NCT02012998 is a Phase 3 clinical trial of HBVAXPRO 5µg in Virus Diseases, sponsored by Sanofi Pasteur, a Sanofi Company.

Who is sponsoring NCT02012998?

NCT02012998 is sponsored by Sanofi Pasteur, a Sanofi Company.

What drugs are being tested in NCT02012998?

Interventions in NCT02012998: HBVAXPRO 5µg.

What condition does NCT02012998 study?

NCT02012998 studies Virus Diseases, Hepatitis B.

Is NCT02012998 still recruiting?

NCT02012998 is currently completed. Last updated 8 September 2017.

Last reviewed 2017-09-08 · How we verify

NCT02012998

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 8 September 2017

What this trial tests

Phase 3 trial testing HBVAXPRO 5µg in Virus Diseases in 751 participants. Completed in 1 February 2015.

Timeline

1 January 2014

Primary endpoint
1 February 2015

1 February 2015

Quick facts

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	751
Start date	1 January 2014
Primary completion	1 February 2015
Estimated completion	1 February 2015
Sites	10 locations across Italy

Drugs / interventions tested

HBVAXPRO 5µg — full drug profile →

Conditions studied

Virus Diseases — all drugs for Virus Diseases →
Hepatitis B — all drugs for Hepatitis B →

Sponsor

Sanofi Pasteur, a Sanofi Company — full company profile →

Who can join

Adults 10 to 12, any sex, with Virus Diseases or Hepatitis B. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Safety and immune response to a challenge dose of hepatitis B vaccine in healthy children primed 10years earlier with hexavalent vaccines in a 3, 5, 11-month schedule: An open-label, controlled, multicentre trial in Italy.
Zanetti A, Desole MG, Romanò L, d'Alessandro A, et al · · 2017 · cited 10× · PMID 28624307 · DOI 10.1016/j.vaccine.2017.05.047

Verify or expand the search:

Other recruiting trials for Virus Diseases

Currently open trials in the same condition.

NCT05797246 — Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP) · Phase 2 · active not recruiting
NCT04376034 — Convalescent Plasma Collection and Treatment in Pediatrics and Adults · Phase 3 · recruiting

Other Sanofi Pasteur, a Sanofi Company trials

Trials by the same sponsor.

NCT07536048 — A Longitudinal Study of Epstein-Barr Virus (EBV) Reactivation in Adults Aged 18 to 29 Years · not yet recruiting
NCT07222059 — Phase 3 Single Arm, Open Study on vYF in Adults · Phase 3 · completed
NCT07013747 — Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne · Phase 1, PHASE2 · recruiting
NCT06838000 — Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) i · Phase 3 · active not recruiting
NCT06793826 — Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of Korea · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02012998 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi Pasteur, a Sanofi Company
Last refreshed: 8 September 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02012998.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing