H1N1v Vaccination of Pregnant Women: A Longitudinal Cohort Study Characterizing Influenza A H1N1v Vaccination in Pregnant Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Copenhagen Studies on Asthma in Childhood
ClinicalTrials.gov Identifier:
NCT01012557
First received: November 10, 2009
Last updated: June 18, 2012
Last verified: June 2012

November 10, 2009
June 18, 2012
November 2009
September 2010   (final data collection date for 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01012557 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • The outcomes of pregnancies will be categorized as normal, abnormal or therapeutic/elective termination [ Time Frame: duration of pregnancy ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
H1N1v Vaccination of Pregnant Women: A Longitudinal Cohort Study Characterizing Influenza A H1N1v Vaccination in Pregnant Women
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
H1N1v Influenza
  • Biological: Focetria
    7.5 mcg H1N1v full MF59 adjuvant i.m.(intramuscular)x 1
  • Biological: Focetria
    3.75 mcg H1N1v half MF59 adjuvant i.m.(intramuscular)x 1
  • Biological: Focetria
    15 mcg N1N1v unadjuvanted i.m.(intramuscular) x 1.
  • Biological: Focetria
    7.5 mcg H1N1v full MF59 adjuvant i.m.(intramuscular) x 1
  • Active Comparator: Pregnant women (>20 weeks), 7.5 mcg H1N1v full MF59 adjuvant
    Intervention: Biological: Focetria
  • Active Comparator: Pregnant women (>20 weeks), 3.75 mcg H1N1v half MF59 adjuvant
    Intervention: Biological: Focetria
  • Active Comparator: Pregnant women (>20 weeks), 15 mcg H1N1v unadjuvanted
    Intervention: Biological: Focetria
  • Active Comparator: Non-pregnant mothers, 7.5 mcg H1N1v full MF59 adjuvant
    Intervention: Biological: Focetria
Bischoff AL, Følsgaard 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
November 2012
September 2010   (final data collection date for primary outcome measure)

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.
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01012557
H1N1v
Yes
Copenhagen Studies on Asthma in Childhood
Copenhagen Studies on Asthma in Childhood
Novartis
Not Provided
Copenhagen Studies on Asthma in Childhood
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP