36 weeks)

• Informed consent form signed by the parent(s) or other legally authorized representative(s) before the 1st study related procedure

• Vaccination with a hepatitis B vaccine at least 30 days before inclusion

• Able to attend all scheduled visits and to comply with all trial procedures(i.e., access to a phone)

• Provide blood sample prior to Dose 1

• Parent or legal representative willing to take rectal temperatures after each vaccination.

Exclusion Criteria:

• Participation in another clinical trial in the 4 weeks preceding the (first)trial vaccination

• Planned participation in another clinical trial during the present trial period

• Personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy

• Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s)

• Chronic illness that could interfere with trial conduct or completion

• Received blood or blood-derived products since birth

• Any vaccination in the 2 weeks preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination. Flu vaccine could be administered only 2 weeks after any trial vaccination

• Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis- (DTwP) based combination vaccines, Haemophilus influenzae type b (Hib)-conjugate, poliovirus, or pneumococcal conjugate vaccines

• Coagulation disorder contraindicating intramuscular (IM) vaccination

• Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion)

• Developmental delay or neurological disorder

• Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Tuscaloosa	Alabama	United States	35401
2		Fayetteville	Arkansas	United States	72703
3		Jonesboro	Arkansas	United States	72401
4		Little Rock	Arkansas	United States	72205
5		Fountain Valley	California	United States
6		Oakland	California	United States	94609
7		Oakland	California	United States	94613
8		Oakland	California	United States	94618
9		Paramount	California	United States	90723
10		Norwich	Connecticut	United States	06360
11		Palm Beach Gardens	Florida	United States	33410
12		Marietta	Georgia	United States	30062
13		Bardstown	Kentucky	United States	40004
14		Bossier City	Louisiana	United States	71111
15		Baltimore	Maryland	United States	21201
16		Woburn	Massachusetts	United States	01801
17		Omaha	Nebraska	United States	68131
18		Ithaca	New York	United States
19		Liverpool	New York	United States	13088
20		Huber Heights	Ohio	United States	45424
21		Youngstown	Ohio	United States	44514
22		Norristown	Pennsylvania	United States	19401
23		Pittsburgh	Pennsylvania	United States	15227
24		Pittsburgh	Pennsylvania	United States	15241
25		Kingsport	Tennessee	United States	37660
26		Amarillo	Texas	United States	79124
27		Ft. Worth	Texas	United States	76107
28		San Antonio	Texas	United States	78205
29		San Antonio	Texas	United States	78229
30		Provo	Utah	United States	84604
31		South Jordan	Utah	United States	84095
32		St George	Utah	United States	84790
33		Spokane	Washington	United States	99216
34		Vancouver	Washington	United States	98664
35		Huntington	West Virginia	United States	25701
36		Marshfield	Wisconsin	United States

Sponsors and Collaborators

• Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Medical Director, Sanofi Pasteur Inc

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info
• Related Info

Publications

None provided.

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT00255047
• Other Study ID Numbers: M5A10
• First Posted: Nov 17, 2005
• Last Update Posted: Feb 14, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Sanofi Pasteur, a Sanofi Company: Pertussis; Whooping cough; Filamentous Haemagglutinin; Fimbriae Types 2 and 3;; Pertactin; Diphtheria; Tetanus; Poliovirus Types 1, 2, and 3.
• Additional relevant MeSH terms: Whooping Cough; Diphtheria

Study Results

Participant Flow

Recruitment Details	Participants were enrolled from 10 November 2005 through 21 September 2006 in 38 Clinics in the Untied States.
Pre-assignment Detail	A total of 2167 participants that met the inclusion and exclusion criteria were enrolled and vaccinated. Data on Stage I, up to the 3rd dose are presented.

Arm/Group Title	Study Group 1: DAPTACEL®, IPOL®, and ActHIB®	Study Group 2: Pentacel®	Study Group 3: DTaP-IPV and ActHIB®	Study Group 4: Pentacel®
Arm/Group Description	Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.	Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.	Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.	Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
Period Title: Overall Study
STARTED	538	535	546	548
COMPLETED	490	487	496	502
NOT COMPLETED	48	48	50	46

Baseline Characteristics

Arm/Group Title	Study Group 1: DAPTACEL®, IPOL®, and ActHIB®	Study Group 2: Pentacel®	Study Group 3: DTaP-IPV and ActHIB®	Study Group 4: Pentacel®	Total
Arm/Group Description	Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.	Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.	Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.	Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.	Total of all reporting groups
Overall Participants	538	535	546	548	2167
Age (Count of Participants)
<=18 years	538 100%	535 100%	546 100%	548 100%	2167 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	2.2 (0.27)	2.1 (0.27)	2.2 (0.27)	2.1 (0.28)	2.1 (0.27)
Sex: Female, Male (Count of Participants)
Female	251 46.7%	242 45.2%	249 45.6%	274 50%	1016 46.9%
Male	287 53.3%	293 54.8%	297 54.4%	274 50%	1151 53.1%
Region of Enrollment (participants) [Number]
United States	538 100%	535 100%	546 100%	548 100%	2167 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.
Description	Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer > LLOQ; or a pre-dose 1 titer > LLOQ and post-dose 3 titer ≥ pre-dose 1 titer.
Time Frame	30 Days post-dose 3 vaccination

Outcome Measure Data

Analysis Population Description

The vaccine response to pertussis antigens were determined in the per-protocol population.

Arm/Group Title	Study Group 1: DAPTACEL®, IPOL®, and ActHIB®	Study Group 2: Pentacel®	Study Group 3: DTaP-IPV and ActHIB®	Study Group 4: Pentacel®
Arm/Group Description	Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.	Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.	Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.	Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
Measure Participants	419	405	411	424
Pertussis Toxoid (PT)	98 18.2%	99 18.5%	99 18.1%	99 18.1%
Filamentous Haemagglutinin (FHA)	86 16%	96 17.9%	95 17.4%	96 17.5%
Pertactin (PRN)	94 17.5%	92 17.2%	94 17.2%	92 16.8%
Fimbriae Types 2 and 3 (FIM)	97 18%	96 17.9%	99 18.1%	97 17.7%

2. Primary Outcome

Title	Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion)
Time Frame	30 Days post-dose 3 vaccination

Outcome Measure Data

Analysis Population Description

Four-fold rise titers (seroconversion) were evaluated in the per-protocol population

Arm/Group Title	Study Group 1: DAPTACEL®, IPOL®, and ActHIB®	Study Group 2: Pentacel®	Study Group 3: DTaP-IPV and ActHIB®	Study Group 4: Pentacel®
Arm/Group Description	Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.	Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.	Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.	Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
Measure Participants	419	405	411	424
Pertussis Toxoid (PT)	89 16.5%	92 17.2%	92 16.8%	92 16.8%
Filamentous Haemagglutinin (FHA)	54 10%	75 14%	77 14.1%	77 14.1%
Pertactin (PRN)	71 13.2%	67 12.5%	76 13.9%	68 12.4%
Fimbriae Types 2 and 3 (FIM)	86 16%	85 15.9%	94 17.2%	90 16.4%

3. Other Pre-specified Outcome

Title	Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Description	Solicited injection site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (body temperature), Vomiting, Abnormal crying, Lethargy, Appetite decreased, Irritability, and Rash.
Time Frame	7 days post-vaccination 3

Outcome Measure Data

Analysis Population Description

Solicited injection site and systemic reactions were evaluated in the intend-to-treat (ITT) population

Arm/Group Title	Study Group 1: DAPTACEL®, IPOL®, and ActHIB®	Study Group 2: Pentacel®	Study Group 3: DTaP-IPV and ActHIB®	Study Group 4: Pentacel®
Arm/Group Description	Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.	Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.	Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.	Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
Measure Participants	538	535	546	548
Any Solicited Injection Site Reaction	203 37.7%	160 29.9%	164 30%	160 29.2%
Any Erythema	34 6.3%	28 5.2%	21 3.8%	18 3.3%
Grade 3 Erythema Any dose (>50 mm)	0 0%	1 0.2%	0 0%	0 0%
Any Swelling	12 2.2%	18 3.4%	10 1.8%	14 2.6%
Grade 3 Swelling Any dose (>50 mm)	0 0%	1 0.2%	0 0%	0 0%
Any Tenderness	186 34.6%	152 28.4%	150 27.5%	148 27%
Grd 3 Tenderness (cries when inj. limb is moved)	11 2%	4 0.7%	6 1.1%	4 0.7%
Any Solicited Systemic Reaction	311 57.8%	303 56.6%	328 60.1%	309 56.4%
Any Fever	102 19%	102 19.1%	124 22.7%	94 17.2%
Grade 3 Fever (> 39.5 C)	3 0.6%	4 0.7%	7 1.3%	1 0.2%
Any Vomitting	49 9.1%	40 7.5%	41 7.5%	42 7.7%
Grade 3 Vomitting (≥3 episodes)	9 1.7%	3 0.6%	3 0.5%	7 1.3%
Any Anormal crying	144 26.8%	114 21.3%	125 22.9%	133 24.3%
Grade 3 Abnormal crying (Inconsolable > 3 hrs)	3 0.6%	1 0.2%	2 0.4%	4 0.7%
Any Lethargy	114 21.2%	97 18.1%	100 18.3%	91 16.6%
Grade 3 Lethargy (disabling)	4 0.7%	0 0%	4 0.7%	0 0%
Any Appetite decreased	84 15.6%	72 13.5%	85 15.6%	65 11.9%
Grade 3 Appetite decreased (skips ≥ 2 meals)	4 0.7%	0 0%	3 0.5%	1 0.2%
Any Irritability	242 45%	239 44.7%	254 46.5%	242 44.2%
Grade 3 Irritability (continuously for >3 hours)	5 0.9%	12 2.2%	11 2%	11 2%

4. Primary Outcome

Title	Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.
Time Frame	30 Days post-dose 3 vaccination.

Outcome Measure Data

Analysis Population Description

Geometric mean titers were evaluated in the per-protocol immunogenicity population

Arm/Group Title	Study Group 1: DAPTACEL®, IPOL®, and ActHIB®	Study Group 2: Pentacel®	Study Group 3: DTaP-IPV and ActHIB®	Study Group 4: Pentacel®
Arm/Group Description	Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.	Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.	Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.	Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
Measure Participants	422	406	414	425
Pertussis Toxoid (EU/mL)	66.48	96.8	116.86	97.8
Filamentous Haemagglutinin (EU/mL)	22.51	53.0	56.88	54.1
Pertactin (EU/mL)	33.63	32.5	44.70	32.5
Fimbriae Types 2 and 3 (EU/mL)	181.66	188.5	273.10	199.0
Polyribosylribitol Phosphate-Tetanus Toxoid; μg/mL	2.38	2.5	3.76	2.5
Diphtheria (IU/mL)	0.32	0.3	0.37	0.3
Tetanus toxoid (IU/mL, ≥ 0.01)	0.97	0.8	1.09	0.8
Poliovirus Types 1 (≥ 1:8 dil)	719.83	397.7	776.44	468.3
Poliovirus Types 2 (≥ 1:8 dil)	734.50	699.5	1203.20	812.5
Poliovirus Types 3 (≥ 1:8 dil)	916.90	666.6	1115.00	819.9

Adverse Events

Time Frame	Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
Arm/Group Title	Study Group 1: DAPTACEL®, IPOL®, and ActHIB®		Study Group 2: Pentacel®		Study Group 3: DTaP-IPV and ActHIB®		Study Group 4: Pentacel®
Arm/Group Description	Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.		Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.		Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.		Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
All Cause Mortality
	Study Group 1: DAPTACEL®, IPOL®, and ActHIB®		Study Group 2: Pentacel®		Study Group 3: DTaP-IPV and ActHIB®		Study Group 4: Pentacel®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Study Group 1: DAPTACEL®, IPOL®, and ActHIB®		Study Group 2: Pentacel®		Study Group 3: DTaP-IPV and ActHIB®		Study Group 4: Pentacel®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/538 (3.3%)		18/535 (3.4%)		21/546 (3.8%)		11/548 (2%)
Congenital, familial and genetic disorders
Congenital aortic anomaly	0/538 (0%)	0	0/535 (0%)	0	1/546 (0.2%)	1	0/548 (0%)	0
Congenital ventricular septal defect	1/538 (0.2%)	1	0/535 (0%)	0	0/546 (0%)	0	0/548 (0%)	0
Hepatic arteriovenous malformation	0/538 (0%)	0	0/535 (0%)	0	0/546 (0%)	0	1/548 (0.2%)	1
Gastrointestinal disorders
Acquired pyloric stenosis	0/538 (0%)	0	1/535 (0.2%)	1	0/546 (0%)	0	0/548 (0%)	0
Gastrooesophageal reflux disease	0/538 (0%)	0	1/535 (0.2%)	1	0/546 (0%)	0	0/548 (0%)	0
Intussusception	1/538 (0.2%)	1	0/535 (0%)	0	0/546 (0%)	0	1/548 (0.2%)	1
General disorders
Pyrexia	0/538 (0%)	0	1/535 (0.2%)	1	0/546 (0%)	0	1/548 (0.2%)	1
Sudden infant death syndrome	1/538 (0.2%)	1	0/535 (0%)	0	0/546 (0%)	0	0/548 (0%)	0
Upper extremity mass	0/538 (0%)	0	1/535 (0.2%)	1	0/546 (0%)	0	0/548 (0%)	0
Infections and infestations
Abscess limb	0/538 (0%)	0	1/535 (0.2%)	1	0/546 (0%)	0	0/548 (0%)	0
Bronchiolitis	7/538 (1.3%)	7	4/535 (0.7%)	4	6/546 (1.1%)	6	3/548 (0.5%)	3
Croup infectious	0/538 (0%)	0	0/535 (0%)	0	0/546 (0%)	0	2/548 (0.4%)	2
Gastroenteritis	0/538 (0%)	0	1/535 (0.2%)	1	3/546 (0.5%)	3	1/548 (0.2%)	1
Gastroenteritis rotavirus	0/538 (0%)	0	0/535 (0%)	0	1/546 (0.2%)	1	0/548 (0%)	0
Gastroenteritis viral	0/538 (0%)	0	0/535 (0%)	0	0/546 (0%)	0	1/548 (0.2%)	1
Hand-foot-and-mouth disease	0/538 (0%)	0	0/535 (0%)	0	1/546 (0.2%)	1	0/548 (0%)	0
Influenza	0/538 (0%)	0	1/535 (0.2%)	1	0/546 (0%)	0	0/548 (0%)	0
Kawasaki´s disease	1/538 (0.2%)	1	0/535 (0%)	0	0/546 (0%)	0	0/548 (0%)	0
Lobar pneumonia	0/538 (0%)	0	1/535 (0.2%)	1	1/546 (0.2%)	1	0/548 (0%)	0
Meningitis viral	2/538 (0.4%)	2	0/535 (0%)	0	0/546 (0%)	0	0/548 (0%)	0
Otitis media	0/538 (0%)	0	0/535 (0%)	0	1/546 (0.2%)	1	0/548 (0%)	0
Pneumonia	0/538 (0%)	0	0/535 (0%)	0	1/546 (0.2%)	1	0/548 (0%)	0
Pyelonephritis	0/538 (0%)	0	0/535 (0%)	0	1/546 (0.2%)	1	0/548 (0%)	0
Sepsis	1/538 (0.2%)	1	0/535 (0%)	0	0/546 (0%)	0	1/548 (0.2%)	1
Urinary tract infection	1/538 (0.2%)	1	0/535 (0%)	0	0/546 (0%)	0	0/548 (0%)	0
Viral infection	0/538 (0%)	0	1/535 (0.2%)	1	2/546 (0.4%)	2	1/548 (0.2%)	1
Injury, poisoning and procedural complications
Subdural haematoma	1/538 (0.2%)	1	0/535 (0%)	0	0/546 (0%)	0	0/548 (0%)	0
Metabolism and nutrition disorders
Dehydration	1/538 (0.2%)	1	2/535 (0.4%)	2	2/546 (0.4%)	2	1/548 (0.2%)	1
Failure to thrive	1/538 (0.2%)	1	0/535 (0%)	0	0/546 (0%)	0	0/548 (0%)	0
General nutrition disorder	1/538 (0.2%)	1	0/535 (0%)	0	0/546 (0%)	0	0/548 (0%)	0
Hyponatraemia	0/538 (0%)	0	1/535 (0.2%)	1	0/546 (0%)	0	0/548 (0%)	0
Nervous system disorders
Convulsion	0/538 (0%)	0	1/535 (0.2%)	1	3/546 (0.5%)	4	1/548 (0.2%)	3
Dyskinesia	0/538 (0%)	0	1/535 (0.2%)	1	0/546 (0%)	0	0/548 (0%)	0
Hypotonia	0/538 (0%)	0	1/535 (0.2%)	1	0/546 (0%)	0	0/548 (0%)	0
Hypotonic-hyporesponsive episode	0/538 (0%)	0	0/535 (0%)	0	1/546 (0.2%)	1	0/548 (0%)	0
Respiratory, thoracic and mediastinal disorders
Apnoea	0/538 (0%)	0	1/535 (0.2%)	1	0/546 (0%)	0	0/548 (0%)	0
Asthma	1/538 (0.2%)	1	0/535 (0%)	0	0/546 (0%)	0	0/548 (0%)	0
Choking	1/538 (0.2%)	1	0/535 (0%)	0	0/546 (0%)	0	0/548 (0%)	0
Laryngeal stenosis	0/538 (0%)	0	0/535 (0%)	0	0/546 (0%)	0	1/548 (0.2%)	1
Respiratory distress	2/538 (0.4%)	2	1/535 (0.2%)	1	1/546 (0.2%)	1	0/548 (0%)	0
Respiratory failure	0/538 (0%)	0	0/535 (0%)	0	0/546 (0%)	0	1/548 (0.2%)	1
Skin and subcutaneous tissue disorders
Eczema	0/538 (0%)	0	1/535 (0.2%)	1	0/546 (0%)	0	0/548 (0%)	0
Other (Not Including Serious) Adverse Events
	Study Group 1: DAPTACEL®, IPOL®, and ActHIB®		Study Group 2: Pentacel®		Study Group 3: DTaP-IPV and ActHIB®		Study Group 4: Pentacel®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	399/538 (74.2%)		394/535 (73.6%)		421/546 (77.1%)		414/548 (75.5%)
Gastrointestinal disorders
Diarrhoea	39/538 (7.2%)	44	34/535 (6.4%)	37	41/546 (7.5%)	43	41/548 (7.5%)	43
Teething	35/538 (6.5%)	44	33/535 (6.2%)	43	30/546 (5.5%)	40	34/548 (6.2%)	48
Vomiting	128/532 (24.1%)	169	119/533 (22.3%)	153	131/538 (24.3%)	174	119/543 (21.9%)	150
General disorders
Pyrexia	27/538 (5%)	35	33/535 (6.2%)	34	22/546 (4%)	25	25/548 (4.6%)	27
Injection site erythema	90/532 (16.9%)	174	65/533 (12.2%)	83	64/538 (11.9%)	107	66/543 (12.2%)	82
Injection site swelling	49/532 (9.2%)	102	50/533 (9.4%)	59	43/538 (8%)	77	49/543 (9%)	71
Injection site pain	342/532 (64.3%)	1406	310/533 (58.2%)	545	301/538 (55.9%)	967	310/543 (57.1%)	542
Fever	219/531 (41.2%)	300	199/533 (37.3%)	254	221/537 (41.2%)	304	208/543 (38.3%)	268
Lethargy	271/532 (50.9%)	456	275/533 (51.6%)	415	262/538 (48.7%)	415	239/543 (44%)	369
Infections and infestations
Bronchiolitis	24/538 (4.5%)	27	34/535 (6.4%)	37	28/546 (5.1%)	30	16/548 (2.9%)	17
Otitis media	72/538 (13.4%)	86	97/535 (18.1%)	117	93/546 (17%)	109	75/548 (13.7%)	94
Upper respiratory tract infection	143/538 (26.6%)	164	141/535 (26.4%)	167	134/546 (24.5%)	162	141/548 (25.7%)	167
Viral infection	16/538 (3%)	17	31/535 (5.8%)	32	20/546 (3.7%)	22	23/548 (4.2%)	23
Metabolism and nutrition disorders
Appetite Decreased	214/532 (40.2%)	295	191/533 (35.8%)	253	192/538 (35.7%)	267	174/543 (32%)	251
Psychiatric disorders
Anbormal crying	287/532 (53.9%)	495	282/533 (52.9%)	446	275/539 (51%)	452	285/543 (52.5%)	442
Irritability	399/532 (75%)	820	394/533 (73.9%)	795	421/539 (78.1%)	820	414/543 (76.2%)	800
Respiratory, thoracic and mediastinal disorders
Cough	37/538 (6.9%)	42	49/535 (9.2%)	54	45/546 (8.2%)	51	44/548 (8%)	47
Nasal congestion	51/538 (9.5%)	59	49/535 (9.2%)	57	50/546 (9.2%)	59	42/548 (7.7%)	46

Limitations/Caveats

[Not Specified]

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

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.