This Study Aims to Determine the Long-term Persistence of Antibodies Against Hepatitis B and to Evaluate the Immunogenicity and Safety of Hepatitis B Vaccine in Adolescents Vaccinated in Infancy With Infanrix™ Hexa

NCT02052661 | Completed Phase 4 Results

• 2 other identifiers: 1067932013-002821-41
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 12-13 years who were vaccinated with four doses of Infanrix™-Hexa in infancy and to assess the anamnestic response, immunogenicity, safety and reactogenicity of a single challenge dose of the hepatitis B vaccine Engerix™-B Kinder.

Conditions

Hepatitis B

Keywords

Infanrix™ hexa; Hepatitis B antibodies; Immunogenicity; Hepatitis B; Adolescents; Infancy; Engerix™-B Kinder; Safety

Outcome Measures

Primary Outcomes (1)

• Anti-HBs Immune Response

  Anti-HBs immune response was defined as the number of subjects with Anti-HBs antibody concentrations ≥ 100 mIU/ml.

  One month after the single challenge dose of Engerix-B Kinder vaccine (Month 1)

Secondary Outcomes (8)

• Anti-HBs Antibody Concentrations at 12-13 Years of Age, After Previous Vaccination With Infanrix Hexa.

  Before (PRE) and 1 month after (POST) the single challenge dose of Engerix-B Kinder vaccine.

• Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml, ≥ 10 mIU/ml, 10 to < 100 mIU/ml and ≥ 100 mIU/ml.

  Before the single challenge dose of Engerix-B Kinder vaccine.

• Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml and ≥ 10 mIU/ml.

  1 month after the single challenge dose of Engerix-B Kinder vaccine.

• Number of Subjects With an Anamnestic Response to the Single Challenge Dose of Engerix-B Kinder Vaccine.

  One month after the single challenge dose of Engerix-B Kinder vaccine.

• Number of Subjects With Any Solicited Local Symptoms.

  During the 4-day (Day 0-3) follow-up period after the single challenge dose of Engerix-B Kinder vaccine.

Study Arms (1)

Engerix-B Kinder Group

EXPERIMENTAL

Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.

Biological: Engerix™-B Kinder

Interventions

Engerix™-B Kinder BIOLOGICAL

Single dose administered intramuscularly in deltoid region of non-dominant arm.

Engerix-B Kinder Group

Eligibility Criteria

• Age: 12 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects' parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
• A male or female between the ages of 12 to 13 (from and including the 12th birthday, up to but excluding the 14th birthday) at the time of enrolment.
• Subjects with documented evidence of previous vaccination with four consecutive doses of Infanrix hexa as part of routine vaccination in Germany: three doses of primary vaccination received by 9 months of age and one booster dose received between 11 and 18 months of age.
• Written informed consent obtained from the parents/LAR(s) of the subject.
• In addition to the informed consent that will be signed by the parents/LAR(s), written informed assent of the subject will be sought.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
• 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.

You may not qualify if:

• Child in care.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
• Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination. Inhaled and topical steroids are allowed.
• Administration of any chronic drug therapy to be continued during the study period.
• 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 challenge dose, with the exception of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (dTpa) vaccine, which can be given as part of routine vaccination practice.
• 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 vaccine/product (pharmaceutical product or device).
• Evidence of previous hepatitis B booster vaccination since administration of the fourth dose of Infanrix hexa booster in the second year of life.
• History of or intercurrent hepatitis B disease.
• Hepatitis B vaccination at birth.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Major congenital defects or serious chronic illness including thrombocytopenia and bleeding disorders.
• History of any neurological disorders or seizures.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (11)

GSK Investigational Site

Kehl, Baden-Wurttemberg, 77694, Germany

Location

GSK Investigational Site

Tuttlingen, Baden-Wurttemberg, 78532, Germany

Location

GSK Investigational Site

Bindlach, Bavaria, 95463, Germany

Location

GSK Investigational Site

Goch, North Rhine-Westphalia, 47574, Germany

Location

GSK Investigational Site

Löhne, North Rhine-Westphalia, 32584, Germany

Location

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, 67227, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04178, Germany

Location

GSK Investigational Site

Radebeul, Saxony, 01445, Germany

Location

GSK Investigational Site

Flensburg, Schleswig-Holstein, 24937, Germany

Location

GSK Investigational Site

Berlin, 13055, Germany

Location

GSK Investigational Site

Neumünster, 24534, Germany

Location

Related Links

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

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 3, 2014
• Study Start: February 18, 2014
• Primary Completion: September 23, 2014
• Study Completion: September 23, 2014
• Last Updated: June 6, 2018
• Results First Posted: August 27, 2015

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (11)