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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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H1N1v Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Pregnant women (>20 weeks), 7.5 mcg H1N1v full MF59 adjuvant

Group Type ACTIVE_COMPARATOR

Focetria

Intervention Type BIOLOGICAL

7.5 mcg H1N1v full MF59 adjuvant i.m.(intramuscular)x 1

Pregnant women (>20 weeks), 3.75 mcg H1N1v half MF59 adjuvant

Group Type ACTIVE_COMPARATOR

Focetria

Intervention Type BIOLOGICAL

3.75 mcg H1N1v half MF59 adjuvant i.m.(intramuscular)x 1

Pregnant women (>20 weeks), 15 mcg H1N1v unadjuvanted

Group Type ACTIVE_COMPARATOR

Focetria

Intervention Type BIOLOGICAL

15 mcg N1N1v unadjuvanted i.m.(intramuscular) x 1.

Non-pregnant mothers, 7.5 mcg H1N1v full MF59 adjuvant

Group Type ACTIVE_COMPARATOR

Focetria

Intervention Type BIOLOGICAL

7.5 mcg H1N1v full MF59 adjuvant i.m.(intramuscular) x 1

Interventions

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Focetria

7.5 mcg H1N1v full MF59 adjuvant i.m.(intramuscular)x 1

Intervention Type BIOLOGICAL

Focetria

3.75 mcg H1N1v half MF59 adjuvant i.m.(intramuscular)x 1

Intervention Type BIOLOGICAL

Focetria

15 mcg N1N1v unadjuvanted i.m.(intramuscular) x 1.

Intervention Type BIOLOGICAL

Focetria

7.5 mcg H1N1v full MF59 adjuvant i.m.(intramuscular) x 1

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes