Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine When Administered Concomitantly With Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Adults
2 other identifiers
interventional
252
1 country
4
Brief Summary
This study compares the safety and immunogenicity profile of combined hepatitis A/B vaccine given alone or concomitantly with MenACWY-CRM to healthy adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2011
Shorter than P25 for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 3, 2011
CompletedFirst Posted
Study publicly available on registry
October 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
March 10, 2014
CompletedJune 8, 2017
May 1, 2017
3 months
October 3, 2011
October 22, 2013
May 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination
Assessment was made to demonstrate the non-inferiority of hepatitis A/B vaccine with MenACWY-CRM as compared to hepatitis A/B vaccine without MenACWY-CRM, as measured by geometric mean concentrations on day 57 in previously unvaccinated subjects or on day 29 after a booster dose in previously vaccinated subjects.
Day 57 (previously unprimed subjects) day 29 (previously primed subjects) postvaccination.
Secondary Outcomes (4)
Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination
28 days post primary or booster vaccination.
Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29
28 days postvaccination (day 29).
hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29
28 days post vaccination (day 29).
Percentages of Subjects With Unsolicited Adverse Events (AEs)
Day 1 to day 57.
Study Arms (3)
Group 1
ACTIVE COMPARATORThis group will receive Inactivated hepatitis A and recombinant hepatitis B or 'Combined inactivated hepatitis A \& recombinant hepatitis B vaccine' alone on the different visits.
Group 2
ACTIVE COMPARATORThis group will receive Inactivated hepatitis A vaccine and recombinant hepatitis B Vaccine or 'Combined inactivated hepatitis A \& recombinant hepatitis B vaccine' concomitantly with MenACWY-CRM.
Group 3
ACTIVE COMPARATORThis group will receive only MenACWY-CRM.
Interventions
Novartis meningococcal ACWY conjugate vaccine will be administered intramuscularly (IM) on day 1.
Combined inactivated hepatitis A and recombinant hepatitis B vaccine will be administered by IM on days 1, 8 \& 29 for subjects unprimed with hepatitis A and B; and a single booster injection on day 1 for primed subjects.
Recombinant hepatitis B vaccine will be administered intramuscularly on days 8 and 29
Inactivated hepatitis A will be administered intramuscularly on days 8 and 29.
Eligibility Criteria
You may qualify if:
- Individuals eligible for enrollment in this study were female and male subjects who had shown to be healthy and who were:
- Between 18 and 64 years of age inclusive and who had given their written informed consent;
- Available for all visits and telephone calls scheduled for the study;
- In good health as determined by medical history, physical examination and clinical judgment of the investigator;
- For female subjects, had a negative urine pregnancy test.
You may not qualify if:
- Individuals not eligible to be enrolled in the study were those:
- Who were breastfeeding.
- Who had a previous personal history of Neisseria meningitidis, hepatitis A or hepatitis B infection.
- Who received previous immunization with any meningococcal vaccine.
- Who received previous hepatitis A and/or B vaccination, determined by history (interview of the subject) and/or by review of his or her vaccination card, if less than 5 years have elapsed since vaccination.
- Who received investigational agents or vaccines within 30 days prior to enrollment or who expected to receive an investigational agent or vaccine prior to completion of the study.
- Who received live licensed vaccines within 30 days and inactive vaccine within 15 days prior to enrollment or for whom receipt of a licensed vaccine was anticipated during the study period (Exception: Influenza vaccine might have been administered up to 15 days prior to each study immunization and no less than 15 days after each study immunization).
- Who experienced, within the 7 days prior to enrollment, significant acute infection (for example requiring systemic antibiotic treatment or antiviral therapy) or had experienced fever (defined as body temperature ≥ 38°C) within 3 days prior to enrollment.
- Who had any serious acute, chronic or progressive disease such as:
- History of cancer
- Complicated diabetes mellitus
- Advanced arteriosclerotic disease
- Autoimmune disease
- HIV infection or AIDS
- Blood dyscrasias
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartis Vaccineslead
- GlaxoSmithKlinecollaborator
Study Sites (4)
03, Novartis Investigational Site
Berlin, 10117, Germany
02, Novartis Investigational Site
Hamburg, 20359, Germany
01, Novartis Investigational Site
München, 80802, Germany
04, Novartis Investigational Site
Rostock, 18057, Germany
Related Publications (1)
Alberer M, Burchard G, Jelinek T, Reisinger EC, Meyer S, Forleo-Neto E, Dagnew AF, Arora AK. Immunogenicity and safety of concomitant administration of a combined hepatitis A/B vaccine and a quadrivalent meningococcal conjugate vaccine in healthy adults. J Travel Med. 2015 Mar-Apr;22(2):105-14. doi: 10.1111/jtm.12180. Epub 2014 Dec 7.
PMID: 25483566DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines and Diagnostics
Study Officials
- STUDY CHAIR
Novartis Vaccines
Novartis Vaccines
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2011
First Posted
October 17, 2011
Study Start
October 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
June 8, 2017
Results First Posted
March 10, 2014
Record last verified: 2017-05