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
This study has been completed.
Sponsor:
Sanofi Pasteur MSD
Information provided by:
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT00693186
First received: June 4, 2008
Last updated: November 17, 2010
Last verified: November 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B |
Biological: HBVaxPRO® 5 µg / 0.5 mL Biological: Engerix B® 10 µg / 0.5 mL |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi Pasteur MSD:
Primary Outcome Measures:
- Percentage of subjects with anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose [ Time Frame: 28 to 42 days ] [ Designated as safety issue: No ]
| Enrollment: | 410 |
| Study Start Date: | October 2008 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 4 Years to 7 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693186
Locations
| Italy | |
| 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, 97015 | |
| AUSL n. 7 di Ragusa Servizio di Epidemiologia Via G. Di Vittorio 59/c | |
| Ragusa, Italy, 97100 | |
| Dipartimento di Prevenzione Servizio di Igiene Pubblica | |
| Sassari, Italy | |
Sponsors and Collaborators
Sanofi Pasteur MSD
More Information
No publications provided by Sanofi Pasteur MSD
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Anne FIQUET MD, Sanofi Pasteur MSD |
| ClinicalTrials.gov Identifier: | NCT00693186 History of Changes |
| Other Study ID Numbers: | HXV01C |
| Study First Received: | June 4, 2008 |
| Last Updated: | November 17, 2010 |
| Health Authority: | Italy: The Italian Medicines Agency |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on May 21, 2013