Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.
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ClinicalTrials.gov Identifier: NCT02697474 |
Recruitment Status :
Completed
First Posted : March 3, 2016
Last Update Posted : April 6, 2022
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The aim of the study is to assess the persistence of anti-Hep B antibody at 9 to 10 years of age after the last priming dose in subjects who completed study A3L12 (NCT00401531), and also evaluate the immune response against hepatitis B one month after vaccination (challenge vaccination) with a stand alone monovalent hepatitis B vaccine.
Primary objectives:
- To describe the persistence of anti-hepatitis B antibody at 9 to 10 years of age after last priming dose in subjects having received hepatitis B vaccine at birth and a hexavalent vaccine at 2, 4 and 6 months of age according to the vaccine received during A3L12 study (Hexaxim® [Group 1] or Infanrix® hexa [Group 2])
- To evaluate the immune response against hepatitis B one month after vaccination with a stand alone monovalent hepatitis B vaccine (challenge vaccination).
Secondary objectives:
- To describe serious adverse events (SAEs) reported throughout the trial after administration of hepatitis B vaccine.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis B | Biological: Euvax B®: Hepatitis B vaccine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Persistence of Anti-Hep B Antibodies at 9 to 10 Years of Age in Subjects Having Received Hep B Vaccine at Birth and a DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine at 2, 4 and 6 Months of Age, and Evaluation of Their Immune Memory Following a Challenge Re-vaccination With a Stand Alone Hep B Vaccine |
Actual Study Start Date : | February 2016 |
Actual Primary Completion Date : | June 2016 |
Actual Study Completion Date : | January 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Hexaxim® Group
Subjects that received Hexaxim® in Study A3L12
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Biological: Euvax B®: Hepatitis B vaccine
0.5 mL, Intramuscular
Other Name: Euvax B® |
Experimental: Infanrix® hexa Group
Subjects that received Infanrix® hexa in Study A3L12
|
Biological: Euvax B®: Hepatitis B vaccine
0.5 mL, Intramuscular
Other Name: Euvax B® |
- Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study [ Time Frame: Day 0 (pre-vaccination) ]
- Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study following vaccination with Euvax B® vaccine [ Time Frame: Day 28 (post-vaccination) ]
- Number of subjects reporting Serious Adverse Events and relatedness to study vaccine throughout the study [ Time Frame: Day 0 up to Day 28 post-vaccination ]

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Ages Eligible for Study: | 9 Years to 10 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Informed consent form signed by subject's parent/legally acceptable representative
- Assent form signed by subject
- Subject and parent(s)/legally acceptable representatives able to attend the scheduled visits and to comply with all trial procedures
- Receipt of primary vaccination with 3 doses of either Hexaxim® or Infanrix® hexa at the age of 2, 4, and 6 months in the A3L12 study, and hepatitis B vaccine at birth.
Exclusion Criteria:
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the inclusion in the trial
- Incomplete primary immunization in the A3L12 study
- Diagnostic of hepatitis B infection (clinical, serological, or virological confirmation) after completion of A3L12 study procedures
- Subjects known to have received hepatitis B vaccine after completion of the A3L12 study procedures
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for Bacille Calmette Guerin (BCG) vaccination (any administration of oral polio vaccine [OPV] in the context of oral polio vaccine-national immunization days [OPV-NIDs] does not fall within the scope of this exclusion criterion)
- Receipt of any blood, blood-derived products or immunosuppressant drugs at the latest 3 months before inclusion
- Known or suspected diagnostic of congenital or acquired immunodeficiency since completion of the A3L12 study procedures
- Serious chronic illness occurring after receipt of the primary series (e.g., leukemia, lymphoma [T or B cells], Crohn's disease)
- Known or suspected subject seropositivity against human immunodeficiency virus (HIV) or hepatitis C since completion of the A3L12 study procedures
- Febrile (temperature ≥ 38.0°C) or acute, moderate or severe systemic illness on the day of inclusion.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697474
Thailand | |
Bangkok, Thailand | |
Khon Kaen, Thailand |
Study Director: | Medical Director | Sanofi Pasteur SA |
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT02697474 |
Other Study ID Numbers: |
A3L49 U1111-1161-2421 ( Other Identifier: WHO ) |
First Posted: | March 3, 2016 Key Record Dates |
Last Update Posted: | April 6, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org |
Hepatitis B DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine Euvax-B® Hexaxim® Infanrix® hexa |
Hepatitis B Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections |
Blood-Borne Infections Communicable Diseases Hepadnaviridae Infections DNA Virus Infections Vaccines Immunologic Factors Physiological Effects of Drugs |