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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693186
• Other study ID #: HXV01C
• Status: Completed
• Phase: Phase 3
• First received: June 4, 2008
• Last updated: September 8, 2017
• Start date: October 2008
• Est. completion date: March 2010

Study information

• Verified date: September 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: March 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Intervention

Biological:
• HBVaxPRO® 5 µg / 0.5 mL
5 µg / 0.5 mL
• Engerix B® 10 µg / 0.5 mL
10 µg

Locations

Country	Name	City	State
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	Unità Operativa Semplice di Epidemiologia (UOSE)	Quarto	Napoli
Italy	AUSL n. 7 di Ragusa Servizio di Epidemiologia Via G. Di Vittorio 59/c	Ragusa
Italy	Dipartimento di Prevenzione Servizio di Igiene Pubblica	Sassari

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose		28 to 42 days