InfluenzaPhase 2NCT01173211
2010-2011 Trivalent Influenza Vaccine (TIV) in Pregnant Women
A Phase 2 study testing Trivalent inactivated influenza vaccine in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Trivalent inactivated influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2010to Nov 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Duke University Medical Center - Duke Perinatal Clinic
Durham, North Carolina, 27705
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, 77030-3411
Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
Nashville, Tennessee, 37232-2573
Group Health Research Institute - Seattle
Seattle, Washington, 98101-1466
Saint Louis University - Center for Vaccine Development
St Louis, Missouri, 63104-1015
About this study
Official title: A Randomized, Double-Blind Trial on the Safety and Immunogenicity of Seasonal 2010-2011 Inactivated Trivalent Influenza Vaccine in Pregnant Women
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.
Read the detailed description
Influenza is a significant cause of morbidity and mortality in the United States. Pregnant women and infants are at an increased risk for the complications of influenza. Pregnant women are considered a high risk population. In the United States, routine vaccination with inactivated trivalent influenza vaccine (TIV) for women who are pregnant or deliver during the influenza season is recommended. However, few studies exist on the safety and immunogenicity of administration of seasonal inactivated TIV. Although influenza vaccination has been recommended during pregnancy, the rates of immunization remain low, at about 13 percent, which partly reflects concern of safety among pregnant women and providers. It is important to gather prospective data on the safety and immunogenicity of inactivated TIV vaccine in pregnant women. This is a multi-site randomized, double-blinded clinical trial in 180 healthy 18-39 year old, pregnant women in their second or third trimester of pregnancy (from 14 weeks of gestation to 33 weeks/6 days gestation, inclusive) and 60 healthy 18-39 year old non-pregnant controls. Study subjects will be randomized 1:1:1 to receive one of the following three 2010-2011 seasonal inactivated trivalent influenza vaccines: Fluarix®, Agriflu®, or Fluzone® (60 pregnant women and 20 non-pregnant women per group). The study will begin enrollment when at least 2 of the 4 study products are available. Once enrolled, a blood sample will be collected and each subject will receive a single 0.5 mL dose of the assigned vaccine. Subjects will be observed for at least 15 minutes after immunization, and the subjects will maintain a memory aid to record oral temperature and systemic and local adverse events (AEs) for 8 days after immunization. Subjects will have a phone call on Day 2 and 8 for review of memory aid, concomitant medication assessment, and assessment of AEs. At approximately Day 28 post-vaccination, subjects will return to the clinic for blood sample collection, AE and concomitant medication assessment, and a targeted physical examination (if indicated). Pregnant subjects will also have scheduled phone calls from Day 28 until the time of delivery or Day 180, whichever is later, to assess for any new-onset chronic medical conditions, and pregnancy-related problems such as miscarriage or serious adverse events (SAEs) since the last visit. At approximately Day 180 post-vaccination, subjects will return to the clinic for blood sample collection and assessment of the receipt of any vaccines since the last visit. Subjects will be asked about any new-onset chronic medical conditions, SAEs since the last visit and pregnancy-related problems such as miscarriage (for the pregnant women cohort). The duration of the study will be approximately 6 months for the non-pregnant subjects and about 6-8 months for the pregnant subjects, depending on delivery date for the pregnant women. Pregnant subjects will have collection of maternal and cord blood at the time of delivery. Pregnant subjects will also have a phone call 1 month after delivery to assess for any new-onset chronic medical conditions or SAEs since the last visit. The primary objectives are to evaluate the safety of a single 0.5 mL intramuscular injection of the 2010-2011 inactivated TIV in pregnant women and to evaluate the immunogenicity of the 2010-2011 inactivated TIV in pregnant women by hemagglutination inhibition assay (HAI). The secondary objectives are to evaluate the persistence of antibodies to the 2010-2011 inactivated TIV in pregnant women at Day 180 and to assess the transfer of maternally derived antibody against viruses in the 2010-2011 inactivated TIV to infants bor
- Conditions
- Influenza
- Being tested
- Trivalent inactivated influenza vaccine
- Keywords
- pregnant, women, influenza, vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent inactivated influenza vaccineBiological
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.
Trivalent inactivated influenza vaccineBiological
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..
Trivalent inactivated influenza vaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Fluarix® | Experimental | 60 pregnant women and 20 non-pregnant women to receive a single intramuscular 0.5 mL dose of Fluarix®. Receives: Biological: Trivalent inactivated influenza vaccine |
| Arm 3: Fluzone® | Experimental | 60 pregnant women and 20 non-pregnant women to receive a single intramuscular 0.5 mL dose of Fluzone®. Receives: Biological: Trivalent inactivated influenza vaccine |
| Arm 2: Agriflu® | Experimental | 60 pregnant women and 20 non-pregnant women to receive a single intramuscular 0.5 mL dose of Agriflu®. Receives: Biological: Trivalent inactivated influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Vaccine-associated Unsolicited Non-serious Adverse Events
Unsolicited non-serious adverse events were collected from participants at follow up contacts, either by phone or in clinic, through 28 days after vaccination. Association to vaccination was determined by a clinician licensed to make a medical diagnosis and listed on the site's Federal Drug Administration's Form 1572.
Measured: Day 0 through Day 28 post vaccination
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.
Measured: During the pregnancy and at the time of delivery
Number of Participants Reporting Neonatal Complications
Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.
Measured: At time of delivery
Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)
Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes, or was described as Guillain-Barré Syndrome. Association was determined by a clinician licensed to diagnose and listed on the site's FDA Form 1572.
Measured: Day 0 through Day 180 after vaccination
Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination
Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Measured: 8 days after vaccination (Days 0-7).
Number of Participants Reporting Solicited Quantitative Local Reactions After Vaccination
Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.
Measured: 8 days after vaccination (Days 0-7).
Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination
Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Measured: 8 days after vaccination (Days 0-7).
Number of Participants Reporting Fever After Vaccination
Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.
Measured: 8 days after vaccination (Days 0-7).
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.
Measured: Day 0 prior to and Day 28 following vaccination
Number of Participants With 4-fold or Greater Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
Blood was collected from all participants prior to vaccination as well as 28 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 28 post vaccination titer was 40 or greater, or the Day 0 titer was greater than or equal to 10 and the Day 28 post vaccination titer was an increase by 4-fold or more.
Measured: Day 0 prior to and Day 28 after vaccination
Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
Blood was collected from all participants prior to vaccination as well as 28 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.
Measured: Day 0 prior to and Day 28 after vaccination
Secondary outcomes (8)
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination
Blood was collected for HAI assay at approximately Day 180 following vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.
Measured: Day 180 (approximately 6 months after vaccination)
Number of Participants With 4-fold or Greater Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination
Blood was collected from all participants at 180 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 180 post vaccination titer was 40 or greater, or the Day 0 titer was greater than or equal to 10 and the Day 180 post vaccination titer was an increase by 4-fold or more.
Measured: Day 180 (approximately 6 months after vaccination)
Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination
Blood was collected from all participants at 180 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.
Measured: Day 180 (approximately 6 months after vaccination)
Maternal HAI GMT Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at Time of Delivery
Maternal blood was collected for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.
Measured: At time of delivery
Number of Participants With 4-fold or Greater Maternal Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at Time of Delivery
Blood was collected from all participants prior to vaccination as well as at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the titer was 40 or greater at delivery, or the Day 0 titer was greater than or equal to 10 and the titer was an increase by 4-fold or more at delivery.
Measured: Day 0 prior to vaccination and at time of delivery
Number of Participants With a Maternal Serum HAI Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2010-2011 Inactivated TIV at Time of Delivery.
Maternal blood was collected for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.
Measured: At time of delivery
HAI GMT Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine in Cord Blood Collected at Time of Delivery
Cord blood was collected at delivery for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.
Measured: At time of delivery
Number of Participants With HAI Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2010-2011 Inactivated TIV in Cord Blood Collected at Time of Delivery.
Cord blood was collected at delivery for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.
Measured: At time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173211
- Sponsor's protocol ID
- 09-0005
- Other IDs
- HHSN272200800002C
- Status last verified
- Mar 2013
- First submitted
- 29 Jul 2010
- Last updated
- 24 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Trial on the Safety and Immunogenicity of Seasonal 2010-2011 Inactivated Trivalent Influenza Vaccine in Pregnant Women
- ClinicalTrials.gov ID
- NCT01173211
- Acronym / sponsor ID
- 09-0005
- Conditions
- Influenza
- Keywords
- pregnant, women, influenza, vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Sep 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 Jul 2010 (estimated)
- Results
- Posted 31 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Influenza is a significant cause of morbidity and mortality in the United States. Pregnant women and infants are at an increased risk for the complications of influenza. Pregnant women are considered a high risk population. In the United States, routine vaccination with inactivated trivalent influenza vaccine (TIV) for women who are pregnant or deliver during the influenza season is recommended. However, few studies exist on the safety and immunogenicity of administration of seasonal inactivated TIV. Although influenza vaccination has been recommended during pregnancy, the rates of immunization remain low, at about 13 percent, which partly reflects concern of safety among pregnant women and providers. It is important to gather prospective data on the safety and immunogenicity of inactivated TIV vaccine in pregnant women. This is a multi-site randomized, double-blinded clinical trial in 180 healthy 18-39 year old, pregnant women in their second or third trimester of pregnancy (from 14 weeks of gestation to 33 weeks/6 days gestation, inclusive) and 60 healthy 18-39 year old non-pregnant controls. Study subjects will be randomized 1:1:1 to receive one of the following three 2010-2011 seasonal inactivated trivalent influenza vaccines: Fluarix®, Agriflu®, or Fluzone® (60 pregnant women and 20 non-pregnant women per group). The study will begin enrollment when at least 2 of the 4 study products are available. Once enrolled, a blood sample will be collected and each subject will receive a single 0.5 mL dose of the assigned vaccine. Subjects will be observed for at least 15 minutes after immunization, and the subjects will maintain a memory aid to record oral temperature and systemic and local adverse events (AEs) for 8 days after immunization. Subjects will have a phone call on Day 2 and 8 for review of memory aid, concomitant medication assessment, and assessment of AEs. At approximately Day 28 post-vaccination, subjects will return to the clinic for blood sample collection, AE and concomitant medication assessment, and a targeted physical examination (if indicated). Pregnant subjects will also have scheduled phone calls from Day 28 until the time of delivery or Day 180, whichever is later, to assess for any new-onset chronic medical conditions, and pregnancy-related problems such as miscarriage or serious adverse events (SAEs) since the last visit. At approximately Day 180 post-vaccination, subjects will return to the clinic for blood sample collection and assessment of the receipt of any vaccines since the last visit. Subjects will be asked about any new-onset chronic medical conditions, SAEs since the last visit and pregnancy-related problems such as miscarriage (for the pregnant women cohort). The duration of the study will be approximately 6 months for the non-pregnant subjects and about 6-8 months for the pregnant subjects, depending on delivery date for the pregnant women. Pregnant subjects will have collection of maternal and cord blood at the time of delivery. Pregnant subjects will also have a phone call 1 month after delivery to assess for any new-onset chronic medical conditions or SAEs since the last visit. The primary objectives are to evaluate the safety of a single 0.5 mL intramuscular injection of the 2010-2011 inactivated TIV in pregnant women and to evaluate the immunogenicity of the 2010-2011 inactivated TIV in pregnant women by hemagglutination inhibition assay (HAI). The secondary objectives are to evaluate the persistence of antibodies to the 2010-2011 inactivated TIV in pregnant women at Day 180 and to assess the transfer of maternally derived antibody against viruses in the 2010-2011 inactivated TIV to infants bor
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Fluarix® | Experimental | Biological: Trivalent inactivated influenza vaccine60 pregnant women and 20 non-pregnant women to receive a single intramuscular 0.5 mL dose of Fluarix®. |
| Arm 3: Fluzone® | Experimental | Biological: Trivalent inactivated influenza vaccine60 pregnant women and 20 non-pregnant women to receive a single intramuscular 0.5 mL dose of Fluzone®. |
| Arm 2: Agriflu® | Experimental | Biological: Trivalent inactivated influenza vaccine60 pregnant women and 20 non-pregnant women to receive a single intramuscular 0.5 mL dose of Agriflu®. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (45 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trivalent inactivated influenza vaccineThree 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. | Biological | Arm 2: Agriflu® |
| Trivalent inactivated influenza vaccineThree 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.. | Biological | Arm 3: Fluzone® |
| Trivalent inactivated influenza vaccineThree 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. | Biological | Arm 1: Fluarix® |
Primary outcome
Number of Participants Reporting Vaccine-associated Unsolicited Non-serious Adverse Events
Time frame: Day 0 through Day 28 post vaccination
Unsolicited non-serious adverse events were collected from participants at follow up contacts, either by phone or in clinic, through 28 days after vaccination. Association to vaccination was determined by a clinician licensed to make a medical diagnosis and listed on the site's Federal Drug Administration's Form 1572.
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Time frame: During the pregnancy and at the time of delivery
Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.
Number of Participants Reporting Neonatal Complications
Time frame: At time of delivery
Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.
Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)
Time frame: Day 0 through Day 180 after vaccination
Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes, or was described as Guillain-Barré Syndrome. Association was determined by a clinician licensed to diagnose and listed on the site's FDA Form 1572.
Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination
Time frame: 8 days after vaccination (Days 0-7).
Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Number of Participants Reporting Solicited Quantitative Local Reactions After Vaccination
Time frame: 8 days after vaccination (Days 0-7).
Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.
Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination
Time frame: 8 days after vaccination (Days 0-7).
Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Number of Participants Reporting Fever After Vaccination
Time frame: 8 days after vaccination (Days 0-7).
Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
Time frame: Day 0 prior to and Day 28 following vaccination
Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.
Number of Participants With 4-fold or Greater Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
Time frame: Day 0 prior to and Day 28 after vaccination
Blood was collected from all participants prior to vaccination as well as 28 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 28 post vaccination titer was 40 or greater, or the Day 0 titer was greater than or equal to 10 and the Day 28 post vaccination titer was an increase by 4-fold or more.
Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
Time frame: Day 0 prior to and Day 28 after vaccination
Blood was collected from all participants prior to vaccination as well as 28 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.
8 secondary outcomes
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination
Time frame: Day 180 (approximately 6 months after vaccination)
Number of Participants With 4-fold or Greater Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination
Time frame: Day 180 (approximately 6 months after vaccination)
Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination
Time frame: Day 180 (approximately 6 months after vaccination)
Maternal HAI GMT Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at Time of Delivery
Time frame: At time of delivery
Number of Participants With 4-fold or Greater Maternal Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at Time of Delivery
Time frame: Day 0 prior to vaccination and at time of delivery
Number of Participants With a Maternal Serum HAI Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2010-2011 Inactivated TIV at Time of Delivery.
Time frame: At time of delivery
HAI GMT Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine in Cord Blood Collected at Time of Delivery
Time frame: At time of delivery
Number of Participants With HAI Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2010-2011 Inactivated TIV in Cord Blood Collected at Time of Delivery.
Time frame: At time of delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trivalent inactivated influenza vaccine in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Vaccine-associated Unsolicited Non-serious Adverse Events (time frame: Day 0 through Day 28 post vaccination). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2014.