Trial record 1 of 1 for:
A3L21
Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™
![]() |
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: NCT00654901 |
Recruitment Status :
Completed
First Posted : April 9, 2008
Results First Posted : June 26, 2013
Last Update Posted : May 13, 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: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Conditions |
Diphtheria Tetanus Pertussis Hepatitis B Poliomyelitis Haemophilus Influenzae Type B Infection |
Interventions |
Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 1) Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 2) Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 3) Biological: Infanrix Hexa™ |
Enrollment | 881 |
Participant Flow
Recruitment Details | Participants were enrolled from 25 March 2008 to 28 November 2008 at 5 clinical centers in Mexico. |
Pre-assignment Details | A total of 881 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated. |
Arm/Group Title | DTaP-IPV-Hep B-PRP~T Batch 1 | DTaP-IPV-Hep B-PRP~T Batch 2 | DTaP-IPV-Hep B-PRP~T Batch 3 | Infanrix Hexa™ |
---|---|---|---|---|
![]() |
Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. | Participants had received 3 primary doses of Batch 2 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. | Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. | Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study. |
Period Title: Overall Study | ||||
Started | 254 | 262 | 252 | 113 |
Completed | 250 | 262 | 250 | 113 |
Not Completed | 4 | 0 | 2 | 0 |
Reason Not Completed | ||||
Lost to Follow-up | 1 | 0 | 1 | 0 |
Withdrawal by Subject | 3 | 0 | 1 | 0 |
Baseline Characteristics
Arm/Group Title | DTaP-IPV-Hep B-PRP~T Batch 1 | DTaP-IPV-Hep B-PRP~T Batch 2 | DTaP-IPV-Hep B-PRP~T Batch 3 | Infanrix Hexa™ | Total | |
---|---|---|---|---|---|---|
![]() |
Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. | Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. | Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. | Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study. | Total of all reporting groups | |
Overall Number of Baseline Participants | 254 | 262 | 252 | 113 | 881 | |
![]() |
[Not Specified]
|
|||||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||||
Number Analyzed | 254 participants | 262 participants | 252 participants | 113 participants | 881 participants | |
<=18 years |
254 100.0%
|
262 100.0%
|
252 100.0%
|
113 100.0%
|
881 100.0%
|
|
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 | 254 participants | 262 participants | 252 participants | 113 participants | 881 participants | |
17.3 (1.51) | 17.2 (1.47) | 17.4 (1.42) | 17.1 (1.51) | 17.3 (1.47) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||||
Number Analyzed | 254 participants | 262 participants | 252 participants | 113 participants | 881 participants | |
Female |
125 49.2%
|
125 47.7%
|
130 51.6%
|
58 51.3%
|
438 49.7%
|
|
Male |
129 50.8%
|
137 52.3%
|
122 48.4%
|
55 48.7%
|
443 50.3%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||||||
Mexico | Number Analyzed | 254 participants | 262 participants | 252 participants | 113 participants | 881 participants |
254 | 262 | 252 | 113 | 881 |
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: | NCT00654901 |
Other Study ID Numbers: |
A3L21 |
First Submitted: | April 3, 2008 |
First Posted: | April 9, 2008 |
Results First Submitted: | May 6, 2013 |
Results First Posted: | June 26, 2013 |
Last Update Posted: | May 13, 2016 |