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Trial record 1 of 1 for:    MTA23
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Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®

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ClinicalTrials.gov Identifier: NCT00258856
Recruitment Status : Completed
First Posted : November 28, 2005
Results First Posted : November 25, 2009
Last Update Posted : February 14, 2014
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: Polysaccharide Diphtheria Conjugate Vaccine
Enrollment 234
Recruitment Details Participants were recruited in 18 US clinic sites from 14 January 2006 through 05 June 2006.
Pre-assignment Details A total of 234 participants that met the inclusion but none of the exclusion criteria were enrolled and vaccinated.
Arm/Group Title Menactra® Group 1 Menactra® Group 2 Meningococcal Vaccine-naïve Group 3 Meningococcal Vaccine-naïve Group 4
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Participants received Menactra® in Study 603-02.

Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination

Participants received Menactra® in Study 603-02.

Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination

Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination. Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination.
Period Title: Overall Study
Started 59 58 58 59
Completed 56 58 56 58
Not Completed 3 0 2 1
Reason Not Completed
Lost to Follow-up             1             0             2             0
Non-compliance             2             0             0             1
Arm/Group Title Menactra® Group 1 Menactra® Group 2 Meningococcal Vaccine-naïve Group 3 Meningococcal Vaccine-naïve Group 4 Total
Hide Arm/Group Description

Participants received Menactra® in Study 603-02.

Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination

Participants received Menactra® in Study 603-02.

Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination

Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination. Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination Total of all reporting groups
Overall Number of Baseline Participants 59 58 58 59 234
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 58 participants 59 participants 234 participants
<=18 years
59
 100.0%
58
 100.0%
58
 100.0%
59
 100.0%
234
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=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 59 participants 58 participants 58 participants 59 participants 234 participants
9.9  (2.56) 10.6  (2.60) 11.7  (2.27) 11.9  (2.06) 11.0  (2.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 58 participants 59 participants 234 participants
Female
26
  44.1%
22
  37.9%
25
  43.1%
23
  39.0%
96
  41.0%
Male
33
  55.9%
36
  62.1%
33
  56.9%
36
  61.0%
138
  59.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 59 participants 58 participants 58 participants 59 participants 234 participants
59 58 58 59 234
1.Primary Outcome
Title Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 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 the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination.

Time Frame 7 or 14 days post-vaccination
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Hide Analysis Population Description
Serum bactericidal assay performed using baby rabbit complement (SBA-BR) titers for each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.
Arm/Group Title Menactra® Group 1 Menactra® Group 2 Meningococcal Vaccine-naïve Group 3 Meningococcal Vaccine-naïve Group 4
Hide Arm/Group Description:

Participants received Menactra® in Study 603-02.

Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination

Participants received Menactra® in Study 603-02.

Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination

Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
Overall Number of Participants Analyzed 56 58 56 58
Measure Type: Number
Unit of Measure: Percentage of participants
Meningococcal serogroup A - PRE 84 89 47 59
Meningococcal serogroup A - POST 100 100 100 100
Meningococcal serogroup C - PRE 62 58 39 47
Meningococcal serogroup C - POST 100 100 98 96
Meningococcal serogroup Y - PRE 96 96 87 98
Meningococcal serogroup Y - POST 100 100 100 100
Meningococcal serogroup W-135 - PRE 81 84 31 36
Meningococcal serogroup W-135 - POST 100 100 100 98
Time Frame 28 days post-vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Menactra® Group 1 Menactra® Group 2 Meningococcal Vaccine-naïve Group 3 Meningococcal Vaccine-naïve Group 4
Hide Arm/Group Description

Participants received Menactra® in Study 603-02.

Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination

Participants received Menactra® in Study 603-02.

Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination

Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination. Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
All-Cause Mortality
Menactra® Group 1 Menactra® Group 2 Meningococcal Vaccine-naïve Group 3 Meningococcal Vaccine-naïve Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Menactra® Group 1 Menactra® Group 2 Meningococcal Vaccine-naïve Group 3 Meningococcal Vaccine-naïve Group 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/58 (0.00%)      0/58 (0.00%)      0/58 (0.00%)      0/59 (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® Group 1 Menactra® Group 2 Meningococcal Vaccine-naïve Group 3 Meningococcal Vaccine-naïve Group 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/58 (22.41%)      20/58 (34.48%)      14/58 (24.14%)      15/59 (25.42%)    
Gastrointestinal disorders         
Abdominal pain upper * 1  3/58 (5.17%)  3 5/58 (8.62%)  6 5/58 (8.62%)  5 1/59 (1.69%)  1
Diarrhoea * 1  2/58 (3.45%)  2 2/58 (3.45%)  2 1/58 (1.72%)  1 5/59 (8.47%)  5
Vomiting * 1  3/58 (5.17%)  3 3/58 (5.17%)  3 2/58 (3.45%)  2 2/59 (3.39%)  2
General disorders         
Pyrexia * 1  3/58 (5.17%)  3 2/58 (3.45%)  2 1/58 (1.72%)  2 3/59 (5.08%)  3
Infections and infestations         
Nasopharyngitis * 1  1/58 (1.72%)  1 3/58 (5.17%)  3 2/58 (3.45%)  2 0/59 (0.00%)  0
Otitis media * 1  1/58 (1.72%)  1 3/58 (5.17%)  3 1/58 (1.72%)  1 0/59 (0.00%)  0
Rhinitis * 1  1/58 (1.72%)  1 3/58 (5.17%)  3 0/58 (0.00%)  0 1/59 (1.69%)  1
Nervous system disorders         
Headache * 1  1/58 (1.72%)  2 2/58 (3.45%)  2 3/58 (5.17%)  4 3/59 (5.08%)  3
Respiratory, thoracic and mediastinal disorders         
Cough * 1  0/58 (0.00%)  0 3/58 (5.17%)  3 4/58 (6.90%)  4 3/59 (5.08%)  3
Pharyngolaryngeal pain * 1  3/58 (5.17%)  3 1/58 (1.72%)  1 4/58 (6.90%)  4 4/59 (6.78%)  4
Upper respiratory tract congestion * 1  1/58 (1.72%)  1 2/58 (3.45%)  2 3/58 (5.17%)  3 2/59 (3.39%)  2
*
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: NCT00258856     History of Changes
Other Study ID Numbers: MTA23
First Submitted: November 24, 2005
First Posted: November 28, 2005
Results First Submitted: October 19, 2009
Results First Posted: November 25, 2009
Last Update Posted: February 14, 2014