Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine Immunizations

• ClinicalTrials.gov Identifier: NCT01359449
• Recruitment Status: Completed
• First Posted: May 24, 2011
• Results First Posted: May 24, 2013
• Last Update Posted: August 19, 2016
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Conditions: Meningitis; Meningococcal Infection
• Interventions: Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®; Biological: Meningococcal Group C Conjugate vaccine: MenC
• Enrollment: 123

Participant Flow

Recruitment Details	Study participants were enrolled from 19 May 2011 through 14 September 2011 in one clinic site in Canada.
Pre-assignment Details	A total of 123 participants that met the inclusion, but no exclusion criteria were enrolled and vaccinated.

Arm/Group Title	Menactra® Vaccine Group	Menjugate® Vaccine Group
Arm/Group Description	Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)	Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Period Title: Overall Study
Started	61	62
Completed	57	58
Not Completed	4	4
Reason Not Completed
Lost to Follow-up	1	0
Protocol Violation	0	2
Withdrawal by Subject	3	2

Baseline Characteristics

Arm/Group Title		Menactra® Vaccine Group	Menjugate® Vaccine Group	Total
Arm/Group Description		Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)	Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.	Total of all reporting groups
Overall Number of Baseline Participants		61	62	123
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	61 participants	62 participants	123 participants
	<=18 years	61 100.0%	62 100.0%	123 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Months
	Number Analyzed	61 participants	62 participants	123 participants
		12.4 (0.3)	12.4 (0.3)	12.4 (0.3)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	61 participants	62 participants	123 participants
	Female	34 55.7%	33 53.2%	67 54.5%
	Male	27 44.3%	29 46.8%	56 45.5%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Canada	Number Analyzed	61 participants	62 participants	123 participants
		61	62	123

Outcome Measures

1. Primary Outcome

Title	Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Description	Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination
Time Frame	28 days post-vaccination

Outcome Measure Data

Analysis Population Description

Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit titers were determined in the per protocol population

Arm/Group Title	Menactra® Vaccine Group	Menjugate® Vaccine Group
Arm/Group Description:	Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)	Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Overall Number of Participants Analyzed	55	62
Geometric Mean (95% Confidence Interval); Unit of Measure: Titers
Serogroup A (at age13 months, N = 0, 60)	NA [1]; (NA to NA)	4.34; (3.69 to 5.10)
Serogroup A (at age 19 months, N = 51, 58)	1740; (1301 to 2327)	4.35; (3.76 to 5.03)
Serogroup C (at age 13 months, N = 0, 60)	NA [1]; (NA to NA)	71.0; (39.3 to 128)
Serogroup C (at age 19 months, N = 51, 58)	957; (594 to 1540)	11.0; (6.75 to 18.1)
Serogroup Y (at age 13 months, N = 0, 60)	NA [1]; (NA to NA)	31.3; (19.6 to 50.0)
Serogroup Y (at age 19 months, N = 51, 58)	719; (553 to 935)	67.1; (38.4 to 117)
Serogroup W-135 (at age 13 months, N = 0, 60)	NA [1]; (NA to NA)	5.28; (4.13 to 6.74)
Serogroup W-135 (at age 19 months, N = 51, 58)	970; (686 to 1371)	7.36; (5.24 to 10.3)

[1]

Data not determined for this group at this time point as per protocol.

2. Primary Outcome

Title	Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Description	Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination
Time Frame	28 days post-vaccination

Outcome Measure Data

Analysis Population Description

Immunogenicity using Serum Bovine Albumin Baby Rabbit titers were determined in the per-protocol population

Arm/Group Title	Menactra® Vaccine Group	Menjugate® Vaccine Group
Arm/Group Description:	Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)	Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Overall Number of Participants Analyzed	55	62
Measure Type: Number; Unit of Measure: Participants
Serogroup A (at age 13 months; N = 0, 60)	NA [1]	1
Serogroup A (at age 19 months; N = 51, 58)	51	2
Serogroup C (at age 13 months; N = 0, 60)	NA [1]	40
Serogroup C (at age 19 months; N = 51, 58)	49	15
Serogroup Y (at age 13 months; N = 0, 60)	NA [1]	36
Serogroup Y (at age 19 months; N = 51, 58)	51	39
Serogroup W-135 (at age 13 months; N = 0, 60)	NA [1]	5
Serogroup W-135 (at age 19 months; N = 51, 58)	50	11

[1]

Data not determined for this group at this time point as per protocol.

3. Secondary Outcome

Title	Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Description	Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination.
Time Frame	28 days post-vaccination

Outcome Measure Data

Analysis Population Description

Geometric Mean Titers of Serum Bovine Albumin Human Complement titers were determined in the per-protocol population

Arm/Group Title	Menactra® Vaccine Group	Menjugate® Vaccine Group
Arm/Group Description:	Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)	Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Overall Number of Participants Analyzed	55	62
Geometric Mean (95% Confidence Interval); Unit of Measure: Titers
Serogroup A (at age 13 months, N = 0, 44)	NA [1]; (NA to NA)	2.23; (2.04 to 2.44)
Serogroup A (at age 19 months, N = 49, 48)	71.7; (48.2 to 107)	2.21; (2.00 to 2.45)
Serogroup C (at age 13 months, N = 0, 50)	NA [1]; (NA to NA)	17.4; (11.6 to 26.1)
Serogroup C (at age 19 months, N = 49, 53)	219; (152 to 315)	6.93; (4.53 to 10.6)
Serogroup Y (at age 13 months, N = 0, 45)	NA [1]; (NA to NA)	2.00; (2.0 to 2.0)
Serogroup Y (at age 19 months, N = 49, 53)	299; (222 to 403)	2.14; (1.98 to 2.31)
Serogroup W-135 (at age 13 months, N = 0, 45)	NA [1]; (NA to NA)	2.06; (1.97 to 2.15)
Serogroup W-135 (at age 19 months, N = 49, 50)	207; (146 to 295)	2.17; (2.01 to 2.34)

[1]

Data not determined for this group at this time point as per protocol.

4. Secondary Outcome

Title	Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Description	Immunogenicity tests were performed at 19 months of age in Menactra vaccine group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate vaccine group after Menjugate® vaccination
Time Frame	28 days post-vaccination

Outcome Measure Data

Analysis Population Description

Immunogenicity using Serum Bovine Albumin Human Complement titers were determined in the per-protocol population

Arm/Group Title	Menactra® Vaccine Group	Menjugate® Vaccine Group
Arm/Group Description:	Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)	Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Overall Number of Participants Analyzed	55	62
Measure Type: Number; Unit of Measure: Participants
Serogroup A (at age 13 months; N = 0, 44)	NA [1]	1
Serogroup A (at age 19 months; N = 49, 48)	48	1
Serogroup C (at age 13 months; N = 0, 50)	NA [1]	39
Serogroup C (at age 19 months; N = 49, 53)	49	21
Serogroup Y (at age 13 months; N = 0, 45)	NA [1]	0
Serogroup Y (at age 19 months; N = 49, 53)	49	2
Serogroup W-135 (at age 13 months; N = 0, 45)	NA [1]	0
Serogroup W-135 (at age 19 months; N = 49, 50)	48	1

[1]

Data not determined for this group at this time point as per protocol.

5. Secondary Outcome

Title	Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Description	Immunogenicity tests were performed at 18 and 19 months of age, respectively, before and after Pediacel® vaccination in the Menactra vaccine group
Time Frame	28 days post-vaccination

Outcome Measure Data

Analysis Population Description

Geometric Mean Titers of of Pediacel vaccine antigens were determined in the per-protocol population of the Menactra® vaccine group.

Arm/Group Title	Menactra® Vaccine Group	Menjugate® Vaccine Group
Arm/Group Description:	Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)	Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Overall Number of Participants Analyzed	51	62
Geometric Mean (95% Confidence Interval); Unit of Measure: Titers
Diphtheria (at age 18 months; N = 46, 0)	0.420; (0.283 to 0.622)	NA [1]; (NA to NA)
Diphtheria (at age 19 months; N = 46, 0)	7.81; (6.03 to 10.1)	NA [1]; (NA to NA)
Tetanus (at age 18 months; N = 44, 0)	0.485; (0.365 to 0.644)	NA [1]; (NA to NA)
Tetanus (at age 19 months; N = 47, 0)	8.71; (7.02 to 10.8)	NA [1]; (NA to NA)
PRP (at age 18 months; N = 44, 0)	0.500; (0.306 to 0.818)	NA [1]; (NA to NA)
PRP (at age 19 months; N = 46, 0)	46.3; (32.2 to 66.4)	NA [1]; (NA to NA)
Polio Type 1 (at age 18 months; N = 45, 0)	138; (95.2 to 201)	NA [1]; (NA to NA)
Polio Type 1 (at age 19 months; N = 46, 0)	4552; (3436 to 6029)	NA [1]; (NA to NA)
Polio Type 2 (at age 18 months; N = 39, 0)	203; (127 to 324)	NA [1]; (NA to NA)
Polio Type 2 (at age 19 months; N = 46, 0)	6889; (5250 to 9039)	NA [1]; (NA to NA)
Polio Type 3 (at age 18 months; N = 38, 0)	133; (84.2 to 209)	NA [1]; (NA to NA)
Polio Type 3 (at age 19 months; N = 45, 0)	5322; (3705 to 7645)	NA [1]; (NA to NA)
Pertussis Toxoid (at age 18 months; N = 45, 0)	8.61; (6.39 to 11.6)	NA [1]; (NA to NA)
Pertussis Toxoid (at age 19 months; N = 47, 0)	162; (132 to 199)	NA [1]; (NA to NA)
Filamentous hemagglutinin (age 18 months; N=45, 0)	19.9; (14.1 to 28.2)	NA [1]; (NA to NA)
Filamentous hemagglutinin (age 19 months; N=47, 0)	239; (182 to 315)	NA [2]; (NA to NA)
Pertactin (at age 18 months; N = 44, 0)	8.45; (6.46 to 11.0)	NA [1]; (NA to NA)
Pertactin (at age 19 months; N = 45, 0)	123; (90.7 to 165)	NA [1]; (NA to NA)
Fimbriae types 2 and 3 (age 18 months; N = 45, 0)	35.7; (26.4 to 48.3)	NA [1]; (NA to NA)
Fimbriae types 2 and 3 (age 19 months; N = 45, 0)	622; (425 to 911)	NA [1]; (NA to NA)

[1]

Participants in this group did not receive Pediacel® vaccine in this study.

[2]

Participants in this group did not receive Pediacel vaccine in this study.

6. Secondary Outcome

Title	Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group)
Description	Pediacel vaccine administered only to the Menactra Vaccine Group. Booster response was defined as subjects with pre-dose titers < 4xLLOQ and have a 4-fold rise rate; or subjects with pre-dose titers ≥ 4xLLOQ and have a 2-fold rise rate
Time Frame	28 days post-vaccination

Outcome Measure Data

Analysis Population Description

Pediacel® vaccine antigen booster responses were determined in the per-protocol population of the Menactra® vaccine group

Arm/Group Title	Menactra® Vaccine Group	Menjugate® Vaccine Group
Arm/Group Description:	Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)	Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Overall Number of Participants Analyzed	51	62
Measure Type: Number; Unit of Measure: Participants
Pertussis toxoid (N = 44, 0)	44	NA [1]
Filamentous hemagglutinin (N = 44, 0)	43	NA [1]
Pertactin (N = 41, 0)	38	NA [1]
Fimbriae types 2 and 3 (N = 42, 0)	42	NA [1]

[1]

Participants in this group did not receive Pediacel® vaccine in this study.

7. Secondary Outcome

Title	Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Description	Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 reactions defined as: Tenderness - Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever - > 39.5°C; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable.
Time Frame	Day 0 up to Day 7 post-vaccination

Outcome Measure Data

Analysis Population Description

Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, intent-to-treat population

Arm/Group Title	Menactra® Vaccine Group	Menjugate® Vaccine Group
Arm/Group Description:	Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)	Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Overall Number of Participants Analyzed	60	62
Measure Type: Number; Unit of Measure: Participants
Any injection site Tenderness	21	21
Grade 3 injection site Tenderness	0	0
Any injection site Erythema	26	23
Grade 3 injection site Erythema	0	0
Any injection site Swelling	9	8
Grade 3 injection site Swelling	0	0
Any Fever	30	18
Grade 3 Fever	1	0
Any Vomiting	5	7
Grade 3 Vomiting	0	0
Any Crying abnormal	25	22
Grade 3 Crying abnormal	0	0
Any Drowsiness	22	12
Grade 3 Drowsiness	0	0
Any Appetite lost	28	24
Grade 3 Appetite lost	0	0
Any Irritability	43	40
Grade 3 Irritability	1	1

8. Secondary Outcome

Title	Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Description	Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 reactions defined as: Tenderness - Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever - > 39.5°C; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable.
Time Frame	Day 0 up to Day 7 post-vaccination

Outcome Measure Data

Analysis Population Description

Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants in the Menactra vaccine group, intent to treat population

Arm/Group Title	Menactra® Vaccine Group	Menjugate® Vaccine Group
Arm/Group Description:	Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)	Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Overall Number of Participants Analyzed	60	62
Measure Type: Number; Unit of Measure: Participants
Any injection site Tenderness	30	NA [1]
Grade 3 injection site Tenderness	2	NA [1]
Any injection site Erythema	19	NA [1]
Grade 3 injection site Erythema	1	NA [1]
Any injection site Swelling	11	NA [1]
Grade 3 injection site Swelling	0	NA [1]
Any Fever	21	NA [1]
Grade 3 Fever	3	NA [1]
Any Vomiting	6	NA [1]
Grade 3 Vomiting	1	NA [1]
Any Crying abnormal	25	NA [1]
Grade 3 Crying abnormal	1	NA [1]
Any Drowsiness	20	NA [1]
Grade 3 Drowsiness	1	NA [1]
Any Appetite lost	32	NA [1]
Grade 3 Appetite lost	1	NA [1]
Any Irritability	40	NA [1]
Grade 3 Irritability	2	NA [1]

[1]

Participants in this group did not receive a second dose of a meningococcal vaccine in this study.

9. Secondary Outcome

Title	Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination
Description	Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability
Time Frame	Day 0 up to Day 7 post-vaccination

Outcome Measure Data

Analysis Population Description

Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants in the Menactra vaccine group, intent to treat population

Arm/Group Title	Menactra® Vaccine Group	Menjugate® Vaccine Group
Arm/Group Description:	Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)	Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Overall Number of Participants Analyzed	60	62
Measure Type: Number; Unit of Measure: Participants
Any injection site Tenderness	36	21
Any injection site Erythema	32	23
Any injection site Swelling	18	8
Any Fever	44	18
Any Vomiting	10	7
Any Crying abnormal	31	22
Any Drowsiness	31	12
Any Appetite lost	45	24
Any Irritability	50	40

Adverse Events

Time Frame	Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Menactra® Vaccine Group		Menjugate® Vaccine Group
Arm/Group Description	Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)		Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
All-Cause Mortality
	Menactra® Vaccine Group		Menjugate® Vaccine Group
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Menactra® Vaccine Group		Menjugate® Vaccine Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/61 (1.64%)		2/62 (3.23%)
Infections and infestations
Bronchiolitis * 1	0/61 (0.00%)	0	1/62 (1.61%)	1
Musculoskeletal and connective tissue disorders
Rickets * 1	0/61 (0.00%)	0	1/62 (1.61%)	1
Nervous system disorders
Febrile convulsion * 1	1/61 (1.64%)	1	0/62 (0.00%)	0
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 13.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5.00%
	Menactra® Vaccine Group		Menjugate® Vaccine Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	50/61 (81.97%)		40/62 (64.52%)
Gastrointestinal disorders
Diarrhoea * 1	5/61 (8.20%)	6	6/62 (9.68%)	6
Teething * 1	13/61 (21.31%)	13	9/62 (14.52%)	10
Vomiting † 1	10/61 (16.39%)	10	7/62 (11.29%)	7
General disorders
Irritability * 1	4/61 (6.56%)	6	0/62 (0.00%)	0
Pyrexia * 1	15/61 (24.59%)	20	14/62 (22.58%)	15
Pyrexia † 1	30/61 (49.18%)	30	18/62 (29.03%)	18
Injection site Tenderness † 1	36/61 (59.02%)	36	21/62 (33.87%)	21
Injection site Erythema † 1	32/61 (52.46%)	32	23/62 (37.10%)	23
Injection site Swelling † 1	18/61 (29.51%)	18	8/62 (12.90%)	8
Infections and infestations
Nasopharyngitis * 1	14/61 (22.95%)	19	8/62 (12.90%)	8
Otitis media * 1	7/61 (11.48%)	9	0/62 (0.00%)	0
Roseola * 1	3/61 (4.92%)	3	0/62 (0.00%)	0
Sinusitis * 1	3/61 (4.92%)	3	0/62 (0.00%)	0
Metabolism and nutrition disorders
Anorexia † 1	45/61 (73.77%)	45	24/62 (38.71%)	24
Nervous system disorders
Somnolence † 1	31/61 (50.82%)	31	12/62 (19.35%)	12
Psychiatric disorders
Irritability † 1	50/61 (81.97%)	50	40/62 (64.52%)	40
Crying † 1	31/61 (50.82%)	31	22/62 (35.48%)	22
Respiratory, thoracic and mediastinal disorders
Cough * 1	4/61 (6.56%)	4	1/62 (1.61%)	2
Nasal congestion * 1	5/61 (8.20%)	5	0/62 (0.00%)	0
Skin and subcutaneous tissue disorders
Dermatitis * 1	4/61 (6.56%)	5	1/62 (1.61%)	1
Rash maculo papular * 1	7/61 (11.48%)	7	4/62 (6.45%)	4
Rash papular * 1	4/61 (6.56%)	5	0/62 (0.00%)	0
† Indicates events were collected by systematic assessment; * Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 13.0

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

Publications of Results:

Noya F, McCormack D, Reynolds DL, Neame D, Oster P. Safety and immunogenicity of two doses of quadrivalent meningococcal conjugate vaccine or one dose of meningococcal group C conjugate vaccine, both administered concomitantly with routine immunization to 12- to 18-month-old children. Can J Infect Dis Med Microbiol. 2014 Jul;25(4):211-6. doi: 10.1155/2014/237560.

• Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
• ClinicalTrials.gov Identifier: NCT01359449
• Other Study ID Numbers: MTA73; U1111-1117-7073 ( Other Identifier: WHO )
• First Submitted: May 23, 2011
• First Posted: May 24, 2011
• Results First Submitted: April 4, 2013
• Results First Posted: May 24, 2013
• Last Update Posted: August 19, 2016