Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 75 Years of Age in India

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01547715
First received: February 23, 2012
Last updated: December 18, 2014
Last verified: December 2014
Results First Received: December 18, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Bacterial Meningitis
Intervention: Biological: Meningococcal ACWY 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
Subjects were enrolled from 3 study sites.

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

Reporting Groups
  Description
2 - 10 Years Subjects between 2 and 10 years of age received one injection of MenACWY –CRM vaccine on day 1.
11 - 18 Years Subjects between 11 and 18 years of age received one injection of MenACWY –CRM vaccine on day 1.
19 - 75 Years Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1.

Participant Flow:   Overall Study
    2 - 10 Years     11 - 18 Years     19 - 75 Years  
STARTED     60     60     60  
COMPLETED     60     60     60  
NOT COMPLETED     0     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
2 - 10 Years Subjects between 2 and 10 years of age received one injection of MenACWY –CRM vaccine on day 1
11 - 18 Years Subjects between 11 and 18 years of age received one injection of MenACWY –CRM vaccine on day 1
19 - 75 Years Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1.
Total Total of all reporting groups

Baseline Measures
    2 - 10 Years     11 - 18 Years     19 - 75 Years     Total  
Number of Participants  
[units: participants]
  60     60     60     180  
Age  
[units: YEARS]
Mean (Standard Deviation)
  5.77  (2.5)     14.03  (1.931)     32.67  (12.297)     17.49  (13.432)  
Gender  
[units: participants]
       
Female     33     33     21     87  
Male     27     27     39     93  



  Outcome Measures
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1.  Primary:   Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A.   [ Time Frame: Day 29 (1 month post vaccination) ]

2.  Primary:   Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C   [ Time Frame: Day 29 (1 month post vaccination) ]

3.  Primary:   Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W.   [ Time Frame: Day 29 (1 month post vaccination) ]

4.  Primary:   Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y.   [ Time Frame: Day 29 (1 month post vaccination) ]

5.  Secondary:   Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1.   [ Time Frame: Day 1 ]

6.  Secondary:   Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29.   [ Time Frame: Day 29 (ie, 1 month post vaccination) ]

7.  Secondary:   Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1.   [ Time Frame: Day 1 ]

8.  Secondary:   Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29.   [ Time Frame: Day 29 (ie, 1 month post vaccination) ]

9.  Secondary:   Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1.   [ Time Frame: Day 1 ]

10.  Secondary:   Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29.   [ Time Frame: Day 29 ]

11.  Secondary:   Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1   [ Time Frame: Day 1 ]

12.  Secondary:   Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29   [ Time Frame: Day 29 (ie, 1 month post vaccination) ]

13.  Secondary:   hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1   [ Time Frame: Day 1 ]

14.  Secondary:   hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29   [ Time Frame: Day 29 ( ie, 1 month post vaccination) ]

15.  Secondary:   hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1   [ Time Frame: Day 1 ]

16.  Secondary:   hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29   [ Time Frame: Day 29 (ie, 1 month post vaccination) ]

17.  Secondary:   hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1   [ Time Frame: Day 1 ]

18.  Secondary:   hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29   [ Time Frame: Day 29 (ie, 1 month post vaccination) ]

19.  Secondary:   hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1   [ Time Frame: Day 1 ]

20.  Secondary:   hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 29   [ Time Frame: Day 29 (ie, 1 month post vaccination) ]

21.  Secondary:   Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination   [ Time Frame: From day 1 to Day 7 post vaccination ]

22.  Secondary:   Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination   [ Time Frame: From day 1 to Day 7 post vaccination ]

23.  Secondary:   Number of Subjects With Unsolicited Adverse Events   [ Time Frame: Day 1 through day 29 ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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



Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01547715     History of Changes
Other Study ID Numbers: V59_43
Study First Received: February 23, 2012
Results First Received: December 18, 2014
Last Updated: December 18, 2014
Health Authority: India: Central Drugs Standard Control Organization