Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01148017
First received: June 16, 2010
Last updated: April 15, 2014
Last verified: April 2014
Results First Received: April 15, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Meningococcal Meningitis
Intervention: Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
ACWY - 4 Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
ACWY - 2 Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
Naïve - 40 Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
Naïve - 60 Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.

Participant Flow:   Overall Study
    ACWY - 4     ACWY - 2     Naïve - 40     Naïve - 60  
STARTED     214     121     53     45  
COMPLETED     134     87     53     45  
NOT COMPLETED     80     34     0     0  
Withdrawal by Subject                 31                 14                 0                 0  
Lost to Follow-up                 23                 10                 0                 0  
Inappropriate enrollment                 1                 0                 0                 0  
Administrative reason                 22                 9                 0                 0  
Unable to classify                 3                 1                 0                 0  



  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.
Analysis was done on the all enrolled population, ie, all subjects who had signed an informed consent, undergone screening procedures, and were enrolled.

Reporting Groups
  Description
ACWY - 4 Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
ACWY - 2 Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
Naïve - 40 Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
Naïve - 60 Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
Total Total of all reporting groups

Baseline Measures
    ACWY - 4     ACWY - 2     Naïve - 40     Naïve - 60     Total  
Number of Participants  
[units: participants]
  214     121     53     45     433  
Age  
[units: Months]
Mean ± Standard Deviation
         
40 months enrollment (N=210, 119, 53, 382)     39.2  ± 1.8     39.3  ± 1.7     38.7  ± 1.8     NA  ± NA [1]   39.2  ± 1.8  
60 months enrollment (N=136, 89, 45, 270)     59.7  ± 2.2     59.6  ± 2.4     NA  ± NA [2]   60  ± 1.7     59.7  ± 2.2  
Gender  
[units: participants]
         
Female     97     55     29     26     207  
Male     117     66     24     19     226  
Region of Enrollment  
[units: participants]
         
United States     214     121     53     45     433  
[1] Subjects in this group were enrolled at 60 months of age.
[2] Subjects in this group were enrolled at 40 months of age.



  Outcome Measures
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1.  Primary:   Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y   [ Time Frame: Visit 9 (continuation from the parent study), 40-month visit. ]

2.  Primary:   Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y   [ Time Frame: Visit 10, 60 months of age ]

3.  Secondary:   Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age   [ Time Frame: Visit 9, 40 months of age. ]

4.  Secondary:   Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y Subjects of 60 Months of Age   [ Time Frame: Visit 10, 60 months of age. ]

5.  Secondary:   hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age   [ Time Frame: Visit 9 (continuation from the parent study), 40-months of age. ]

6.  Secondary:   hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 60 Months of Age   [ Time Frame: Visit 10, 60 months of age. ]

7.  Secondary:   Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-vaccination   [ Time Frame: Visit 11, 1 month after vaccination. ]

8.  Secondary:   Percentage of Subjects With Seroresponse at 1 Month Post-vaccination   [ Time Frame: Visit 11, 1 month after vaccination. ]

9.  Secondary:   Percentages of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity   [ Time Frame: From day 1 to 7 after vaccination. ]

10.  Secondary:   Percentages of Subjects Reporting Unsolicited AEs and SAEs   [ Time Frame: Day 1 to 7 after vaccination for any unsolicited AEs, day 1 to study termination for SAEs and medically attended AEs (for the naive-40 group), day 8 to study termination for SAEs and medically attended AEs (for the other groups). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Posting Director
Organization: Novartis Vaccines
e-mail: RegistryContactVaccinesUS@novartis.com


No publications provided


Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01148017     History of Changes
Other Study ID Numbers: V59P14E1
Study First Received: June 16, 2010
Results First Received: April 15, 2014
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration