H1N1 Vaccine in Pregnant Women

Completed · Phase 2

Conditions studied: Influenza

In brief

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.

Key facts

Study ID: NCT00963430
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 120
Starts: 2009-09-01
Expected to finish: 2010-05-01
Last updated by the study team: 2012-12-03

Who can join

Age: 18 and older, up to 39. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Saint Louis University - Center for Vaccine Development — St Louis, Missouri, United States
Duke University Medical Center — Durham, North Carolina, United States
Vanderbilt University — Nashville, Tennessee, United States
Baylor College of Medicine - Department of Molecular Virology and Microbiology — Houston, Texas, United States
Group Health Cooperative — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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