Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc

Hepatitis B Clinical Trial

Official title:

Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of GSK Biologicals' Combined Hepatitis A & B Vaccine, vs Separately Administered Monovalent Hepatitis A and Hepatitis B Vaccines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289731
• Other study ID #: 100382
• Secondary ID: 1003831003841003
• Status: Completed
• Phase: Phase 4
• Start date: November 24, 2003
• Est. completion date: December 21, 2004

Study information

• Verified date: October 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The focus of this study is to evaluate how risk factors like age, gender, body mass index, smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated with GSK Biologicals' combined hepatitis A/hepatitis B vaccine or monovalent hepatitis A and B vaccines (from GSK Biologicals' or different manufacturers). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Description:

The study will also evaluate the persistence of hepatitis A and hepatitis B antibodies at months 12, 24 and 36 after the first dose of primary vaccination course.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 596
• Est. completion date: December 21, 2004
• Est. primary completion date: December 21, 2004
• 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 should be enrolled in the study.

• Healthy and non-healthy male or female aged 41 years or older at the time of the first vaccination.

• Written informed consent obtained from the subject.

• No serological signs of hepatitis A or B infection at screening.

• 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 (drug or vaccine) 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 100382.

• 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.

• Female planning to become pregnant or planning to discontinue contraceptive precautions during the primary vaccination period.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• TWINRIX™
Intramuscular injection, 3 doses
• Engerix™-B
Intramuscular injection, 3 doses
• HAVRIX™
Intramuscular injection, 2 doses
• HB VAX PRO™
Intramuscular injection, 3 doses
• Vaqta™
Intramuscular injection, 2 doses

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Wilrijk
Czechia	GSK Investigational Site	Hradec Kralove
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,  Czechia,  Germany, 

References & Publications (1)

Van der Wielen M, Van Damme P, Chlibek R, Smetana J, von Sonnenburg F. Hepatitis A/B vaccination of adults over 40 years old: comparison of three vaccine regimens and effect of influencing factors. Vaccine. 2006 Jun 29;24(26):5509-15. Epub 2006 May 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody Concentrations for Anti-hepatitis A Virus (Anti-HAV) and Anti-hepatitis B Surface (Anti-HBs) Antigens	Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (=) 15 mIU/mL and = 3.3 mIU/mL, respectively.	At Month 7 after Twinrix vaccination
Primary	Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value	Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration = 15mIU/mL; seropositivity for anti-HBs antibodies was defined as anti-HBs antibody concentration = 3.3 mIU/mL.	At Month 7
Primary	Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen	A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (=) 10 mIU/mL.	At Month 7
Secondary	Anti-HAV and Anti-HBs Antibody Concentrations	Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (=) 15 mIU/mL and = 3.3 mIU/mL, respectively.	At Month 7
Secondary	Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender	Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (=) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations = 3.3 mIU/mL. The seropositivity rates were stratified by gender (females and males).	At Month 7
Secondary	Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age	Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (=) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations = 3.3 mIU/mL. The seropositivity rates were stratified by age as follows: = 50 years of age (YOA), 51-60 YOA and = 61 YOA.	At Month 7
Secondary	Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI)	Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (=) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations = 3.3 mIU/mL. The seropositivity rates were stratified by BMI as follows: healthy, overweight and obese.	At Month 7
Secondary	Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status	Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (=) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations = 3.3 mIU/mL. The seropositivity rates were stratified by smoking status (smokers and non-smokers).	At Month 7
Secondary	Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption	Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (=) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations = 3.3 mIU/mL. The seropositivity rates were stratified by alcohol consumption as follows: None or Mild, Moderate and Heavy.	At Month 7
Secondary	Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication	Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (=) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations = 3.3 mIU/mL. The seropositivity rates were stratified by concomitant medication (concomitant medication and no concomitant medication).	At Month 7
Secondary	Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition	Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (=) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations = 3.3 mIU/mL. The seropositivity rates were stratified by medical condition as follows: no medical condition, past medical condition and current medical condition.	At Month 7
Secondary	Number of Seroprotected Subjects Against HBs Antigen, by Gender	A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (=) 10 mIU/mL. The seroprotection rates were stratified by gender (females and males).	At Month 7
Secondary	Number of Seroprotected Subjects Against HBs Antigen, by Age	A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (=) 10 mIU/mL. The seroprotection rates were stratified by age as follows: = 50 years of age (YOA), 51-60 YOA and = 61 YOA.	At Month 7
Secondary	Number of Seroprotected Subjects Against HBs Antigen, by BMI	A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (=) 10 mIU/mL. The seroprotection rates were stratified by BMI as follows: healthy, overweight and obese.	At Month 7
Secondary	Number of Seroprotected Subjects Against HBs Antigen, by Smoking Status	A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (=) 10 mIU/mL. The seroprotection rates were stratified by smoking status (smokers and non-smokers).	At Month 7
Secondary	Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption	A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (=) 10 mIU/mL. The seroprotection rates were stratified by alcohol consumption as follows: none or mild, moderate and heavy.	At Month 7
Secondary	Number of Seroprotected Subjects Against HBs Antigen, by Concomitant Medication	A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (=) 10 mIU/mL. The seroprotection rates were stratified by concomitant medication (concomitant medication and no concomitant medication).	At Month 7
Secondary	Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition	A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (=) 10 mIU/mL. The seroprotection rates were stratified by medical condition as follows: no medical condition, past medical condition and current medical condition.	At Month 7
Secondary	Anti-HAV and Anti-HBs Antibody Concentrations, by Gender	Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (=) 15 mIU/mL and = 3.3 mIU/mL, respectively. The antibody concentrations were stratified by gender (females and males).	At Month 7
Secondary	Anti-HAV and Anti-HBs Antibody Concentrations, by Age	Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (=) 15 mIU/mL and = 3.3 mIU/mL, respectively. The antibody concentrations were stratified by age as follows: = 50 years of age (YOA), 51-60 YOA and = 61 YOA.	At Month 7
Secondary	Anti-HAV and Anti-HBs Antibody Concentrations, by BMI	Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (=) 15 mIU/mL and = 3.3 mIU/mL, respectively. The antibody concentrations were stratified by BMI as follows: healthy, overweight and obese.	At Month 7
Secondary	Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status	Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (=) 15 mIU/mL and = 3.3 mIU/mL, respectively. The antibody concentrations were stratified by smoking status (smokers and non-smokers).	At Month 7
Secondary	Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption	Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (=) 15 mIU/mL and = 3.3 mIU/mL, respectively. The antibody concentrations were stratified by alcohol consumption as follows: none or mild, moderate and heavy.	At Month 7
Secondary	Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication	Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (=) 15 mIU/mL and = 3.3 mIU/mL, respectively. The antibody concentrations were stratified by concomitant medication (concomitant medication and no concomitant medication).	At Month 7
Secondary	Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition	Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (=) 15 mIU/mL and = 3.3 mIU/mL, respectively. The antibody concentrations were stratified by medical condition as follows: no medical condition, past medical condition and current medical condition.	At Month 7
Secondary	Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value	Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (=) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations = 3.3 mIU/mL. Anti-HBs AUSAB = anti-HBs antibody concentrations were tested with AUSAB EIA /Abbott assay; Anti-HBs in-house = anti-HBs antibody concentrations were tested with in-house assay (bridging).	At Month 12 (M12), Month 24 (M24) and Month 36 (M36)
Secondary	Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen	A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (=) 10 mIU/mL. Anti-HBs AUSAB = anti-HBs antibody concentrations were tested with AUSAB EIA /Abbott assay; Anti-HBs in-house = anti-HBs antibody concentrations were tested with in-house assay (bridging).	At Month 12 (M12), Month 24 (M24) and Month 36 (M36)
Secondary	Anti-HAV and Anti-HBs Antibody Concentrations	Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (=) 15 mIU/mL and = 3.3 mIU/mL, respectively. Anti-HBs AUSAB = anti-HBs antibody concentrations were tested with AUSAB EIA /Abbott assay; Anti-HBs in-house = anti-HBs antibody concentrations were tested with in-house assay (bridging).	At Month 12 (M12), Month 24 (M24) and Month 36 (M36)
Secondary	Number of Subjects With Serious Adverse Events (SAEs)	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: 3 subjects reported SAEs prior to administration of the first dose of vaccination.	From Day 0 up to Month 7
Secondary	Number of Subjects With SAEs	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: 3 subjects reported SAEs prior to administration of the first dose of vaccination.	At Month 12 (M12), Month 24 (M24) and Month 36 (M36)

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