Safety and Immune Response of Novartis MenACWY-CRM Conjugate Vaccine When Given to Healthy Toddlers

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Vaccines )

ClinicalTrials.gov Identifier:

NCT00626327

First received: February 20, 2008

Last updated: April 12, 2013

Last verified: April 2013

History of Changes

Results First Received: February 12, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Meningococcal Infections
Interventions:	Biological: MenACWY-CRM + MMRV Biological: MMRV Biological: MenACWY-CRM

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 90 centers in the USA

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+ MMRV	Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
MMRV	Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
MenACWY-CRM	Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months

Participant Flow: Overall Study

	MenACWY-CRM+ MMRV	MMRV	MenACWY-CRM
STARTED	504	616	510
COMPLETED	426	557	422
NOT COMPLETED	78	59	88
Withdrawal by Subject	21	29	30
Adverse Event	1	0	0
Lost to Follow-up	24	21	23
Inappropriate enrollment	4	5	3
Administrative Reason	2	0	6
Protocol Violation	26	4	26

Baseline Characteristics

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Reporting Groups

	Description
MenACWY-CRM+ MMRV	Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
MMRV	Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
MenACWY-CRM	Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
Total	Total of all reporting groups

Baseline Measures

	MenACWY-CRM+ MMRV	MMRV	MenACWY-CRM	Total
Number of Participants [units: participants]	504	616	510	1630
Age [units: months] Mean ± Standard Deviation	8.5 ± 0.8	12.1 ± 0.3	8.5 ± 0.8	9.8 ± 1.9
Gender [units: Subjects]
Female	251	304	252	807
Male	253	312	258	823

Outcome Measures

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1. Primary:

Percentages of Subjects With a Seroresponse to Measles, Mumps, Rubella and Varicella Following Concomitant Administration of MMRV Vaccine With MenACWY-CRM Vaccine [ Time Frame: 6 weeks post vaccination ]

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2. Primary:

Percentages of Subjects With Serum Bactericidal Titers ≥1:8 Following Concomitant Administration of MenACWY-CRM Vaccine With MMRV Vaccine. [ Time Frame: 6 weeks post second dose ]

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3. Primary:

Percentages of Subjects With hSBA ≥1:8 Following Two Doses of MenACWY-CRM Vaccine [ Time Frame: 6 weeks post vaccine dose 2 ]

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4. Secondary:

Percentages of Subjects With hSBA ≥1:4 After Two Doses of MenACWY-CRM Vaccine [ Time Frame: 6 weeks post vaccine dose 2 ]

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5. Secondary:

Geometric Mean Titers Against Serogroups A, C, W-135 and Y, Following Two Doses of MenACWY-CRM Vaccine [ Time Frame: 6 weeks post vaccine dose 2 ]

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6. Secondary:

Geometric Mean Titers Against Measles, Mumps, Rubella and Varicella Following One Dose of MMRV Vaccine. [ Time Frame: 6 weeks post vaccination ]

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7. Secondary:

Percentages of Subjects Showing Seroconversion Response to Varicella Following Concomitant Administration of MMRV With MenACWY-CRM Vaccine. [ Time Frame: 6 weeks post vaccination ]

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8. Secondary:

Percentages of Subjects With hSBA ≥1:4 and hSBA ≥1:8 Following One Dose of MenACWY-CRM Vaccine [ Time Frame: 1 month post vaccine dose 1 ]

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9. Secondary:

Geometric Mean Titers After One Dose of MenACWY-CRM Vaccine [ Time Frame: 1 month post vaccine dose 1 ]

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10. Secondary:

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination [ Time Frame: upto 7 days after any vaccination ]

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11. Secondary:

Number of Subjects Reporting Unsolicited Adverse Events After Vaccination [ Time Frame: Day 1- Day 180 (Through out the study) ]

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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

Responsible Party:	Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:	NCT00626327 History of Changes
Other Study ID Numbers:	V59P21, BB-IND 11278
Study First Received:	February 20, 2008
Results First Received:	February 12, 2013
Last Updated:	April 12, 2013
Health Authority:	United States: Food and Drug Administration

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