Novartis H1N1 Vaccine in Pregnant Women

Exclusion Criteria

• •Pregnant women:
• •Has a known allergy or hypersensitivity to eggs or other components in the vaccines (these may include, but are not limited to: polymyxin and neomycin).
• •Has a history of severe reactions following previous immunization with influenza virus vaccines.
• •Has participated in a novel influenza H1N1 2009 vaccine study in the past 2 years, has received a H1N1 2009 vaccine or has history of novel influenza H1N1 2009 infection evaluated by a healthcare professional prior to enrollment.
• •Has received any other live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 21 days following vaccination. Measles, mumps, and rubella vaccine and tetanus, diphtheria, and acellular pertussis vaccine and human papillomavirus vaccine are permitted post-partum.
• •Has received an experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study, or expects to receive another experimental/investigational agent during the study period (prior to 180 days post vaccination).
• •Has an acute illness and/or an oral temperature \>/= 100.0 F, within 72 hours of vaccination (This may result in a temporary delay of vaccination).
• •Has immunosuppression as a result of an underlying illness or treatment, or use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months.
• •Has an active neoplastic disease (excluding non-melanoma skin cancer), a history of any hematologic malignancy, current bleeding disorder, or taking anticoagulants.
• •Long term use of glucocorticoids, including oral or parenteral, or high-dose inhaled steroids (\>800 micrograms/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed) or has received betamethasone or dexamethasone to accelerate fetal lung maturity.
• •Has a history of receiving immunoglobulin or other blood product (with exception of Rhogam) within the 3 months prior to enrollment in this study.
• •Has a diagnosis of a current and uncontrolled major psychiatric disorder.
• •Has been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
• •The subject is receiving any of the following psychiatric drugs: aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, trifluopromazine, chlorprothixene, chlorpromazine, perphenazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate. Subjects who are receiving an antidepressant drug (not listed above) and are stable for at least 3 months prior to enrollment without decompensating are allowed enrollment into the study.
• •Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
• •History of alcohol or drug abuse in the last 5 years.
• •Has a seizure disorder or is on an anti-seizure medication.
• •Has a history of Guillain-Barré Syndrome.
• •Plan to travel outside of North America in the time between vaccination and 21 days following vaccination
• •Has an acute or chronic medical condition that, in the opinion of the investigator would render vaccination unsafe, or would interfere with the evaluation of responses (this includes, but is not limited to, known cardiac disease, chronic liver disease, significant renal disease, unstable or progressive neurological disorder, transplant recipients or uncontrolled diabetes, juvenile diabetes (Type I) or advanced diabetes with renal disease or eye disease, diabetes controlled by diet or insulin is acceptable).
• •Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
• •Non-pregnant women:
• •Has a known allergy or hypersensitivity to eggs, egg proteins, other components in the vaccines (these may include, but not limited to: polymyxin and neomycin).
• •Has a history of severe reactions following previous immunization with influenza virus vaccines.
• •Has participated in a novel influenza H1N1 2009 vaccine study in the past 2 years, has received H1N1 2009 vaccine or has history of novel influenza H1N1 2009 infection evaluated by a healthcare professional prior to enrollment.
• •Has received any other live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 21 days following vaccination.
• •Has received an experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study, or expects to receive another experimental/investigational agent during the study period (prior to 180 days post vaccination).
• •Is breastfeeding or intends to become pregnant during the study period between enrollment and 30 days following receipt of the H1N1 vaccine.
• •Has an acute illness and/or an oral temperature greater than or equal to 100.0 F, within 72 hours of vaccination (This may result in a temporary delay of vaccination).
• •Has immunosuppression as a result of an underlying illness or treatment, or use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months.
• •Has an active neoplastic disease (excluding non-melanoma skin cancer), a history of any hematologic malignancy, current bleeding disorder, or taking anticoagulants.
• •Long term use of glucocorticoids, including oral or parenteral, or high-dose inhaled steroids (\>800 micrograms/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
• •Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
• •Has a diagnosis of a current and uncontrolled major psychiatric disorder.
• •Has been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
• •The subject is receiving any of the following psychiatric drugs: aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, trifluopromazine, chlorprothixene, chlorpromazine, perphenazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate. Subjects who are receiving an antidepressant drug (not listed above) and are stable for at least 3 months prior to enrollment without decompensating are allowed enrollment into the study.
• •Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• •History of alcohol or drug abuse in the last 5 years.
• •Has a seizure disorder or is on an anti-seizure medication.
• •Has a history of Guillain-Barré Syndrome.
• •Plan to travel outside of North America in the time between vaccination and 21 days following vaccination.
• •Has an acute or chronic medical condition that, in the opinion of the investigator would render vaccination unsafe, or would interfere with the evaluation of responses (this includes, but is not limited to, known cardiac disease, chronic liver disease, significant renal disease, unstable or progressive neurological disorder, transplant recipients or uncontrolled diabetes, juvenile diabetes (Type I) or advanced diabetes with renal disease or eye disease, diabetes controlled by diet or insulin is acceptable.
• •Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.