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Novartis Vaccine and Diagnostics Carriage Trial

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ClinicalTrials.gov Identifier: NCT01214850
Recruitment Status : Completed
First Posted : October 5, 2010
Results First Posted : January 23, 2014
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition: N. Meningitidis Carriage
Interventions: Biological: Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ)
Biological: MenACWY-CRM conjugate vaccine
Biological: Japanese Encephalitis vaccine

  Participant Flow

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 10 sites in United Kingdom

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total 2968 subjects were enrolled of which 14 subjects were not randomized and were therefore removed from the study (2 subjects withdrew consent and 11 subjects were withdrawn due to inappropriate enrollment and 1 withdrawn due to protocol violation).

Reporting Groups
  Description
rMenB+OMV Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
MenACWY Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart

Participant Flow:   Overall Study
    rMenB+OMV   MenACWY   Control
STARTED   979   988   987 
COMPLETED   796   844   826 
NOT COMPLETED   183   144   161 
Withdrawal by Subject                38                31                28 
Lost to Follow-up                124                98                123 
Protocol Violation                5                5                6 
Adverse event or death                11                8                3 
Inappropriate enrollment                2                1                0 
Administrative reason                1                0                0 
Unable to classify                2                1                1 



  Baseline Characteristics

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
rMenB+OMV Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
MenACWY Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Total Total of all reporting groups

Baseline Measures
   rMenB+OMV   MenACWY   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 979   988   987   2954 
Age 
[Units: Years]
Mean (Standard Deviation)
 19.9  (1.6)   19.9  (1.6)   19.8  (1.6)   19.9  (1.6) 
Gender 
[Units: Participants]
       
Female   516   533   547   1596 
Male   463   455   440   1358 


  Outcome Measures

1.  Primary:   Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination   [ Time Frame: 61 days (31 days after receiving the second injection) ]

2.  Primary:   Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination   [ Time Frame: 31 days after MenACWY-CRM injection ]

3.  Secondary:   Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination   [ Time Frame: Up to 361 days after vaccination ]

4.  Secondary:   Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination   [ Time Frame: Up to 361 days after vaccination ]

5.  Secondary:   Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination   [ Time Frame: Up to 361 days after vaccination ]

6.  Secondary:   Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination   [ Time Frame: Up to 361 days after vaccination ]

7.  Secondary:   Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination   [ Time Frame: Up to 361 days after vaccination ]

8.  Secondary:   Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination   [ Time Frame: Up to 361 days after vaccination ]

9.  Secondary:   Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination   [ Time Frame: Up to 361 days after vaccination ]

10.  Secondary:   Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination   [ Time Frame: Up to 361 days after vaccination ]

11.  Secondary:   Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination   [ Time Frame: Up to 361 days after vaccination ]

12.  Secondary:   Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination   [ Time Frame: Up to 361 days after vaccination ]

13.  Secondary:   Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination   [ Time Frame: Up to 361 days after vaccination ]

14.  Secondary:   Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination   [ Time Frame: Up to 361 days after vaccination ]

15.  Secondary:   Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination   [ Time Frame: Up to 361 days after vaccination ]

16.  Secondary:   Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination   [ Time Frame: Up to 361 days after vaccination ]

17.  Secondary:   Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination   [ Time Frame: Up to 361 days after vaccination ]

18.  Secondary:   Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination   [ Time Frame: Up to 361 days after vaccination ]

19.  Secondary:   Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination   [ Time Frame: Up to 361 days after vaccination ]

20.  Secondary:   Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination   [ Time Frame: Up to 361 days after vaccination ]

21.  Secondary:   Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination   [ Time Frame: Up to 361 days after vaccination ]

22.  Secondary:   The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV   [ Time Frame: Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage) ]

23.  Secondary:   The Duration of Carriage of Any N. Meningitidis Strain After Vaccination With MenACWY-CRM   [ Time Frame: Any time post vaccination (the date of first observation of the carriage and the date of the last observation of the carriage) ]

24.  Secondary:   The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine   [ Time Frame: Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage) ]

25.  Secondary:   The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With MenACWY Vaccine   [ Time Frame: Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage) ]

26.  Secondary:   Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination   [ Time Frame: Up to 361 days after vaccination ]

27.  Secondary:   Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers   [ Time Frame: Up to 12 months after vaccination ]

28.  Secondary:   Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group   [ Time Frame: Up to 361 days after vaccination ]

29.  Secondary:   The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.   [ Time Frame: Up to 361 days after vaccination ]

30.  Secondary:   Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.   [ Time Frame: Up to 361 days after vaccination ]

31.  Secondary:   The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.   [ Time Frame: Up to 361 days after vaccination ]

32.  Secondary:   Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group.   [ Time Frame: 61 days ]

33.  Secondary:   The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group   [ Time Frame: Up to 361 days after vaccination ]

34.  Secondary:   Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group.   [ Time Frame: Up to 361 days after vaccination ]

35.  Secondary:   Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group   [ Time Frame: Day 1 through day 7 after any vaccination ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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 less than or equal to 60 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
e-mail: RegistryContactVaccinesUS@novartis.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01214850     History of Changes
Other Study ID Numbers: V72_29
First Submitted: September 30, 2010
First Posted: October 5, 2010
Results First Submitted: September 4, 2013
Results First Posted: January 23, 2014
Last Update Posted: April 21, 2016