I went to clincialtrials.gov and found that most of the 44 studies are still recruiting subjects to test. One study,
A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly is active and is no longer recruiting.
How many people for the study?
Estimated Enrollment:850
What is the duration of the study?
Study Start Date:August 2009
Estimated Study Completion Date:December 2010
Estimated Primary Completion Date:March 2010 (Final data collection date for primary outcome measure)
4 months...
Who will be included in study?
Inclusion Criteria :
Healthy adults aged 18 years or older on the day of inclusion
Informed consent has been signed and dated
Able to attend all scheduled visits and comply with all trial procedures
For a woman of child-bearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination, until at least 4 weeks after last vaccination.
Who is excluded?
Exclusion Criteria :
Known pregnancy or positive urine pregnancy test
Currently breastfeeding a child
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
Planned participation in another clinical trial during the present trial period
Receipt of any vaccine in the 4 weeks preceding the trial vaccination
Planned receipt of any vaccine prior to the Day 42 blood sample
Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B antigen, or Hepatitis C
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
Self reported thrombocytopenia contraindicating intramuscular (IM) vaccination
Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
Chronic illness that in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
Employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator.
Previous participation in a swine-origin H1N1 pandemic flu trial except if performed in 1976
Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009
Febrile illness (temperature ≥ 100.4°F [≥ 38.0°C]) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination
Personal or family history of Guillain-Barré syndrome
Active neoplastic disease or a history of any hematologic malignancy
Known seizure/epilepsy history and/or taking anti-seizure medication
Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study
That doesn't seem reassuring to me at all. 4 months? 850 people all of whom are healthy and are not pregnant or nursing? Who are they hoping to vaccinate first--isn't it kids, and pregnant women? But, they're not going to be included in this trial any way.
So, when will they test this on pregnant women? When will they test it on children? When will they test it on people in "receipt of psychiatric drugs"? That's a lot of people, isn't it?
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