Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers

• Sponsor: Sanofi Pasteur, a Sanofi Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00483574
• Collaborator: (none)
• Enrollment: 1,378
• Locations: 80
• Arms: 2
• Duration (Months): 23
• Patients Per Site: 17.2
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US.

Safety Objective:

To describe the safety profile of two doses of Menactra® Vaccine.

Condition or Disease	Intervention/Treatment	Phase
Meningococcal Meningitis; Measles; Mumps; Rubella; Varicella	Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Biological: Measles-mumps-rubella-varicella vaccine; Biological: Routine paediatric vaccine - Pneumococcal conjugate (PCV); Biological: Routine paediatric vaccine - Hepatitis A	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1378 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Safety Study of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) When Administered With Other Pediatric Vaccines to Healthy Toddlers
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: Menactra® and Routine Pediatric Vaccines Participants received Menactra® alone at age 9 months and Menactra® concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella [MMRV: ProQuad], pneumococcal conjugate [PCV], and hepatitis A [HepA]) at age 12 months.	Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; 0.5 mL, IM at age 9 and 12 months; Other Names: Menactra® ; Biological: Measles-mumps-rubella-varicella vaccine; 0.5 mL, intramuscular at 12 months of age; Other Names: MMRV: ProQuad ; Biological: Routine paediatric vaccine - Pneumococcal conjugate (PCV); 0.5 mL, Intramuscular at age 12 months; Other Names: Pneumococcal conjugate (PCV), ; Biological: Routine paediatric vaccine - Hepatitis A; 0.5 mL, Intramuscular at age 12 months; Other Names: Hepatitis A
Other: Group 2: Routine Pediatric Vaccines Participants received routine pediatric vaccines (measles-mumps-rubella-varicella [MMRV: ProQuad], pneumococcal conjugate[PCV], and hepatitis A [HepA]) at age 12 months.	Biological: Measles-mumps-rubella-varicella vaccine; 0.5 mL, intramuscular at 12 months of age; Other Names: MMRV: ProQuad ; Biological: Routine paediatric vaccine - Pneumococcal conjugate (PCV); 0.5 mL, Intramuscular at age 12 months; Other Names: Pneumococcal conjugate (PCV), ; Biological: Routine paediatric vaccine - Hepatitis A; 0.5 mL, Intramuscular at age 12 months; Other Names: Hepatitis A

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. [Day 0 to 7 Post-vaccination]

   Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability

Other Outcome Measures

1. Safety Overview After Any Vaccination in Participants Who Received MMR+V [Day 0 to 7 Post-vaccination]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Months to 12 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria :

• Healthy, as determined by medical history and physical examination

• Aged 9 months (249 to 305 days) or 12 months (365 to 400 days) at the time of enrollment

• The parent or legal guardian has signed and dated the Independent Ethics Committee (IEC)-/Institutional Review Board (IRB)-approved informed consent form.

Exclusion Criteria :

• Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, autoimmune disorders, diabetes, atopic conditions, congenital defects, convulsions, encephalopathy, blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system, acute untreated tuberculosis) that could interfere with trial conduct or completion.

• Known or suspected impairment of immunologic function.

• Acute medical illness within the last 72 hours or a temperature ≥ 100.4ºF (≥ 38.0ºC) at the time of enrollment.

• History of documented invasive meningococcal disease or previous meningococcal vaccination.

• Has received the fourth dose of Prevnar, or the first dose of measles-mumps-rubella (MMR), varicella, or hepatitis A (HepA) vaccine.

• Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C seropositivity as reported by the parent or legal guardian.

• Received either immune globulin or other blood products within the last 3 months.

• Suspected or known hypersensitivity to any of the vaccine components.

• Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination.

• Parent or legal guardian unable or unwilling to comply with the study procedures.

• Participation in another interventional clinical trial in the 30 days preceding enrollment, or participation in another clinical trial involving the investigation of a drug, vaccine, medical procedure, or medical device during the subject's trial period.

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

• Received any vaccine in the 30-day period prior to receipt of the study vaccine(s), or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of the study vaccine(s).

• Personal or family history of Guillain-Barré Syndrome (GBS).

• History of seizures, including febrile seizures, or any other neurologic disorder.

• Known hypersensitivity to dry natural rubber latex.

For the subjects scheduled to provide blood samples:

• Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to either of the study blood draws. Topical antibiotics and antibiotic drops are not included in this exclusion criterion.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States	35205
2		Birmingham	Alabama	United States	35244
3		Dothan	Alabama	United States	36305
4		Pinson	Alabama	United States	35126
5		Tuscaloosa	Alabama	United States	35406
6		Chandler	Arizona	United States	85234
7		Bentonville	Arkansas	United States	72712
8		Conway	Arkansas	United States	72034
9		Hardy	Arkansas	United States	72542
10		Jonesboro	Arkansas	United States	72401
11		Downy	California	United States	90241
12		Fountain Valley	California	United States	92708
13		Huntington Beach	California	United States	92647
14		Huntington Park	California	United States	90255
15		LaCosta	California	United States	92009
16		LaJolla	California	United States	92037
17		Pico Rivera	California	United States	90660
18		Centennial	Colorado	United States	80112
19		Longmont	Colorado	United States	80501
20		Thornton	Colorado	United States	80233
21		Lake Mary	Florida	United States	32746
22		Tampa	Florida	United States	33614
23		Stone Mountain	Georgia	United States	30087
24		Boise	Idaho	United States	83704
25		Evansville	Indiana	United States	47710
26		Arkansas City	Kansas	United States	67005
27		Wichita	Kansas	United States	67207
28		Lexington	Kentucky	United States	40503
29		Louisville	Kentucky	United States	40202
30		Louisville	Kentucky	United States	40207
31		Louisville	Kentucky	United States	40272
32		Fall River	Massachusetts	United States	02724
33		Clifton	New Jersey	United States	07013
34		Endwell	New York	United States	13760
35		Liverpool	New York	United States	13088
36		Utica	New York	United States	13502
37		Garner	North Carolina	United States	27529
38		Raleigh	North Carolina	United States	27615
39		Winston-Salem	North Carolina	United States	27103
40		Fargo	North Dakota	United States	58104
41		Minot	North Dakota	United States	58701
42		Cincinnati	Ohio	United States	45245
43		Fairfield	Ohio	United States	45014
44		Huber Heights	Ohio	United States	45424
45		Kettering	Ohio	United States	45429
46		Mason	Ohio	United States	45040
47		Poland	Ohio	United States	44514
48		Youngstown	Ohio	United States	44505
49		Meadowbrook	Pennsylvania	United States	19046
50		Philadelphia	Pennsylvania	United States	19114
51		Philadelphia	Pennsylvania	United States	19116
52		Pittsburgh	Pennsylvania	United States	15217
53		Barrington	Rhode Island	United States	02806
54		Providence	Rhode Island	United States	02903
55		Warwick	Rhode Island	United States	02886
56		Barnwell	South Carolina	United States	29812
57		Mount Pleasant	South Carolina	United States	29464
58		Watertown	South Dakota	United States	57201
59		Bristol	Tennessee	United States	37620
60		Jackson	Tennessee	United States	38305
61		Tullahoma	Tennessee	United States	37388
62		Amarillo	Texas	United States	79106
63		Amarillo	Texas	United States	79124
64		Carrollton	Texas	United States	75007
65		Fort Worth	Texas	United States	76012
66		Grapevine	Texas	United States	76057
67		Houston	Texas	United States	77065
68		Houston	Texas	United States	77084
69		San Antonio	Texas	United States	78229
70		Sugar Land	Texas	United States	77479
71		Tomball	Texas	United States	77375
72		Salt Lake City	Utah	United States	84109
73		Salt Lake City	Utah	United States	84121
74		West Valley City	Utah	United States	84120
75		Newport News	Virginia	United States	23606
76		Norfolk	Virginia	United States	23507
77		Vienna	Virginia	United States	22180
78		Bellingham	Washington	United States	98226
79		Santiago de Chile		Chile
80		Santiago		Chile

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: NCT00483574
• Other Study ID Numbers: MTA48
• First Posted: Jun 7, 2007
• Last Update Posted: May 16, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Sanofi Pasteur, a Sanofi Company: Menactra® vaccine; Meningococcal meningitis; Measles; Mumps; Rubella; Varicella virus; Haemophilus influenzae type b; Pneumococcal conjugate vaccine
• Additional relevant MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella; Meningitis, Meningococcal; Meningitis; Vaccines

Study Results

Participant Flow

Recruitment Details	Participants were enrolled from 30 May 2007 to 28 March 2008 at 82 US clinical centers.
Pre-assignment Detail	A total of 1378 participants met inclusion and exclusion criteria, of which 1374 were vaccinated and included in this analysis.

Arm/Group Title	Group 1: Menactra and Routine Pediatric Vaccines	Group 2: Routine Pediatric Vaccines
Arm/Group Description	Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)	Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
Period Title: Overall Study
STARTED	1053	321
COMPLETED	951	308
NOT COMPLETED	102	13

Baseline Characteristics

Arm/Group Title	Group 1: Menactra and Routine Pediatric Vaccines	Group 2: Routine Pediatric Vaccines	Total
Arm/Group Description	Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)	Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)	Total of all reporting groups
Overall Participants	1053	321	1374
Age (Count of Participants)
<=18 years	1053 100%	321 100%	1374 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (Days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Days]	282.8 (10.79)	374.6 (8.93)	304.3 (40.22)
Sex: Female, Male (Count of Participants)
Female	511 48.5%	158 49.2%	669 48.7%
Male	542 51.5%	163 50.8%	705 51.3%
Region of Enrollment (participants) [Number]
United States	1053 100%	321 100%	1374 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination.
Description	Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability
Time Frame	Day 0 to 7 Post-vaccination

Outcome Measure Data

Analysis Population Description

Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. Data on 23 participants in Group 1 that received MMR+V vaccines instead of a MMRV single vaccine in addition to the PCV and HepA vaccines were analyzed separately.

Arm/Group Title	Group 1: Menactra and Routine Pediatric Vaccines	Group 2: Routine Pediatric Vaccines
Arm/Group Description	Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)	Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
Measure Participants	1030	321
Any Injection Site Reaction at 9 Months - Menactra	52 4.9%	NA NaN
Any Tenderness at 9 Months - Menactra	37 3.5%	NA NaN
Grade 3 Tenderness (Cries when limb is moved)	1 0.1%	NA NaN
Any Erythema at 9 Months - Menactra	30 2.8%	NA NaN
Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm])	0 0%	NA NaN
Any Swelling at 9 Months - Menactra	17 1.6%	NA NaN
Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm])	0 0%	NA NaN
Any Injection Site Reaction at 12 Months -Menactra	58 5.5%	NA NaN
Any Tenderness at 12 Months - Menactra	49 4.7%	NA NaN
Grade 3 Tenderness (Cries when limb is moved)	1 0.1%	NA NaN
Any Erythema at 12 Months - Menactra	30 2.8%	NA NaN
Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm])	0 0%	NA NaN
Any Swelling at 12 Months - Menactra	16 1.5%	NA NaN
Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm])	0 0%	NA NaN
Any Injection Site Reaction at 12 Months, MMRV	44 4.2%	59 18.4%
Any Tenderness at 12 Months - MMRV	39 3.7%	43 13.4%
Grade 3 Tenderness (Cries when limb is moved)	1 0.1%	0 0%
Any Erythema at 12 Months - MMRV	23 2.2%	33 10.3%
Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm])	0 0%	0 0%
Any Swelling at 12 Months - MMRV	12 1.1%	14 4.4%
Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm])	0 0%	0 0%
Any Injection Site Reaction at 12 Months, PCV	53 5%	56 17.4%
Any Tenderness at 12 Months - PCV	46 4.4%	46 14.3%
Grade 3 Tenderness (Cries when limb is moved)	2 0.2%	0 0%
Any Erythema at 12 Months - PCV	29 2.8%	33 10.3%
Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm])	0 0%	1 0.3%
Any Swelling at 12 Months - PCV	20 1.9%	17 5.3%
Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm])	0 0%	1 0.3%
Any Injection Site Reaction at 12 Months, HepA	50 4.7%	52 16.2%
Any Tenderness at 12 Months - HepA	43 4.1%	41 12.8%
Grade 3 Tenderness (Cries when limb is moved)	1 0.1%	0 0%
Any Erythema at 12 Months - HepA	25 2.4%	27 8.4%
Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm])	0 0%	0 0%
Any Swelling at 12 Months - HepA	16 1.5%	14 4.4%
Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm])	0 0%	0 0%
Any Systemic Reaction at 9 Months	69 6.6%	0 0%
Any Fever, (rectal or oral temperature route)	12 1.1%	0 0%
Grade 3 Fever (>103.1 ºF [>39.5 ºC]), Any Route	1 0.1%	0 0%
Any Vomiting at 9 Months	14 1.3%	0 0%
Grade 3 Vomiting (≥ 6 episodes per 24 hours)	0 0%	0 0%
Any Crying Abnormal at 9 Months	33 3.1%	0 0%
Grade 3 Crying Abnormal (> 3 hours)	2 0.2%	0 0%
Any Drowsiness at 9 Months	30 2.8%	0 0%
Grade 3 Drowsiness (Sleeps most of time)	1 0.1%	0 0%
Any Appetite Lost at 9 Months	30 2.8%	0 0%
Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals)	1 0.1%	0 0%
Any Irritability at 9 Months	57 5.4%	0 0%
Grade 3 Irritability (Inconsolable)	3 0.3%	0 0%
Any Solicited Systemic Reaction at 12 Months	73 6.9%	75 23.4%
Any Fever, (rectal or oral temperature route)	25 2.4%	22 6.9%
Grade 3 Fever (>103.1 ºF [>39.5 ºC]), Any Route	2 0.2%	3 0.9%
Any Vomiting at 12 Months	11 1%	10 3.1%
Grade 3 Vomiting (≥ 6 episodes per 24 hours)	0 0%	0 0%
Any Crying Abnormal at 12 Months	40 3.8%	39 12.1%
Grade 3 Crying Abnormal (> 3 hours)	2 0.2%	1 0.3%
Any Drowsiness at 12 Months	40 3.8%	39 12.1%
Grade 3 Drowsiness (Sleeps most of time)	1 0.1%	1 0.3%
Any Appetite Lost at 12 Months	36 3.4%	32 10%
Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals)	3 0.3%	1 0.3%
Any Irritability at 12 Months	62 5.9%	65 20.2%
Grade 3 Irritability (Inconsolable)	4 0.4%	4 1.2%

2. Other Pre-specified Outcome

Title	Safety Overview After Any Vaccination in Participants Who Received MMR+V
Time Frame	Day 0 to 7 Post-vaccination

Outcome Measure Data

Analysis Population Description

Summary of the safety analysis of the 23 participants in Group 1 that received MMR+V vaccines instead of a MMRV single vaccine in addition to the PCV and HepA vaccines.

Arm/Group Title	Group 1: Menactra and Routine Pediatric Vaccines	Group 2: Routine Pediatric Vaccines
Arm/Group Description	Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella [MMR+V: ProQuad], pneumococcal conjugate [PCV], and hepatitis A [HepA]) at age 12 months. (0.5 mL, intramuscular, respectively)	Participants received routine pediatric vaccines (measles-mumps-rubella-varicella [MMRV: ProQuad], pneumococcal conjugate[PCV], and hepatitis A [HepA]) at age 12 months.
Measure Participants	23	0
Injection Site Reaction at 9-Month, Menactra	44 4.2%
Injection Site Reaction at 12-Month, Menactra	57 5.4%
Injection Site Reaction at 12-Month, MMR	52 4.9%
Injection Site Reaction at 12-Month, Varivax	41 3.9%
Injection Site Reaction at 12-Month, PCV	68 6.5%
Injection Site Reaction at 12-Month, HepA	65 6.2%
Any Solicited Systemic Reaction at 9-Month vac	52 4.9%
Any Solicited Systemic Reaction at 12-Month vac	70 6.6%
Unsolicited Adverse Event at 9-Month	52 4.9%
Unsolicited Adverse Event at 12-Month	36 3.4%
Serious Adverse Events	0 0%

Adverse Events

Time Frame	Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Arm/Group Title	Group 1: Menactra and Routine Pediatric Vaccines		Group 2: Routine Pediatric Vaccines
Arm/Group Description	Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)		Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
All Cause Mortality
	Group 1: Menactra and Routine Pediatric Vaccines		Group 2: Routine Pediatric Vaccines
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Group 1: Menactra and Routine Pediatric Vaccines		Group 2: Routine Pediatric Vaccines
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	42/1053 (4%)		5/321 (1.6%)
Congenital, familial and genetic disorders
Inborn error of metabolism	1/1053 (0.1%)	1	0/321 (0%)	0
Gastrointestinal disorders
Vomiting	1/1053 (0.1%)	1	0/321 (0%)	0
Immune system disorders
Drug Hypersensitivity	0/1053 (0%)	0	1/321 (0.3%)	1
Infections and infestations
Bronchiolitis	5/1053 (0.5%)	6	0/321 (0%)	0
Campylobacter intestinal infection	1/1053 (0.1%)	1	0/321 (0%)	0
Cellulitis	0/1053 (0%)	0	1/321 (0.3%)	1
Croup Infections	2/1053 (0.2%)	2	2/321 (0.6%)	2
Gastroenteritis	1/1053 (0.1%)	1	0/321 (0%)	0
Mastoiditis	2/1053 (0.2%)	2	0/321 (0%)	0
Pneumonia	2/1053 (0.2%)	2	0/321 (0%)	0
Pneumonia respiratory syncytial viral	2/1053 (0.2%)	2	0/321 (0%)	0
Respiratory syncytial virus infection	1/1053 (0.1%)	1	0/321 (0%)	0
Staphylococcal abscess	2/1053 (0.2%)	2	0/321 (0%)	0
Upper respiratory tract infection	1/1053 (0.1%)	1	0/321 (0%)	0
Viral rash	1/1053 (0.1%)	1	0/321 (0%)	0
Injury, poisoning and procedural complications
Burns third degree	1/1053 (0.1%)	1	0/321 (0%)	0
Respiratory fume inhalation disorder	1/1053 (0.1%)	1	0/321 (0%)	0
Thermal burn	1/1053 (0.1%)	1	0/321 (0%)	0
Metabolism and nutrition disorders
Dehydration	3/1053 (0.3%)	3	0/321 (0%)	0
Hypoglycaemia	0/1053 (0%)	0	1/321 (0.3%)	1
Nervous system disorders
Convulsion	2/1053 (0.2%)	2	0/321 (0%)	0
Febrile convulsion	7/1053 (0.7%)	8	0/321 (0%)	0
Psychiatric disorders
Breath holding	1/1053 (0.1%)	1	0/321 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asphyxia	1/1053 (0.1%)	1	0/321 (0%)	0
Asthma	4/1053 (0.4%)	4	0/321 (0%)	0
Bronchial hyperactivity	1/1053 (0.1%)	1	0/321 (0%)	0
Respiratory distress	1/1053 (0.1%)	1	0/321 (0%)	0
Other (Not Including Serious) Adverse Events
	Group 1: Menactra and Routine Pediatric Vaccines		Group 2: Routine Pediatric Vaccines
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	530/1053 (50.3%)		95/321 (29.6%)
Gastrointestinal disorders
Diarrhoea	109/1053 (10.4%)	126	18/321 (5.6%)	20
General disorders
Injection site bruising	85/1053 (8.1%)	102	18/321 (5.6%)	20
Pyrexia	65/1053 (6.2%)	76	17/321 (5.3%)	18
Infections and infestations
Otitis media	183/1053 (17.4%)	210	26/321 (8.1%)	27
Upper respiratory tract infection	150/1053 (14.2%)	165	16/321 (5%)	17
Respiratory, thoracic and mediastinal disorders
Cough	133/1053 (12.6%)	146	13/321 (4%)	13
Rhinorrhoea	82/1053 (7.8%)	90	7/321 (2.2%)	7
Skin and subcutaneous tissue disorders
Rash	53/1053 (5%)	55	11/321 (3.4%)	11

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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.