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.
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.
