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Influenza Vaccine in Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00905125
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : April 6, 2011
Last Update Posted : June 13, 2012
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Fluzone®
Biological: Fluarix®
Enrollment 102
Recruitment Details Enrollment began on 11JUN2009 and was closed on 03SEP2009 due to the availability of the 2009-2010 seasonal Influenza vaccine and onset of Influenza season.
Pre-assignment Details  
Arm/Group Title Fluzone® Fluarix®
Hide Arm/Group Description Single 0.5 mL intramuscular injection of Fluzone® Single 0.5 mL intramuscular injection of Fluarix®
Period Title: Overall Study
Started 46 56
Completed 42 53
Not Completed 4 3
Arm/Group Title Fluzone® Fluarix® Total
Hide Arm/Group Description Single 0.5 mL intramuscular injection of Fluzone® Single 0.5 mL intramuscular injection of Fluarix® Total of all reporting groups
Overall Number of Baseline Participants 46 56 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 56 participants 102 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
46
 100.0%
56
 100.0%
102
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 56 participants 102 participants
28.0  (5.9) 28.4  (5.0) 28.2  (5.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 56 participants 102 participants
Female
46
 100.0%
56
 100.0%
102
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants 56 participants 102 participants
46 56 102
1.Primary Outcome
Title Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2008-2009 Seasonal Inactivated Trivalent Influenza Vaccine (TIV)
Hide Description 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 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.
Time Frame Day 0 prior to and Day 28 after receiving single dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants are included in this ITT analysis if blood was collected at both timepoints. One participant was excluded because the baseline blood draw was done after vaccination.
Arm/Group Title Fluzone® Fluarix®
Hide Arm/Group Description:
Single 0.5 mL intramuscular injection of Fluzone®
Single 0.5 mL intramuscular injection of Fluarix®
Overall Number of Participants Analyzed 45 55
Measure Type: Number
Unit of Measure: Participants
Influenza B antigen, Day 0 4 3
Influenza B antigen, Day 28 35 33
Influenza H1N1 antigen, Day 0 7 7
Influenza H1N1 antigen, Day 28 43 47
Influenza H3N2 antigen, Day 0 14 22
Influenza H3N2 antigen, Day 28 42 51
2.Primary Outcome
Title Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Hide Description 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.
Time Frame At time of delivery.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from whom outcome data were collected are included in the ITT safety population for this outcome measure.
Arm/Group Title Fluzone® Fluarix®
Hide Arm/Group Description:
Single 0.5 mL intramuscular injection of Fluzone®
Single 0.5 mL intramuscular injection of Fluarix®
Overall Number of Participants Analyzed 45 55
Measure Type: Number
Unit of Measure: Participants
Stillborn 1 1
Miscarriage 1 0
Gestational diabetes 2 4
Polyhydramnios 1 0
Oligohydramnios 5 2
Pregnancy induced hypertension 2 4
Pre-eclampsia 1 6
Eclampsia 0 0
Fetal distress 1 5
Abruptio placenta 1 0
Chorioamnionitis 2 3
Fever greater than 100.4 degrees Fahrenheit 4 5
Anaphylaxis 0 0
Antibiotics prior to delivery 18 21
Fetal abnormalities detected during pregnancy 2 2
Assisted vaginal delivery 3 3
Non-elective Cesarean section 7 9
Abnormal amniotic fluid 13 11
Postpartum fever 3 1
Postpartum endometritis 1 0
Postpartum bleeding 2 2
Postpartum bacteremia 0 0
3.Primary Outcome
Title Number of Participants Reporting Neonatal Complications.
Hide Description 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.
Time Frame At time of delivery.
Hide Outcome Measure Data
Hide Analysis Population Description
All live births are included in this outcome measure, which excludes three participants whose pregnancies ended in miscarriage or stillbirth (reported as maternal complications). Three participants gave birth to twins, who are each counted separately.
Arm/Group Title Fluzone® Fluarix®
Hide Arm/Group Description:
Single 0.5 mL intramuscular injection of Fluzone®
Single 0.5 mL intramuscular injection of Fluarix®
Overall Number of Participants Analyzed 44 56
Measure Type: Number
Unit of Measure: Participants
Pre-term (less than 37 weeks) 3 4
Large for gestational age 4 9
Small for gestational age 3 2
Abnormal infant exam 8 11
Congenital abnormalities 4 2
Hematological complications 0 5
Infection 0 1
Sepsis 0 0
Meningitis 0 0
Metabolic complications 0 0
Respiratory complications 7 4
Respiratory support used 5 4
Fever 100.4 degrees Fahrenheit or greater 1 0
Admission to special nursery/intensive care 7 3
4.Primary Outcome
Title Number of Participants Reporting Serious Adverse Events (SAE)
Hide Description 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. All events are included regardless of association to vaccination.
Time Frame Through 6 months post vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants are included in the ITT safety population for this outcome measure.
Arm/Group Title Fluzone® Fluarix®
Hide Arm/Group Description:
Single 0.5 mL intramuscular injection of Fluzone®
Single 0.5 mL intramuscular injection of Fluarix®
Overall Number of Participants Analyzed 46 56
Measure Type: Number
Unit of Measure: Participants
8 13
5.Primary Outcome
Title Number of Participants Reporting Unsolicited Non-serious Adverse Events Considered Associated With Vaccination
Hide Description 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.
Time Frame Day 0 through Day 28 post vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants are included in the ITT safety population for this outcome measure.
Arm/Group Title Fluzone® Fluarix®
Hide Arm/Group Description:
Single 0.5 mL intramuscular injection of Fluzone®
Single 0.5 mL intramuscular injection of Fluarix®
Overall Number of Participants Analyzed 46 56
Measure Type: Number
Unit of Measure: Participants
0 3
6.Primary Outcome
Title Number of Participants Reporting Solicited Injection Site Reactions at Each Severity Based on the Functional Grading Scale
Hide Description Participants recorded a daily maximum severity at which local reactions of pain, tenderness and swelling were experienced. Mild reactions had no interference with daily activities, moderate reactions interfered with daily activity, and severe reactions were defined as preventing daily activity. Participants are reported at the highest severity experienced across the 8 days.
Time Frame Days 0-7 after vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants are included in the ITT safety population for this outcome measure.
Arm/Group Title Fluzone® Fluarix®
Hide Arm/Group Description:
Single 0.5 mL intramuscular injection of Fluzone®
Single 0.5 mL intramuscular injection of Fluarix®
Overall Number of Participants Analyzed 46 56
Measure Type: Number
Unit of Measure: Participants
Mild pain 14 22
Moderate pain 4 1
Severe pain 0 0
Mild tenderness 34 39
Moderate tenderness 4 2
Severe tenderness 0 0
Mild swelling 3 3
Moderate swelling 0 0
Severe swelling 0 0
7.Primary Outcome
Title Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness at Each Grade
Hide Description Participants recorded a daily measured value of swelling and redness, if present. The protocol defined grading of small, medium and large, with small as less than 20 mm, medium as 20-50 mm and large as greater than 50 mm. Participants are counted at the largest measured grade experienced across the 8 day period after vaccination.
Time Frame Days 0-7 after vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants are included in the ITT safety population for this outcome measure.
Arm/Group Title Fluzone® Fluarix®
Hide Arm/Group Description:
Single 0.5 mL intramuscular injection of Fluzone®
Single 0.5 mL intramuscular injection of Fluarix®
Overall Number of Participants Analyzed 46 56
Measure Type: Number
Unit of Measure: Participants
Small swelling 2 3
Medium swelling 2 1
Large swelling 0 0
Small redness 4 7
Medium redness 3 1
Large redness 0 0
8.Primary Outcome
Title Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale
Hide Description Participants recorded a daily maximum severity at which systemic symptoms of feverishness, malaise, myalgia, headache and nausea were experienced. Mild reactions had no interference with daily activities, moderate reactions interfered with daily activity, and severe reactions were defined as preventing daily activity. Participants are reported at the highest severity experienced across the 8 days.
Time Frame Days 0-7 after vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants are included in the ITT safety population for this outcome measure.
Arm/Group Title Fluzone® Fluarix®
Hide Arm/Group Description:
Single 0.5 mL intramuscular injection of Fluzone®
Single 0.5 mL intramuscular injection of Fluarix®
Overall Number of Participants Analyzed 46 56
Measure Type: Number
Unit of Measure: Participants
Mild feverishness 5 2
Moderate feverishness 0 0
Severe feverishness 0 0
Mild malaise 11 15
Moderate malaise 7 10
Severe malaise 1 0
Mild myalgia 6 6
Moderate myalgia 3 3
Severe myalgia 0 0
Mild headache 10 7
Moderate headache 6 0
Severe headache 0 0
Mild nausea 7 6
Moderate nausea 1 6
Severe nausea 0 0
9.Primary Outcome
Title Number of Participants Reporting Fever Based on the Protocol-defined Grading Scale for Oral Temperature
Hide Description Participants recorded a daily oral temperature on a memory aid for 8 days (Days 0-7) after vaccination. The protocol defined mild fever as oral temperatures 37.8 to less than 38 degree Celsius, moderate fever as 38 to less than 39 degrees Celsius and severe fever as oral temperatures of 39 degrees Celsius or higher. Participants are reported at the highest severity experienced across the 8 days.
Time Frame Days 0-7 after vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants are included in the ITT safety population for this outcome measure.
Arm/Group Title Fluzone® Fluarix®
Hide Arm/Group Description:
Single 0.5 mL intramuscular injection of Fluzone®
Single 0.5 mL intramuscular injection of Fluarix®
Overall Number of Participants Analyzed 46 56
Measure Type: Number
Unit of Measure: Participants
Mild fever 0 0
Moderate fever 0 0
Severe fever 0 0
10.Primary Outcome
Title Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2008-2009 Seasonal Influenza Trivalent Influenza Vaccine
Hide Description 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 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.
Time Frame Day 0 prior to and Day 28 after receiving single dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants are included in this ITT analysis if blood was collected at both timepoints. One participant was excluded because the baseline blood draw was done after vaccination.
Arm/Group Title Fluzone® Fluarix®
Hide Arm/Group Description:
Single 0.5 mL intramuscular injection of Fluzone®
Single 0.5 mL intramuscular injection of Fluarix®
Overall Number of Participants Analyzed 45 55
Mean (95% Confidence Interval)
Unit of Measure: Titer
Influenza B antigen, Day 0
10.8
(8.1 to 14.4)
10.0
(8.1 to 12.5)
Influenza B antigen, Day 28
67.5
(52.8 to 86.5)
41.7
(33.5 to 52.0)
Influenza H1N1 antigen, Day 0
11.7
(8.5 to 16.0)
10.9
(8.6 to 13.7)
Influenza H1N1 antigen, Day 28
126.0
(95.6 to 166.2)
126.4
(92.3 to 173.2)
Influenza H3N2 antigen, Day 0
20.2
(15.0 to 27.1)
23.6
(17.7 to 31.6)
Influenza H3N2 antigen, Day 28
206.3
(141.1 to 301.8)
205.3
(151.0 to 279.2)
11.Primary Outcome
Title Number of Participants With a Four-fold or Greater Rise in HAI Antibody Titer Against Each Antigen in the 2008-2009 Seasonal Influenza Trivalent Influenza Vaccine
Hide Description 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 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a four-fold increase in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 28 titer was 40 or greater, or the Day 0 titer was greater than or equal to 10, and the Day 28 titer was an increase by four-fold or more.
Time Frame Day 0 prior to and Day 28 receiving a single dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants are included in this ITT analysis if blood was collected at both timepoints. One participant was excluded because the baseline blood draw was done after vaccination.
Arm/Group Title Fluzone® Fluarix®
Hide Arm/Group Description:
Single 0.5 mL intramuscular injection of Fluzone®
Single 0.5 mL intramuscular injection of Fluarix®
Overall Number of Participants Analyzed 45 55
Measure Type: Number
Unit of Measure: Participants
Influenza B antigen 25 24
Influenza H1N1 antigen 35 39
Influenza H3N2 antigen 35 40
12.Secondary Outcome
Title Number of Participants With a Serum Microneutralization Antibody Titer of Greater Than or Equal to 40 Against Each Antigen in the 2008-2009 TIV
Hide Description Blood was collected for microneutralization assay at Day 0 prior to vaccination and again at 28 days following vaccination. The microneutralization assay was to be conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.
Time Frame Day 0 prior to and Day 28 after receiving a single dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Microneutralization assays were deemed not necessary by the sponsor and conduct of these assays is not planned.
Arm/Group Title Fluzone® Fluarix®
Hide Arm/Group Description:
Single 0.5 mL intramuscular injection of Fluzone®
Single 0.5 mL intramuscular injection of Fluarix®
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Number of Participants With a Four-fold or Greater Rise in Microneutralization Antibody Titer Against Each Antigen in the 2008-2009 TIV
Hide Description Blood was collected for microneutralization assay at Day 0 prior to vaccination and again at 28 days following vaccination. The microneutralization assay was to be conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. The threshold of a four-fold increase in titer would be met if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 28 titer was 40 or greater, or the Day 0 titer was greater than or equal to 10, and the Day 28 titer was an increase by four-fold or more.
Time Frame Day 0 prior to and Day 28 receiving a single dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Microneutralization assays were deemed not necessary by the sponsor and conduct of these assays is not planned.
Arm/Group Title Fluzone® Fluarix®
Hide Arm/Group Description:
Single 0.5 mL intramuscular injection of Fluzone®
Single 0.5 mL intramuscular injection of Fluarix®
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Microneutralization Assay Geometric Mean Antibody Titers Against Each Antigen in the 2008-2009 TIV
Hide Description Blood was collected for microneutralization assay at Day 0 prior to vaccination and again at 28 days following vaccination. The microneutralization assay was to be conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.
Time Frame Day 0 prior to and Day 28 after receiving a single dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Microneutralization assays were deemed not necessary by the sponsor and conduct of these assays is not planned.
Arm/Group Title Fluzone® Fluarix®
Hide Arm/Group Description:
Single 0.5 mL intramuscular injection of Fluzone®
Single 0.5 mL intramuscular injection of Fluarix®
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Solicited systemic symptoms and injection site reactions were collected for 7 days after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluzone® Fluarix®
Hide Arm/Group Description Single 0.5 mL intramuscular injection of Fluzone® Single 0.5 mL intramuscular injection of Fluarix®
All-Cause Mortality
Fluzone® Fluarix®
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Fluzone® Fluarix®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/46 (17.39%)      13/56 (23.21%)    
Cardiac disorders     
Foetal heart rate deceleration * 1  0/46 (0.00%)  0 1/56 (1.79%)  1
Congenital, familial and genetic disorders     
Polydactyly * 1  1/46 (2.17%)  1 1/56 (1.79%)  1
Thyroid malformation * 1  0/46 (0.00%)  0 1/56 (1.79%)  1
Pilonidal cyst congenital * 1  1/46 (2.17%)  1 0/56 (0.00%)  0
Congenital anomaly * 1  1/46 (2.17%)  1 0/56 (0.00%)  0
Congenital central nervous system anomaly * 1  1/46 (2.17%)  1 0/56 (0.00%)  0
Hepatobiliary disorders     
Hyperbilirubinaemia * 1  1/46 (2.17%)  1 0/56 (0.00%)  0
Immune system disorders     
Rhesus incompatibility * 1  0/46 (0.00%)  0 1/56 (1.79%)  1
Pregnancy, puerperium and perinatal conditions     
Retained products of conception * 1  1/46 (2.17%)  1 1/56 (1.79%)  1
HELLP syndrome * 1  1/46 (2.17%)  1 1/56 (1.79%)  1
Postpartum haemorrhage * 1  0/46 (0.00%)  0 2/56 (3.57%)  2
Premature labour * 1  1/46 (2.17%)  1 0/56 (0.00%)  0
Intra-uterine death * 1  1/46 (2.17%)  1 1/56 (1.79%)  1
Premature baby * 1  1/46 (2.17%)  1 0/56 (0.00%)  0
Stillbirth * 1  1/46 (2.17%)  1 0/56 (0.00%)  0
Renal and urinary disorders     
Nephrolithiasis * 1  0/46 (0.00%)  0 1/56 (1.79%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory distress * 1  0/46 (0.00%)  0 1/56 (1.79%)  1
Neonatal asphyxia * 1  0/46 (0.00%)  0 1/56 (1.79%)  1
Surgical and medical procedures     
Caesarean section * 1  1/46 (2.17%)  1 2/56 (3.57%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fluzone® Fluarix®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/46 (91.30%)      50/56 (89.29%)    
Gastrointestinal disorders     
Nausea † 1  8/46 (17.39%)  8 12/56 (21.43%)  12
General disorders     
Feeling hot † 1  5/46 (10.87%)  5 2/56 (3.57%)  2
Malaise † 1  19/46 (41.30%)  19 25/56 (44.64%)  25
Injection site pain † 1  18/46 (39.13%)  18 23/56 (41.07%)  23
Tenderness † 1 [1]  38/46 (82.61%)  38 41/56 (73.21%)  41
Injection site erythema † 1  7/46 (15.22%)  7 8/56 (14.29%)  8
Injection site swelling † 1  4/46 (8.70%)  4 4/56 (7.14%)  4
Musculoskeletal and connective tissue disorders     
Myalgia † 1  9/46 (19.57%)  9 9/56 (16.07%)  9
Nervous system disorders     
Headache † 1  16/46 (34.78%)  16 7/56 (12.50%)  7
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
[1]
Tenderness was solicited as a reaction at the vaccination site.
In September of 2009, the trial was closed to enrollment prior to accruing the intended 200 participants due to the availability of the 2009-2010 seasonal Influenza vaccine and onset of Influenza season.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Shital M. Patel, M.D.
Organization: Medicine and Molecular Virology & Microbiology, Baylor College of Medicine
Phone: 713-798-3793
EMail: shitalp@bcm.edu
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00905125    
Other Study ID Numbers: 09-0033
N01AI80002C
First Submitted: May 18, 2009
First Posted: May 20, 2009
Results First Submitted: February 17, 2011
Results First Posted: April 6, 2011
Last Update Posted: June 13, 2012