Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01453348
Other study ID # V59_53
Secondary ID 2011-001333-17
Status Completed
Phase Phase 3
First received October 3, 2011
Last updated May 8, 2017
Start date October 2011
Est. completion date January 2012

Study information

Verified date May 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 252
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility 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.

Study Design


Intervention

Biological:
MenACWY-CRM
Novartis meningococcal ACWY conjugate vaccine will be administered intramuscularly (IM) on day 1.
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.
Recombinant hepatitis B vaccine
Recombinant hepatitis B vaccine will be administered intramuscularly on days 8 and 29
Inactivated hepatitis A vaccine
Inactivated hepatitis A will be administered intramuscularly on days 8 and 29.

Locations

Country Name City State
Germany 03, Novartis Investigational Site Berlin
Germany 02, Novartis Investigational Site Hamburg
Germany 01, Novartis Investigational Site München
Germany 04, Novartis Investigational Site Rostock

Sponsors (2)

Lead Sponsor Collaborator
Novartis Vaccines GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination Assessment was made to demonstrate the non-inferiority of hepatitis A/B vaccine with MenACWY-CRM as compared to hepatitis A/B vaccine without MenACWY-CRM, as measured by geometric mean concentrations on day 57 in previously unvaccinated subjects or on day 29 after a booster dose in previously vaccinated subjects. Day 57 (previously unprimed subjects) day 29 (previously primed subjects) postvaccination.
Secondary Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination Immunogenicity was assessed as the percentages of subjects with anti-HAV concentration =20 mIU/mL and anti- HBsAg antibody concentration =10 mIU/mL, 28 days after primary or booster vaccination. 28 days post primary or booster vaccination.
Secondary Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29 Immunogenicity was assessed as the seroresponse rates for meningococcal serogroups A, C, W and Y elicited by MenACWY-CRM on day 29 when given concomitantly with combined hepatitis A/B vaccine or given alone.
For a subject with a baseline hSBA titer < 1:4, seroresponse is defined as a postvaccination hSBA titer =1:8; for a subject with a baseline hSBA titer = 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
28 days postvaccination (day 29).
Secondary hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 Immunogenicity was assessed in terms of geometric mean titers (GMTs) of antibodies to meningococcal serogroups A, C, W and Y on day 29 when given concomitantly with combined hepatitis A/B vaccine or given alone. 28 days post vaccination (day 29).
Secondary Percentages of Subjects With Unsolicited Adverse Events (AEs) Safety was assessed in terms of percentage of all spontaneously reported AEs collected from the time the subject signed the informed consent form (day 1), until the subject stopped study participation (day 57). Day 1 to day 57.
See also
  Status Clinical Trial Phase
Completed NCT01182311 - Duration of Long-term Immunity After Hepatitis B Virus Immunization
Completed NCT04971928 - Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment Phase 1
Completed NCT03285620 - A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants Phase 1
Completed NCT01884415 - Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis Phase 3
Recruiting NCT05404919 - Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates Phase 2
Completed NCT02153320 - Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers Phase 1
Completed NCT00352963 - Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age). Phase 3
Completed NCT03567382 - Arresting Vertical Transmission of Hepatitis B Virus Phase 4
Not yet recruiting NCT04056728 - A Phase IV Study to Assess the Safety of EupentaTM Inj Phase 4
Not yet recruiting NCT03604016 - Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver Phase 4
Completed NCT00753649 - Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants Phase 4
Recruiting NCT03027258 - Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome N/A
Terminated NCT02604199 - A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection Phase 2
Completed NCT02540538 - Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders Phase 1
Completed NCT02169674 - Hepatitis B Booster Study in Adolescence Phase 4
Completed NCT02421666 - A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV N/A
Completed NCT01917357 - A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject Phase 3
Completed NCT01732354 - Study for Consolidation Period of Chronic Hepatitis B
Completed NCT01368497 - Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection Phase 3
Recruiting NCT01462981 - Cohort of Hepatitis B Research of Amsterdam N/A