Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in Adults

Hepatitis B Clinical Trial

Official title:

Evaluate the Effect of Risk Factors That Influence the Immunogenicity of GSK Biologicals' Twinrix Compared to Hepatitis A and Hepatitis B Vaccines Given Separately and to Show the Non-inferiority Between the Vaccines in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603252
• Other study ID #: 111149
• Status: Completed
• Phase: Phase 4
• First received: January 16, 2008
• Last updated: March 13, 2017
• Start date: January 2008
• Est. completion date: June 2008

Study information

• Verified date: March 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This protocol posting describes the booster phase of the study. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00289731).

Description:

All subjects will receive a dose of the vaccine that they received in the primary study (100382), approximately 4 years after the first dose. Blood samples will be taken before and after the administration of the vaccine dose to evaluate the anti-HAV and anti-HBs antibody response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 41 Years and older

Eligibility

Inclusion Criteria:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.

• A male or female who completed the primary vaccination phase of the study.

• Written informed consent obtained from the subject.

• If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.

• History of any hepatitis A or hepatitis B vaccination or infection, since the primary vaccination study.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

• Acute disease at the time of enrolment.

• Pregnant or lactating female.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Twinrix

• Engerix-B

• Havrix

• HBVAXPRO

• Vaqta

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Wilrijk
Germany	GSK Investigational Site	Bad Bramstedt	Schleswig-Holstein
Germany	GSK Investigational Site	Bad Segeberg	Schleswig-Holstein
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Elmshorn	Schleswig-Holstein
Germany	GSK Investigational Site	Finsterwalde	Brandenburg
Germany	GSK Investigational Site	Geringswalde	Sachsen
Germany	GSK Investigational Site	Pirna	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HAV immune response to the challenge dose
Primary	Anti-HBs antibody response to the challenge dose
Secondary	Percentage of subjects with anti-HAV antibody titres = 15 mIU/ml and GMTs calculated on seropositive subjects		Two weeks and one month after the challenge dose
Secondary	Percentage of subjects with anti-HBs antibody titres = 3.3 mIU/ml, = 10 mIU/ml, = 100 mIU/ml and anti-HBs GMTs calculated on seropositive subjects		Two weeks and one month after the challenge dose
Secondary	Occurrence and intensity of solicited local symptoms		In the 4-day follow-up period after the challenge dose
Secondary	Occurrence, intensity and relationship of solicited general symptoms		In the 4-day follow-up period after the challenge dose
Secondary	Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported		During the 31-day follow-up period after the challenge dose
Secondary	Occurrence of all serious adverse events (SAEs) reported		Following the administration of the challenge dose

External 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.