H1N1v Vaccination of Pregnant Women: Longitudinal Cohort Study, Denmark, Phase 3

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| Summary | |
| --- | |
| EudraCT Number: | 2009-016877-14 |
| Sponsor's Protocol Code Number: | H1N1-2009 |
| National Competent Authority: | Denmark - DHMA |
| Clinical Trial Type: | EEA CTA |
| Trial Status: | Completed |
| Date on which this record was first entered in the EudraCT database: | 2009-10-30 |
| Trial results | |

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| A. Protocol Information

| B. Sponsor Information

| D. IMP Identification

| D.8 Information on Placebo

| E. General Information on the Trial

• 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. | | 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. |
| 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. |
| E.2.2 | Secondary objectives of the trial | | 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. | | 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. |
| 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. |
| E.2.3 | Trial contains a sub-study | No | |
| E.3 | Principal inclusion criteria | | Inclusion criteria
• Healthy pregnant and non-pregnant women living in Eastern Denmark
• Fluent in Danish | | Inclusion criteria
• Healthy pregnant and non-pregnant women living in Eastern Denmark
• Fluent in Danish |
| Inclusion criteria
• Healthy pregnant and non-pregnant women living in Eastern Denmark
• Fluent in Danish |
| E.4 | Principal 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 | | • 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 |
| • 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 |
| E.5 End points |
| E.5.1 | 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). | | 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). |
| 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). |
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No | |
| E.6.2 | Prophylaxis | Yes | |
| E.6.3 | Therapy | No | |
| E.6.4 | Safety | Yes | |
| E.6.5 | Efficacy | Yes | |
| E.6.6 | Pharmacokinetic | No | |
| E.6.7 | Pharmacodynamic | No | |
| E.6.8 | Bioequivalence | No | |
| E.6.9 | Dose response | Yes | |
| E.6.10 | Pharmacogenetic | No | |
| E.6.11 | Pharmacogenomic | No | |
| E.6.12 | Pharmacoeconomic | No | |
| E.6.13 | Others | No | |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No | |
| E.7.1.1 | First administration to humans | No | |
| E.7.1.2 | Bioequivalence study | No | |
| E.7.1.3 | Other | No | |
| E.7.1.3.1 | Other trial type description |
| E.7.2 | Therapeutic exploratory (Phase II) | No | |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes | |
| E.7.4 | Therapeutic use (Phase IV) | No | |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes | |
| E.8.1.1 | Randomised | Yes | |
| E.8.1.2 | Open | No | |
| E.8.1.3 | Single blind | No | |
| E.8.1.4 | Double blind | Yes | |
| E.8.1.5 | Parallel group | Yes | |
| E.8.1.6 | Cross over | No | |
| E.8.1.7 | Other | No | |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No | |
| E.8.2.2 | Placebo | No | |
| E.8.2.3 | Other | Yes | |
| E.8.2.3.1 | Comparator description | | 3 arms: full dose no adjuvans, half dose full adjuvans, 1/4 dose half adjuvans. | | 3 arms: full dose no adjuvans, half dose full adjuvans, 1/4 dose half adjuvans. |
| 3 arms: full dose no adjuvans, half dose full adjuvans, 1/4 dose half adjuvans. |
| E.8.3 | The trial involves single site in the Member State concerned | No | |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes | |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 2 | |
| E.8.5 | The trial involves multiple Member States | No | |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No | |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT | |
| E.8.7 | Trial has a data monitoring committee | Yes | |
| E.8.8 | Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial | | One year after delivery for the last included woman | | One year after delivery for the last included woman |
| One year after delivery for the last included woman |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 | |
| E.8.9.1 | In the Member State concerned months | 6 | |
| E.8.9.1 | In the Member State concerned days | 0 | |
| E.8.9.2 | In all countries concerned by the trial years | 2 | |
| E.8.9.2 | In all countries concerned by the trial months | 6 | |
| E.8.9.2 | In all countries concerned by the trial days | 0 | |

| F. Population of Trial Subjects

| G. Investigator Networks to be involved in the Trial

| N. Review by the Competent Authority or Ethics Committee in the country concerned

| P. End of Trial