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

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ClinicalTrials.gov Identifier: NCT01453348
Recruitment Status : Completed
First Posted : October 17, 2011
Results First Posted : March 10, 2014
Last Update Posted : June 8, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Meningococcal Disease
Meningococcal Meningitis
Hepatitis A
Hepatitis B
Interventions Biological: MenACWY-CRM
Biological: Combined inactivated hepatitis A & recombinant hepatitis B
Biological: Recombinant hepatitis B vaccine
Biological: Inactivated hepatitis A vaccine
Enrollment 252
Recruitment Details Subjects were enrolled at four centers in Germany.
Pre-assignment Details All enrolled subjects were included in the trial.
Arm/Group Title HepA/B HepA/B+MenACWY-CRM MenACWY-CRM
Hide 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
Reason Not Completed
Death             0             0             1
Withdrawal by Subject             0             1             0
Protocol Violation             1             0             0
Arm/Group Title HepA/B HepA/B+MenACWY-CRM MenACWY-CRM Total
Hide 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 Number of Baseline Participants 84 84 84 252
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 84 participants 84 participants 84 participants 252 participants
39.0  (12.3) 39.9  (12.6) 39.7  (11.0) 39.5  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 84 participants 84 participants 252 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%
1.Primary Outcome
Title Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 78 78
Geometric Mean (95% Confidence Interval)
Unit of Measure: Concentrations (mIU/mL)
Prevaccination AntiHAV
48
(27 to 85)
30
(17 to 54)
28 days after primary or booster AntiHAV
786
(591 to 1046)
884
(664 to 1176)
Prevaccination AntiHBV (N=78, 76)
22
(12 to 39)
31
(17 to 57)
28 days after primary or booster AntiHBV (N=78,76)
844
(513 to 1387)
711
(429 to 1179)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Comments The testing was done by assessing the confidence interval of the ratio
Method ANCOVA
Comments The Analysis of variance (ANCOVA) model included vaccine group and center as factors, age as covariate and was adjusted for baseline.
Method of Estimation Estimation Parameter Ratio of GMC
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.6 to 1.32
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide 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 [Not Specified]
Comments The testing was done by assessing the confidence interval of the ratio
Method ANCOVA
Comments The ANCOVA model included vaccines group and center as factors, age as covariate and was adjusted for baseline.
Method of Estimation Estimation Parameter Ratio of GMC
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.59 to 2.37
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 83 82
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
AntiHAV antibody concentration ≥20mIU/mL (Day 1)
42
(31 to 54)
33
(23 to 44)
28 days after primary/booster AntiHAV
96
(90 to 99)
99
(93 to 100)
AntiHBsAg antibody concentration ≥10mIU/mL (Day 1)
47
(36 to 58)
44
(33 to 55)
28 days after primary/booster AntiHBV
75
(64 to 84)
80
(70 to 88)
3.Secondary Outcome
Title Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29
Hide 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).
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 83 83
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
MenA-hSBA Overall Seroresponse (N=83, 82)
71
(60 to 81)
65
(53 to 75)
MenC-hSBA Overall Seroresponse
66
(55 to 76)
59
(48 to 70)
MenW-hSBA Overall Seroresponse (N=83, 82)
40
(29 to 51)
34
(24 to 45)
MenY-hSBA Overall Seroresponse
70
(59 to 79)
64
(53 to 74)
4.Secondary Outcome
Title hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29
Hide 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).
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 84 84
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Men A Human Complement SBA; Day 1 (N= 84, 84)
2.68
(2.27 to 3.17)
2.71
(2.29 to 3.2)
Men A Human Complement SBA; Day 29 (N=83, 82)
43
(27 to 67)
36
(23 to 58)
Men C Human Complement SBA; Day 1 (N= 84, 84)
7.39
(5.49 to 9.94)
6.35
(4.71 to 8.57)
Men C Human Complement SBA; Day 29 (N=83, 83)
75
(50 to 112)
56
(37 to 83)
Men W Human Complement SBA; Day 1 (N=84, 83)
30
(21 to 42)
31
(22 to 45)
Men W Human Complement SBA; Day 29 (N=83, 83)
110
(84 to 145)
109
(82 to 144)
Men Y Human Complement SBA; Day 1 (N= 84, 84)
6.63
(5.06 to 8.68)
5.56
(4.23 to 7.3)
Men Y Human Complement SBA; Day 29 (N=83, 83)
78
(55 to 111)
62
(44 to 89)
5.Secondary Outcome
Title Percentages of Subjects With Unsolicited Adverse Events (AEs)
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 84 85 83
Measure Type: Number
Unit of Measure: percentage of subjects
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
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HepA/B HepA/B+ACWY ACWY
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/84 (1.19%)   0/85 (0.00%)   1/83 (1.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
RENAL CANCER *  1/84 (1.19%)  0/85 (0.00%)  0/83 (0.00%) 
Psychiatric disorders       
COMPLETED SUICIDE *  0/84 (0.00%)  0/85 (0.00%)  1/83 (1.20%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HepA/B HepA/B+ACWY ACWY
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/84 (29.76%)   21/85 (24.71%)   12/83 (14.46%) 
General disorders       
FATIGUE *  2/84 (2.38%)  6/85 (7.06%)  0/83 (0.00%) 
INFLUENZA LIKE ILLNESS *  2/84 (2.38%)  1/85 (1.18%)  5/83 (6.02%) 
INJECTION SITE PAIN *  4/84 (4.76%)  5/85 (5.88%)  1/83 (1.20%) 
Infections and infestations       
NASOPHARYNGITIS *  6/84 (7.14%)  9/85 (10.59%)  5/83 (6.02%) 
Nervous system disorders       
HEADACHE *  15/84 (17.86%)  6/85 (7.06%)  2/83 (2.41%) 
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
EMail: RegistryContactVaccinesUS@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01453348     History of Changes
Other Study ID Numbers: V59_53
2011-001333-17 ( EudraCT Number )
First Submitted: October 3, 2011
First Posted: October 17, 2011
Results First Submitted: October 22, 2013
Results First Posted: March 10, 2014
Last Update Posted: June 8, 2017