Trial record 1 of 1 for:
MTA48
Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
![]() |
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: NCT00483574 |
Recruitment Status :
Completed
First Posted : June 7, 2007
Results First Posted : July 6, 2011
Last Update Posted : May 16, 2016
|
Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Conditions |
Meningococcal Meningitis Measles Mumps Rubella Varicella |
Interventions |
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Biological: Measles-mumps-rubella-varicella vaccine Biological: Routine paediatric vaccine - Pneumococcal conjugate (PCV) Biological: Routine paediatric vaccine - Hepatitis A |
Enrollment | 1378 |
Participant Flow
Recruitment Details | Participants were enrolled from 30 May 2007 to 28 March 2008 at 82 US clinical centers. |
Pre-assignment Details | A total of 1378 participants met inclusion and exclusion criteria, of which 1374 were vaccinated and included in this analysis. |
Arm/Group Title | Group 1: Menactra and Routine Pediatric Vaccines | Group 2: Routine Pediatric Vaccines |
---|---|---|
![]() |
Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively) | Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively) |
Period Title: Overall Study | ||
Started | 1053 | 321 |
Completed | 951 | 308 |
Not Completed | 102 | 13 |
Reason Not Completed | ||
Adverse Event | 6 | 0 |
Protocol Violation | 28 | 9 |
Lost to Follow-up | 16 | 4 |
Withdrawal by Subject | 52 | 0 |
Baseline Characteristics
Arm/Group Title | Group 1: Menactra and Routine Pediatric Vaccines | Group 2: Routine Pediatric Vaccines | Total | |
---|---|---|---|---|
![]() |
Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively) | Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively) | Total of all reporting groups | |
Overall Number of Baseline Participants | 1053 | 321 | 1374 | |
![]() |
[Not Specified]
|
|||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 1053 participants | 321 participants | 1374 participants | |
<=18 years |
1053 100.0%
|
321 100.0%
|
1374 100.0%
|
|
Between 18 and 65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
>=65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Days |
||||
Number Analyzed | 1053 participants | 321 participants | 1374 participants | |
282.8 (10.79) | 374.6 (8.93) | 304.3 (40.22) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 1053 participants | 321 participants | 1374 participants | |
Female |
511 48.5%
|
158 49.2%
|
669 48.7%
|
|
Male |
542 51.5%
|
163 50.8%
|
705 51.3%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||||
United States | Number Analyzed | 1053 participants | 321 participants | 1374 participants |
1053 | 321 | 1374 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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. |
EMail: | RegistryContactUs@sanofipasteur.com |
Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
ClinicalTrials.gov Identifier: | NCT00483574 |
Other Study ID Numbers: |
MTA48 |
First Submitted: | June 6, 2007 |
First Posted: | June 7, 2007 |
Results First Submitted: | May 10, 2011 |
Results First Posted: | July 6, 2011 |
Last Update Posted: | May 16, 2016 |