NCT00693186

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

1.2 years

First QC Date

June 4, 2008

Last Update Submit

September 8, 2017

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

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

    28 to 42 days

Study Arms (2)

1

EXPERIMENTAL
Biological: HBVaxPRO® 5 µg / 0.5 mL

2

EXPERIMENTAL
Biological: Engerix B® 10 µg / 0.5 mL

Interventions

HBVaxPRO® 5 µg / 0.5 mLBIOLOGICAL

5 µg / 0.5 mL

1
Engerix B® 10 µg / 0.5 mLBIOLOGICAL

10 µg

2

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unità Operativa Semplice di Epidemiologia (UOSE)

Quarto, Napoli, Italy

Location

Azienda per i Servizi Sanitari n. 5 "Bassa Friulana"

Latisana, Udine, Italy

Location

Ospedale Maggiore di Modica - Via Resistenza Partigiana (c/o Ospedale Maggiore)

Modica, 97015, Italy

Location

AUSL n. 7 di Ragusa Servizio di Epidemiologia Via G. Di Vittorio 59/c

Ragusa, 97100, Italy

Location

Dipartimento di Prevenzione Servizio di Igiene Pubblica

Sassari, Italy

Location

Related Publications (1)

  • 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.

    PMID: 22789511DERIVED

MeSH Terms

Conditions

Hepatitis B

Interventions

Hepatitis B VaccinesEngerix-B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Medical Director

    Sanofi Pasteur, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 6, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

September 11, 2017

Record last verified: 2017-09

Locations

IT(5)