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

NCT ID: NCT02012998

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 751 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-02-28

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.

Conditions

Virus Diseases; Hepatitis B

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HBVAXPRO Challenge dose

HBVAXPRO 5µg

Group Type: EXPERIMENTAL

HBVAXPRO 5µg

Intervention Type: BIOLOGICAL

0.5mL intramuscular injection

Interventions

HBVAXPRO 5µg

0.5mL intramuscular injection

Intervention Type: BIOLOGICAL

Other Intervention Names

Hepatitis B vaccine (rDNA)

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur, a Sanofi Company

Locations

Sanofi Pasteur MSD Investigational Site 004

Bologna, , Italy

Sanofi Pasteur MSD Investigational Site 009

Cagliari, , Italy

Sanofi Pasteur MSD Investigational Site 005

Capannori, , Italy

Sanofi Pasteur MSD Investigational Site 003

Chiavari, , Italy

Sanofi Pasteur MSD Investigational Site 002

Latisana, , Italy

Sanofi Pasteur MSD Investigational Site 008

Massafra, , Italy

Sanofi Pasteur MSD Investigational Site 006

Nocera Inferiore, , Italy

Sanofi Pasteur MSD Investigational Site 010

Ragusa, , Italy

Sanofi Pasteur MSD Investigational Site 007

Salerno, , Italy

Sanofi Pasteur MSD Investigational Site 001

Sassari, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 28624307 (View on PubMed)

Other Identifiers

2013-001602-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HXV02C

Identifier Type: -

Identifier Source: org_study_id