Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants
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ClinicalTrials.gov Identifier: NCT00401531 |
Recruitment Status :
Completed
First Posted : November 20, 2006
Results First Posted : April 1, 2014
Last Update Posted : April 1, 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 |
Hepatitis B Polio Diphtheria Pertussis Haemophilus Influenzae Type b |
Interventions |
Biological: DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines |
Enrollment | 412 |
Participant Flow
Recruitment Details | Participants were enrolled from 22 October 2006 to 19 November 2007 in 4 clinical centers in Thailand. |
Pre-assignment Details | A total of 412 participants who met all the inclusion, but none of the exclusion criteria were enrolled and vaccinated. |
Arm/Group Title | DTaP-IPV-Hep B-PRP-T + Prevnar™ | Infanrix Hexa™ + Prevnar™ |
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Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. | Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. |
Period Title: Overall Study | ||
Started | 206 | 206 |
Completed | 197 | 196 |
Not Completed | 9 | 10 |
Reason Not Completed | ||
Adverse Event | 2 | 0 |
Protocol Violation | 3 | 7 |
Lost to Follow-up | 1 | 1 |
Withdrawal by Subject | 3 | 2 |
Baseline Characteristics
Arm/Group Title | DTaP-IPV-Hep B-PRP-T + Prevnar™ | Infanrix Hexa™ + Prevnar™ | Total | |
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Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. | Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. | Total of all reporting groups | |
Overall Number of Baseline Participants | 206 | 206 | 412 | |
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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 | 206 participants | 206 participants | 412 participants | |
<=18 years |
206 100.0%
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206 100.0%
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412 100.0%
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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 | 206 participants | 206 participants | 412 participants |
1.88 (0.170) | 1.90 (0.187) | 1.89 (0.179) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 206 participants | 206 participants | 412 participants | |
Female |
94 45.6%
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111 53.9%
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205 49.8%
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Male |
112 54.4%
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95 46.1%
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207 50.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Thailand | Number Analyzed | 206 participants | 206 participants | 412 participants |
206 | 206 | 412 |
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: | NCT00401531 |
Other Study ID Numbers: |
A3L12 |
First Submitted: | November 16, 2006 |
First Posted: | November 20, 2006 |
Results First Submitted: | February 14, 2014 |
Results First Posted: | April 1, 2014 |
Last Update Posted: | April 1, 2014 |