A Study to Evaluate Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of Engerix™-B Kinder Challenge Dose, in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa During Infancy

NCT02798952 | Completed Phase 4 Results

• 2 other identifiers: 1067942015-003391-74
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 14-15 years who were vaccinated with four doses of Infanrix™-Hexa in the first two years of life 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

Hepatitis B antibodies; Safety; Challenge dose; Persistence; Engerix B Kinder; Infanrix hexa; Immunogenicity; Adolescents

Outcome Measures

Primary Outcomes (1)

• Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations

  Concentrations were expressed in geometric mean concentrations (GMCs).

  At Day 30.

Secondary Outcomes (8)

• Anti-HBs Antibody Concentrations

  At Day 0

• Number of Seropositive Subjects for Anti-HBs.

  At Day 0 and Day 30

• Number of Seroprotected Subjects for Anti-HBs.

  At Day 0 and day 30

• Number of Subjects With Anti-HBs Concentrations Above the Cut-off.

  At Day 0 and Day 30

• Number of Subjects With an Anamnestic Response to the Hepatitis B Challenge Dose.

  At Day 30

Study Arms (1)

HBV Group

EXPERIMENTAL

Subjects received a single challenge dose of Engerix-B Kinder.

Biological: Engerix-B Kinder

Interventions

Engerix-B Kinder BIOLOGICAL

Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 14-15 years of age.

HBV Group

Eligibility Criteria

• Age: 14 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.
• In addition to the informed consent that will be signed by the parents/LAR(s), written informed assent of the subject will be sought.
• A male or female between the ages of 14 to 15 at the time of vaccination.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• 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.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy or ovariectomy.
• 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 other than the study vaccine during the period starting 30 days before the dose of study vaccine, or planned use during the study period.
• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
• Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
• Administration of long-acting immune-modifying drugs at any time during the study period.
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending 30 days after the dose of HBV vaccine administration with the exception of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, which can be given as part of routine vaccination practice. Seasonal or pandemic influenza vaccine can be given at any time during the study, and according to the Summary of Product Characteristics and national recommendations.
• 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.
• 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 (14)

GSK Investigational Site

Kehl, Baden-Wurttemberg, 77694, Germany

Location

GSK Investigational Site

Mannheim, Baden-Wurttemberg, 68161, Germany

Location

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, 70499, Germany

Location

GSK Investigational Site

Tuttlingen, Baden-Wurttemberg, 78532, Germany

Location

GSK Investigational Site

Bindlach, Bavaria, 95463, Germany

Location

GSK Investigational Site

Cham, Bavaria, 93413, Germany

Location

GSK Investigational Site

Würzburg, Bavaria, 97070, Germany

Location

GSK Investigational Site

Goch, North Rhine-Westphalia, 47574, Germany

Location

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, 67227, Germany

Location

GSK Investigational Site

Wurzen, Saxony, 04808, Germany

Location

GSK Investigational Site

Berlin, 13055, Germany

Location

GSK Investigational Site

Bramsche, 49565, Germany

Location

GSK Investigational Site

Mönchengladbach, 41236, Germany

Location

GSK Investigational Site

Neumünster, 24534, Germany

Location

Related Publications (1)

• Schwarz TF, Behre U, Adelt T, Donner M, Suryakiran PV, Janssens W, Mesaros N, Panzer F. Long-term antibody persistence against hepatitis B in adolescents 14-15-years of age vaccinated with 4 doses of hexavalent DTPa-HBV-IPV/Hib vaccine in infancy. Hum Vaccin Immunother. 2019;15(1):235-241. doi: 10.1080/21645515.2018.1509658. Epub 2018 Sep 11.

  PMID: 30118633 BACKGROUND

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

eg763112@gsk.com

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: June 9, 2016
• First Posted: June 14, 2016
• Study Start: August 23, 2016
• Primary Completion: July 5, 2017
• Study Completion: July 5, 2017
• Last Updated: January 18, 2020
• Results First Posted: February 1, 2019

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

DE (14)