Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers

This study has been completed.

Study NCT00422292 Information provided by Sanofi-Aventis

First Received on January 12, 2007. Last Updated on May 10, 2011 History of Changes

Results First Received: May 10, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator); Primary Purpose: Prevention
Conditions:	Meningococcal Meningitis Measles Mumps Rubella Varicella
Interventions:	Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine Biological: Measles, Mumps, Rubella and Varicella

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 15 January 2007 to 16 March 2008 in 92 clinical centers in the US.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 2289 participants who met the inclusion and exclusion criteria were enrolled and vaccinated; 1643 were included in the final analyses presented. 625 participants that got ActHIB as part of their 12 month study vaccinations prior to Protocol Amendment 2 approval were excluded from all analyses and presented in a separate report.

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

A total of 2289 participants who met the inclusion and exclusion criteria were enrolled and vaccinated; 1643 were included in the final analyses presented.

625 participants that got ActHIB as part of their 12 month study vaccinations prior to Protocol Amendment 2 approval were excluded from all analyses and presented in a separate report.

Reporting Groups

	Description
Group 1: Menactra® at 9 and 12 Months	Participants who received only Menactra® vaccination at 9 and 12 months of age
Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months	Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months	Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Group 4: MMRV + PCV at 12 Months	Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age

Participant Flow: Overall Study

	Group 1: Menactra® at 9 and 12 Months	Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months	Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months	Group 4: MMRV + PCV at 12 Months
STARTED	257	664	246	476
COMPLETED	239	598	224	452
NOT COMPLETED	18	66	22	24
Serious adverse events	1	4	0	0
Adverse Event	1	0	1	0
Protocol Violation	4	25	8	5
Lost to Follow-up	6	12	6	6
Withdrawal by Subject	6	25	7	13

Baseline Characteristics

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Reporting Groups

	Description
Group 1: Menactra® at 9 and 12 Months	Participants who received only Menactra® vaccination at 9 and 12 months of age
Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months	Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months	Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Group 4: MMRV + PCV at 12 Months	Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age

Baseline Measures

	Group 1: Menactra® at 9 and 12 Months	Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months	Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months	Group 4: MMRV + PCV at 12 Months	Total
Number of Participants [units: participants]	257	664	246	476	1643
Age [units: participants]
<=18 years	257	664	246	476	1643
Between 18 and 65 years	0	0	0	0	0
>=65 years	0	0	0	0	0
Age [units: Days] Mean ± Standard Deviation	283.4 ± 11.3	283.0 ± 11.3	282.8 ± 10.3	374.8 ± 8.6	283.4 ± 11.3
Gender [units: participants]
Female	119	349	118	231	817
Male	138	315	128	245	826
Region of Enrollment [units: participants]
United States	257	664	246	476	1643

Outcome Measures

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1. Primary:

Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) [ Time Frame: Day 30 after the 12-month vaccination ]

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2. Primary:

Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 [ Time Frame: Day 30 after the 12-month vaccination ]

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3. Other Pre-specified:

Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 [ Time Frame: Day 30 after 12-month vaccination ]

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4. Other Pre-specified:

Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age [ Time Frame: Days 0 to 7 after vaccination ]

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5. Other Pre-specified:

Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age [ Time Frame: Days 0 to 7 after vaccination ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
e-mail: RegistryContactUs@sanofipasteur.com

No publications provided

Responsible Party:	Medical Monitor, Sanofi Pasteur, Inc
ClinicalTrials.gov Identifier:	NCT00422292 History of Changes
Other Study ID Numbers:	MTA37
Study First Received:	January 12, 2007
Results First Received:	May 10, 2011
Last Updated:	May 10, 2011
Health Authority:	United States: Food and Drug Administration