Trial record 1 of 1 for:
M5A10
Safety and Immune Response of Different Pediatric Combination Vaccines.
![]() |
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: NCT00255047 |
Recruitment Status :
Completed
First Posted : November 17, 2005
Results First Posted : November 10, 2010
Last Update Posted : February 14, 2014
|
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: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Conditions |
Diphtheria Polio Pertussis |
Interventions |
Biological: DAPTACEL®. (DTaP), IPOL®., and ActHIB®. Biological: Pentacel®: DTaP-IPV/Hib combined Biological: DTaP-IPV and ActHIB® |
Enrollment | 2167 |
Participant Flow
Recruitment Details | Participants were enrolled from 10 November 2005 through 21 September 2006 in 38 Clinics in the Untied States. |
Pre-assignment Details | A total of 2167 participants that met the inclusion and exclusion criteria were enrolled and vaccinated. Data on Stage I, up to the 3rd dose are presented. |
Arm/Group Title | Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Study Group 2: Pentacel® | Study Group 3: DTaP-IPV and ActHIB® | Study Group 4: Pentacel® |
---|---|---|---|---|
![]() |
Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively. | Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively. | Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively. | Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively. |
Period Title: Overall Study | ||||
Started | 538 | 535 | 546 | 548 |
Completed | 490 | 487 | 496 | 502 |
Not Completed | 48 | 48 | 50 | 46 |
Reason Not Completed | ||||
Serious Adverse Events | 2 | 1 | 2 | 1 |
Adverse Event | 0 | 3 | 2 | 1 |
Protocol Violation | 13 | 13 | 16 | 20 |
Lost to Follow-up | 9 | 8 | 5 | 6 |
Withdrawal by Subject | 24 | 23 | 25 | 18 |
Baseline Characteristics
Arm/Group Title | Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Study Group 2: Pentacel® | Study Group 3: DTaP-IPV and ActHIB® | Study Group 4: Pentacel® | Total | |
---|---|---|---|---|---|---|
![]() |
Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively. | Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively. | Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively. | Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively. | Total of all reporting groups | |
Overall Number of Baseline Participants | 538 | 535 | 546 | 548 | 2167 | |
![]() |
[Not Specified]
|
|||||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||||
Number Analyzed | 538 participants | 535 participants | 546 participants | 548 participants | 2167 participants | |
<=18 years |
538 100.0%
|
535 100.0%
|
546 100.0%
|
548 100.0%
|
2167 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: Months |
||||||
Number Analyzed | 538 participants | 535 participants | 546 participants | 548 participants | 2167 participants | |
2.2 (0.27) | 2.1 (0.27) | 2.2 (0.27) | 2.1 (0.28) | 2.1 (0.27) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||||
Number Analyzed | 538 participants | 535 participants | 546 participants | 548 participants | 2167 participants | |
Female |
251 46.7%
|
242 45.2%
|
249 45.6%
|
274 50.0%
|
1016 46.9%
|
|
Male |
287 53.3%
|
293 54.8%
|
297 54.4%
|
274 50.0%
|
1151 53.1%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||||||
United States | Number Analyzed | 538 participants | 535 participants | 546 participants | 548 participants | 2167 participants |
538 | 535 | 546 | 548 | 2167 |
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
ClinicalTrials.gov Identifier: | NCT00255047 |
Other Study ID Numbers: |
M5A10 |
First Submitted: | November 15, 2005 |
First Posted: | November 17, 2005 |
Results First Submitted: | September 14, 2010 |
Results First Posted: | November 10, 2010 |
Last Update Posted: | February 14, 2014 |