Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00310817
First received: April 3, 2006
Last updated: October 6, 2015
Last verified: October 2015
Results First Received: August 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Meningococcal Meningitis
Interventions: Biological: MenACWY-CRM conjugate vaccine, adjuvanted
Biological: MenACWY polysaccharide vaccine
Biological: MenACWY-CRM conjugate vaccine, unadjuvanted

  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
Subjects were enrolled at one center in Finland and in two centers in Poland.

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

Reporting Groups
  Description
MenACWY-CRM(Ad+) 12 to 35 Months Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
MenACWY-CRM(Ad-) 12 to 35 Months Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
MenACWY-CRM(Ad-) 36 to 59 Months Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
MenACWY-PS (36 to 59 Months) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY conjugate vaccine without adjuvant on day 169 or day 337.

Participant Flow:   Overall Study
    MenACWY-CRM(Ad+) 12 to 35 Months     MenACWY-CRM(Ad-) 12 to 35 Months     MenACWY-CRM(Ad-) 36 to 59 Months     MenACWY-PS (36 to 59 Months)  
STARTED     207     206     128     82  
COMPLETED     196     198     120     74  
NOT COMPLETED     11     8     8     8  
AE or Death                 3                 1                 0                 0  
Withdrawal by Subject                 1                 4                 6                 7  
Lost to Follow-up                 2                 1                 0                 0  
Inappropriate Enrollment                 1                 0                 1                 0  
Protocol Violation                 1                 1                 1                 1  
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.
No text entered.

Reporting Groups
  Description
MenACWY-CRM(Ad+) 12 to 35 Months Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
MenACWY-CRM(Ad-) 12 to 35 Months Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
MenACWY-CRM(Ad-) 36 to 59 Months Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
MenACWY-PS (36 to 59 Months) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
Total Total of all reporting groups

Baseline Measures
    MenACWY-CRM(Ad+) 12 to 35 Months     MenACWY-CRM(Ad-) 12 to 35 Months     MenACWY-CRM(Ad-) 36 to 59 Months     MenACWY-PS (36 to 59 Months)     Total  
Number of Participants  
[units: participants]
  207     206     128     82     623  
Age  
[units: Months]
Mean (Standard Deviation)
  24.1  (6.4)     23.7  (6.2)     45.1  (6.7)     44.7  (6.4)     31.0  (11.8)  
Gender  
[units: participants]
         
Female     110     107     68     44     329  
Male     97     99     60     38     294  



  Outcome Measures
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1.  Primary:   Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age   [ Time Frame: 28 days after first vaccination. ]

2.  Secondary:   Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age   [ Time Frame: 28 days after first vaccination ]

3.  Secondary:   hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age   [ Time Frame: 28 days after first vaccination ]

4.  Secondary:   hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age   [ Time Frame: 6 months after first vaccination and 12 months after first vaccination ]

5.  Secondary:   Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age   [ Time Frame: 6 months after first vaccination and 12 months after first vaccination ]

6.  Secondary:   Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age   [ Time Frame: 6 months after first vaccination and 12 months after first vaccination ]

7.  Secondary:   hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age   [ Time Frame: 21 days after second vaccination ]

8.  Secondary:   Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age   [ Time Frame: 21 days after second vaccination ]

9.  Secondary:   Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age   [ Time Frame: 21 days after the second vaccination ]

10.  Secondary:   Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age   [ Time Frame: 28 days after first vaccination. ]

11.  Secondary:   hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age   [ Time Frame: 28 days after first vaccination ]

12.  Secondary:   Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age   [ Time Frame: 28 days after first vaccination. ]

13.  Secondary:   Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age   [ Time Frame: 21 days after second vaccination ]

14.  Secondary:   Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age   [ Time Frame: 21 days after second vaccination ]

15.  Secondary:   hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age   [ Time Frame: 21 days after second vaccination ]

16.  Secondary:   hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age   [ Time Frame: 6 months after first vaccination and 12 months after first vaccination ]

17.  Secondary:   Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age   [ Time Frame: 6 months after first vaccination and 12 months after first vaccination ]

18.  Secondary:   Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age   [ Time Frame: 6 months after first vaccination and 12 months after first vaccination ]

19.  Secondary:   hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age   [ Time Frame: 21 days after the second vaccination ]

20.  Secondary:   Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age   [ Time Frame: 21 days after second vaccination ]

21.  Secondary:   Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age   [ Time Frame: 21 days after second vaccination ]

22.  Secondary:   hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age   [ Time Frame: 12 months after second vaccination ]

23.  Secondary:   Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age   [ Time Frame: 12 months after second vaccination ]

24.  Secondary:   Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age   [ Time Frame: 12 months after second vaccination ]

25.  Secondary:   Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination   [ Time Frame: From day 1 through day 7 after first or second vaccination(s) ]

26.  Secondary:   Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination   [ Time Frame: 28 days after first vaccination and 21 days after second vaccination ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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



Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00310817     History of Changes
Other Study ID Numbers: V59P7
EUDRACT NUMBER: 2004-001896-21
Study First Received: April 3, 2006
Results First Received: August 29, 2013
Last Updated: October 6, 2015
Health Authority: United States: Food and Drug Administration
Finland: Finnish Medicines Agency
Poland: CEBK (Central Register of Clinical Trials)