Trial Outcomes & Findings for Influenza Vaccine in Pregnant Women (NCT NCT00905125)
NCT ID: NCT00905125
Last Updated: 2012-06-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
Day 0 prior to and Day 28 after receiving single dose.
Results posted on
2012-06-13
Participant Flow
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.
Participant milestones
| Measure |
Fluzone®
Single 0.5 mL intramuscular injection of Fluzone®
|
Fluarix®
Single 0.5 mL intramuscular injection of Fluarix®
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
56
|
|
Overall Study
COMPLETED
|
42
|
53
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Influenza Vaccine in Pregnant Women
Baseline characteristics by cohort
| Measure |
Fluzone®
n=46 Participants
Single 0.5 mL intramuscular injection of Fluzone®
|
Fluarix®
n=56 Participants
Single 0.5 mL intramuscular injection of Fluarix®
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=39 Participants
|
56 Participants
n=41 Participants
|
102 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age Continuous
|
28.0 years
STANDARD_DEVIATION 5.9 • n=39 Participants
|
28.4 years
STANDARD_DEVIATION 5.0 • n=41 Participants
|
28.2 years
STANDARD_DEVIATION 5.4 • n=35 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=39 Participants
|
56 Participants
n=41 Participants
|
102 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=39 Participants
|
56 participants
n=41 Participants
|
102 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Day 0 prior to and Day 28 after receiving single dose.Population: 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.
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.
Outcome measures
| Measure |
Fluzone®
n=45 Participants
Single 0.5 mL intramuscular injection of Fluzone®
|
Fluarix®
n=55 Participants
Single 0.5 mL intramuscular injection of Fluarix®
|
|---|---|---|
|
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)
Influenza B antigen, Day 0
|
4 Participants
|
3 Participants
|
|
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)
Influenza B antigen, Day 28
|
35 Participants
|
33 Participants
|
|
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)
Influenza H1N1 antigen, Day 0
|
7 Participants
|
7 Participants
|
|
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)
Influenza H1N1 antigen, Day 28
|
43 Participants
|
47 Participants
|
|
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)
Influenza H3N2 antigen, Day 0
|
14 Participants
|
22 Participants
|
|
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)
Influenza H3N2 antigen, Day 28
|
42 Participants
|
51 Participants
|
PRIMARY outcome
Timeframe: At time of delivery.Population: All participants from whom outcome data were collected are included in the ITT safety population for this outcome measure.
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.
Outcome measures
| Measure |
Fluzone®
n=45 Participants
Single 0.5 mL intramuscular injection of Fluzone®
|
Fluarix®
n=55 Participants
Single 0.5 mL intramuscular injection of Fluarix®
|
|---|---|---|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Stillborn
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Miscarriage
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Gestational diabetes
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Polyhydramnios
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Oligohydramnios
|
5 Participants
|
2 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Pregnancy induced hypertension
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Pre-eclampsia
|
1 Participants
|
6 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Eclampsia
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Fetal distress
|
1 Participants
|
5 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Abruptio placenta
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Chorioamnionitis
|
2 Participants
|
3 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Fever greater than 100.4 degrees Fahrenheit
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Anaphylaxis
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Antibiotics prior to delivery
|
18 Participants
|
21 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Fetal abnormalities detected during pregnancy
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Assisted vaginal delivery
|
3 Participants
|
3 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Non-elective Cesarean section
|
7 Participants
|
9 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Abnormal amniotic fluid
|
13 Participants
|
11 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Postpartum fever
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Postpartum endometritis
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Postpartum bleeding
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
Postpartum bacteremia
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At time of delivery.Population: 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.
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.
Outcome measures
| Measure |
Fluzone®
n=44 Participants
Single 0.5 mL intramuscular injection of Fluzone®
|
Fluarix®
n=56 Participants
Single 0.5 mL intramuscular injection of Fluarix®
|
|---|---|---|
|
Number of Participants Reporting Neonatal Complications.
Pre-term (less than 37 weeks)
|
3 Participants
|
4 Participants
|
|
Number of Participants Reporting Neonatal Complications.
Large for gestational age
|
4 Participants
|
9 Participants
|
|
Number of Participants Reporting Neonatal Complications.
Small for gestational age
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Neonatal Complications.
Abnormal infant exam
|
8 Participants
|
11 Participants
|
|
Number of Participants Reporting Neonatal Complications.
Congenital abnormalities
|
4 Participants
|
2 Participants
|
|
Number of Participants Reporting Neonatal Complications.
Hematological complications
|
0 Participants
|
5 Participants
|
|
Number of Participants Reporting Neonatal Complications.
Infection
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Neonatal Complications.
Sepsis
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Neonatal Complications.
Meningitis
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Neonatal Complications.
Metabolic complications
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Neonatal Complications.
Respiratory complications
|
7 Participants
|
4 Participants
|
|
Number of Participants Reporting Neonatal Complications.
Respiratory support used
|
5 Participants
|
4 Participants
|
|
Number of Participants Reporting Neonatal Complications.
Fever 100.4 degrees Fahrenheit or greater
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Neonatal Complications.
Admission to special nursery/intensive care
|
7 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Through 6 months post vaccination.Population: All participants are included in the ITT safety population for this outcome measure.
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.
Outcome measures
| Measure |
Fluzone®
n=46 Participants
Single 0.5 mL intramuscular injection of Fluzone®
|
Fluarix®
n=56 Participants
Single 0.5 mL intramuscular injection of Fluarix®
|
|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAE)
|
8 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Day 0 through Day 28 post vaccination.Population: All participants are included in the ITT safety population for this outcome measure.
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.
Outcome measures
| Measure |
Fluzone®
n=46 Participants
Single 0.5 mL intramuscular injection of Fluzone®
|
Fluarix®
n=56 Participants
Single 0.5 mL intramuscular injection of Fluarix®
|
|---|---|---|
|
Number of Participants Reporting Unsolicited Non-serious Adverse Events Considered Associated With Vaccination
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Days 0-7 after vaccination.Population: All participants are included in the ITT safety population for this outcome measure.
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.
Outcome measures
| Measure |
Fluzone®
n=46 Participants
Single 0.5 mL intramuscular injection of Fluzone®
|
Fluarix®
n=56 Participants
Single 0.5 mL intramuscular injection of Fluarix®
|
|---|---|---|
|
Number of Participants Reporting Solicited Injection Site Reactions at Each Severity Based on the Functional Grading Scale
Mild pain
|
14 Participants
|
22 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions at Each Severity Based on the Functional Grading Scale
Moderate pain
|
4 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions at Each Severity Based on the Functional Grading Scale
Severe pain
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions at Each Severity Based on the Functional Grading Scale
Mild tenderness
|
34 Participants
|
39 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions at Each Severity Based on the Functional Grading Scale
Moderate tenderness
|
4 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions at Each Severity Based on the Functional Grading Scale
Severe tenderness
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions at Each Severity Based on the Functional Grading Scale
Mild swelling
|
3 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions at Each Severity Based on the Functional Grading Scale
Moderate swelling
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions at Each Severity Based on the Functional Grading Scale
Severe swelling
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 0-7 after vaccination.Population: All participants are included in the ITT safety population for this outcome measure.
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.
Outcome measures
| Measure |
Fluzone®
n=46 Participants
Single 0.5 mL intramuscular injection of Fluzone®
|
Fluarix®
n=56 Participants
Single 0.5 mL intramuscular injection of Fluarix®
|
|---|---|---|
|
Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness at Each Grade
Small swelling
|
2 Participants
|
3 Participants
|
|
Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness at Each Grade
Medium swelling
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness at Each Grade
Large swelling
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness at Each Grade
Small redness
|
4 Participants
|
7 Participants
|
|
Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness at Each Grade
Medium redness
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness at Each Grade
Large redness
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 0-7 after vaccination.Population: All participants are included in the ITT safety population for this outcome measure.
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.
Outcome measures
| Measure |
Fluzone®
n=46 Participants
Single 0.5 mL intramuscular injection of Fluzone®
|
Fluarix®
n=56 Participants
Single 0.5 mL intramuscular injection of Fluarix®
|
|---|---|---|
|
Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale
Mild feverishness
|
5 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale
Moderate feverishness
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale
Severe feverishness
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale
Mild malaise
|
11 Participants
|
15 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale
Moderate malaise
|
7 Participants
|
10 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale
Severe malaise
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale
Mild myalgia
|
6 Participants
|
6 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale
Moderate myalgia
|
3 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale
Severe myalgia
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale
Mild headache
|
10 Participants
|
7 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale
Moderate headache
|
6 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale
Severe headache
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale
Mild nausea
|
7 Participants
|
6 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale
Moderate nausea
|
1 Participants
|
6 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale
Severe nausea
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 0-7 after vaccination.Population: All participants are included in the ITT safety population for this outcome measure.
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.
Outcome measures
| Measure |
Fluzone®
n=46 Participants
Single 0.5 mL intramuscular injection of Fluzone®
|
Fluarix®
n=56 Participants
Single 0.5 mL intramuscular injection of Fluarix®
|
|---|---|---|
|
Number of Participants Reporting Fever Based on the Protocol-defined Grading Scale for Oral Temperature
Mild fever
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Fever Based on the Protocol-defined Grading Scale for Oral Temperature
Moderate fever
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Fever Based on the Protocol-defined Grading Scale for Oral Temperature
Severe fever
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 prior to and Day 28 after receiving single dose.Population: 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.
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.
Outcome measures
| Measure |
Fluzone®
n=45 Participants
Single 0.5 mL intramuscular injection of Fluzone®
|
Fluarix®
n=55 Participants
Single 0.5 mL intramuscular injection of Fluarix®
|
|---|---|---|
|
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2008-2009 Seasonal Influenza Trivalent Influenza Vaccine
Influenza B antigen, Day 0
|
10.8 Titer
Interval 8.1 to 14.4
|
10.0 Titer
Interval 8.1 to 12.5
|
|
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2008-2009 Seasonal Influenza Trivalent Influenza Vaccine
Influenza B antigen, Day 28
|
67.5 Titer
Interval 52.8 to 86.5
|
41.7 Titer
Interval 33.5 to 52.0
|
|
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2008-2009 Seasonal Influenza Trivalent Influenza Vaccine
Influenza H1N1 antigen, Day 0
|
11.7 Titer
Interval 8.5 to 16.0
|
10.9 Titer
Interval 8.6 to 13.7
|
|
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2008-2009 Seasonal Influenza Trivalent Influenza Vaccine
Influenza H1N1 antigen, Day 28
|
126.0 Titer
Interval 95.6 to 166.2
|
126.4 Titer
Interval 92.3 to 173.2
|
|
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2008-2009 Seasonal Influenza Trivalent Influenza Vaccine
Influenza H3N2 antigen, Day 0
|
20.2 Titer
Interval 15.0 to 27.1
|
23.6 Titer
Interval 17.7 to 31.6
|
|
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2008-2009 Seasonal Influenza Trivalent Influenza Vaccine
Influenza H3N2 antigen, Day 28
|
206.3 Titer
Interval 141.1 to 301.8
|
205.3 Titer
Interval 151.0 to 279.2
|
PRIMARY outcome
Timeframe: Day 0 prior to and Day 28 receiving a single dose.Population: 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.
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.
Outcome measures
| Measure |
Fluzone®
n=45 Participants
Single 0.5 mL intramuscular injection of Fluzone®
|
Fluarix®
n=55 Participants
Single 0.5 mL intramuscular injection of Fluarix®
|
|---|---|---|
|
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
Influenza B antigen
|
25 Participants
|
24 Participants
|
|
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
Influenza H1N1 antigen
|
35 Participants
|
39 Participants
|
|
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
Influenza H3N2 antigen
|
35 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Day 0 prior to and Day 28 after receiving a single dose.Population: Microneutralization assays were deemed not necessary by the sponsor and conduct of these assays is not planned.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 prior to and Day 28 receiving a single dose.Population: Microneutralization assays were deemed not necessary by the sponsor and conduct of these assays is not planned.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 prior to and Day 28 after receiving a single dose.Population: Microneutralization assays were deemed not necessary by the sponsor and conduct of these assays is not planned.
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.
Outcome measures
Outcome data not reported
Adverse Events
Fluzone®
Serious events: 8 serious events
Other events: 42 other events
Deaths: 0 deaths
Fluarix®
Serious events: 13 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluzone®
n=46 participants at risk
Single 0.5 mL intramuscular injection of Fluzone®
|
Fluarix®
n=56 participants at risk
Single 0.5 mL intramuscular injection of Fluarix®
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Retained products of conception
|
2.2%
1/46 • Number of events 1 • 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.
|
1.8%
1/56 • Number of events 1 • 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.
|
|
Pregnancy, puerperium and perinatal conditions
HELLP syndrome
|
2.2%
1/46 • Number of events 1 • 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.
|
1.8%
1/56 • Number of events 1 • 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.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
0.00%
0/46 • 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.
|
3.6%
2/56 • Number of events 2 • 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.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/46 • 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.
|
1.8%
1/56 • Number of events 1 • 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.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
2.2%
1/46 • Number of events 1 • 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.
|
0.00%
0/56 • 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.
|
|
Congenital, familial and genetic disorders
Polydactyly
|
2.2%
1/46 • Number of events 1 • 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.
|
1.8%
1/56 • Number of events 1 • 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.
|
|
Pregnancy, puerperium and perinatal conditions
Intra-uterine death
|
2.2%
1/46 • Number of events 1 • 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.
|
1.8%
1/56 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/46 • 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.
|
1.8%
1/56 • Number of events 1 • 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.
|
|
Congenital, familial and genetic disorders
Thyroid malformation
|
0.00%
0/46 • 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.
|
1.8%
1/56 • Number of events 1 • 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.
|
|
Surgical and medical procedures
Caesarean section
|
2.2%
1/46 • Number of events 1 • 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.
|
3.6%
2/56 • Number of events 2 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal asphyxia
|
0.00%
0/46 • 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.
|
1.8%
1/56 • Number of events 1 • 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.
|
|
Cardiac disorders
Foetal heart rate deceleration
|
0.00%
0/46 • 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.
|
1.8%
1/56 • Number of events 1 • 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.
|
|
Immune system disorders
Rhesus incompatibility
|
0.00%
0/46 • 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.
|
1.8%
1/56 • Number of events 1 • 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.
|
|
Congenital, familial and genetic disorders
Pilonidal cyst congenital
|
2.2%
1/46 • Number of events 1 • 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.
|
0.00%
0/56 • 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.
|
|
Congenital, familial and genetic disorders
Congenital anomaly
|
2.2%
1/46 • Number of events 1 • 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.
|
0.00%
0/56 • 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.
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
2.2%
1/46 • Number of events 1 • 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.
|
0.00%
0/56 • 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.
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
2.2%
1/46 • Number of events 1 • 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.
|
0.00%
0/56 • 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.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.2%
1/46 • Number of events 1 • 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.
|
0.00%
0/56 • 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.
|
|
Congenital, familial and genetic disorders
Congenital central nervous system anomaly
|
2.2%
1/46 • Number of events 1 • 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.
|
0.00%
0/56 • 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.
|
Other adverse events
| Measure |
Fluzone®
n=46 participants at risk
Single 0.5 mL intramuscular injection of Fluzone®
|
Fluarix®
n=56 participants at risk
Single 0.5 mL intramuscular injection of Fluarix®
|
|---|---|---|
|
General disorders
Feeling hot
|
10.9%
5/46 • Number of events 5 • 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.
|
3.6%
2/56 • Number of events 2 • 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.
|
|
General disorders
Malaise
|
41.3%
19/46 • Number of events 19 • 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.
|
44.6%
25/56 • Number of events 25 • 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.6%
9/46 • Number of events 9 • 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.
|
16.1%
9/56 • Number of events 9 • 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.
|
|
Nervous system disorders
Headache
|
34.8%
16/46 • Number of events 16 • 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.
|
12.5%
7/56 • Number of events 7 • 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.
|
|
Gastrointestinal disorders
Nausea
|
17.4%
8/46 • Number of events 8 • 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.
|
21.4%
12/56 • Number of events 12 • 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.
|
|
General disorders
Injection site pain
|
39.1%
18/46 • Number of events 18 • 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.
|
41.1%
23/56 • Number of events 23 • 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.
|
|
General disorders
Tenderness
|
82.6%
38/46 • Number of events 38 • 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.
|
73.2%
41/56 • Number of events 41 • 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.
|
|
General disorders
Injection site erythema
|
15.2%
7/46 • Number of events 7 • 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.
|
14.3%
8/56 • Number of events 8 • 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.
|
|
General disorders
Injection site swelling
|
8.7%
4/46 • Number of events 4 • 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.
|
7.1%
4/56 • Number of events 4 • 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.
|
Additional Information
Shital M. Patel, M.D.
Medicine and Molecular Virology & Microbiology, Baylor College of Medicine
Phone: 713-798-3793
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60