(Nasal and topical steroids are allowed. This is inclusive of routine childhood immunizations provided outside the scope of this study, and seasonal influenza vaccines. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7).
Department of Health and Human Services,The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. Epub 2012 Apr 23.U.S. Participants will be randomly (by chance) assigned to 1 of 2 possible H1N1 vaccine groups. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Discover. Study procedures include: medical history, physical exam, maintaining a memory aid, and blood sample collection. Department of Health and Human Services,The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):Biological: Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A.Why Should I Register and Submit Results?Kotloff KL, Halasa NB, Harrison CJ, Englund JA, Walter EB, King JC, Creech CB, Healy SA, Dolor RJ, Stephens I, Edwards KM, Noah DL, Hill H, Wolff M. Clinical and immune responses to inactivated influenza A(H1N1)pdm09 vaccine in children. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported.
Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. This is inclusive of seasonal influenza vaccines.Have 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.Have a history of severe reactions following previous immunization with influenza virus vaccines.Have an acute illness, including an oral temperature greater than 100.4 degrees Fahrenheit, within 3 days prior to vaccination.Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.Participated in a novel influenza H1N1 2009 vaccine study in the past two years or have a history of novel influenza H1N1 2009 infection prior to enrollment.Have known active human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection.Have a history of alcohol or drug abuse in the last 5 years.Plan to travel outside of North America in the time between the first vaccination and 42 days following the first vaccination.Have a history of Guillain-Barré Syndrome.Have any condition that the investigator believes may interfere with successful completion of the study. Can influenza trigger heart attacks? For subjects aged 10-17 years, serum for antibody assays will also be obtained at Day 8-10 following each vaccination. The study will enroll up to 450 healthy adults ages 18 and older with no history of H1N1 infection or vaccination. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported.
Vaccine. Participants will include up to 450 healthy adults age 18 and older who have no history of novel influenza H1N1 2009 infection or novel influenza H1N1 2009 vaccination. Adults are more likely to have measurable levels of serum hemagglutination inhibition assay (HAI) or neutralizing antibody than are children. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. The vaccine will be administered on Days 0 and 21. ARTICLE . ).Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis including major depression.Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others.Are receiving any psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate) or any drugs for treatment of depression.Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study (prior to the Day 201 follow-up call - 180 days after the second vaccination).Have received any 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 the second vaccination. 2014 Aug;33(8):865-71. doi: 10.1097/INF.0000000000000329.U.S.