Trial record 3 of 3 for:
A3L24
A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants
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ClinicalTrials.gov Identifier: NCT01177722 |
Recruitment Status :
Completed
First Posted : August 9, 2010
Results First Posted : May 5, 2014
Last Update Posted : May 5, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
Conditions |
Diphtheria Tetanus Whooping Cough Hepatitis B Poliomyelitis |
Interventions |
Biological: DTaP-IPV-Hep B-PRP-T Vaccine Biological: DTaP-Hep B-IPV vaccine |
Enrollment | 1375 |
Participant Flow
Recruitment Details | Participants were enrolled from 03 August 2010 to 23 November 2010 in 2 clinical centers in Columbia and 1 clinical center in Costa Rica. |
Pre-assignment Details | A total of 1375 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated. |
Arm/Group Title | DTap-IPV-Hep B-PRP~T Batch A | DTaP-IPV-Hep B-PRP~T Batch B | DTaP-IPV-Hep B-PRP~T Batch C | Infanrix Hexa |
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Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. |
Period Title: Overall Study | ||||
Started | 344 [1] | 344 [2] | 342 | 345 |
Completed | 331 | 334 | 333 | 338 |
Not Completed | 13 | 10 | 9 | 7 |
Reason Not Completed | ||||
Serious Adverse Event | 0 | 0 | 1 | 0 |
Protocol Violation | 0 | 0 | 1 | 0 |
Lost to Follow-up | 3 | 4 | 3 | 1 |
Withdrawal by Subject | 10 | 6 | 4 | 6 |
[1]
A Batch B participant got Batch A vaccine data analyses was according to actual vaccine administered
[2]
A randomized participant got Batch A vaccine, analyses was according to actual vaccine administered.
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Baseline Characteristics
Arm/Group Title | DTap-IPV-Hep B-PRP~T Batch A | DTaP-IPV-Hep B-PRP~T Batch B | DTaP-IPV-Hep B-PRP~T Batch C | Infanrix Hexa | Total | |
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Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Total of all reporting groups | |
Overall Number of Baseline Participants | 344 | 344 | 342 | 345 | 1375 | |
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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 | 344 participants | 344 participants | 342 participants | 345 participants | 1375 participants | |
<=18 years |
344 100.0%
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344 100.0%
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342 100.0%
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345 100.0%
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1375 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: Days |
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Number Analyzed | 344 participants | 344 participants | 342 participants | 345 participants | 1375 participants | |
58.8 (3.49) | 58.7 (3.25) | 58.5 (3.16) | 58.7 (3.31) | 58.7 (3.30) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 344 participants | 344 participants | 342 participants | 345 participants | 1375 participants | |
Female |
161 46.8%
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165 48.0%
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152 44.4%
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156 45.2%
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634 46.1%
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Male |
183 53.2%
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179 52.0%
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190 55.6%
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189 54.8%
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741 53.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 344 participants | 344 participants | 342 participants | 345 participants | 1375 participants |
Colombia | 233 | 234 | 233 | 233 | 933 | |
Costa Rica | 111 | 110 | 109 | 112 | 442 |
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: | NCT01177722 |
Other Study ID Numbers: |
A3L24 UTN: U1111-1111-5801 ( Other Identifier: WHO ) |
First Submitted: | August 6, 2010 |
First Posted: | August 9, 2010 |
Results First Submitted: | February 22, 2014 |
Results First Posted: | May 5, 2014 |
Last Update Posted: | May 5, 2014 |