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

Not Applicable

Completed

• Conditions: H1N1v Influenza
• Interventions: Biological: Focetria

• Registration Number: NCT01012557
• Lead Sponsor: Copenhagen Studies on Asthma in Childhood

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-10
• Study First Submitted QC: 2009-11-12
• Study First Posted: 2009-11-13
• Primary Completion: 2010-09
• Study Completion: 2011-12
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 296

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregnant women (>20 weeks), 7.5 mcg H1N1v full MF59 adjuvant	Focetria	-
Non-pregnant mothers, 7.5 mcg H1N1v full MF59 adjuvant	Focetria	-
Pregnant women (>20 weeks), 3.75 mcg H1N1v half MF59 adjuvant	Focetria	-
Pregnant women (>20 weeks), 15 mcg H1N1v unadjuvanted	Focetria	-

Primary Outcome Measures

Name	Time	Method
Geometric mean HI titer (GMT) on Day 1, Day 22, and at all the other relevant time points to assess persistence.	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])	Day 1, Day 22
Day 22/Day 1, and at all the other relevant time points to assess persistence/Day 1 geometric mean ratio (GMR) of HI	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	Day 1, Day 22

Secondary Outcome Measures

Name	Time	Method
The outcomes of pregnancies will be categorized as normal, abnormal or therapeutic/elective termination	duration of pregnancy
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.	12 months

Trial Locations

Locations (2)

COPSAC; 🇩🇰 Gentofte, Denmark

Næstved Hospital, Pediatric Department; 🇩🇰 Næstved, Denmark