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Completed

NCT Number: NCT02012998

Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA

To evaluate the immune response to Hepatitis B virus in children who have been primed with HEXAVAC or INFANRIX HEXA 10 years ago.

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Key information

Conditions

Virus Diseases Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases

Age range

10 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi Pasteur MSD Investigational Site 004, Bologna, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy child
  • Child vaccinated with 3 doses of HEXAVAC or 3 doses of INFANRIX HEXA as infant
  • Child vaccinated with the third dose of HEXAVAC or INFANRIX HEXA at least 10 years prior to challenge dose

Exclusion criteria

  • Receipt of more than 3 doses of any Hepatitis B containing vaccine
  • History of clinical diagnosis of infection due to Hepatitis B
  • History or current close contact with known carriers of Hepatitis B virus
  • Prior known sensitivity or allergy to any component of HBVAXPRO
  • Chronic illness / medical condition that could interfere with study conduct or completion
  • Coagulation disorder that would contraindicate intramuscular injection
  • Subject is pregnant
  • Receipt of corticosteroids for more than 14 days in the 30 days prior to study
  • Receipt of Immunoglobulins, blood or blood-derived products in the 3 months prior to study
  • Planned participation in another clinical study

Treatment and study plan

HBVAXPRO 5µg

Biological

0.5mL intramuscular injection

Other names: Hepatitis B vaccine (rDNA)

Primary outcomes

  1. Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL

    Time frame: One month after the challenge dose

Secondary outcomes

  1. Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL

    Time frame: Prior to challenge dose (At Day 0 prior to administration of the challenge dose)

  2. Solicited injection-site adverse reactions and pyrexia

    Time frame: Day 0 to day 4 after vaccination

  3. Unsolicited injection-site adverse reactions and systemic adverse events

    Time frame: Day 0 to day 14 after vaccination

  4. Serious adverse events

    Time frame: From signature of the informed consent to the last visit of the subject, an expected average of one month

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

An Open-label, Controlled, Multi-centre Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO to Explore the Anamnestic Immune Response in Healthy Children Vaccinated 10 Years Ago With a Primary Series (3 Doses) of Either HEXAVAC or INFANRIX HEXA

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 17, 2013
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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