Trial record 2 of 2 for:
A3L11
Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants
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ClinicalTrials.gov Identifier: NCT00404651 |
Recruitment Status :
Completed
First Posted : November 29, 2006
Results First Posted : May 9, 2014
Last Update Posted : May 9, 2014
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention |
Conditions |
Diphtheria Tetanus Pertussis Hepatitis B Poliomyelitis |
Interventions |
Biological: DTaP-IPV-HB-PRP~T vaccine Biological: DTaP-HBV-IPV vaccine |
Enrollment | 1189 |
Participant Flow
Recruitment Details | Participants were enrolled from 14 November 2006 to 13 July 2007 in 6 clinical centers in Mexico. |
Pre-assignment Details | A total of 1189 participants who met the inclusion and exclusion criteria were enrolled and vaccinated. |
Arm/Group Title | DTaP-IPV-HB-PRP~T Batch 1 | DTaP-IPV-HB-PRP~T Batch 2 | DTaP-IPV-HB-PRP~T Batch 3 | Infanrix Hexa™ |
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Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. |
Period Title: Overall Study | ||||
Started | 340 | 343 | 339 | 167 |
Completed | 301 | 315 | 294 | 146 |
Not Completed | 39 | 28 | 45 | 21 |
Reason Not Completed | ||||
Serious Adverse Event | 0 | 0 | 2 | 0 |
Protocol Violation | 10 | 5 | 14 | 5 |
Lost to Follow-up | 15 | 11 | 13 | 10 |
Withdrawal by Subject | 14 | 12 | 16 | 6 |
Baseline Characteristics
Arm/Group Title | DTaP-IPV-HB-PRP~T Batch 1 | DTaP-IPV-HB-PRP~T Batch 2 | DTaP-IPV-HB-PRP~T Batch 3 | Infanrix Hexa™ | Total | |
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Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. | Total of all reporting groups | |
Overall Number of Baseline Participants | 340 | 343 | 339 | 167 | 1189 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 340 participants | 343 participants | 339 participants | 167 participants | 1189 participants | |
<=18 years |
340 100.0%
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343 100.0%
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339 100.0%
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167 100.0%
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1189 100.0%
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Between 18 and 65 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Months |
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Number Analyzed | 340 participants | 343 participants | 339 participants | 167 participants | 1189 participants | |
2.00 (0.200) | 2.00 (0.197) | 2.01 (0.193) | 1.98 (0.189) | 2.00 (0.195) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 340 participants | 343 participants | 339 participants | 167 participants | 1189 participants | |
Female |
160 47.1%
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163 47.5%
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167 49.3%
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82 49.1%
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572 48.1%
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Male |
180 52.9%
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180 52.5%
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172 50.7%
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85 50.9%
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617 51.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Mexico | Number Analyzed | 340 participants | 343 participants | 339 participants | 167 participants | 1189 participants |
340 | 343 | 339 | 167 | 1189 |
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: | NCT00404651 |
Other Study ID Numbers: |
A3L11 |
First Submitted: | November 28, 2006 |
First Posted: | November 29, 2006 |
Results First Submitted: | February 14, 2014 |
Results First Posted: | May 9, 2014 |
Last Update Posted: | May 9, 2014 |