H1N1 Vaccine in Pregnant Women
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Inactivated H1N1 Vaccine
Intervention description: Two doses of inactivated influenza H1N1 vaccine delivered intramuscularly (IM) as 15 or 30 mcg dose. The 15 mcg dose will be administered as a single 0.5 mL IM injection in the deltoid muscle of the preferred arm. The 30 mcg dose will be administered as a single 1.0 mL injection in the deltoid muscle.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: Female
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: H1N1, influenza A viruses, pregnant women

Summary:

      The purpose of this study is to evaluate an investigational 2009 H1N1 influenza vaccine to
      determine vaccine safety in pregnant women and the body's immune response (body's defense
      against disease) to different strengths of the H1N1 influenza vaccine. In this study, 2
      strengths of the H1N1 influenza vaccine will be tested (given 3 weeks apart). Participants
      will include approximately 120 healthy pregnant women, ages 18-39 years, in their second or
      third trimester of pregnancy (14-34 weeks gestation). 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 8 days following each vaccination. Participants will
      be involved in study related procedures for about 7 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant female between the ages of 18 and 39 years, inclusive.

          -  Is from 14-34 weeks of gestation, inclusive.

          -  Had at least one prenatal visit during which pregnancy was confirmed.

          -  Is in good health, as determined by vital signs (heart rate 100 beats per minute;
             blood pressure: systolic 140 mm Hg; diastolic less than or equal to 90 mm Hg; oral
             temperature less than 100 degrees Fahrenheit), medical history to ensure any existing
             medical diagnoses or conditions are stable and not considered clinically significant,
             and targeted physical examination based on medical history. A stable medical condition
             is defined as health outcomes of the specific disease are considered to be within
             acceptable limits in the last 3 months.

          -  Able to understand and comply with planned study procedures.

          -  Provides written informed consent prior to initiation of any study procedures.

          -  Agrees to sign medical release for herself and her infant(s) to allow study staff to
             gather pregnancy outcome data, if needed per clinical site policy.

        Exclusion Criteria:

          -  Has a known allergy to eggs or other components in the vaccines (these may include,
             but are not limited to: gelatin, formaldehyde, octoxinol and chicken protein).

          -  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 or
             has history of novel influenza H1N1 2009 infection 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 prior to vaccination or
             plan receipt of such vaccines within 21 days following the last vaccination (except
             for seasonal inactivated influenza vaccine which may be received 2 weeks post either
             vaccination). Measles, mumps, and rubella vaccine and tetanus, diphtheria, and
             acellular pertussis vaccine are permitted post-partum.

          -  Has received an experimental/investigational agent (vaccine, drug, biologic, device,
             blood product, or medication) within one month prior to vaccination in this study, or
             expects to receive another experimental/investigational agent during the study period
             (prior to the Day 201 follow-up call - 180 days after the second vaccination).

          -  Has an acute illness and/or an oral temperature greater than or equal to 100.0 degrees
             Fahrenheit, 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 active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
             infection.

          -  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 the first vaccination and
             42 days following the first 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.