Trial record 1 of 1 for:
A3L49
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 |
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Recruitment Status :
Completed
First Posted : March 3, 2016
Last Update Posted : April 26, 2017
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis B | Biological: Euvax B®: Hepatitis B vaccine | Phase 3 |
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.
| 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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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® |
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Experimental: Infanrix® hexa Group
Subjects that received Infanrix® hexa in Study A3L12
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Biological: Euvax B®: Hepatitis B vaccine
0.5 mL, Intramuscular
Other Name: Euvax B® |
Primary Outcome Measures :
- 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) ]
Secondary Outcome Measures :
- 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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 9 Years to 10 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Information from the National Library of Medicine
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
Locations
| Thailand | |
| Bangkok, Thailand | |
| Khon Kaen, Thailand | |
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
| Study Director: | Medical Director | Sanofi Pasteur SA |
Additional Information:
| Responsible Party: | Sanofi Pasteur, a Sanofi Company |
| ClinicalTrials.gov Identifier: | NCT02697474 History of Changes |
| Other Study ID Numbers: |
A3L49 U1111-1161-2421 ( Other Identifier: WHO ) |
| First Posted: | March 3, 2016 Key Record Dates |
| Last Update Posted: | April 26, 2017 |
| Last Verified: | April 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Individual participant data (IPD) and supporting clinical documents are available for request at http://www.clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: http://www.Clinicalstudydatarequest.com/Sanofi" |
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
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Hepatitis B DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine Euvax-B® Hexaxim® Infanrix® hexa |
Additional relevant MeSH terms:
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Hepatitis Hepatitis B Liver Diseases Digestive System Diseases Hepadnaviridae Infections DNA Virus Infections |
Virus Diseases Hepatitis, Viral, Human Vaccines Antibodies Immunologic Factors Physiological Effects of Drugs |