Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine
Sponsor
Novartis Vaccines (Industry)
Overall Status
Completed
CT.gov ID
NCT01453348
Collaborator
GlaxoSmithKline (Industry)
252
4
3
3
63
20.8
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
252 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Study Start Date
:
Oct 1, 2011
Actual Primary Completion Date
:
Jan 1, 2012
Actual Study Completion Date
:
Jan 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
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.
Biological: Recombinant hepatitis B vaccine
Recombinant hepatitis B vaccine will be administered intramuscularly on days 8 and 29
Biological: Inactivated hepatitis A vaccine
Inactivated hepatitis A will be administered intramuscularly on days 8 and 29.
|
| Active Comparator: 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. |
Biological: MenACWY-CRM
Novartis meningococcal ACWY conjugate vaccine will be administered intramuscularly (IM) on day 1.
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.
Biological: Recombinant hepatitis B vaccine
Recombinant hepatitis B vaccine will be administered intramuscularly on days 8 and 29
Biological: Inactivated hepatitis A vaccine
Inactivated hepatitis A will be administered intramuscularly on days 8 and 29.
|
| Active Comparator: Group 3 This group will receive only MenACWY-CRM. |
Biological: MenACWY-CRM
Novartis meningococcal ACWY conjugate vaccine will be administered intramuscularly (IM) on day 1.
|
Outcome Measures
Primary Outcome Measures
- Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination [Day 57 (previously unprimed subjects) day 29 (previously primed subjects) postvaccination.]
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.
Secondary Outcome Measures
- Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination [28 days post 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.
- Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29 [28 days postvaccination (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.
- hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 [28 days post vaccination (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.
- Percentages of Subjects With Unsolicited Adverse Events (AEs) [Day 1 to day 57.]
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).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
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.
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:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 03, Novartis Investigational Site | Berlin | Germany | 10117 | |
| 2 | 02, Novartis Investigational Site | Hamburg | Germany | 20359 | |
| 3 | 01, Novartis Investigational Site | München | Germany | 80802 | |
| 4 | 04, Novartis Investigational Site | Rostock | Germany | 18057 |
Sponsors and Collaborators
- Novartis Vaccines
- GlaxoSmithKline
Investigators
- Study Chair: Novartis Vaccines, Novartis Vaccines
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT01453348
Other Study ID Numbers:
- V59_53
- 2011-001333-17
First Posted:
Oct 17, 2011
Last Update Posted:
Jun 8, 2017
Last Verified:
May 1, 2017
Keywords provided by Novartis Vaccines
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subjects were enrolled at four centers in Germany. |
|---|---|
| Pre-assignment Detail | All enrolled subjects were included in the trial. |
| Arm/Group Title | HepA/B | HepA/B+MenACWY-CRM | MenACWY-CRM |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine. |
| Period Title: Overall Study | |||
| STARTED | 84 | 84 | 84 |
| COMPLETED | 83 | 83 | 83 |
| NOT COMPLETED | 1 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | HepA/B | HepA/B+MenACWY-CRM | MenACWY-CRM | Total |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine. | Total of all reporting groups |
| Overall Participants | 84 | 84 | 84 | 252 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
39.0
(12.3)
|
39.9
(12.6)
|
39.7
(11.0)
|
39.5
(11.9)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
45
53.6%
|
40
47.6%
|
50
59.5%
|
135
53.6%
|
| Male |
39
46.4%
|
44
52.4%
|
34
40.5%
|
117
46.4%
|
Outcome Measures
| Title | Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination |
|---|---|
| Description | 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. |
| Time Frame | Day 57 (previously unprimed subjects) day 29 (previously primed subjects) postvaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | HepA/B+MenACWY-CRM | HepA/B |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 78 | 78 |
| Prevaccination AntiHAV |
48
|
30
|
| 28 days after primary or booster AntiHAV |
786
|
884
|
| Prevaccination AntiHBV (N=78, 76) |
22
|
31
|
| 28 days after primary or booster AntiHBV (N=78,76) |
844
|
711
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HepA/B+MenACWY-CRM, HepA/B |
|---|---|---|
| Comments | The primary criterion for immunogenicity was that the lower-limit of the two-sided 95% Confidence Interval (CI) on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs (Hep A/B + MenACWY-CRM to Hep A/B) is below or equal to 0.5. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (GMC anti-HAV + MenACWY-CRM / GMC anti-HAV) | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMC |
| Estimated Value | 0.89 | |
| Confidence Interval |
(2-Sided) 95% 0.6 to 1.32 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HepA/B+MenACWY-CRM, HepA/B |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (GMC anti-HBsAg + MenACWY-CRM / GMC anti-HBsAg) | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMC |
| Estimated Value | 1.19 | |
| Confidence Interval |
(2-Sided) 95% 0.59 to 2.37 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination |
|---|---|
| Description | 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. |
| Time Frame | 28 days post primary or booster vaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | HepA/B+MenACWY-CRM | HepA/B |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 83 | 82 |
| AntiHAV antibody concentration ≥20mIU/mL (Day 1) |
42
|
33
|
| 28 days after primary/booster AntiHAV |
96
|
99
|
| AntiHBsAg antibody concentration ≥10mIU/mL (Day 1) |
47
|
44
|
| 28 days after primary/booster AntiHBV |
75
|
80
|
| Title | Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29 |
|---|---|
| Description | 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. |
| Time Frame | 28 days postvaccination (day 29). |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | HepA/B+MenACWY-CRM | MenACWY-CRM |
|---|---|---|
| Arm/Group Description | 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. | Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine. |
| Measure Participants | 83 | 83 |
| MenA-hSBA Overall Seroresponse (N=83, 82) |
71
|
65
|
| MenC-hSBA Overall Seroresponse |
66
|
59
|
| MenW-hSBA Overall Seroresponse (N=83, 82) |
40
|
34
|
| MenY-hSBA Overall Seroresponse |
70
|
64
|
| Title | hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 |
|---|---|
| Description | 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. |
| Time Frame | 28 days post vaccination (day 29). |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | HepA/B+MenACWY-CRM | MenACWY-CRM |
|---|---|---|
| Arm/Group Description | 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. | Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine. |
| Measure Participants | 84 | 84 |
| Men A Human Complement SBA; Day 1 (N= 84, 84) |
2.68
|
2.71
|
| Men A Human Complement SBA; Day 29 (N=83, 82) |
43
|
36
|
| Men C Human Complement SBA; Day 1 (N= 84, 84) |
7.39
|
6.35
|
| Men C Human Complement SBA; Day 29 (N=83, 83) |
75
|
56
|
| Men W Human Complement SBA; Day 1 (N=84, 83) |
30
|
31
|
| Men W Human Complement SBA; Day 29 (N=83, 83) |
110
|
109
|
| Men Y Human Complement SBA; Day 1 (N= 84, 84) |
6.63
|
5.56
|
| Men Y Human Complement SBA; Day 29 (N=83, 83) |
78
|
62
|
| Title | Percentages of Subjects With Unsolicited Adverse Events (AEs) |
|---|---|
| Description | 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). |
| Time Frame | Day 1 to day 57. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on safety set- subjects who provided any post-baseline safety data. |
| Arm/Group Title | HepA/B | HepA/B+MenACWY-CRM | MenACWY-CRM |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine. |
| Measure Participants | 84 | 85 | 83 |
| Any AE |
43
|
39
|
36
|
| Atleast possibly related AE |
23
|
27
|
17
|
| Any SAE |
1
|
0
|
1
|
| AE leading to withdrawal |
0
|
1
|
1
|
| Death |
0
|
0
|
1
|
Adverse Events
| Time Frame | Day 1 to day 57. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||||
| Arm/Group Title | HepA/B | HepA/B+ACWY | ACWY | |||
| Arm/Group Description | 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. | 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. | Subject ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine. | |||
All Cause Mortality |
||||||
| HepA/B | HepA/B+ACWY | ACWY | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| HepA/B | HepA/B+ACWY | ACWY | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/84 (1.2%) | 0/85 (0%) | 1/83 (1.2%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| RENAL CANCER | 1/84 (1.2%) | 0/85 (0%) | 0/83 (0%) | |||
| Psychiatric disorders | ||||||
| COMPLETED SUICIDE | 0/84 (0%) | 0/85 (0%) | 1/83 (1.2%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| HepA/B | HepA/B+ACWY | ACWY | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 25/84 (29.8%) | 21/85 (24.7%) | 12/83 (14.5%) | |||
| General disorders | ||||||
| FATIGUE | 2/84 (2.4%) | 6/85 (7.1%) | 0/83 (0%) | |||
| INFLUENZA LIKE ILLNESS | 2/84 (2.4%) | 1/85 (1.2%) | 5/83 (6%) | |||
| INJECTION SITE PAIN | 4/84 (4.8%) | 5/85 (5.9%) | 1/83 (1.2%) | |||
| Infections and infestations | ||||||
| NASOPHARYNGITIS | 6/84 (7.1%) | 9/85 (10.6%) | 5/83 (6%) | |||
| Nervous system disorders | ||||||
| HEADACHE | 15/84 (17.9%) | 6/85 (7.1%) | 2/83 (2.4%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Posting Director |
|---|---|
| Organization | Novartis Vaccines and Diagnostics |
| Phone | |
| RegistryContactVaccinesUS@novartis.com |
Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT01453348
Other Study ID Numbers:
- V59_53
- 2011-001333-17
First Posted:
Oct 17, 2011
Last Update Posted:
Jun 8, 2017
Last Verified:
May 1, 2017