Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01453348
First received: October 3, 2011
Last updated: February 6, 2014
Last verified: February 2014
Results First Received: October 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Meningococcal Disease
Meningococcal Meningitis
Hepatitis A
Hepatitis B
Interventions: Biological: MenACWY-CRM
Biological: Combined inactivated hepatitis A and recombinant hepatitis B vaccine
Biological: Recombinant hepatitis B vaccine
Biological: Inactivated hepatitis A vaccine

  Participant Flow
  Hide 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 at four centers in Germany.

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
HepA/B Subjects ≥18 to ≤64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
HepA/B+MenACWY-CRM Subjects ≥18 to ≤64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
MenACWY-CRM Subjects ≥18 to ≤64 years of age who received one dose of MenACWY-CRM conjugate vaccine.

Participant Flow:   Overall Study
    HepA/B     HepA/B+MenACWY-CRM     MenACWY-CRM  
STARTED     84     84     84  
COMPLETED     83     83     83  
NOT COMPLETED     1     1     1  
Death                 0                 0                 1  
Withdrawal by Subject                 0                 1                 0  
Protocol Violation                 1                 0                 0  



  Baseline Characteristics
  Hide 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
HepA/B Subjects ≥18 to ≤64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
HepA/B+MenACWY-CRM Subjects ≥18 to ≤64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
MenACWY-CRM Subjects ≥18 to ≤64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
Total Total of all reporting groups

Baseline Measures
    HepA/B     HepA/B+MenACWY-CRM     MenACWY-CRM     Total  
Number of Participants  
[units: participants]
  84     84     84     252  
Age  
[units: years]
Mean ± Standard Deviation
  39.0  ± 12.3     39.9  ± 12.6     39.7  ± 11.0     39.5  ± 11.9  
Gender  
[units: participants]
       
Female     45     40     50     135  
Male     39     44     34     117  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Geometric Mean antiHAV and antiHBV Concentrations, 28 Days After Primary and Booster Vaccination   [ Time Frame: Day 57 (previously unprimed subjects) Day 29 (previously primed subjects) postvaccination. ]

2.  Secondary:   Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination   [ Time Frame: 28 days post primary or booster vaccination. ]

3.  Secondary:   Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29   [ Time Frame: 28 days post vaccination (day 29). ]

4.  Secondary:   Geometric Mean Human Serum Bactericidal Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29   [ Time Frame: 28 days post vaccination (day 29). ]

5.  Secondary:   Percentages of Subjects With Unsolicited Adverse Events   [ Time Frame: Day 1 to Day 57. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

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 and Diagnostics
e-mail: RegistryContactVaccinesUS@novartis.com


No publications provided


Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01453348     History of Changes
Other Study ID Numbers: V59_53, 2011-001333-17
Study First Received: October 3, 2011
Results First Received: October 22, 2013
Last Updated: February 6, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices