Evaluation of Antibody Persistence and Immune Memory Against the Hepatitis B Antigen in Previously Vaccinated Children

NCT ID: NCT01138098

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-07
• Study Completion Date: 2010-11-26

Brief Summary

This study will evaluate the persistence of immunity to hepatitis B 10 to 11 years after vaccination with Infanrix hexa™ or Engerix™-B and also the ability to mount an immune response to the challenge dose of Engerix™-B.

Detailed Description

Subjects who participated in the primary study 217744/031 (NCT01457495) will be invited at the age of 11-12 years to participate in this follow-up study.

Conditions

Hepatitis B

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Infanrix-hexa/Engerix-B Group

Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (217744/031 (NCT01457495)) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Engerix™-B

Intervention Type: BIOLOGICAL

Intramuscular, single dose

Infanrix-IPV+Hib/Engerix-B Group

Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (217744/031 (NCT01457495)) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.

Group Type: ACTIVE_COMPARATOR

Engerix™-B

Intervention Type: BIOLOGICAL

Intramuscular, single dose

Interventions

Engerix™-B

Intramuscular, single dose

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that their parents/Legally acceptable representative) can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female aged 11-12 years at the time of study entry (from and including the 11th birthday until and excluding the 13th birthday).
• Written informed consent obtained from the parent or Legally Acceptable Representative of the subject.
• Study procedures will be explained to subjects and depending on their understanding, optional informed assent will be sought at the discretion of the investigator.
• Written informed assent obtained from the subject in addition to the informed consent signed by the parent(s)/ Legally Acceptable Representative (s).
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Subjects who have received all three doses of Infanrix hexa or Engerix-B in the primary study 217744/031 (NCT01457495).
• Female subjects of non-childbearing potential may be enrolled in the study.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:

• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test on the day of vaccination, and
• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Child in care.
• Use of any investigational or non-registered product drug or vaccine) other than the study vaccine within 30 days preceding the challenge dose of HBV vaccine, or planned use during the study period.
• Receipt of hepatitis B (containing) vaccine after vaccination in the primary study 217744/031 (NCT01457495).
• History of hepatitis B disease.
• Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after the HBV vaccine challenge dose.
• Administration of immunoglobulins and/or any blood products within the three months preceding the challenge dose of HBV vaccine or planned administration during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose of HBV vaccine.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• Known hypersensitivity to any component of the HBV vaccine or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component.
• Acute disease and/or fever at the time of enrolment.
• Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic setting
• Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Banská Bystrica, , Slovakia

GSK Investigational Site

Dolný Kubín, , Slovakia

GSK Investigational Site

Dubnica nad Váhom, , Slovakia

GSK Investigational Site

Martin, , Slovakia

GSK Investigational Site

Nitra, , Slovakia

GSK Investigational Site

Nová Dubnica, , Slovakia

GSK Investigational Site

Nové Zámky, , Slovakia

GSK Investigational Site

Púchov, , Slovakia

GSK Investigational Site

Rožňava, , Slovakia

GSK Investigational Site

Trebišov, , Slovakia

GSK Investigational Site

Zlaté Moravce, , Slovakia

Countries

Slovakia

References

Avdicova M, Crasta PD, Hardt K, Kovac M. Lasting immune memory against hepatitis B following challenge 10-11 years after primary vaccination with either three doses of hexavalent DTPa-HBV-IPV/Hib or monovalent hepatitis B vaccine at 3, 5 and 11-12 months of age. Vaccine. 2015 May 28;33(23):2727-33. doi: 10.1016/j.vaccine.2014.06.070. Epub 2014 Jun 22.

Reference Type: DERIVED

PMID: 24962750 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

113954

Identifier Type: -

Identifier Source: org_study_id