Clinical trial NCT02012998: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Virus Diseases
Hepatitis B
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2013-12-17
Enrollment: 751
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL
timeFrame: One month after the challenge dose
Secondary outcomes:
measure: Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL
timeFrame: Prior to challenge dose (At Day 0 prior to administration of the challenge dose)
measure: Solicited injection-site adverse reactions and pyrexia
timeFrame: Day 0 to day 4 after vaccination
measure: Unsolicited injection-site adverse reactions and systemic adverse events
timeFrame: Day 0 to day 14 after vaccination
measure: Serious adverse events
timeFrame: From signature of the informed consent to the last visit of the subject, an expected average of one month
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Sanofi Pasteur MSD Investigational Site 004
city: Cagliari
country: Italy
facility: Sanofi Pasteur MSD Investigational Site 009
city: Capannori
country: Italy
facility: Sanofi Pasteur MSD Investigational Site 005
city: Chiavari
country: Italy
facility: Sanofi Pasteur MSD Investigational Site 003
city: Latisana
country: Italy
facility: Sanofi Pasteur MSD Investigational Site 002
city: Massafra
country: Italy
facility: Sanofi Pasteur MSD Investigational Site 008
city: Nocera Inferiore
country: Italy
facility: Sanofi Pasteur MSD Investigational Site 006
city: Ragusa
country: Italy
facility: Sanofi Pasteur MSD Investigational Site 010
city: Salerno
country: Italy
facility: Sanofi Pasteur MSD Investigational Site 007
city: Sassari
country: Italy
facility: Sanofi Pasteur MSD Investigational Site 001
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Medical Director
role: STUDY_DIRECTOR
References:
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.