A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXA

An Open-label, Randomised, Controlled, Multi-centre Study of the Immunogenicity and Safety of a Booster Dose of Two Different Hepatitis B Vaccines to Explore the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children Previously Vaccinated at About 3, 5 and 11 to 13 Months of Age With Either HEXAVAC® or INFANRIX®-HEXA

Primary objective:

• To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA during the first two years of life the percentage of subjects with an anti-HBs antibody titre ≥10 mIU/mL 1 month after a booster dose of either HBVaxPRO® 5 µg or Engerix B® 10 µg .

Secondary objectives:

• Additional immunogenicity assessments
• Standard safety assessment.

Study Overview

• Status: Completed
• Conditions: Hepatitis B
• Intervention / Treatment: Biological: HBVaxPRO® 5 µg / 0.5 mL; Biological: Engerix B® 10 µg / 0.5 mL

• Study Type: Interventional
• Enrollment (Actual): 410
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Modica, Italy, 97015
    • Ospedale Maggiore di Modica - Via Resistenza Partigiana (c/o Ospedale Maggiore)
  • Ragusa, Italy, 97100
    • AUSL n. 7 di Ragusa Servizio di Epidemiologia Via G. Di Vittorio 59/c
  • Sassari, Italy
    • Dipartimento di Prevenzione Servizio di Igiene Pubblica
  • Napoli
    • Quarto, Napoli, Italy
      • Unità Operativa Semplice di Epidemiologia (UOSE)
  • Udine
    • Latisana, Udine, Italy
      • Azienda per i Servizi Sanitari n. 5 "Bassa Friulana"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy child of 4 to 7 years of age of either gender,
• Child vaccinated with 2 doses of HEXAVAC® during the first 6 months of life and with a 3rd dose of HEXAVAC® before the end of the second year of life or Child vaccinated with 2 doses of INFANRIX®-HEXA during the first 6 months of life and with a 3rd dose of INFANRIX®-HEXA before the end of the second year of life,
• Informed consent form signed by the parent(s) or by the legal representative.
• Parent(s) or legal representative able to understand and comply with the study procedures.

Exclusion Criteria:

• Any recent (<=3 days) history of febrile illness prior to vaccination,
• Receipt of more than 3 doses of any Hepatitis B containing vaccine, either alone or in any combination,
• History of clinical or serological-confirmed diagnosis of infection due to hepatitis B,
• History or current close contact with known carriers of hepatitis B virus,
• Prior known sensitivity/allergy to any component of the study vaccines,
• Any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems,
• Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
• Any immune impairment or humoral/cellular deficiency or depressed immunity,
• Any recent (<=30 days) long-term (>=14 days) administration of systemic corticosteroids given daily or on alternate days at >=20 mg/day prednisone equivalent or scheduled administration through Visit 2,
• Any receipt (<=3 months) of immunoglobulins or blood-derived products, or scheduled administration through Visit 2,
• Any recent (<=14 days) receipt of an inactivated vaccine or scheduled administration through Visit 2,
• Any recent (<=28 days) receipt of a live vaccine or scheduled administration through Visit 2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	Biological: HBVaxPRO® 5 µg / 0.5 mL; 5 µg / 0.5 mL
EXPERIMENTAL: 2	Biological: Engerix B® 10 µg / 0.5 mL; 10 µg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects with anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose	28 to 42 days

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

General Publications

• Zanetti A, Parlato A, Romano L, Desole MG, Ferrera G, Giurdanella F, Zuliani M, Richard P, Thomas S, Fiquet A. Challenge with a hepatitis B vaccine in two cohorts of 4-7-year-old children primed with hexavalent vaccines: an open-label, randomised trial in Italy. Vaccine. 2012 Aug 24;30(39):5770-5. doi: 10.1016/j.vaccine.2012.06.078. Epub 2012 Jul 9.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2008
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): March 1, 2010

Study Registration Dates

• First Submitted: June 4, 2008
• First Submitted That Met QC Criteria: June 5, 2008
• First Posted (ESTIMATE): June 6, 2008

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis B; Hepatitis
• Other Study ID Numbers: HXV01C