H1N1v Vaccination of Pregnant Women: A Longitudinal Cohort Study Characterizing Influenza A H1N1v Vaccination in Pregnant Women
H1N1v Influenza
About this trial
This is an interventional prevention trial for H1N1v Influenza focused on measuring 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.
Eligibility Criteria
Inclusion Criteria:
- Healthy pregnant and non pregnant women living in Eastern Denmark
- Fluent in Danish
Exclusion Criteria:
- 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.
Sites / Locations
- COPSAC
- Næstved Hospital, Pediatric Department
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Pregnant women (>20 weeks), 7.5 mcg H1N1v full MF59 adjuvant
Pregnant women (>20 weeks), 3.75 mcg H1N1v half MF59 adjuvant
Pregnant women (>20 weeks), 15 mcg H1N1v unadjuvanted
Non-pregnant mothers, 7.5 mcg H1N1v full MF59 adjuvant