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
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 ]

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 ]

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

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

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 ]

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

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 ]

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 ]

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


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