Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine

NCT ID: NCT01453348

Last Updated: 2017-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-01-31

Brief Summary

This study compares the safety and immunogenicity profile of combined hepatitis A/B vaccine given alone or concomitantly with MenACWY-CRM to healthy adults.

Conditions

Meningococcal Disease; Meningococcal Meningitis; Hepatitis A; Hepatitis B

Study Design

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

Study Groups

Group 1

This group will receive Inactivated hepatitis A and recombinant hepatitis B or 'Combined inactivated hepatitis A \& recombinant hepatitis B vaccine' alone on the different visits.

Group Type: ACTIVE_COMPARATOR

Combined inactivated hepatitis A & recombinant hepatitis B

Intervention Type: BIOLOGICAL

Combined inactivated hepatitis A and recombinant hepatitis B vaccine will be administered by IM on days 1, 8 \& 29 for subjects unprimed with hepatitis A and B; and a single booster injection on day 1 for primed subjects.

Recombinant hepatitis B vaccine

Intervention Type: BIOLOGICAL

Recombinant hepatitis B vaccine will be administered intramuscularly on days 8 and 29

Inactivated hepatitis A vaccine

Intervention Type: BIOLOGICAL

Inactivated hepatitis A will be administered intramuscularly on days 8 and 29.

Group 2

This group will receive Inactivated hepatitis A vaccine and recombinant hepatitis B Vaccine or 'Combined inactivated hepatitis A \& recombinant hepatitis B vaccine' concomitantly with MenACWY-CRM.

Group Type: ACTIVE_COMPARATOR

MenACWY-CRM

Intervention Type: BIOLOGICAL

Novartis meningococcal ACWY conjugate vaccine will be administered intramuscularly (IM) on day 1.

Combined inactivated hepatitis A & recombinant hepatitis B

Intervention Type: BIOLOGICAL

Combined inactivated hepatitis A and recombinant hepatitis B vaccine will be administered by IM on days 1, 8 \& 29 for subjects unprimed with hepatitis A and B; and a single booster injection on day 1 for primed subjects.

Recombinant hepatitis B vaccine

Intervention Type: BIOLOGICAL

Recombinant hepatitis B vaccine will be administered intramuscularly on days 8 and 29

Inactivated hepatitis A vaccine

Intervention Type: BIOLOGICAL

Inactivated hepatitis A will be administered intramuscularly on days 8 and 29.

Group 3

This group will receive only MenACWY-CRM.

Group Type: ACTIVE_COMPARATOR

MenACWY-CRM

Intervention Type: BIOLOGICAL

Novartis meningococcal ACWY conjugate vaccine will be administered intramuscularly (IM) on day 1.

Interventions

MenACWY-CRM

Novartis meningococcal ACWY conjugate vaccine will be administered intramuscularly (IM) on day 1.

Intervention Type: BIOLOGICAL

Combined inactivated hepatitis A & recombinant hepatitis B

Combined inactivated hepatitis A and recombinant hepatitis B vaccine will be administered by IM on days 1, 8 \& 29 for subjects unprimed with hepatitis A and B; and a single booster injection on day 1 for primed subjects.

Intervention Type: BIOLOGICAL

Recombinant hepatitis B vaccine

Recombinant hepatitis B vaccine will be administered intramuscularly on days 8 and 29

Intervention Type: BIOLOGICAL

Inactivated hepatitis A vaccine

Inactivated hepatitis A will be administered intramuscularly on days 8 and 29.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Individuals eligible for enrollment in this study were female and male subjects who had shown to be healthy and who were:

1. Between 18 and 64 years of age inclusive and who had given their written informed consent;

2. Available for all visits and telephone calls scheduled for the study;

3. In good health as determined by medical history, physical examination and clinical judgment of the investigator;

4. For female subjects, had a negative urine pregnancy test.

Exclusion Criteria

Individuals not eligible to be enrolled in the study were those:

1. Who were breastfeeding.

2. Who had a previous personal history of Neisseria meningitidis, hepatitis A or hepatitis B infection.

3. Who received previous immunization with any meningococcal vaccine.

4. Who received previous hepatitis A and/or B vaccination, determined by history (interview of the subject) and/or by review of his or her vaccination card, if less than 5 years have elapsed since vaccination.

5. Who received investigational agents or vaccines within 30 days prior to enrollment or who expected to receive an investigational agent or vaccine prior to completion of the study.

6. Who received live licensed vaccines within 30 days and inactive vaccine within 15 days prior to enrollment or for whom receipt of a licensed vaccine was anticipated during the study period (Exception: Influenza vaccine might have been administered up to 15 days prior to each study immunization and no less than 15 days after each study immunization).

7. Who experienced, within the 7 days prior to enrollment, significant acute infection (for example requiring systemic antibiotic treatment or antiviral therapy) or had experienced fever (defined as body temperature ≥ 38°C) within 3 days prior to enrollment.

8. Who had any serious acute, chronic or progressive disease such as:

• History of cancer
• Complicated diabetes mellitus
• Advanced arteriosclerotic disease
• Autoimmune disease
• HIV infection or AIDS
• Blood dyscrasias
• Congestive heart failure
• Renal failure
• Severe malnutrition (Note: Subjects with mild asthma were eligible for enrollment. Subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids were not eligible for enrollment).

9. Who had epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome.

10. Who had a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine component, including but not limited to latex allergy and antibiotic allergy.

11. Who had a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):

• Receipt of immunosuppressive therapy within 30 days prior to enrollment (systemic corticosteroids administered for more than 5 days, or in a daily dose > 1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy);
• Receipt of immunostimulants;
• Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study.

12. Who were known to have a bleeding diathesis, or any condition that might have been associated with a prolonged bleeding time.

13. Who had any condition that, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.

14. Who were part of the study personnel or close family members of those conducting this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

03, Novartis Investigational Site

Berlin, , Germany

02, Novartis Investigational Site

Hamburg, , Germany

01, Novartis Investigational Site

München, , Germany

04, Novartis Investigational Site

Rostock, , Germany

Countries

Germany

References

Alberer M, Burchard G, Jelinek T, Reisinger EC, Meyer S, Forleo-Neto E, Dagnew AF, Arora AK. Immunogenicity and safety of concomitant administration of a combined hepatitis A/B vaccine and a quadrivalent meningococcal conjugate vaccine in healthy adults. J Travel Med. 2015 Mar-Apr;22(2):105-14. doi: 10.1111/jtm.12180. Epub 2014 Dec 7.

Reference Type: DERIVED

PMID: 25483566 (View on PubMed)

Other Identifiers

2011-001333-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V59_53

Identifier Type: -

Identifier Source: org_study_id