Trial record 1 of 1 for:
A3L04
Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
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ClinicalTrials.gov Identifier: NCT00313911 |
Recruitment Status :
Completed
First Posted : April 12, 2006
Results First Posted : November 19, 2012
Last Update Posted : April 21, 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 Haemophilus Influenzae Type b Hepatitis B |
Interventions |
Biological: DTaP-IPV-HB-PRP~T Biological: Tritanrix-HepB/Hib |
Enrollment | 2133 |
Participant Flow
Recruitment Details | Participants were enrolled and treated from 17 July 2006 to 02 January 2008 in 1 clinical center in Mexico and 1 clinical center in Peru. |
Pre-assignment Details | A total of 2133 participants who met the inclusion and exclusion criteria were enrolled and vaccinated. |
Arm/Group Title | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV |
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Participants received 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) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. | Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. |
Period Title: Overall Study | ||
Started | 1422 [1] | 711 [2] |
Completed | 1328 | 670 |
Not Completed | 94 | 41 |
Reason Not Completed | ||
Serious adverse event | 6 | 1 |
Adverse Event | 2 | 3 |
Protocol Violation | 19 | 10 |
Lost to Follow-up | 27 | 14 |
Withdrawal by Subject | 39 | 12 |
Did not meet age criteria | 1 | 1 |
[1]
N for outcomes adjusted to include participant in Group 2 that got vaccine assigned to this group.
[2]
A participant in this group mistakenly got Group 1 vaccine. N in outcomes adjusted accordingly.
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Baseline Characteristics
Arm/Group Title | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV | Total | |
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Participants received 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) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. | Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. | Total of all reporting groups | |
Overall Number of Baseline Participants | 1422 | 711 | 2133 | |
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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 | 1422 participants | 711 participants | 2133 participants | |
<=18 years |
1422 100.0%
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711 100.0%
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2133 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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>=65 years |
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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Age Continuous | Number Analyzed | 1422 participants | 711 participants | 2133 participants |
1.89 (0.195) | 1.88 (0.197) | 1.88 (0.196) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1422 participants | 711 participants | 2133 participants | |
Female |
706 49.6%
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344 48.4%
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1050 49.2%
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Male |
716 50.4%
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367 51.6%
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1083 50.8%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 1422 participants | 711 participants | 2133 participants |
Mexico | 712 | 355 | 1067 | |
Peru | 710 | 356 | 1066 |
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: | NCT00313911 |
Other Study ID Numbers: |
A3L04 |
First Submitted: | April 11, 2006 |
First Posted: | April 12, 2006 |
Results First Submitted: | September 18, 2012 |
Results First Posted: | November 19, 2012 |
Last Update Posted: | April 21, 2014 |