Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry
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ClinicalTrials.gov Identifier: NCT01945424 |
Recruitment Status :
Completed
First Posted : September 18, 2013
Last Update Posted : February 12, 2020
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Condition or disease | Intervention/treatment |
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Pregnancy Influenza | Biological: Quadrivalent Influenza Vaccine (QIV) |
Pregnant women will be enrolled in the registry prospectively (after exposure to QIV in routine clinical settings but before knowledge of the pregnancy outcome). Women exposed to QIV with or without adverse events will be recorded in the Global Pharmacovigilance Database and medically reviewed. Pregnancy outcomes will be sought via questionnaires sent to the reporter at enrollment, estimated time of delivery, and six months after delivery. Descriptive statistical methods will be the primary approach for summarizing data.
No vaccine products will be provided or administered as part of this registry protocol.
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 244 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 15 Months |
Official Title: | Sanofi Pasteur Quadrivalent Influenza Vaccine Pregnancy Registry Protocol |
Actual Study Start Date : | August 16, 2013 |
Actual Primary Completion Date : | September 15, 2019 |
Actual Study Completion Date : | September 15, 2019 |

Group/Cohort | Intervention/treatment |
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Pregnancy Cases
Pregnant women exposed to Sanofi Pasteur's Quadrivalent Influenza Vaccine (QIV)
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Biological: Quadrivalent Influenza Vaccine (QIV)
No Intervention as part of this protocol |
- Number of cases and outcomes of pregnancies following exposure to QIV vaccine [ Time Frame: Up to six years ]Data will be summarized using descriptive statistical methods and stratified by pregnancy outcome (spontaneous abortion, elective termination, fetal death/stillbirth, live birth) and timing of vaccine exposure. Infant outcomes include birth defects and physical and social development.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Pregnant women will be enrolled in the registry prospectively (after exposure to Quadrivalent Influenza Vaccine (QIV) but before the conduct of any prenatal tests that could provide knowledge of the outcome of pregnancy). If the condition of the fetus has already been assessed through prenatal testing (e.g., targeted ultrasound, amniocentesis, etc.), such reports will be considered retrospective reports. Retrospective reports are also eligible for the registry but they will be analyzed separately from prospective reports.
Exclusion Criteria:
- N/A

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945424
United States, California | |
San Diego, California, United States | |
United States, New York | |
Albany, New York, United States | |
United States, Ohio | |
Columbus, Ohio, United States | |
United States, Pennsylvania | |
Harrisburg, Pennsylvania, United States | |
United States, Tennessee | |
Nashville, Tennessee, United States |
Study Director: | Clinical Sciences & Operations | Sanofi Pasteur, a Sanofi Company |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT01945424 |
Other Study ID Numbers: |
QIV08 U1111-1143-8433 ( Other Identifier: WHO ) |
First Posted: | September 18, 2013 Key Record Dates |
Last Update Posted: | February 12, 2020 |
Last Verified: | February 2020 |
Quadrivalent Influenza Vaccine Pregnancy Registry Influenza |
Influenza, Human Respiratory Tract Infections Infections Orthomyxoviridae Infections |
RNA Virus Infections Virus Diseases Respiratory Tract Diseases |