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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

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
HBVaxPRO® 5 µg / 0.5 mL
Engerix B® 10 µg / 0.5 mL
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Percentage of subjects with anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose

Secondary Outcome Measures

Full Information

First Posted
June 4, 2008
Last Updated
September 8, 2017
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00693186
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (Actual)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
410 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
HBVaxPRO® 5 µg / 0.5 mL
Intervention Description
5 µg / 0.5 mL
Intervention Type
Biological
Intervention Name(s)
Engerix B® 10 µg / 0.5 mL
Intervention Description
10 µg
Primary Outcome Measure Information:
Title
Percentage of subjects with anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose
Time Frame
28 to 42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Unità Operativa Semplice di Epidemiologia (UOSE)
City
Quarto
State/Province
Napoli
Country
Italy
Facility Name
Azienda per i Servizi Sanitari n. 5 "Bassa Friulana"
City
Latisana
State/Province
Udine
Country
Italy
Facility Name
Ospedale Maggiore di Modica - Via Resistenza Partigiana (c/o Ospedale Maggiore)
City
Modica
ZIP/Postal Code
97015
Country
Italy
Facility Name
AUSL n. 7 di Ragusa Servizio di Epidemiologia Via G. Di Vittorio 59/c
City
Ragusa
ZIP/Postal Code
97100
Country
Italy
Facility Name
Dipartimento di Prevenzione Servizio di Igiene Pubblica
City
Sassari
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22789511
Citation
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.
Results Reference
derived

Learn more about this trial

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

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