Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children

• ClinicalTrials.gov Identifier: NCT00771849
• Recruitment Status: Completed
• First Posted: October 15, 2008
• Results First Posted: April 24, 2009
• 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: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Conditions: Meningitis; Meningococcemia
• Interventions: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Biological: Haemophilus Influenzae Type b (Hib) vaccine
• Enrollment: 103

Participant Flow

Recruitment Details	Subjects were recruited from August 2003 through March 2004 at 2 clinics in the United Kingdom.
Pre-assignment Details	A total of 103 subjects that met the inclusion but none of the exclusion criteria were enrolled, 102 subjects were vaccinated.

Arm/Group Title	Menactra® Vaccine Group	Hiberix® Vaccine Group
Arm/Group Description	Participants received Menactra® Vaccine	Participants received Hiberix® Vaccine
Period Title: Overall Study
Started	52	51 [1]
Completed	50	47
Not Completed	2	4
Reason Not Completed
Lost to Follow-up	1	2
Withdrawal by Subject	1	1
Not vaccinated	0	1
[1] One subject was not vaccinated

Baseline Characteristics

Arm/Group Title		Menactra® Vaccine Group	Hiberix® Vaccine Group	Total
Arm/Group Description		Participants received Menactra® Vaccine	Participants received Hiberix® Vaccine	Total of all reporting groups
Overall Number of Baseline Participants		52	51	103
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	52 participants	51 participants	103 participants
	<=18 years	52 100.0%	51 100.0%	103 100.0%
	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	52 participants	51 participants	103 participants
		37.0 (8.5)	37.6 (8.3)	37.3 (8.3)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	52 participants	51 participants	103 participants
	Female	28 53.8%	22 43.1%	50 48.5%
	Male	24 46.2%	29 56.9%	53 51.5%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United Kingdom	Number Analyzed	52 participants	51 participants	103 participants
		52	51	103

Outcome Measures

1. Primary Outcome

Title	Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.
Description	[Not Specified]
Time Frame	Day 0 (before) and 28 days post-vaccination

Outcome Measure Data

Analysis Population Description

SBA geometric mean titers for each of the 4 meningococcal serogroups was evaluated in the per-protocol population.

Arm/Group Title	Menactra® Vaccine Group	Hiberix® Vaccine Group
Arm/Group Description:	Participants received Menactra® Vaccine	Participants received Hiberix® Vaccine
Overall Number of Participants Analyzed	44	36
Geometric Mean (95% Confidence Interval); Unit of Measure: Titers
Meningococcal Serogroup A - Day 0	136.33; (69.39 to 267.84)	99.66; (47.66 to 208.40)
Meningococcal Serogroup A - Day 28	11404.16; (7383.63 to 17613.96)	199.31; (93.14 to 426.52)
Meningococcal Serogroup C - Day 0	76.11; (36.57 to 158.41)	26.91; (12.49 to 57.97)
Meningococcal Serogroup C - Day 28	12534.67; (8407.56 to 18687.71)	22.63; (10.50 to 48.76)
Meningococcal Serogroup Y - Day 0	236.61; (133.11 to 420.60)	266.05; (151.05 to 468.59)
Meningococcal Serogroup Y - Day 28	4031.98; (2399.10 to 6776.24)	298.63; (155.64 to 572.99)
Meningococcal Serogroup W-135 - Day 0	26.07; (13.30 to 51.13)	24.44; (11.76 to 50.79)
Meningococcal Serogroup W-135 - Day 28	5978.03; (3852.54 to 9276.19)	32; (16.33 to 62.71)

2. Secondary Outcome

Title	Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination.
Description	[Not Specified]
Time Frame	28 days post-vaccination

Outcome Measure Data

Analysis Population Description

SBA titers for each of the 4 meningococcal serogroups was evaluated in the per-protocol population.

Arm/Group Title	Menactra® Vaccine Group	Hiberix® Vaccine Group
Arm/Group Description:	Participants received Menactra® Vaccine	Participants received Hiberix® Vaccine
Overall Number of Participants Analyzed	44	36
Measure Type: Number; Unit of Measure: Participants
Meningococcal Serogroup A	43	11
Meningococcal Serogroup C	41	2
Meningococcal Serogroup Y	35	1
Meningococcal Serogroup W-135	43	8

Adverse Events

Time Frame	Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
Adverse Event Reporting Description	One participant in the Menactra® vaccine group and 3 participants in the Hiberix® vaccine group that did not complete the study also did not report any unsolicited adverse event.
Arm/Group Title	Menactra® Vaccine Group		Hiberix® Vaccine Group
Arm/Group Description	Participants received Menactra® Vaccine		Participants received Hiberix® Vaccine
All-Cause Mortality
	Menactra® Vaccine Group		Hiberix® Vaccine Group
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Menactra® Vaccine Group		Hiberix® Vaccine Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/52 (1.92%)		0/50 (0.00%)
Nervous system disorders
Febrile convulsion * 1	1/52 (1.92%)	1	0/50 (0.00%)	0
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 6.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Menactra® Vaccine Group		Hiberix® Vaccine Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/52 (28.85%)		22/50 (44.00%)
Gastrointestinal disorders
Diarrhoea NOS * 1	2/51 (3.92%)		3/47 (6.38%)
Pyrexia * 1	1/51 (1.96%)		3/47 (6.38%)
Infections and infestations
Gastroenteritis NOS * 1	0/51 (0.00%)		3/47 (6.38%)
Otitis media NOS * 1	0/51 (0.00%)		3/47 (6.38%)
Upper respiratory tract infection NOS * 1	10/51 (19.61%)		14/47 (29.79%)
Respiratory, thoracic and mediastinal disorders
Cough * 1	3/51 (5.88%)		3/47 (6.38%)
* 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:

El Bashir H, Heath PT, Papa T, Ruggeberg JU, Johnson N, Sinha R, Balfour G, Booy R. Antibody responses to meningococcal (groups A, C, Y and W135) polysaccharide diphtheria toxoid conjugate vaccine in children who previously received meningococcal C conjugate vaccine. Vaccine. 2006 Mar 24;24(14):2544-9. doi: 10.1016/j.vaccine.2005.12.018. Epub 2005 Dec 27.

• Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
• ClinicalTrials.gov Identifier: NCT00771849
• Other Study ID Numbers: MTA15
• First Submitted: October 13, 2008
• First Posted: October 15, 2008
• Results First Submitted: March 16, 2009
• Results First Posted: April 24, 2009
• Last Update Posted: April 14, 2016