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Trial record 4 of 10 for:    Menomune A/C/Y/W 135

Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune®

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ClinicalTrials.gov Identifier: NCT00269477
Recruitment Status : Completed
First Posted : December 23, 2005
Results First Posted : December 14, 2009
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Meningitis
Meningococcal Infection
Intervention Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Enrollment 145
Recruitment Details Participants were recruited from 20 December 2005 to 31 May 2006, in 8 United States clinical sites.
Pre-assignment Details A total of 145 participants who participated in a previous study MTA02 and other meningococcal-vaccine naive participants were enrolled.
Arm/Group Title Menactra® Vaccine Group 1 Menactra® Vaccine Group 2 Meningococcal Vaccine-naive Group 3 Meningococcal Vaccine-naive Group 4
Hide Arm/Group Description Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination. Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination. Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
Period Title: Overall Study
Started 9 18 58 60
Completed 4 12 57 60
Not Completed 5 6 1 0
Reason Not Completed
Protocol Violation             5             5             1             0
Missed post-vaccination blood draw             0             1             0             0
Arm/Group Title Menactra® Vaccine Group 1 Menactra® Vaccine Group 2 Meningococcal Vaccine-naive Group 3 Meningococcal Vaccine-naive Group 4 Total
Hide Arm/Group Description Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination. Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination. Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination. Total of all reporting groups
Overall Number of Baseline Participants 9 18 58 60 145
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 18 participants 58 participants 60 participants 145 participants
<=18 years
5
  55.6%
10
  55.6%
53
  91.4%
54
  90.0%
122
  84.1%
Between 18 and 65 years
4
  44.4%
8
  44.4%
5
   8.6%
6
  10.0%
23
  15.9%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 18 participants 58 participants 60 participants 145 participants
18.1  (1.62) 18.8  (1.86) 16.4  (1.38) 16.6  (1.81) 17.9  (2.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 18 participants 58 participants 60 participants 145 participants
Female
5
  55.6%
13
  72.2%
27
  46.6%
28
  46.7%
73
  50.3%
Male
4
  44.4%
5
  27.8%
31
  53.4%
32
  53.3%
72
  49.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 18 participants 58 participants 60 participants 145 participants
9 18 58 60 145
1.Primary Outcome
Title Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination.
Hide Description

Groups 1 and 2 received booster vaccination, Groups 3 and 4 received primary vaccination.

Serum bactericidal activity for each Menactra® vaccine serogroups were at pre-vaccination and at 28 days post-booster or post-primary vaccination.

Time Frame 28 days post-vaccination (5 years after Menactra® or Menomune® vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
SBA-BR titer for each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.
Arm/Group Title Menactra® Vaccine Group 1 Menactra® Vaccine Group 2 Meningococcal Vaccine-naive Group 3 Meningococcal Vaccine-naive Group 4
Hide Arm/Group Description:
Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
Overall Number of Participants Analyzed 4 12 57 60
Measure Type: Number
Unit of Measure: Participants
Meningococcal serogroup A - Day 0 4 12 25 25
Meningococcal serogroup A - Day 28 4 12 56 60
Meningococcal serogroup C - Day 0 2 8 15 20
Meningococcal serogroup C - Day 28 4 12 56 60
Meningococcal serogroup Y - Day 0 3 12 49 52
Meningococcal serogroup Y - Day 28 4 12 57 60
Meningococcal serogroup W-135 - Day 0 3 12 25 28
Meningococcal serogroup W-135 - Day 28 4 12 57 60
2.Other Pre-specified Outcome
Title Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions
Hide Description Solicited injection site reactions: Erythema, Swelling, and Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Time Frame Day 0 to 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population
Arm/Group Title Menactra® Vaccine Group 1 Menactra® Vaccine Group 2 Meningococcal Vaccine-naive Group 3 Meningococcal Vaccine-naive Group 4
Hide Arm/Group Description:
Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
Overall Number of Participants Analyzed 9 18 58 60
Measure Type: Number
Unit of Measure: Participants
Any Erythema 2 2 13 14
Grade 3 Erythema (≥ 2 inches) 1 0 1 0
Any Swelling 1 0 12 3
Grade 3 Swelling (≥ 2 inches) 1 0 1 0
Any Injection Site Pain 2 8 36 37
Grade 3 Injection Site Pain (Incapacitating) 0 0 0 0
Any Fever 0 0 2 0
Grade 3 Fever (≥ 39.6 ºC) 0 0 0 0
Any Headache 0 5 20 28
Grade 3 Headache (Prevents daily activities) 0 1 0 1
Any Malaise 1 3 15 22
Grade 3 Malaise (Prevents daily activities) 0 0 0 0
Any Myalgia 2 6 24 28
Grade 3 Myalgia (Prevents daily activities) 0 0 0 0
Time Frame 28 days post-booster or post-primary Menactra® vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Menactra® Vaccine Group 1 Menactra® Vaccine Group 2 Meningococcal Vaccine-naive Group 3 Meningococcal Vaccine-naive Group 4
Hide Arm/Group Description Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination. Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination. Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
All-Cause Mortality
Menactra® Vaccine Group 1 Menactra® Vaccine Group 2 Meningococcal Vaccine-naive Group 3 Meningococcal Vaccine-naive Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Menactra® Vaccine Group 1 Menactra® Vaccine Group 2 Meningococcal Vaccine-naive Group 3 Meningococcal Vaccine-naive Group 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/18 (0.00%)      0/58 (0.00%)      0/60 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Menactra® Vaccine Group 1 Menactra® Vaccine Group 2 Meningococcal Vaccine-naive Group 3 Meningococcal Vaccine-naive Group 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/9 (11.11%)      5/18 (27.78%)      32/58 (55.17%)      23/60 (38.33%)    
Gastrointestinal disorders         
Abdominal pain upper * 1  0/9 (0.00%)  0 0/18 (0.00%)  0 2/58 (3.45%)  2 4/60 (6.67%)  5
Diarrhoea * 1  0/9 (0.00%)  0 0/18 (0.00%)  0 3/58 (5.17%)  3 4/60 (6.67%)  4
Nausea * 1  0/9 (0.00%)  0 0/18 (0.00%)  0 0/58 (0.00%)  0 3/60 (5.00%)  3
Vomiting * 1  0/9 (0.00%)  0 0/18 (0.00%)  0 2/58 (3.45%)  2 3/60 (5.00%)  3
General disorders         
Injection site haemorrhage * 1  0/9 (0.00%)  0 0/18 (0.00%)  0 1/58 (1.72%)  1 3/60 (5.00%)  3
Injection site induration * 1  1/9 (11.11%)  1 0/18 (0.00%)  0 0/58 (0.00%)  0 0/60 (0.00%)  0
Venipuncture site bruise * 1  0/9 (0.00%)  0 1/18 (5.56%)  1 0/58 (0.00%)  0 1/60 (1.67%)  1
Infections and infestations         
Nasopharyngitis * 1  0/9 (0.00%)  0 0/18 (0.00%)  0 4/58 (6.90%)  4 3/60 (5.00%)  3
Pharyngitis * 1  0/9 (0.00%)  0 0/18 (0.00%)  0 3/58 (5.17%)  3 1/60 (1.67%)  1
Rhinitis * 1  0/9 (0.00%)  0 0/18 (0.00%)  0 3/58 (5.17%)  3 0/60 (0.00%)  0
Upper respiratory tract infection * 1  0/9 (0.00%)  0 1/18 (5.56%)  1 6/58 (10.34%)  6 1/60 (1.67%)  1
Injury, poisoning and procedural complications         
Joint sprain * 1  0/9 (0.00%)  0 0/18 (0.00%)  0 3/58 (5.17%)  3 0/60 (0.00%)  0
Nervous system disorders         
Headache * 1  1/9 (11.11%)  1 0/18 (0.00%)  0 9/58 (15.52%)  9 11/60 (18.33%)  18
Reproductive system and breast disorders         
Dysmenorrhoea * 1  1/9 (11.11%)  3 2/18 (11.11%)  2 2/58 (3.45%)  4 4/60 (6.67%)  4
Respiratory, thoracic and mediastinal disorders         
Cough * 1  0/9 (0.00%)  0 1/18 (5.56%)  1 2/58 (3.45%)  2 3/60 (5.00%)  3
Nasal congestion * 1  0/9 (0.00%)  0 0/18 (0.00%)  0 4/58 (6.90%)  4 3/60 (5.00%)  4
Sinus congestion * 1  0/9 (0.00%)  0 1/18 (5.56%)  1 1/58 (1.72%)  1 0/60 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 7.1
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.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00269477     History of Changes
Other Study ID Numbers: MTA35
First Submitted: December 22, 2005
First Posted: December 23, 2005
Results First Submitted: November 10, 2009
Results First Posted: December 14, 2009
Last Update Posted: April 14, 2016