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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016660-36 | EudraCT Number |
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| Name | Class |
|---|---|
| MCM Vaccines B.V. | INDUSTRY |
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The purpose of this study is to evaluate the immunogenicity and safety of an inactivated, non adjuvanted A(H1N1)v influenza vaccine in 120 pregnant women.
Study procedures will include 2 doses of vaccine, blood samples, cord blood samples at delivery and recording temperature and vaccine side effects in a memory aid for 7 days following each vaccination. Participants will be involved in study related procedures about 3 at 5 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vaccine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-adjuvanted A(H1N1)v influenza vaccine | Biological | 15 mcg HA/0.5 ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity: proportion of subjects achieving a serum HAI antibody titer of greater than or equal to 1:40, proportion of subjects with 4-fold or greater HAI antibody titer increases against H1N1 2009 virus following H1N1 vaccine. | Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: occurence of local and systemic adverse events | Throughout the course of the study | |
| Immunogenicity: proportion of subjects achieving a serum HAI antibody titer of greater than or equal to 1:40, proportion of subjects with 4-fold or greater HAI antibody titer increases against H1N1 2009 virus following H1N1 vaccine. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Odile Launay, MD | Groupe hospitalier Cochin Saint Vincent de Paul | Principal Investigator |
| Vassilis Tsatsaris, MD | Groupe hospitalier Cochin Saint Vincent de Paul | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon-Hôpital Saint-Jacques | Besançon | 25030 | France | |||
| Hôpital Antoine Béclère |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22147712 | Result | Tsatsaris V, Capitant C, Schmitz T, Chazallon C, Bulifon S, Riethmuller D, Picone O, Poulain P, Lewin F, Laine F, Jacqz-Aigrain E, Aboulker JP, Launay O; Inserm C09-33 PREFLUVAC (Immunogenicity and Safety of an Inactivated Nonadjuvanted A[H1N1v] Influenza Vaccine in Pregnant Women) Study Group. Maternal immune response and neonatal seroprotection from a single dose of a monovalent nonadjuvanted 2009 influenza A(H1N1) vaccine: a single-group trial. Ann Intern Med. 2011 Dec 6;155(11):733-41. doi: 10.7326/0003-4819-155-11-201112060-00005. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Day 42 and at delivery |
| Safety:occurence of vaccine-associated serious adverse events | Throughout the course of the study |
| Clamart |
| 92141 |
| France |
| Groupe hospitalier Cochin Saint Vincent de Paul | Paris | 75679 | France |
| Hôpital Robert Debré | Paris | 75935 | France |
| Hôpital Sud de Rennes | Rennes | 35056 | France |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |