PregnancyNCT01945424
Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry
An observational study of Pregnancy and Influenza, run by Sanofi Pasteur, a Sanofi Company at 5 sites in United States.
Trial summary
The Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Quadrivalent Influenza Vaccine (QIV)
- Type of treatment
- Vaccines
- How many people
- 244 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Aug 2013to 15 Sep 2019
- How long will I take part?
- 15 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women exposed to Sanofi Pasteur's Quadrivalent Influenza Vaccine (QIV)
Who may be able to join
- 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.
Who cannot join
- N/A
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Albany, New York
Study site
Columbus, Ohio
Study site
Harrisburg, Pennsylvania
Study site
Nashville, Tennessee
Study site
San Diego, California
About this study
Official title: Sanofi Pasteur Quadrivalent Influenza Vaccine Pregnancy Registry Protocol
The Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes.
Read the detailed description
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.
- Being tested
- Quadrivalent Influenza Vaccine (QIV)
- Keywords
- Quadrivalent Influenza Vaccine, Pregnancy Registry, Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent Influenza Vaccine (QIV)Biological
No Intervention as part of this protocol
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy Cases | Pregnant women exposed to Sanofi Pasteur's Quadrivalent Influenza Vaccine (QIV) Receives: Biological: Quadrivalent Influenza Vaccine (QIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases and outcomes of pregnancies following exposure to QIV vaccine
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.
Measured: Up to six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study start16 Aug 2013
- Primary completion15 Sep 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 244 participants (actual)
- Target duration
- 15 Months
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945424
- Sponsor's protocol ID
- QIV08
- Other IDs
- U1111-1143-8433
- Status last verified
- Feb 2020
- First submitted
- 13 Sep 2013
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Ledlie S, Gandhi-Banga S, Shrestha A, Mallett Moore T, Khromava A. Exposure to quadrivalent influenza vaccine during pregnancy: Results from a global pregnancy registry. Influenza Other Respir Viruses. 2022 Jan;16(1):90-100. doi: 10.1111/irv.12897. Epub 2021 Sep 14.
PubMed 34520127
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sanofi Pasteur Quadrivalent Influenza Vaccine Pregnancy Registry Protocol
- ClinicalTrials.gov ID
- NCT01945424
- Acronym / sponsor ID
- QIV08
- Keywords
- Quadrivalent Influenza Vaccine, Pregnancy Registry, Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2013 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 18 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes.
Detailed description
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 15 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnancy Cases | – | Biological: Quadrivalent Influenza Vaccine (QIV)Pregnant women exposed to Sanofi Pasteur's Quadrivalent Influenza Vaccine (QIV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women exposed to Sanofi Pasteur's Quadrivalent Influenza Vaccine (QIV)
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadrivalent Influenza Vaccine (QIV)No Intervention as part of this protocol | Biological | Pregnancy Cases |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Derived from this study: PubMed 34520127Ledlie S, Gandhi-Banga S, Shrestha A, Mallett Moore T, Khromava A. Exposure to quadrivalent influenza vaccine during pregnancy: Results from a global pregnancy registry. Influenza Other Respir Viruses. 2022 Jan;16(1):90-100. doi: 10.1111/irv.12897. Epub 2021 Sep 14.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi Pasteur, a Sanofi Company
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Influenza, run by Sanofi Pasteur, a Sanofi Company at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases and outcomes of pregnancies following exposure to QIV vaccine (time frame: Up to six years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01945424, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.