Post-Partum Immunization With Live Attenuated Influenza Vaccine (LAIV) or Trivalent Influenza Vaccine (TIV) in Post-Partum Breast Feeding Women

Completed · Phase 2 · Has a placebo group

Conditions studied: Influenza

In brief

The purpose of this research study is to learn more about the safety of 2 licensed flu vaccines, nasal spray and flu vaccine shot, in mothers and their infants, when given to women who are breastfeeding and to compare the immune response (body's defense against foreign substances) of breastfeeding mothers, who receive intranasal flu vaccine, with breastfeeding mothers receiving the flu vaccine shot. Healthy women (240 volunteers, 28-120 days post delivery) who plan to breastfeed through 28 days post vaccination and who have not received influenza vaccine for the influenza season for which they are being enrolled, will be assigned by chance to 1 of the 2 vaccines in the following manner: flu vaccine nasal spray and a placebo (inactive substance) shot or a flu vaccine shot and a placebo nasal spray. Study procedures include: nasal swabs, blood samples, and completion of memory aids. Participants will be involved in this United States based study for about 6 months.

Key facts

Study ID

NCT01181323

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

240

Starts

2011-09-01

Expected to finish

2013-05-01

Last updated by the study team

2015-01-28

Who can join

Age: 18 and older, up to 49. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Maternal Subject
• Women age 18-49 years of age (inclusive) within 28-120 days of delivery.
• Is in good health, as determined by vital signs (heart rate </=100 beats per minute (bpm); blood pressure: systolic <150 mm Hg; diastolic <90 mm Hg; oral temperature <100.0 degrees Fahrenheit), medical history and a targeted physical examination if indicated based on medical history.
• Willing and capable of providing written informed consent for herself and infant.
• Available for entire study duration, clinic visits and phone calls.
• Planning on breast feeding from time of vaccination through 28 days post-vaccination. Breast milk must be at least one half of the source of the infant's feeding.
• Willing to practice adequate contraception for at least 28 days after receipt of study vaccine if not surgically sterile via post-partum tubal ligation, bilateral oophorectomy or hysterectomy. Adequate contraception may include, but is not limited to, abstinence, monogamous relationship with a vasectomized partner, barrier methods such as condoms or diaphragms with spermicides, or licensed hormonal methods that are compatible with breastfeeding an infant.
• May be reached by any IRB-approved form of communication during study period. May include telephone, email, web based, social media, and/or text messaging, based on specific local IRB recommendations.
• Agree to sign a medical release for herself and her infant (if needed) so that study personnel may obtain medical information about her or her infant's health.
• Infant The infant(s) should be in good health as assessed by medical history, interview, rectal temperature and a targeted physical examination based on medical history.
• Infant born greater than or equal to 36 weeks gestation.
• Successful receipt of breast milk for at least two days prior to enrollment. Breast milk must be at least one half of the source of feeding, i.e., some supplementation is acceptable.

You may not qualify if…

• Maternal Subject
• History of receipt of licensed influenza vaccine for the current influenza season. (If enrolled in 2011-2012 season [October 2011 - February 2012], subject must not have received 2011-2012 influenza vaccine. If enrolled in the 2012-2013 season [July 2012 or later], subject must not have received 2012-2013 influenza vaccine).
• History of previous participation in this study.
• Known allergy to eggs, egg proteins or other components in the vaccines (i.e. formaldehyde, polyethylene glycol, p-isooctylphenyl ether, sucrose, gelatin, polysorbate 80, gentamicin, arginine, sodium phosphate, sodium chloride, octylphenol ethoxylate, EDTA).
• If enrolled in the 2011-2012 season, known or suspected latex allergy. For the 2012-2013 season, known or suspected latex allergy is not a reason for exclusion.
• History of severe reactions following immunization with contemporary influenza virus vaccines.
• Received any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to vaccination in this study, or expects to receive a licensed vaccine during the 28 days after vaccination in this study.
• Received an experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) within 28 days prior to vaccination in this study, or expects to receive an experimental/investigational agent within the study time period (180 days after vaccination in this study).
• Received antiviral agent against influenza A and/or B within 48 hours prior to vaccination in this study. Antiviral agents should not be administered until 2 weeks after vaccination in this study unless medically necessary.
• A moderate to severe acute illness and/or an oral temperature >/= 100.0 F, within 72 hr prior to vaccination. (This may result in a temporary delay of vaccination).
• Immunosuppression as a result of an underlying illness or treatment, or use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months.
• Active neoplastic disease or a history of any hematologic malignancy (cancers of blood or bone marrow) or current bleeding or blood clotting disorder.
• Current diagnosis of asthma.
• History of asthma, wheezing, or bronchospasm in the last 5 years.
• Long term (at least 14 days of prednisone 2 mg/kg or equivalent other glucocorticoid) use of oral or parenteral steroids, high-dose inhaled steroids (>800 microgram/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (topical steroids are allowed).
• Use of intranasal steroids within 14 days prior to vaccination in this study or within 14 days after receipt of study vaccine.
• Use of intranasal products within 6 hours prior to vaccination in this study or expects to use intranasal products within 6 hours post study vaccination.
• History of receiving immunoglobulin or other blood product (with exception of RhoGAM) within the 3 months prior to vaccination in this study.
• Diagnosis of a current and uncontrolled major psychiatric disorder.
• Has been hospitalized within the past 10 years for psychiatric illness, suicide attempt, or confinement for danger to self or others.
• The subject is receiving listed 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 a single antidepressant drug and are stable for at least 3 months prior to enrollment without decompensating are allowed enrollment into the study.
• The subject is receiving medications contraindicated with breast feeding.
• Known active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection.
• An active neurological (such as, but not limited to seizure disorder), auto-immune or vascular disease.
• Active breast infection or breast abscess. (Study vaccination will be delayed until this breast infection or breast abscess has been treated and is resolved.)

Where it is running

• Washington Hospital Center - Obstetrics and Gynecology — Washington D.C., District of Columbia, United States
• Emory Children's Center - Pediatric Infectious Diseases — Atlanta, Georgia, United States
• Saint Louis University - Center for Vaccine Development — St Louis, Missouri, United States
• Duke Translational Medicine Institute - Clinical Vaccine Unit — Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center - Infectious Diseases — Cincinnati, Ohio, United States
• Group Health Research Institute - Seattle — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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