Study of a Booster Dose of Meningococcal Diphtheria Toxoid Conjugate Vaccine in Adolescents

• ClinicalTrials.gov Identifier: NCT00777790
• Recruitment Status: Completed
• First Posted: October 22, 2008
• Results First Posted: March 19, 2009
• 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: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Conditions: Meningitis; Meningococcemia
• Intervention: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
• Enrollment: 241

Participant Flow

Recruitment Details	Subjects were recruited from 20 February 2004 to 08 April 2004 at 9 medical clinics in the US.
Pre-assignment Details	A total of 241 subjects that met the inclusion criteria were enrolled and vaccinated.

Arm/Group Title	Menactra® Group	Menomune® Group	Control Group
Arm/Group Description	Subjects that received Menactra® vaccine in Study MTA02	Subjects that received Menomune® vaccine in Study MTA02	Meningococcal vaccine-naïve subjects
Period Title: Overall Study
Started	76	77	88
Completed	76	77	88
Not Completed	0	0	0

Baseline Characteristics

Arm/Group Title		Menactra® Group	Menomune® Group	Control Group	Total
Arm/Group Description		Subjects that received Menactra® vaccine in Study MTA02	Subjects that received Menomune® vaccine in Study MTA02	Meningococcal vaccine-naïve subjects	Total of all reporting groups
Overall Number of Baseline Participants		76	77	88	241
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	76 participants	77 participants	88 participants	241 participants
	<=18 years	56 73.7%	57 74.0%	68 77.3%	181 75.1%
	Between 18 and 65 years	20 26.3%	20 26.0%	20 22.7%	60 24.9%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	76 participants	77 participants	88 participants	241 participants
		16.6 (1.91)	16.8 (1.85)	15.7 (1.97)	16.4 (1.97)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	76 participants	77 participants	88 participants	241 participants
	Female	30 39.5%	31 40.3%	44 50.0%	105 43.6%
	Male	46 60.5%	46 59.7%	44 50.0%	136 56.4%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	76 participants	77 participants	88 participants	241 participants
		76	77	88	241

Outcome Measures

1. Primary Outcome

Title	Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
Description	Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.
Time Frame	Day 0 and 8 and 28 days post-vaccination

Outcome Measure Data

Analysis Population Description

GMT results were on the per-protocol population for immunogenicity.

Arm/Group Title	Menactra® Group	Menomune® Group	Control Group
Arm/Group Description:	Subjects that received Menactra® vaccine in Study MTA02	Subjects that received Menomune® vaccine in Study MTA02	Meningococcal vaccine-naïve subjects
Overall Number of Participants Analyzed	71	72	84
Geometric Mean (95% Confidence Interval); Unit of Measure: Titer
Serogroup A (Day 0)	1075.2; (763.6 to 1514.1)	193.6; (113.7 to 329.9)	83.3; (47.3 to 146.8)
Serogroup A (Day 8)	9300.5; (7539.3 to 11473.2)	4423.9; (3272.7 to 5980.0)	12897.1; (9908.1 to 16787.9)
Serogroup A (Day 28)	4300.9; (3408.5 to 5427.0)	3219.9; (2413.6 to 4295.5)	6239.2; (4922.7 to 7907.8)
Serogroup C (Day 0)	246.2; (139.2 to 435.5)	124.4; (65.9 to 234.8)	39.7; (24.1 to 65.2)
Serogroup C (Day 8)	17888.7; (14004.2 to 22850.7)	1149.4; (692.8 to 1907.0)	7003.3; (4979.4 to 9849.7)
Serogroup C (Day 28)	8601.8; (6552.2 to 11292.6)	664.0; (396.3 to 1112.5)	2802.3; (1932.3 to 4063.9)
Serogroup Y (Day 0)	570.0; (353.9 to 918.3)	398.6; (259.8 to 611.7)	204.3; (131.4 to 317.8)
Serogroup Y (Day 8)	13088.9; (9486.0 to 18060.2)	3098.2; (2170.0 to 4423.4)	7061.3; (5029.8 to 9913.2)
Serogroup Y (Day 28)	5821.0; (4140.6 to 8183.3)	2489.6; (1786.5 to 3469.3)	4411.8; (3117.8 to 6242.7)
Serogroup W-135 (Day 0)	451.0; (300.2 to 677.4)	126.8; (80.0 to 200.9)	23.0; (15.7 to 33.7)
Serogroup W-135 (Day 8)	9861.6; (7442.9 to 13066.4)	2008.9; (1516.2 to 2661.9)	6036.6; (4555.5 to 7999.3)
Serogroup W-135 (Day 28)	4882.9; (3712.1 to 6422.9)	1625.5; (1250.6 to 2112.8)	3018.3; (2369.7 to 3844.4)

Adverse Events

Time Frame	Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Menactra® Group		Menomune® Group		Control Group
Arm/Group Description	Subjects that received Menactra® vaccine in Study MTA02		Subjects that received Menomune® vaccine in Study MTA02		Meningococcal vaccine-naïve subjects
All-Cause Mortality
	Menactra® Group		Menomune® Group		Control Group
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--
Serious Adverse Events
	Menactra® Group		Menomune® Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0.00%)		0/77 (0.00%)		0/88 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Menactra® Group		Menomune® Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/76 (9.21%)		5/77 (6.49%)		9/88 (10.23%)
Reproductive system and breast disorders
Dysmenorrhoea * 1	1/76 (1.32%)	1	3/77 (3.90%)	3	5/88 (5.68%)	5
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain * 1	6/76 (7.89%)	6	2/77 (2.60%)	3	4/88 (4.55%)	4
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 6.0

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:

Keyserling H, Papa T, Koranyi K, Ryall R, Bassily E, Bybel MJ, Sullivan K, Gilmet G, Reinhardt A. Safety, immunogenicity, and immune memory of a novel meningococcal (groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV-4) in healthy adolescents. Arch Pediatr Adolesc Med. 2005 Oct;159(10):907-13.

• Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
• ClinicalTrials.gov Identifier: NCT00777790
• Other Study ID Numbers: MTA19
• First Submitted: October 21, 2008
• First Posted: October 22, 2008
• Results First Submitted: December 2, 2008
• Results First Posted: March 19, 2009
• Last Update Posted: February 14, 2014