Trial record 1 of 1 for:
QID01
Study of Intradermal Quadrivalent Influenza Vaccine in Adults Aged 18 Through 64 Years
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| ClinicalTrials.gov Identifier: NCT01712984 |
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Recruitment Status :
Completed
First Posted : October 24, 2012
Results First Posted : February 10, 2014
Last Update Posted : May 7, 2015
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
| Condition |
Influenza |
| Interventions |
Biological: Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal |
| Enrollment | 3360 |
Participant Flow
| Recruitment Details | The study participants were enrolled from 22 October 2012 to 28 May 2013 at 38 clinic sites in the United States. |
| Pre-assignment Details | A total of 3360 participants who met all of the inclusion and none of the exclusion criteria were randomized, 3355 received one of the trial vaccines and their data are presented in this report. |
| Arm/Group Title | QIV ID Vaccine Group | TIV ID1 Vaccine Group | TIV ID2 Vaccine Group |
|---|---|---|---|
 Arm/Group Description |
Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine | Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1) | Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2) |
| Period Title: Overall Study | |||
| Started | 1672 | 837 | 846 |
| Completed | 1656 | 821 | 836 |
| Not Completed | 16 | 16 | 10 |
| Reason Not Completed | |||
| Adverse Event | 0 | 0 | 1 |
| Protocol Violation | 2 | 0 | 1 |
| Lost to Follow-up | 8 | 10 | 1 |
| Withdrawal by Subject | 6 | 6 | 7 |
Baseline Characteristics
| Arm/Group Title | QIV ID Vaccine Group | TIV ID1 Vaccine Group | TIV ID2 Vaccine Group | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine | Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1) | Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2) | Total of all reporting groups | |
| Overall Number of Baseline Participants | 1672 | 837 | 846 | 3355 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 1672 participants | 837 participants | 846 participants | 3355 participants | |
| <=18 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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| Between 18 and 65 years |
1672 100.0%
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837 100.0%
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846 100.0%
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3355 100.0%
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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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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 1672 participants | 837 participants | 846 participants | 3355 participants | |
| 41.6 (13.2) | 41.2 (13.5) | 41.9 (13.3) | 41.6 (13.3) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 1672 participants | 837 participants | 846 participants | 3355 participants | |
| Female |
1022 61.1%
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505 60.3%
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528 62.4%
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2055 61.3%
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| Male |
650 38.9%
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332 39.7%
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318 37.6%
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1300 38.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 1672 participants | 837 participants | 846 participants | 3355 participants |
| 1672 | 837 | 846 | 3355 | ||
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
| ClinicalTrials.gov Identifier: | NCT01712984 |
| Other Study ID Numbers: |
QID01 U1111-1124-8066 ( Other Identifier: WHO ) |
| First Submitted: | October 22, 2012 |
| First Posted: | October 24, 2012 |
| Results First Submitted: | December 15, 2013 |
| Results First Posted: | February 10, 2014 |
| Last Update Posted: | May 7, 2015 |