Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA
Primary Purpose
Virus Diseases, Hepatitis B
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
HBVAXPRO 5µg
Sponsored by
About this trial
This is an interventional prevention trial for Virus Diseases
Eligibility Criteria
Inclusion Criteria:
- Healthy child
- Child vaccinated with 3 doses of HEXAVAC or 3 doses of INFANRIX HEXA as infant
- Child vaccinated with the third dose of HEXAVAC or INFANRIX HEXA at least 10 years prior to challenge dose
Exclusion Criteria:
- Receipt of more than 3 doses of any Hepatitis B containing vaccine
- History of clinical diagnosis of infection due to Hepatitis B
- History or current close contact with known carriers of Hepatitis B virus
- Prior known sensitivity or allergy to any component of HBVAXPRO
- Chronic illness / medical condition that could interfere with study conduct or completion
- Coagulation disorder that would contraindicate intramuscular injection
- Subject is pregnant
- Receipt of corticosteroids for more than 14 days in the 30 days prior to study
- Receipt of Immunoglobulins, blood or blood-derived products in the 3 months prior to study
- Planned participation in another clinical study
Sites / Locations
- Sanofi Pasteur MSD Investigational Site 004
- Sanofi Pasteur MSD Investigational Site 009
- Sanofi Pasteur MSD Investigational Site 005
- Sanofi Pasteur MSD Investigational Site 003
- Sanofi Pasteur MSD Investigational Site 002
- Sanofi Pasteur MSD Investigational Site 008
- Sanofi Pasteur MSD Investigational Site 006
- Sanofi Pasteur MSD Investigational Site 010
- Sanofi Pasteur MSD Investigational Site 007
- Sanofi Pasteur MSD Investigational Site 001
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HBVAXPRO Challenge dose
Arm Description
HBVAXPRO 5µg
Outcomes
Primary Outcome Measures
Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL
Secondary Outcome Measures
Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL
Solicited injection-site adverse reactions and pyrexia
Unsolicited injection-site adverse reactions and systemic adverse events
Serious adverse events
Full Information
NCT ID
NCT02012998
First Posted
December 11, 2013
Last Updated
September 8, 2017
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT02012998
Brief Title
Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA
Official Title
An Open-label, Controlled, Multi-centre Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO to Explore the Anamnestic Immune Response in Healthy Children Vaccinated 10 Years Ago With a Primary Series (3 Doses) of Either HEXAVAC or INFANRIX HEXA
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the immune response to Hepatitis B virus in children who have been primed with HEXAVAC or INFANRIX HEXA 10 years ago.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virus Diseases, Hepatitis B
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
751 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HBVAXPRO Challenge dose
Arm Type
Experimental
Arm Description
HBVAXPRO 5µg
Intervention Type
Biological
Intervention Name(s)
HBVAXPRO 5µg
Other Intervention Name(s)
Hepatitis B vaccine (rDNA)
Intervention Description
0.5mL intramuscular injection
Primary Outcome Measure Information:
Title
Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL
Time Frame
One month after the challenge dose
Secondary Outcome Measure Information:
Title
Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL
Time Frame
Prior to challenge dose (At Day 0 prior to administration of the challenge dose)
Title
Solicited injection-site adverse reactions and pyrexia
Time Frame
Day 0 to day 4 after vaccination
Title
Unsolicited injection-site adverse reactions and systemic adverse events
Time Frame
Day 0 to day 14 after vaccination
Title
Serious adverse events
Time Frame
From signature of the informed consent to the last visit of the subject, an expected average of one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy child
Child vaccinated with 3 doses of HEXAVAC or 3 doses of INFANRIX HEXA as infant
Child vaccinated with the third dose of HEXAVAC or INFANRIX HEXA at least 10 years prior to challenge dose
Exclusion Criteria:
Receipt of more than 3 doses of any Hepatitis B containing vaccine
History of clinical diagnosis of infection due to Hepatitis B
History or current close contact with known carriers of Hepatitis B virus
Prior known sensitivity or allergy to any component of HBVAXPRO
Chronic illness / medical condition that could interfere with study conduct or completion
Coagulation disorder that would contraindicate intramuscular injection
Subject is pregnant
Receipt of corticosteroids for more than 14 days in the 30 days prior to study
Receipt of Immunoglobulins, blood or blood-derived products in the 3 months prior to study
Planned participation in another clinical study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi Pasteur MSD Investigational Site 004
City
Bologna
Country
Italy
Facility Name
Sanofi Pasteur MSD Investigational Site 009
City
Cagliari
Country
Italy
Facility Name
Sanofi Pasteur MSD Investigational Site 005
City
Capannori
Country
Italy
Facility Name
Sanofi Pasteur MSD Investigational Site 003
City
Chiavari
Country
Italy
Facility Name
Sanofi Pasteur MSD Investigational Site 002
City
Latisana
Country
Italy
Facility Name
Sanofi Pasteur MSD Investigational Site 008
City
Massafra
Country
Italy
Facility Name
Sanofi Pasteur MSD Investigational Site 006
City
Nocera Inferiore
Country
Italy
Facility Name
Sanofi Pasteur MSD Investigational Site 010
City
Ragusa
Country
Italy
Facility Name
Sanofi Pasteur MSD Investigational Site 007
City
Salerno
Country
Italy
Facility Name
Sanofi Pasteur MSD Investigational Site 001
City
Sassari
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
28624307
Citation
Zanetti A, Desole MG, Romano L, d'Alessandro A, Conversano M, Ferrera G, Panico MG, Tomasi A, Zoppi G, Zuliani M, Thomas S, Soubeyrand B, Eymin C, Lockhart S. Safety and immune response to a challenge dose of hepatitis B vaccine in healthy children primed 10years earlier with hexavalent vaccines in a 3, 5, 11-month schedule: An open-label, controlled, multicentre trial in Italy. Vaccine. 2017 Jul 13;35(32):4034-4040. doi: 10.1016/j.vaccine.2017.05.047. Epub 2017 Jun 16.
Results Reference
derived
Learn more about this trial
Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA
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