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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02012998

Enrollment

751

Registered

2013-12-17

Start date

2014-01-31

Completion date

2015-02-28

Last updated

2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Virus Diseases

Brief summary

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

Interventions

BIOLOGICALHBVAXPRO 5µg

0.5mL intramuscular injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 12 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL	One month after the challenge dose

Secondary

Measure	Time frame
Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL	Prior to challenge dose (At Day 0 prior to administration of the challenge dose)
Solicited injection-site adverse reactions and pyrexia	Day 0 to day 4 after vaccination
Unsolicited injection-site adverse reactions and systemic adverse events	Day 0 to day 14 after vaccination
Serious adverse events	From signature of the informed consent to the last visit of the subject, an expected average of one month

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026