Trial record 2 of 2 for:
A3L10
Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule
![]() |
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: NCT00315055 |
Recruitment Status :
Completed
First Posted : April 17, 2006
Results First Posted : February 4, 2014
Last Update Posted : September 12, 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 |
Hepatitis B Polio Diphtheria Pertussis |
Interventions |
Biological: DTaP-IPV-HB-PRP~T vaccine Biological: DTaP-IPV//PRP~T combined Biological: Hepatitis B vaccine |
Enrollment | 310 |
Participant Flow
Recruitment Details | Participants were enrolled and treated from 01 June 2006 to 18 June 2007 in 1 clinical center in Turkey. |
Pre-assignment Details | A total of 310 participants who met the inclusion but non of the exclusion criteria were enrolled and vaccinated. |
Arm/Group Title | DTaP-IPV-Hep B-PRP~T | PENTAXIM™ and ENGERIX® |
---|---|---|
![]() |
Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60). | Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60). |
Period Title: Overall Study | ||
Started | 155 | 155 |
Completed | 152 | 150 |
Not Completed | 3 | 5 |
Reason Not Completed | ||
Protocol Violation | 2 | 4 |
Lost to Follow-up | 1 | 1 |
Baseline Characteristics
Arm/Group Title | DTaP-IPV-Hep B-PRP~T | PENTAXIM™ and ENGERIX® | Total | |
---|---|---|---|---|
![]() |
Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60). | Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60). | Total of all reporting groups | |
Overall Number of Baseline Participants | 155 | 155 | 310 | |
![]() |
[Not Specified]
|
|||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 155 participants | 155 participants | 310 participants | |
<=18 years |
155 100.0%
|
155 100.0%
|
310 100.0%
|
|
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: Months |
||||
Number Analyzed | 155 participants | 155 participants | 310 participants | |
2.08 (0.090) | 2.08 (0.102) | 2.08 (0.096) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 155 participants | 155 participants | 310 participants | |
Female |
67 43.2%
|
72 46.5%
|
139 44.8%
|
|
Male |
88 56.8%
|
83 53.5%
|
171 55.2%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||||
Turkey | Number Analyzed | 155 participants | 155 participants | 310 participants |
155 | 155 | 310 |
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: | NCT00315055 |
Other Study ID Numbers: |
A3L10 |
First Submitted: | April 13, 2006 |
First Posted: | April 17, 2006 |
Results First Submitted: | September 9, 2013 |
Results First Posted: | February 4, 2014 |
Last Update Posted: | September 12, 2014 |