Trial record 1 of 1 for:
QIV04
Study of Quadrivalent Influenza Vaccine Among Children
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01240746 |
Recruitment Status :
Completed
First Posted : November 15, 2010
Results First Posted : January 14, 2014
Last Update Posted : July 14, 2015
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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 |
Condition |
Influenza |
Interventions |
Biological: Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative Biological: Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative Biological: Quadrivalent Influenza Vaccine, No Preservative |
Enrollment | 4363 |
Participant Flow
Recruitment Details | The study participants were enrolled from 11 November 2010 to 20 June 2011 in 69 clinical centers in the US |
Pre-assignment Details | A total of 4363 participants who met all the inclusion criteria and none of the exclusion criteria were enrolled, randomized and vaccinated in the study. |
Arm/Group Title | Study Group 1 (2010-2011 Trivalent Influenza Vaccine) | Study Group 2 (Investigational Trivalent Influenza Vaccine) | Study Group 3 (Investigational Quadrivalent Influenza Vaccine) |
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Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen. | Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen | Participants received the Investigational Quadrivalent Influenza Vaccine (QIV) |
Period Title: Overall Study | |||
Started | 736 | 725 | 2902 |
Completed | 677 | 677 | 2659 |
Not Completed | 59 | 48 | 243 |
Reason Not Completed | |||
Adverse Event | 2 | 0 | 10 |
Lost to Follow-up | 23 | 20 | 102 |
Protocol Violation | 24 | 15 | 72 |
Withdrawal by Subject | 10 | 13 | 59 |
Baseline Characteristics
Arm/Group Title | Study Group 1 (Trivalent Influenza Vaccine) | Study Group 2 (Investigational Trivalent Influenza Vaccine) | Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Total | |
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Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen | Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen | Participants received the Investigational Quadrivalent Influenza Vaccine (QIV) | Total of all reporting groups | |
Overall Number of Baseline Participants | 736 | 725 | 2902 | 4363 | |
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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 | 736 participants | 725 participants | 2902 participants | 4363 participants | |
<=18 years |
736 100.0%
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725 100.0%
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2902 100.0%
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4363 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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>=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: Months |
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Number Analyzed | 736 participants | 725 participants | 2902 participants | 4363 participants | |
49.6 (29.0) | 49.6 (28.7) | 49.8 (29.7) | 49.8 (29.4) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 736 participants | 725 participants | 2902 participants | 4363 participants | |
Female |
367 49.9%
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359 49.5%
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1427 49.2%
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2153 49.3%
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Male |
369 50.1%
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366 50.5%
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1475 50.8%
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2210 50.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 736 participants | 725 participants | 2902 participants | 4363 participants |
736 | 725 | 2902 | 4363 |
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: | NCT01240746 |
Other Study ID Numbers: |
QIV04 UTN: U1111-1114-3713 ( Other Identifier: WHO ) |
First Submitted: | November 11, 2010 |
First Posted: | November 15, 2010 |
Results First Submitted: | July 3, 2013 |
Results First Posted: | January 14, 2014 |
Last Update Posted: | July 14, 2015 |