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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016877-14-DK

Enrollment

500

Registered

2009-10-30

Start date

2009-11-04

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Protection against Influenza A H1N1v disease

Interventions

Trade Name: Focetria Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria • Healthy pregnant and non-pregnant women living in Eastern Denmark • Fluent in Danish Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Assess the maternally transferred specific antibodies against H1N1v in the newborn. Assess whether the immune response to H1N1 in pregnant women is different from that of non-pregnant women of similar age.;Main Objective: It is the overriding objective to study the optimal vaccination strategy in 2nd - 3rd trimester pregnant women with the objectives to: • Assess whether the adjuvanted vaccine offers a meaningful benefit in pregnant women in terms of immune response over the non-adjuvanted vaccine, and if so, whether a low dose adjuvanted vaccine is sufficient. • Assess the persistence of immune response over a 15 month time period after one single vaccination of the pregnant mother. • Gain insight on safety of the Novartis egg-based MF59 adjuvanted H1N1 vaccine Focetria in pregnant women and their babies. ;Primary end point(s): The immunogenicity criteria for success, as determined by HI, related to the EMEA/CPMP/VEG/4717/2003-Rev.1 (pandemic guideline) and EMEA/CHMP/VWP/263499/2006 (pre-pandemic guideline) are: For adults subjects aged 18-60 years: • The percentage of subjects with seroconversion or significant increase in HI antibody is > 40% • The percentage of subjects achieving an HI titer =40 is > 70% • The GMR is >2.5 The assessment of criteria is based on the corresponding proportions and geometric means ratio empirically found (i.e. on the point estimates).	—

Measure

Time frame

Secondary Objective: Assess the maternally transferred specific antibodies against H1N1v in the newborn. Assess whether the immune response to H1N1 in pregnant women is different from that of non-pregnant women of similar age.;Main Objective: It is the overriding objective to study the optimal vaccination strategy in 2nd - 3rd trimester pregnant women with the objectives to: • Assess whether the adjuvanted vaccine offers a meaningful benefit in pregnant women in terms of immune response over the non-adjuvanted vaccine, and if so, whether a low dose adjuvanted vaccine is sufficient. • Assess the persistence of immune response over a 15 month time period after one single vaccination of the pregnant mother. • Gain insight on safety of the Novartis egg-based MF59 adjuvanted H1N1 vaccine Focetria in pregnant women and their babies. ;Primary end point(s): The immunogenicity criteria for success, as determined by HI, related to the EMEA/CPMP/VEG/4717/2003-Rev.1 (pandemic guideline) and EMEA/CHMP/VWP/263499/2006 (pre-pandemic guideline) are: For adults subjects aged 18-60 years: • The percentage of subjects with seroconversion or significant increase in HI antibody is > 40% • The percentage of subjects achieving an HI titer =40 is > 70% • The GMR is >2.5 The assessment of criteria is based on the corresponding proportions and geometric means ratio empirically found (i.e. on the point estimates).

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026