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Meningococcal DiseasePhase 3NCT01453348

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

A Phase 3 study testing MenACWY-CRM, Combined inactivated hepatitis A & recombinant hepatitis B and Recombinant hepatitis B vaccine in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
What is being tested?
MenACWY-CRM, Combined inactivated hepatitis A & recombinant hepatitis B and Recombinant hepatitis B vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
4 sitesGermany
Study dates
Oct 2011to Jan 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Individuals eligible for enrollment in this study were female and male subjects who had shown to be healthy and who were:
  • Between 18 and 64 years of age inclusive and who had given their written informed consent;
  • Available for all visits and telephone calls scheduled for the study;
  • In good health as determined by medical history, physical examination and clinical judgment of the investigator;
  • For female subjects, had a negative urine pregnancy test.

Who cannot join

  • Individuals not eligible to be enrolled in the study were those:
  • Who were breastfeeding.
  • Who had a previous personal history of Neisseria meningitidis, hepatitis A or hepatitis B infection.
  • Who received previous immunization with any meningococcal vaccine.
  • 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.
  • 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.
Show all 27Show fewer
  • 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).
  • 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.
  • 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).
  • Who had epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome.
  • 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.
  • 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.
  • Who were known to have a bleeding diathesis, or any condition that might have been associated with a prolonged bleeding time.
  • Who had any condition that, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.
  • Who were part of the study personnel or close family members of those conducting this study.

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • 03, Novartis Investigational Site

    Berlin, 10117

  • 02, Novartis Investigational Site

    Hamburg, 20359

  • 01, Novartis Investigational Site

    München, 80802

  • 04, Novartis Investigational Site

    Rostock, 18057

Other trials in Germany

About this study

Official title: A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine When Administered Concomitantly With Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Adults

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

Being tested
MenACWY-CRM, Combined inactivated hepatitis A & recombinant hepatitis B, Recombinant hepatitis B vaccine, Inactivated hepatitis A vaccine
Keywords
meningococcal, conjugate, vaccine, adults
Medical subject headings
Meningococcal Infections, Meningitis, Meningococcal, Hepatitis A, Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MenACWY-CRMBiological

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

  • Combined inactivated hepatitis A & recombinant hepatitis BBiological

    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 vaccineBiological

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

  • Inactivated hepatitis A vaccineBiological

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

Study groups in NCT01453348
Study groupRoleWhat they receive
Group 1Active comparatorThis group will receive Inactivated hepatitis A and recombinant hepatitis B or 'Combined inactivated hepatitis A \& recombinant hepatitis B vaccine' alone on the different visits.
Receives: Biological: Combined inactivated hepatitis A & recombinant hepatitis B; Biological: Recombinant hepatitis B vaccine; Biological: Inactivated hepatitis A vaccine
Group 2Active comparatorThis 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.
Receives: Biological: MenACWY-CRM; Biological: Combined inactivated hepatitis A & recombinant hepatitis B; Biological: Recombinant hepatitis B vaccine; Biological: Inactivated hepatitis A vaccine
Group 3Active comparatorThis group will receive only MenACWY-CRM.
Receives: Biological: MenACWY-CRM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 57 (previously unprimed subjects) day 29 (previously primed subjects) postvaccination.

Secondary outcomes (4)

  1. 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.

    Measured: 28 days post primary or booster vaccination.

  2. 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.

    Measured: 28 days postvaccination (day 29).

  3. 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.

    Measured: 28 days post vaccination (day 29).

  4. 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).

    Measured: Day 1 to day 57.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01453348
Sponsor's protocol ID
V59_53
Other IDs
2011-001333-17
Status last verified
May 2017
First submitted
3 Oct 2011
Last updated
8 Jun 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 25483566

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MenACWY-CRM, Combined inactivated hepatitis A & recombinant hepatitis B and Recombinant hepatitis B vaccine in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination (time frame: Day 57 (previously unprimed subjects) day 29 (previously primed subjects) postvaccination.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01453348, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2017.

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