Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children

This study has been completed.

Study NCT00616421 Information provided by Novartis

First Received on January 31, 2008. Last Updated on December 7, 2011 History of Changes

Results First Received: February 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention
Condition:	Meningococcal Infections
Interventions:	Biological: MenACWY-CRM Biological: Licensed meningococcal ACWY vaccine

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 at 67 centers in the USA and Canada.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects enrolled were included in the trial.

Reporting Groups

	Description
MenACWY-CRM (2 Doses)	2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study days 1 and 61 in children 2 to 5 years of age
MenACWY-CRM (1 Dose)	1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study day 1
Licensed Polysaccharide Vaccine	1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1

Participant Flow: Overall Study

	MenACWY-CRM (2 Doses)	MenACWY-CRM (1 Dose)	Licensed Polysaccharide Vaccine
STARTED	359	1278	1270
COMPLETED	333	1240	1229
NOT COMPLETED	26	38	41
Withdrawal by Subject	9	11	8
Lost to Follow-up	12	26	30
Inappropriate enrollment	3	0	1
Administrative reason	1	0	0
Protocol Violation	0	1	2
Unable to classify	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
MenACWY-CRM (2 Doses)	2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study days 1 and 61 in children 2 to 5 years of age
MenACWY-CRM (1 Dose)	1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study day 1
Licensed Polysaccharide Vaccine	1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1

Baseline Measures

	MenACWY-CRM (2 Doses)	MenACWY-CRM (1 Dose)	Licensed Polysaccharide Vaccine	Total
Number of Participants [units: participants]	359	1278	1270	2907
Age [units: years] Mean ± Standard Deviation	3.5 ± 1.1	5.5 ± 2.5	5.6 ± 2.6	5.3 ± 2.5
Gender [units: participants]
Female	171	622	580	1373
Male	188	656	690	1534

Outcome Measures

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1. Primary:

Number of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age [ Time Frame: 1 month postvaccination ]

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2. Primary:

Number of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age [ Time Frame: 1 month postvaccination ]

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3. Secondary:

Number Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age. [ Time Frame: 1 month postvaccination ]

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4. Secondary:

Number of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age [ Time Frame: 1 month postvaccination ]

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5. Secondary:

Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age [ Time Frame: 1 month postvaccination ]

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6. Secondary:

Number of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age [ Time Frame: 1 month postvaccination ]

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7. Secondary:

Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age [ Time Frame: 1 month postvaccination ]

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8. Secondary:

Number of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose) [ Time Frame: 1 month postvaccination ]

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9. Secondary:

Number of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) [ Time Frame: 1 month postvaccination ]

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10. Secondary:

Number of Subjects With hSBA GMTs, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) [ Time Frame: 1 month postvaccination ]

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11. Secondary:

Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age [ Time Frame: Study days 1 to 7 ]

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12. Secondary:

Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age [ Time Frame: Study days 1 to 7 ]

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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 NOT 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.

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
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Results Point of Contact:

Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
e-mail: RegistryContactVaccinesUS@Novartis.com

No publications provided by Novartis

Publications automatically indexed to this study:

Halperin SA, Gupta A, Jeanfreau R, Klein NP, Reisinger K, Walter E, Bedell L, Gill C, Dull PM. Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine. 2010 Nov 23;28(50):7865-72. Epub 2010 Oct 29.

Responsible Party:	Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:	NCT00616421 History of Changes
Other Study ID Numbers:	V59P20, 11278
Study First Received:	January 31, 2008
Results First Received:	February 28, 2011
Last Updated:	December 7, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada