Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine

• ClinicalTrials.gov Identifier: NCT00862277
• Recruitment Status: Completed
• First Posted: March 16, 2009
• Results First Posted: January 13, 2011
• Last Update Posted: April 14, 2016
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Retrospective
• Conditions: Meningococcal Infections; Meningitis
• Interventions: Biological: Menactra®; Biological: Menomune®
• Enrollment: 763

Participant Flow

Recruitment Details	Participants were enrolled from 16 December 2008 to 16 March 2009 in 21 medical centers in the US.
Pre-assignment Details	A total of 763 participants who met the inclusion and exclusion criteria were enrolled. One participant withdrew before sampling and is excluded from analysis and this report.

Arm/Group Title	Group 1: Menactra® From Previous Studies	Group 2: Menomune® From Previous Study	Group 3: Control
Arm/Group Description	Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21	Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04	Meningococcal vaccine-naive, age-matched participants
Period Title: Overall Study
Started	561	96	105
Completed	560	94	100
Not Completed	1	2	5
Reason Not Completed
Protocol Violation	1	2	5

Baseline Characteristics

Arm/Group Title		Group 1: Menactra® From Previous Studies	Group 2: Menomune® From Previous Study	Group 3: Control	Total
Arm/Group Description		Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21	Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04	Meningococcal vaccine-naive, age-matched participants	Total of all reporting groups
Overall Number of Baseline Participants		561	96	105	762
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	561 participants	96 participants	105 participants	762 participants
	<=18 years	205 36.5%	0 0.0%	57 54.3%	262 34.4%
	Between 18 and 65 years	356 63.5%	96 100.0%	48 45.7%	500 65.6%
	>=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	561 participants	96 participants	105 participants	762 participants
		19.1 (2.87)	23.3 (2.17)	19.3 (3.98)	19.7 (3.27)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	561 participants	96 participants	105 participants	762 participants
	Female	264 47.1%	49 51.0%	64 61.0%	377 49.5%
	Male	297 52.9%	47 49.0%	41 39.0%	385 50.5%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	561 participants	96 participants	105 participants	762 participants
		561	96	105	762

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment
Description	[Not Specified]
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

Serum Bactericidal Assay Baby Rabbit Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.

Arm/Group Title	Group 1: Menactra® From Previous Studies	Group 2: Menomune® From Previous Study	Group 3: Control
Arm/Group Description:	Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21	Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04	Meningococcal vaccine-naive, age-matched participants
Overall Number of Participants Analyzed	559	94	100
Measure Type: Number; Unit of Measure: Percentage of Participants
Serogroup A ≥ 8, [n = 557, 93, 99]	53	34	20
Serogroup A ≥ 128, [n = 557, 93, 99]	50	29	17
Serogroup C ≥ 8 [n = 557, 92, 99]	39	28	16
Serogroup C ≥ 128 [n = 557, 92, 99]	31	22	12
Serogroup Y ≥ 8 [n = 558, 93, 99]	91	83	72
Serogroup Y ≥ 128 [n = 558, 93, 99]	85	77	62
Serogroup W-135 ≥ 8 [n = 556, 92, 99]	84	64	50
Serogroup W-135 ≥128 [n = 556, 92, 99]	77	55	47

2. Primary Outcome

Title	Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment
Description	[Not Specified]
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

Serum Bactericidal Assay Baby Rabbit Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.

Arm/Group Title	Group 1: Menactra® From Previous Studies	Group 2: Menomune® From Previous Study	Group 3: Control
Arm/Group Description:	Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21	Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04	Meningococcal vaccine-naive, age-matched participants
Overall Number of Participants Analyzed	559	94	100
Geometric Mean (95% Confidence Interval); Unit of Measure: Titers
Serogroup A [n = 557, 93, 99]	74.0; (58.2 to 94.2)	19.1; (11.7 to 31.2)	11.0; (7.08 to 17.0)
Serogroup C [n = 557, 92, 99]	24.9; (20.1 to 30.7)	16.9; (9.91 to 28.7)	8.58; (5.86 to 12.6)
Serogroup Y [n=558, 93, 99]	369; (317 to 430)	183; (121 to 277)	84.1; (54.9 to 129)
Serogroup W-135 [n = 556, 92, 99]	246; (205 to 295)	59.4; (37.6 to 93.8)	38.7; (23.6 to 63.3)

Adverse Events

Time Frame	There were no safety outcomes; safety data were not collected in this study.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Group 1: Menactra® From Previous Studies	Group 2: Menomune® From Previous Study	Group 3: Control
Arm/Group Description	Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21	Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04	Meningococcal vaccine-naive, age-matched participants
All-Cause Mortality
	Group 1: Menactra® From Previous Studies	Group 2: Menomune® From Previous Study	Group 3: Control
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events
	Group 1: Menactra® From Previous Studies	Group 2: Menomune® From Previous Study	Group 3: Control
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0	0/0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Group 1: Menactra® From Previous Studies	Group 2: Menomune® From Previous Study	Group 3: Control
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0	0/0

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

• Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
• ClinicalTrials.gov Identifier: NCT00862277
• Other Study ID Numbers: MTA64
• First Submitted: March 13, 2009
• First Posted: March 16, 2009
• Results First Submitted: December 11, 2010
• Results First Posted: January 13, 2011
• Last Update Posted: April 14, 2016