2010-2011 Trivalent Influenza Vaccine (TIV) in Pregnant Women
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Trivalent inactivated influenza vaccine; Trivalent inactivated influenza vaccine; Trivalent inactivated influenza vaccine
Intervention description: Three licensed 2010-2011 seasonal inactivated trivalent influenza vaccines. Single intramuscular 0.5 mL dose. Each vaccine is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose. Thimerosal is a preservative used in some vaccines. Fluzone, Agriflu and Fluarix do not contain thimerosal. For Fluarix, the tip cap and rubber plunger of the needleless prefilled syringes contain dry natural latex rubber.; Three licensed 2010-2011 seasonal inactivated trivalent influenza vaccines. Single intramuscular 0.5 mL dose. Each vaccine is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose. Thimerosal is a preservative used in some vaccines. Fluzone, Agriflu and Fluarix do not contain thimerosal. For Fluarix, the tip cap and rubber plunger of the needleless prefilled syringes contain dry natural latex rubber..; Three licensed 2010-2011 seasonal inactivated trivalent influenza vaccines. Single intramuscular 0.5 mL dose. Each vaccine is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose. Thimerosal is a preservative used in some vaccines. Fluzone®, Agriflu® and Fluarix® do not contain thimerosal. For Fluarix, the tip cap and rubber plunger of the needleless prefilled syringes contain dry natural latex rubber.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 183.0
Sex: Female
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pregnant, women, influenza, vaccine

Summary:

      The purpose of this study is to see how much antibody (proteins produced by the immune system
      that help fight infections) the body makes after getting a flu vaccine. Researchers will also
      look at how the body reacts to the flu vaccine and how it affects the babies of pregnant
      women. The study will enroll approximately 240 women ages 18-39 years, including 180 pregnant
      women in their second or third trimester of pregnancy (at least 14 weeks pregnant) and 60
      non-pregnant women. Participants will be randomly (by chance) assigned to 1 of 3 vaccine
      groups. Each participant will receive one shot of a 2010-2011 flu season licensed vaccine.
      The vaccine will be given as an intramuscular injection (shot in the muscle) in the upper
      arm. Study procedures include pregnancy testing, blood draws, and memory aids. Patient
      participation may be up to 8 months. The information from this study will help guide
      researchers in developing flu vaccines for pregnant women.
    

Eligibility criteria:

        Inclusion Criteria:

        Pregnant women:

          -  Pregnant female between the ages of 18 and 39 years, inclusive.

          -  Is a singleton pregnancy and is from 14 weeks/0 days through 33 weeks/6 days of
             gestation.

          -  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
             (bpm); blood pressure: systolic <140 mm Hg; diastolic less than or equal to 90 mm Hg;
             oral temperature <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 a specific disease are considered to be within
             acceptable limits in the last 3 months.

          -  Intends to be available through 6 months following receipt of 2010-2011 seasonal
             influenza vaccine or until all delivery record information has been obtained,
             whichever is longer.

          -  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 to allow study staff to
             gather pertinent medical information and pregnancy outcome data, if needed per
             clinical site policy.

        Non-pregnant women:

          -  Female between the ages of 18-39 years, inclusive.

          -  For the 30 days prior to enrollment through 30 days following receipt of 2010-2011
             inactivated trivalent influenza vaccine (TIV) in the study must fulfill one of the
             following: (i) she is not able to bear children because she has been surgically
             sterilized (hysterectomy) or is at least 1 year status post tubal ligation or 1 year
             post-menopausal or (ii) she agrees to practice effective methods of contraception
             including, but not limited to, abstinence, barrier methods (such as a condom or
             diaphragm) used with a spermicide, birth control pills, patches or hormonal shots or
             hormonal implants, NuvaRing and IUDs (intrauterine devices), or monogamy with
             vasectomized partner.

          -  For a female subject of childbearing potential, must have a negative pregnancy test
             (urine or serum) within 24 hours prior to vaccination.

          -  Is in good health, as determined by vital signs, 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 (if
             indicated). A stable chronic medical condition is defined as no change in prescription
             medication, dose, or frequency of medication in the last 3 months and health outcomes
             of the specific disease are considered to be within acceptable limits in the last 6
             months. Any change that is due to change of health care provider, insurance company
             etc, or that is done for financial reasons, as long as in the same class of medication
             will not be considered a violation of this inclusion criterion. Any change in
             prescription medication due to improvement of a disease outcome will not be considered
             a violation of this inclusion criterion.

          -  Intends to be available through 6 months following receipt of 2010-2011 inactivated
             TIV.

          -  Able to understand and comply with planned study procedures.

          -  Provides written informed consent prior to initiation of any study procedures.

        Infants born to pregnant women:

          -  Infant aged 6 weeks (plus/minus 14 days), born to mothers enrolled in this study.

          -  Had a cord blood sample collected at time of labor and delivery.

          -  Parent(s)/legal guardian(s) must be willing and able to comply with planned study
             procedures and be available for study visit.

          -  Subject and/or parent(s)/legal guardian(s) must provide written informed consent prior
             to initiation of any study procedures.

        Exclusion Criteria:

        Pregnant women:

          -  Has received the 2010-2011 trivalent influenza vaccine (inactivated or live).

          -  Has a known allergy or hypersensitivity to eggs, egg proteins, latex or other
             components in the vaccines (including, but not limited to: formaldehyde, polyethylene
             glycol p-isooctylphenyl ether, sucrose, gelatin, polysorbate 80, kanamycin, polymyxin
             and neomycin).

          -  Has a history of severe reactions following previous immunization with influenza virus
             vaccines.

          -  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 28 days following vaccination. Measles, mumps, and rubella vaccine and
             tetanus, diphtheria, and acellular pertussis vaccine and human papillomavirus vaccine
             are permitted post-partum.

          -  Is enrolled or plans to enroll in another interventional clinical trial with an
             investigational product during the current pregnancy and while participating in this
             study (observational studies are allowed).

          -  Has an acute illness and/or an oral temperature >/= 100.0 degrees 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 (a
             daily aspirin may be acceptable).

          -  Long term use of glucocorticoids, including oral or parenteral, or high-dose inhaled
             steroids (>800 mcg/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 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.

          -  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 hypertension,
             chronic liver disease, significant renal disease, unstable or progressive neurological
             disorder, transplant recipients or diabetes, juvenile diabetes [Type I] or advanced
             diabetes with renal disease or eye disease. Gestational diabetes controlled by diet or
             insulin is acceptable).

          -  Has any of the following active medical conditions at the time of enrollment:

        Hyperemesis gravidarium, premature labor (regular uterine contractions with cervical
        change), fetus with known major congenital anomaly or genetic abnormality, fetal growth
        restriction, preeclampsia, or known uterine anomaly (e.g. bicornuate uterus, submucosal
        fibroids > 5cm).

          -  Has a history of preeclampsia or preterm birth <35 weeks gestation during a previous
             pregnancy

          -  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 received the 2010-2011 trivalent influenza vaccine (inactivated or live).

          -  Has a known allergy or hypersensitivity to eggs, egg proteins, latex or other
             components in the vaccines (these may include, but not limited to: formaldehyde,
             polyethylene glycol p-isooctylphenyl ether, sucrose, gelatin, polysorbate 80,
             kanamycin, polymyxin and neomycin).

          -  Has a history of severe reactions following previous immunization with influenza virus
             vaccines.

          -  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 28 days following vaccination.

          -  Is enrolled or plans to enroll in another interventional clinical trial with an
             investigational product at the time of enrollment or during participation in this
             trial (observational studies are allowed).

          -  Has an acute illness and/or an oral temperature greater than or equal to 100.0 degrees
             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 (daily
             aspirin may be acceptable.

          -  Long term use of glucocorticoids, including oral or parenteral, or high-dose inhaled
             steroids (>800 mcg/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 below) and are stable for at least 3
             months prior to enrollment without decompensating are allowed enrollment into the
             study.

          -  Known active infection with 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.

          -  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 oral agents 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.

        Infants born to pregnant women:

        - 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.