InfluenzaNCT01037829
Novartis Pandemic Influenza A (H1N1) Vaccine(s) Observational Comparative Safety Study
An observational study of Influenza, run by Novartis Vaccines at 17 sites in 3 countries.
Trial summary
The primary objective of this observational, comparative safety study is to evaluate the safety of the Novartis Pandemic Influenza A (H1N1) vaccine in pregnant women and their off spring, followed for up to 3 months of age as compared to pregnant women who have not received the Novartis Pandemic Influenza A (H1N1)… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Non-intervention observational study
- Type of treatment
- Vaccines
- How many people
- 4,529 participants
- Where
- 17 sitesin 3 countries
- Study dates
- Jan 2010to Nov 2010
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women
Who may be able to join
- Currently pregnant OR was pregnant following the introduction of the Novartis Pandemic Influenza A (H1N1) vaccine in the country of interest and have already experienced a pregnancy outcome
- Consents to participate in the study
Who cannot join
- Is not currently pregnant OR was not pregnant at the time of or after the introduction of the Novartis Pandemic Influenza A (H1N1) vaccine in the country of interest
- Does not consent to participate in the study
- Has received a non-Novartis pandemic influenza vaccinee
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
Italy13 sites
Study site
Bari, 79124
Study site
Cagliari, 09126
Study site
Como, 22100
Study site
Milan, 20126
Study site
Milan, 20157
Study site
Monza, 20052
Study site
Prato, 59100
Study site
Roma, 00135
Study site
Rome, 00168
Study site
Siena, 53100
Study site
Trieste, 34100
Study site
Udine, 33100
Study site
Vicenza, 36100
Argentina3 sites
Study site
Buenos Aires, 1706
Study site
Córdoba, X5000
Study site
Villa Nueva, 5519
About this study
Official title: A Post-Marketing, Observational, Comparative Safety Study of the Novartis Pandemic Influenza A (H1N1) Vaccine(s) in Pregnant Women Versus Non-Vaccinated Pregnant Women
The primary objective of this observational, comparative safety study is to evaluate the safety of the Novartis Pandemic Influenza A (H1N1) vaccine in pregnant women and their off spring, followed for up to 3 months of age as compared to pregnant women who have not received the Novartis Pandemic Influenza A (H1N1) vaccine. This study will be conducted at investigative sites within the Netherlands, Italy, and Argentina.
- Conditions
- Influenza
- Being tested
- Non-intervention observational study
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-intervention observational studyOther
Non-intervention observational study
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy women | Comparison of pregnancy outcomes between (Novartis) H1N1 vaccinated women and (Novartis) H1N1 unvaccinated women. Receives: Other: Non-intervention observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal live-born delivery
Measured: 3 months follow-up on all live births
Spontaneous and elective abortions
Measured: 3 months follow-up on all live births
Congenital malformations
Measured: 3 months follow-up on all live births
Pre-term birth (prematurity)
Measured: 3 months follow-up on all live births
Low birth weight
Measured: 3 months follow-up on all live births
Neonatal mortality
Measured: 3 months follow-up on all live births
Secondary outcomes (1)
Maternal complications of gestational diabetes, preeclampsia, maternal death
Measured: During pregnancy and post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,529 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037829
- Sponsor's protocol ID
- V111_12
- Status last verified
- Sep 2011
- First submitted
- 21 Dec 2009
- Last updated
- 29 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Marketing, Observational, Comparative Safety Study of the Novartis Pandemic Influenza A (H1N1) Vaccine(s) in Pregnant Women Versus Non-Vaccinated Pregnant Women
- ClinicalTrials.gov ID
- NCT01037829
- Acronym / sponsor ID
- V111_12
- Conditions
- Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,529 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 23 Dec 2009 (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 primary objective of this observational, comparative safety study is to evaluate the safety of the Novartis Pandemic Influenza A (H1N1) vaccine in pregnant women and their off spring, followed for up to 3 months of age as compared to pregnant women who have not received the Novartis Pandemic Influenza A (H1N1) vaccine. This study will be conducted at investigative sites within the Netherlands, Italy, and Argentina.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnancy women | – | Other: Non-intervention observational studyComparison of pregnancy outcomes between (Novartis) H1N1 vaccinated women and (Novartis) H1N1 unvaccinated women. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (2 listed)
- Currently pregnant OR was pregnant following the introduction of the Novartis Pandemic Influenza A (H1N1) vaccine in the country of interest and have already experienced a pregnancy outcome
- Consents to participate in the study
Key exclusion criteria (3 listed)
- Is not currently pregnant OR was not pregnant at the time of or after the introduction of the Novartis Pandemic Influenza A (H1N1) vaccine in the country of interest
- Does not consent to participate in the study
- Has received a non-Novartis pandemic influenza vaccinee
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 |
|---|---|---|
| Non-intervention observational studyNon-intervention observational study | Other | Pregnancy women |
Primary outcome
Normal live-born delivery
Time frame: 3 months follow-up on all live births
Spontaneous and elective abortions
Time frame: 3 months follow-up on all live births
Congenital malformations
Time frame: 3 months follow-up on all live births
Pre-term birth (prematurity)
Time frame: 3 months follow-up on all live births
Low birth weight
Time frame: 3 months follow-up on all live births
Neonatal mortality
Time frame: 3 months follow-up on all live births
1 secondary outcome
Maternal complications of gestational diabetes, preeclampsia, maternal death
Time frame: During pregnancy and post delivery
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 29 Sep 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by Novartis Vaccines at 17 sites in 3 countries.
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 2 inclusion and 3 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 29 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Italy, Argentina, Netherlands. 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?
Normal live-born delivery (time frame: 3 months follow-up on all live births). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2011.