H1N1v InfluenzaNCT01012557
H1N1v Vaccination of Pregnant Women: A Longitudinal Cohort Study Characterizing Influenza A H1N1v Vaccination in Pregnant Women
A study testing Focetria in people with H1N1v Influenza, run by Copenhagen Studies on Asthma in Childhood at 2 sites in Denmark.
Trial summary
Pregnant women are at particular risk during the imminent H1N1v influenza pandemic. The new H1N1v virus requires urgent political and medical decisions on vaccination strategies in order to minimize severe disease and death from this pandemic. However, there is a lack of evidence to build such decisions upon. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- H1N1v Influenza
- What is being tested?
- Focetria
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 2 sitesDenmark
- Study dates
- Nov 2009to Dec 2011
- Phase
- Interventional
- 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
Who may be able to join
- Healthy pregnant and non pregnant women living in Eastern Denmark
- Fluent in Danish
Who cannot join
- Heart disease, endocrine disease, tuberculosis and sarcoidosis.
- History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients, and to eggs (including ovalbumin), and chicken proteins.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
COPSAC
Gentofte Municipality, 2620
Næstved Hospital, Pediatric Department
Næstved, 4700
About this study
Official title: H1N1v Vaccination of Pregnant Women: A Longitudinal Cohort Study Characterizing Influenza AH1N1v Vaccination in Pregnant Women
Pregnant women are at particular risk during the imminent H1N1v influenza pandemic. The new H1N1v virus requires urgent political and medical decisions on vaccination strategies in order to minimize severe disease and death from this pandemic. However, there is a lack of evidence to build such decisions upon. A vaccine will be provided in the fourth quarter of 2009, but there is little knowledge on the immunogenicity. Particularly its clinical effectiveness and duration of immunity in pregnant women and their newborn infants is unknown. Therefore, it will be important to study the optimal vaccination regimens with respect to dosing and use of adjuvant to decide future health policies on vaccination of pregnant women. We have a unique possibility to study these aspects of H1N1v infection in pregnant women in our ongoing unselected, prospective, birth-cohort study recruiting 800 pregnant mothers between Q1- 2009 and Q4-2010. Pregnant women from East-Denmark are being enrolled during the 2nd trimester and their infant will undergo a close clinical follow-up. The H1N1v pandemic is expected to reach Denmark Q4-2009. The timing of this enrollment and the imminent pandemic allows for an "experiment of nature" whereby the first half of the mothers completes pregnancy before the H1N1v pandemic. The other half of this cohort will be pregnant while H1N1v is prevalent in the community and will require H1N1v vaccination. The aim of this randomized, controlled, trial is to compare and evaluate the dose-related immune protection conferred by vaccine and adjuvant (Novartis vaccine Focetria) in pregnant women and non-pregnant women. In addition the protocol will assess the passive immunity conferred to the newborn from these vaccine regimes. The study will provide evidence-based guidance for health policies on vaccination for the population of pregnant women during future H1N1v pandemics.
- Conditions
- H1N1v Influenza
- Being tested
- Focetria
- Keywords
- H1N1v, vaccine, pregnant, women, Assess whether the adjuvanted vaccine offers a meaningful benefit in pregnant women in terms of immune response over the non-adjuvanted vaccine., Assess the persistence of immune response over a 15 month time period after one single vaccination of the pregnant mother., Assess whether the immune response to H1N1 in pregnant women is different from that of non-pregnant women of similar age., Gain insight on safety of the Novartis egg-based MF59 adjuvanted H1N1 vaccine Focetria in pregnant women and their babies., Assess the maternally transferred specific antibodies against H1N1v in the newborn, Passive immunity transferred to the infant.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FocetriaBiological
7.5 mcg H1N1v full MF59 adjuvant i.m.(intramuscular)x 1
FocetriaBiological
3.75 mcg H1N1v half MF59 adjuvant i.m.(intramuscular)x 1
FocetriaBiological
15 mcg N1N1v unadjuvanted i.m.(intramuscular) x 1.
FocetriaBiological
7.5 mcg H1N1v full MF59 adjuvant i.m.(intramuscular) x 1
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women (>20 weeks), 7.5 mcg H1N1v full MF59 adjuvant | Active comparator | Not described Receives: Biological: Focetria |
| Pregnant women (>20 weeks), 3.75 mcg H1N1v half MF59 adjuvant | Active comparator | Not described Receives: Biological: Focetria |
| Pregnant women (>20 weeks), 15 mcg H1N1v unadjuvanted | Active comparator | Not described Receives: Biological: Focetria |
| Non-pregnant mothers, 7.5 mcg H1N1v full MF59 adjuvant | Active comparator | Not described Receives: Biological: Focetria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 22/Day 1, and at all the other relevant time points to assess persistence/Day 1 geometric mean ratio (GMR) of HI
Measured: Day 1, Day 22
Geometric mean HI titer (GMT) on Day 1, Day 22, and at all the other relevant time points to assess persistence.
Measured: Day 1, Day 22
Percentage of subjects achieving a seroconversion or a significant increase (defined as: HI ≥1:40 for subjects negative at baseline [<1:10]; a minimum 4-fold increase in HI titer for subjects positive at baseline [HI≥1:10])
Measured: Day 1, Day 22
Percentage of subjects with a HI titer ≥1:40 (i.e. seroprotection) on Day 1, Day 22, and at all the other relevant time points to assess persistence
Measured: Day 1, Day 22
Secondary outcomes (2)
The safety of the study vaccines will be assessed based on number of subjects exposed to study vaccines with reported selected adverse events per vaccine group.
Measured: 12 months
The outcomes of pregnancies will be categorized as normal, abnormal or therapeutic/elective termination
Measured: duration of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for H1N1v 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen Studies on Asthma in Childhood
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012557
- Sponsor's protocol ID
- H1N1v
- Status last verified
- Nov 2022
- First submitted
- 10 Nov 2009
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bischoff AL, Folsgaard NV, Vissing NH, Birch S, Brix S, Bisgaard H. Airway mucosal immune-suppression in neonates of mothers receiving A(H1N1)pnd09 vaccination during pregnancy. Pediatr Infect Dis J. 2015 Jan;34(1):84-90. doi: 10.1097/INF.0000000000000529.
PubMed 25229268Bischoff AL, Folsgaard NV, Carson CG, Stokholm J, Pedersen L, Holmberg M, Bisgaard A, Birch S, Tsai TF, Bisgaard H. Altered response to A(H1N1)pnd09 vaccination in pregnant women: a single blinded randomized controlled trial. PLoS One. 2013 Apr 18;8(4):e56700. doi: 10.1371/journal.pone.0056700. Print 2013.
PubMed 23637733
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- H1N1v Vaccination of Pregnant Women: A Longitudinal Cohort Study Characterizing Influenza AH1N1v Vaccination in Pregnant Women
- ClinicalTrials.gov ID
- NCT01012557
- Acronym / sponsor ID
- H1N1v
- Conditions
- H1N1v Influenza
- Keywords
- H1N1v, vaccine, pregnant, women, Assess whether the adjuvanted vaccine offers a meaningful benefit in pregnant women in terms of immune response over the non-adjuvanted vaccine., Assess the persistence of immune response over a 15 month time period after one single vaccination of the pregnant mother., Assess whether the immune response to H1N1 in pregnant women is different from that of non-pregnant women of similar age., Gain insight on safety of the Novartis egg-based MF59 adjuvanted H1N1 vaccine Focetria in pregnant women and their babies.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Copenhagen Studies on Asthma in ChildhoodUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Nov 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Nov 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.
Pregnant women are at particular risk during the imminent H1N1v influenza pandemic. The new H1N1v virus requires urgent political and medical decisions on vaccination strategies in order to minimize severe disease and death from this pandemic. However, there is a lack of evidence to build such decisions upon. A vaccine will be provided in the fourth quarter of 2009, but there is little knowledge on the immunogenicity. Particularly its clinical effectiveness and duration of immunity in pregnant women and their newborn infants is unknown. Therefore, it will be important to study the optimal vaccination regimens with respect to dosing and use of adjuvant to decide future health policies on vaccination of pregnant women. We have a unique possibility to study these aspects of H1N1v infection in pregnant women in our ongoing unselected, prospective, birth-cohort study recruiting 800 pregnant mothers between Q1- 2009 and Q4-2010. Pregnant women from East-Denmark are being enrolled during the 2nd trimester and their infant will undergo a close clinical follow-up. The H1N1v pandemic is expected to reach Denmark Q4-2009. The timing of this enrollment and the imminent pandemic allows for an "experiment of nature" whereby the first half of the mothers completes pregnancy before the H1N1v pandemic. The other half of this cohort will be pregnant while H1N1v is prevalent in the community and will require H1N1v vaccination. The aim of this randomized, controlled, trial is to compare and evaluate the dose-related immune protection conferred by vaccine and adjuvant (Novartis vaccine Focetria) in pregnant women and non-pregnant women. In addition the protocol will assess the passive immunity conferred to the newborn from these vaccine regimes. The study will provide evidence-based guidance for health policies on vaccination for the population of pregnant women during future H1N1v pandemics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregnant women (>20 weeks), 7.5 mcg H1N1v full MF59 adjuvant | Active comparator | Biological: Focetria |
| Pregnant women (>20 weeks), 3.75 mcg H1N1v half MF59 adjuvant | Active comparator | Biological: Focetria |
| Pregnant women (>20 weeks), 15 mcg H1N1v unadjuvanted | Active comparator | Biological: Focetria |
| Non-pregnant mothers, 7.5 mcg H1N1v full MF59 adjuvant | Active comparator | Biological: Focetria |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy pregnant and non pregnant women living in Eastern Denmark
- Fluent in Danish
Key exclusion criteria (2 listed)
- Heart disease, endocrine disease, tuberculosis and sarcoidosis.
- History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients, and to eggs (including ovalbumin), and chicken proteins.
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 |
|---|---|---|
| Focetria7.5 mcg H1N1v full MF59 adjuvant i.m.(intramuscular)x 1 | Biological | Pregnant women (>20 weeks), 7.5 mcg H1N1v full MF59 adjuvant |
| Focetria3.75 mcg H1N1v half MF59 adjuvant i.m.(intramuscular)x 1 | Biological | Pregnant women (>20 weeks), 3.75 mcg H1N1v half MF59 adjuvant |
| Focetria15 mcg N1N1v unadjuvanted i.m.(intramuscular) x 1. | Biological | Pregnant women (>20 weeks), 15 mcg H1N1v unadjuvanted |
| Focetria7.5 mcg H1N1v full MF59 adjuvant i.m.(intramuscular) x 1 | Biological | Non-pregnant mothers, 7.5 mcg H1N1v full MF59 adjuvant |
Primary outcome
Day 22/Day 1, and at all the other relevant time points to assess persistence/Day 1 geometric mean ratio (GMR) of HI
Time frame: Day 1, Day 22
Geometric mean HI titer (GMT) on Day 1, Day 22, and at all the other relevant time points to assess persistence.
Time frame: Day 1, Day 22
Percentage of subjects achieving a seroconversion or a significant increase (defined as: HI ≥1:40 for subjects negative at baseline [<1:10]; a minimum 4-fold increase in HI titer for subjects positive at baseline [HI≥1:10])
Time frame: Day 1, Day 22
Percentage of subjects with a HI titer ≥1:40 (i.e. seroprotection) on Day 1, Day 22, and at all the other relevant time points to assess persistence
Time frame: Day 1, Day 22
2 secondary outcomes
The safety of the study vaccines will be assessed based on number of subjects exposed to study vaccines with reported selected adverse events per vaccine group.
Time frame: 12 months
The outcomes of pregnancies will be categorized as normal, abnormal or therapeutic/elective termination
Time frame: duration of pregnancy
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 15 Nov 2022.
- Background: PubMed 25229268Bischoff AL, Folsgaard NV, Vissing NH, Birch S, Brix S, Bisgaard H. Airway mucosal immune-suppression in neonates of mothers receiving A(H1N1)pnd09 vaccination during pregnancy. Pediatr Infect Dis J. 2015 Jan;34(1):84-90. doi: 10.1097/INF.0000000000000529.
- Results publication: PubMed 23637733Bischoff AL, Folsgaard NV, Carson CG, Stokholm J, Pedersen L, Holmberg M, Bisgaard A, Birch S, Tsai TF, Bisgaard H. Altered response to A(H1N1)pnd09 vaccination in pregnant women: a single blinded randomized controlled trial. PLoS One. 2013 Apr 18;8(4):e56700. doi: 10.1371/journal.pone.0056700. Print 2013.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focetria in people with H1N1v Influenza, run by Copenhagen Studies on Asthma in Childhood at 2 sites in Denmark.
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 2 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 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Day 22/Day 1, and at all the other relevant time points to assess persistence/Day 1 geometric mean ratio (GMR) of HI (time frame: Day 1, Day 22). The study lists 4 primary outcomes in all. 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 NCT01012557, which also lists 2 linked publications.
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 15 Nov 2022.