An interventional study of Focetria and Focetria in H1N1v Influenza, sponsored by Copenhagen Studies on Asthma in Childhood. Completed at 2 sites in Denmark. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-15.
Sponsored by Copenhagen Studies on Asthma in Childhood · Not applicable, Interventional, and Prevention
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 296 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Copenhagen Studies on Asthma in Childhood is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: Focetria
Biological: Focetria
Biological: Focetria
Biological: Focetria
7.5 mcg H1N1v full MF59 adjuvant i.m.(intramuscular)x 1
3.75 mcg H1N1v half MF59 adjuvant i.m.(intramuscular)x 1
15 mcg N1N1v unadjuvanted i.m.(intramuscular) x 1.
7.5 mcg H1N1v full MF59 adjuvant i.m.(intramuscular) x 1
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
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
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Copenhagen Studies on Asthma in Childhood