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

Phase 3

Completed

• Conditions: Hepatitis B
• Interventions: Biological: Engerix B® 10 µg / 0.5 mL; Biological: HBVaxPRO® 5 µg / 0.5 mL

• Registration Number: NCT00693186
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Study Start: 2008-10
• Primary Completion: 2009-12
• Study Completion: 2010-03
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 410

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Engerix B® 10 µg / 0.5 mL	-
1	HBVaxPRO® 5 µg / 0.5 mL	-

Primary Outcome Measures

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

Trial Locations

Locations (5)

Unità Operativa Semplice di Epidemiologia (UOSE); 🇮🇹 Quarto, Napoli, Italy

Azienda per i Servizi Sanitari n. 5 "Bassa Friulana"; 🇮🇹 Latisana, Udine, Italy

Ospedale Maggiore di Modica - Via Resistenza Partigiana (c/o Ospedale Maggiore); 🇮🇹 Modica, Italy

Dipartimento di Prevenzione Servizio di Igiene Pubblica; 🇮🇹 Sassari, Italy

AUSL n. 7 di Ragusa Servizio di Epidemiologia Via G. Di Vittorio 59/c; 🇮🇹 Ragusa, Italy