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Trial record 83 of 578 for:    meningitis

Immunogenicity and Safety of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01897402
Recruitment Status : Completed
First Posted : July 12, 2013
Results First Posted : April 23, 2015
Last Update Posted : April 23, 2015
Sponsor:
Information provided by (Responsible Party):
JN-International Medical Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Meningococcal Meningitis
Meningococcal Infections
Interventions Biological: Test Vaccine
Biological: US Licensed Vaccine
Enrollment 525
Recruitment Details Participants recruited and were enrolled at three sites in Maryland between October 21, 2013 and May 22, 2014. The sites screened 1086 subjects with 559 screen failures. The majority, 390 subjects (69.8 %), failed due to inclusion or exclusion criteria (IC/EC). The most common failure criterion was Laboratory abnormalities (150 subjects, 26.8 %).
Pre-assignment Details Other common reasons for screen failure were inability to re-schedule within enrollment window after trial start was delayed (101 subjects, 18.1 % of screen failures) and lost to follow up 65 subjects (11.6%). These two reasons account for 166 (29.7%) subjects who met IC/EC, but did not enter the trial.
Arm/Group Title Test Vaccine US Licensed Vaccine
Hide Arm/Group Description NmVac4-A/C/Y/W-135-DT™ conjugate vaccine Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Period Title: Overall Study
Started 265 260
Completed 246 244
Not Completed 19 16
Arm/Group Title Test Vaccine US Licensed Vaccine Total
Hide Arm/Group Description NmVac4-A/C/Y/W-135-DT™ conjugate vaccine Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Total of all reporting groups
Overall Number of Baseline Participants 266 261 527
Hide Baseline Analysis Population Description
Population contains all randomized subjects. Two randomized subjects could not be vaccinated. Three subjects, one female and 3 males received incorrect vaccine. They are listed according to randomized treatment in the baseline population, but were analyzed according to the actual vaccine received in the safety population (secondary outcomes).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 266 participants 261 participants 527 participants
37.1  (11.1) 36.0  (10.88) 36.6  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 266 participants 261 participants 527 participants
Female
116
  43.6%
112
  42.9%
228
  43.3%
Male
150
  56.4%
149
  57.1%
299
  56.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 266 participants 261 participants 527 participants
Asian 1 3 4
American Indian/ Alaska Native 0 2 2
Caucasian 87 89 176
Black/ African-American 176 160 336
Native Hawaiian/Pacific Islander 0 0 0
Hispanic or Latino 2 6 8
Other 0 1 1
1.Primary Outcome
Title Seroresponse (Percent Seroconversion).
Hide Description Rise in antibody titers in serum at 4 weeks after vaccination, compared to baseline titer for meningococcal serogroups A, C, Y, and W-135. Serum Bactericidal Assay with human complement: Antibody titer ≥1:8 for subjects with titer <1:8 at baseline or a 4-fold rise in antibody levels.
Time Frame Week 4 after injection
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Test Vaccine US Licensed Vaccine
Hide Arm/Group Description:

NmVac4-A/C/Y/W-135-DT™ conjugate vaccine

Test Vaccine: NmVac4-A/C/Y/W-135-DT™ conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each of Serogroup A, C, W-135, and Y PS conjugated to approximately 26 µg total diphtheria toxoid.

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

US Licensed Vaccine: Meningococcal (Groups A,C,Y,W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135 and Y conjugated to approximately 48 µg total diphtheria toxoid.

Overall Number of Participants Analyzed 222 226
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of per protocol participants
Serogroup A
70.7
(64.3 to 76.6)
70.1
(63.6 to 76.1)
Serogroup C
66.5
(59.9 to 72.7)
72.5
(66.1 to 78.3)
Serogroup Y
63.1
(56.3 to 69.4)
64.1
(57.5 to 70.4)
Serogroup W-135
66.2
(59.6 to 72.4)
65.9
(59.3 to 72.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Vaccine, US Licensed Vaccine
Comments The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-7.9 to 9.1
Estimation Comments Serogroup A
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Test Vaccine, US Licensed Vaccine
Comments The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value -6.0
Confidence Interval (2-Sided) 95%
-14.6 to 2.6
Estimation Comments Serogroup C
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Test Vaccine, US Licensed Vaccine
Comments The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-9.9 to 7.9
Estimation Comments Serogroup Y
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Test Vaccine, US Licensed Vaccine
Comments The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-8.5 to 9.1
Estimation Comments Serogroup W-135
2.Secondary Outcome
Title Solicited Adverse Events From Diary Cards
Hide Description Local and systemic rates from Diary Cards filled by the participants.
Time Frame Day 0 to Day 7 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: All vaccinated participants, grouped by actual vaccine received.
Arm/Group Title Test Vaccine - Male Test Vaccine - Female US Licensed Vaccine - Male US Licensed Vaccine - Female
Hide Arm/Group Description:
NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Overall Number of Participants Analyzed 151 114 147 113
Measure Type: Number
Unit of Measure: percentage of participants
At least 1 local reaction 53.6 65.8 40.8 46.5
At least 1 systemic reaction 35.1 37.7 34.7 42.5
3.Secondary Outcome
Title Non Solicited Adverse Events
Hide Description Non solicited local and systemic adverse Event (AE) rates throughout the course of the study, based on laboratory test results, vital signs, examination and questioning the subjects.
Time Frame up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: All vaccinated participants, grouped by actual vaccine received.
Arm/Group Title Test Vaccine US Licensed Vaccine
Hide Arm/Group Description:
NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Overall Number of Participants Analyzed 265 260
Measure Type: Number
Unit of Measure: participants
Subjects with at least 1 AE 45 54
Subjects with at least 1 treatment related AE 1 5
Time Frame Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3).
Adverse Event Reporting Description

Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls.

Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.

 
Arm/Group Title Test Vaccine US Licensed Vaccine
Hide Arm/Group Description NmVac4-A/C/Y/W-135-DT™ conjugate vaccine Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
All-Cause Mortality
Test Vaccine US Licensed Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Test Vaccine US Licensed Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/265 (0.00%)      1/260 (0.38%)    
Investigations     
Blood Creatinine Increased  1 [1]  0/265 (0.00%)  0 1/260 (0.38%)  1
Glomerular Filtration Rate Decreased  1 [1]  0/265 (0.00%)  0 1/260 (0.38%)  1
Nervous system disorders     
Cerebrovascular Accident * 1 [1]  0/265 (0.00%)  0 1/260 (0.38%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
[1]
Not associated with the vaccine. All 3 Serious Adverse Events affected the same subject.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Test Vaccine US Licensed Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   173/265 (65.28%)      141/260 (54.23%)    
Gastrointestinal disorders     
Diarrhea  1 [1]  22/265 (8.30%)  20/260 (7.69%) 
Nausea  1 [1]  25/265 (9.43%)  15/260 (5.77%) 
General disorders     
Tenderness around injection site  1 [2]  134/265 (50.57%)  100/260 (38.46%) 
Pain around injection site  1 [2]  109/265 (41.13%)  86/260 (33.08%) 
Fatigue  1 [1]  43/265 (16.23%)  42/260 (16.15%) 
Hardness around injection site  1 [2]  37/265 (13.96%)  26/260 (10.00%) 
Swelling around injection site  1 [2]  35/265 (13.21%)  23/260 (8.85%) 
Malaise  1 [1]  24/265 (9.06%)  26/260 (10.00%) 
Chills  1 [1]  19/265 (7.17%)  14/260 (5.38%) 
Investigations     
Blood Pressure Systolic Increased  1 [3]  16/265 (6.04%)  12/260 (4.62%) 
Metabolism and nutrition disorders     
Anorexia  1 [1]  18/265 (6.79%)  12/260 (4.62%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1 [1]  53/265 (20.00%)  49/260 (18.85%) 
Arthralgia  1 [1]  21/265 (7.92%)  21/260 (8.08%) 
Nervous system disorders     
Headache  1 [1]  46/265 (17.36%)  40/260 (15.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
[1]
Systemic from Dairy Cards
[2]
Local from Dairy Cards
[3]
Systemic
Three subjects, 1 female and 2 males, received incorrect vaccine. They are listed according to randomized treatment in the baseline population, but were analyzed according to the actual vaccine received in the safety population (outcomes 2 and 3).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
All abstracts, presentations or manuscripts, and any data analyses conducted independently by the Investigator must be submitted in advance to the sponsor for review and approval. The sponsor will not unreasonably withhold publication of study findings. The objective of this policy is to ensure consistency between data filed with a regulatory authority and those appearing in the publication.
Results Point of Contact
Name/Title: Regulatory Affairs Director
Organization: JN-International Medical Corporation
Phone: 4028843477
Responsible Party: JN-International Medical Corporation
ClinicalTrials.gov Identifier: NCT01897402     History of Changes
Other Study ID Numbers: JN-NM-002
First Submitted: July 9, 2013
First Posted: July 12, 2013
Results First Submitted: March 26, 2015
Results First Posted: April 23, 2015
Last Update Posted: April 23, 2015