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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001333-17 | EudraCT Number |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This study compares the safety and immunogenicity profile of combined hepatitis A/B vaccine given alone or concomitantly with MenACWY-CRM to healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | 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. |
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| Group 2 | Active Comparator | 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. |
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| Group 3 | Active Comparator | This group will receive only MenACWY-CRM. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MenACWY-CRM | Biological | Novartis meningococcal ACWY conjugate vaccine will be administered intramuscularly (IM) on day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Individuals eligible for enrollment in this study were female and male subjects who had shown to be healthy and who were:
Exclusion Criteria:
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.
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:
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):
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.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 03, Novartis Investigational Site | Berlin | 10117 | Germany | |||
| 02, Novartis Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25483566 | Derived | 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. |
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All enrolled subjects were included in the trial.
Subjects were enrolled at four centers in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | HepA/B | Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Combined inactivated hepatitis A & recombinant hepatitis B | 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. |
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| Recombinant hepatitis B vaccine | Biological | Recombinant hepatitis B vaccine will be administered intramuscularly on days 8 and 29 |
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| Inactivated hepatitis A vaccine | Biological | Inactivated hepatitis A will be administered intramuscularly on days 8 and 29. |
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| 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). |
| 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). |
| 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. |
| Hamburg |
| 20359 |
| Germany |
| 01, Novartis Investigational Site | München | 80802 | Germany |
| 04, Novartis Investigational Site | Rostock | 18057 | Germany |
| FG001 | HepA/B+MenACWY-CRM | Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine. |
| FG002 | MenACWY-CRM | Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HepA/B | Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine. |
| BG001 | HepA/B+MenACWY-CRM | Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine. |
| BG002 | MenACWY-CRM | Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis was done on Per Protocol (PP) population who provided evaluable serum samples and whose assay results were available at the relevant time points, and had no major protocol deviations | Posted | Geometric Mean | 95% Confidence Interval | Concentrations (mIU/mL) | Day 57 (previously unprimed subjects) day 29 (previously primed subjects) postvaccination. |
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| 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. | Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit. | Posted | Number | 95% Confidence Interval | percentage of subjects | 28 days post primary or booster vaccination. |
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| 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. | Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit. | Posted | Number | 95% Confidence Interval | percentage of subjects | 28 days postvaccination (day 29). |
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| 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. | Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 28 days post vaccination (day 29). |
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| 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). | Analysis was done on safety set- subjects who provided any post-baseline safety data. | Posted | Number | percentage of subjects | Day 1 to day 57. |
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Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HepA/B | Subject ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine. | 1 | 84 | 25 | 84 | ||
| EG001 | HepA/B+ACWY | Subject ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine. | 0 | 85 | 21 | 85 | ||
| EG002 | ACWY | Subject ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine. | 1 | 83 | 12 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| RENAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| COMPLETED SUICIDE | Psychiatric disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FATIGUE | General disorders | Non-systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | Non-systematic Assessment |
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| INJECTION SITE PAIN | General disorders | Non-systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | Non-systematic Assessment |
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| HEADACHE | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D008585 | Meningitis, Meningococcal |
| D006506 | Hepatitis A |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
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| ID | Term |
|---|---|
| C556088 | MenACWY-CRM vaccine |
| D017325 | Hepatitis B Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Male |
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| Prevaccination AntiHBV (N=78, 76) |
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| 28 days after primary or booster AntiHBV (N=78,76) |
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(GMC anti-HAV + MenACWY-CRM / GMC anti-HAV) |
| The primary criterion for immunogenicity was that the the lower-limit of the two-sided 95% CI on the ratio of ELISA GMCs (Hep A/B + MenACWY-CRM to Hep A/B) is below or equal to 0.5. | ANCOVA | The ANCOVA model included vaccines group and center as factors, age as covariate and was adjusted for baseline. | The testing was done by assessing the confidence interval of the ratio | Ratio of GMC | 1.19 | 2-Sided | 95 | 0.59 | 2.37 | Non-Inferiority or Equivalence | (GMC anti-HBsAg + MenACWY-CRM / GMC anti-HBsAg) |
| HepA/B |
Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine. |
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| OG001 | MenACWY-CRM | Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine. |
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Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine. |
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| OG002 | MenACWY-CRM | Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine. |
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