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Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines

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: NCT01270503
Recruitment Status : Completed
First Posted : January 5, 2011
Results First Posted : November 14, 2014
Last Update Posted : November 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 Disease
Intervention Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Enrollment 538
Recruitment Details The study participants were enrolled from 16 December 2010 through 15 November 2012 at 130 clinic centers in thePhillipines
Pre-assignment Details A total of 538 participants who met all of the inclusion and none of the exclusion criteria were vaccinated in this study.
Arm/Group Title Menactra® Vaccine Group
Hide Arm/Group Description Participants who received a single dose of Menactra vaccine
Period Title: Overall Study
Started 538
Completed 537
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Menactra® Vaccine Group
Hide Arm/Group Description Participants who received a single dose of Menactra vaccine
Overall Number of Baseline Participants 538
Hide Baseline Analysis Population Description
Safety analysis set
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 538 participants
<=18 years
468
  87.0%
Between 18 and 65 years
70
  13.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Continuous Number Analyzed 538 participants
9.3  (10.3)
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 538 participants
Female 272
Male 263
[1]
Measure Description: Gender information was missing for 3 participants in the study
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Philippines Number Analyzed 538 participants
538
1.Primary Outcome
Title Safety Overview Within 30 Days in Participants Vaccinated With Menactra®
Hide Description [Not Specified]
Time Frame Day 0 up to Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Post-vaccination safety were assessed in the Safety Analysis Set.
Arm/Group Title Menactra® Vaccine Group
Hide Arm/Group Description:
Participants who received a single dose of Menactra vaccine
Overall Number of Participants Analyzed 537
Measure Type: Number
Unit of Measure: Participants
Serious adverse event 0
Non-serious related adverse event not listed in PI 2
2.Secondary Outcome
Title Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra®
Hide Description [Not Specified]
Time Frame Day 0 up to Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Post-vaccination safety were assessed in the Safety Analysis Set.
Arm/Group Title Menactra® Vaccine Group
Hide Arm/Group Description:
Participants received a single dose of Menactra vaccine
Overall Number of Participants Analyzed 537
Measure Type: Number
Unit of Measure: Participants
Pyrexia 2
Other non-serious related adverse events 0
Time Frame Adverse event data were collected from Day 0 (post vaccination) up to Day 30 post vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Menactra® Vaccine Group
Hide Arm/Group Description Participants who received a single dose of Menactra vaccine
All-Cause Mortality
Menactra® Vaccine Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Menactra® Vaccine Group
Affected / at Risk (%)
Total   0/538 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Menactra® Vaccine Group
Affected / at Risk (%)
Total   0/537 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01270503     History of Changes
Other Study ID Numbers: MTA71
U1111-1116-4853 ( Other Identifier: WHO )
First Submitted: January 4, 2011
First Posted: January 5, 2011
Results First Submitted: October 31, 2014
Results First Posted: November 14, 2014
Last Update Posted: November 14, 2014