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.

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02697474
• Other study ID #: A3L49
• Secondary ID: U1111-1161-2421
• Status: Completed
• Phase: Phase 3
• Start date: February 2016
• Est. completion date: January 2017

Study information

• Verified date: March 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Subjects age 9 to 10 years who had received 3 injections of Hexaxim® or Infanrix® hexa and have completed the A3L12 study will be invited to participate in this study. They will receive one dose of Euvax-B® vaccine at Day 0.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Intervention

Biological:
• Euvax B®: Hepatitis B vaccine
0.5 mL, Intramuscular
• Euvax B®: Hepatitis B vaccine
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study		Day 0 (pre-vaccination)
Primary	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		Day 28 (post-vaccination)
Secondary	Number of subjects reporting Serious Adverse Events and relatedness to study vaccine throughout the study		Day 0 up to Day 28 post-vaccination

External Links

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