HBVaxPRO® 5 µg / 0.5 mL
Biological5 µg / 0.5 mL
NCT Number: NCT00693186
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.
Looking for future studies?
Notify Me4 year–7 year
All sexes
Interventional
Phase 3
Unità Operativa Semplice di Epidemiologia (UOSE), Quarto, Napoli, Italy
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5 µg / 0.5 mL
10 µg
Time frame: 28 to 42 days
Sanofi Pasteur, a Sanofi Company
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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