Trial Outcomes & Findings for H1N1 Vaccine in Pregnant Women (NCT NCT00963430)
NCT ID: NCT00963430
Last Updated: 2012-12-03
Results Overview
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 were reported as experiencing the symptom at any severity on any of the 8 days.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
Within 8 days (Day 0-7) post first vaccination
Results posted on
2012-12-03
Participant Flow
Participants were healthy pregnant women recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 09Sep2009 and 16Oct2009.
Participant milestones
| Measure |
15 Mcg H1N1 Vaccine
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
59
|
57
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
H1N1 Vaccine in Pregnant Women
Baseline characteristics by cohort
| Measure |
15 Mcg H1N1 Vaccine
n=60 Participants
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=60 Participants
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
31.7 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
31.2 years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
31.4 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
60 participants
n=7 Participants
|
120 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 8 days (Day 0-7) post first vaccinationPopulation: All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.
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 were reported as experiencing the symptom at any severity on any of the 8 days.
Outcome measures
| Measure |
15 Mcg H1N1 Vaccine
n=60 Participants
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=60 Participants
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
Number of Participants Reporting Solicited Subjective Local Reactions After First Vaccination
Pain
|
15 Participants
|
21 Participants
|
|
Number of Participants Reporting Solicited Subjective Local Reactions After First Vaccination
Tenderness
|
26 Participants
|
37 Participants
|
|
Number of Participants Reporting Solicited Subjective Local Reactions After First Vaccination
Swelling
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Within 8 days (Day 0-7) post second vaccinationPopulation: All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.
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 were reported as experiencing the symptom at any severity on any of the 8 days.
Outcome measures
| Measure |
15 Mcg H1N1 Vaccine
n=49 Participants
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=54 Participants
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
Number of Participants Reporting Solicited Subjective Local Reactions After Second Vaccination
Pain
|
10 Participants
|
20 Participants
|
|
Number of Participants Reporting Solicited Subjective Local Reactions After Second Vaccination
Tenderness
|
26 Participants
|
37 Participants
|
|
Number of Participants Reporting Solicited Subjective Local Reactions After Second Vaccination
Swelling
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 8 days (Day 0-7) post first vaccinationPopulation: All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.
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.
Outcome measures
| Measure |
15 Mcg H1N1 Vaccine
n=60 Participants
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=60 Participants
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
Number of Participants Reporting Solicited Quantitative Local Reactions After First Vaccination
Redness
|
5 Participants
|
8 Participants
|
|
Number of Participants Reporting Solicited Quantitative Local Reactions After First Vaccination
Swelling
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Within 8 days (Day 0-7) post second vaccinationPopulation: All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.
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.
Outcome measures
| Measure |
15 Mcg H1N1 Vaccine
n=49 Participants
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=54 Participants
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
Number of Participants Reporting Solicited Quantitative Local Reactions After Second Vaccination
Redness
|
2 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Quantitative Local Reactions After Second Vaccination
Swelling
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 8 days (Day 0-7) post first vaccinationPopulation: All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.
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.
Outcome measures
| Measure |
15 Mcg H1N1 Vaccine
n=60 Participants
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=60 Participants
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
Number of Participants Reporting Solicited Subjective Systemic Reactions After First Vaccination
Feverishness
|
5 Participants
|
4 Participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Reactions After First Vaccination
Headache
|
17 Participants
|
18 Participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Reactions After First Vaccination
Nausea
|
10 Participants
|
12 Participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Reactions After First Vaccination
Malaise
|
19 Participants
|
24 Participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Reactions After First Vaccination
Myalgia
|
12 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Within 8 days (Day 0-7) post second vaccinationPopulation: All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.
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.
Outcome measures
| Measure |
15 Mcg H1N1 Vaccine
n=49 Participants
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=54 Participants
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
Number of Participants Reporting Solicited Subjective Systemic Reactions After Second Vaccination
Feverishness
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Reactions After Second Vaccination
Myalgia
|
3 Participants
|
6 Participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Reactions After Second Vaccination
Nausea
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Reactions After Second Vaccination
Malaise
|
8 Participants
|
14 Participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Reactions After Second Vaccination
Headache
|
11 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Within 8 days (Day 0-7) post first vaccinationPopulation: All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.
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.
Outcome measures
| Measure |
15 Mcg H1N1 Vaccine
n=60 Participants
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=60 Participants
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
Number of Participants Reporting Fever After First Vaccination
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Within 8 days (Day 0-7) post second vaccinationPopulation: All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.
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.
Outcome measures
| Measure |
15 Mcg H1N1 Vaccine
n=49 Participants
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=54 Participants
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
Number of Participants Reporting Fever After Second Vaccination
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 prior to and Day 21 after the first vaccinationPopulation: Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints, with 5 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.
Blood was collected from all participants prior to the initial vaccination as well as 21 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination titer was an increase by 4-fold or more.
Outcome measures
| Measure |
15 Mcg H1N1 Vaccine
n=55 Participants
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=58 Participants
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine
|
49 Participants
|
56 Participants
|
PRIMARY outcome
Timeframe: Day 21 after the first vaccinationPopulation: Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint, with 5 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.
Blood was collected from all participants at Day 21 post first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Outcome measures
| Measure |
15 Mcg H1N1 Vaccine
n=55 Participants
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=58 Participants
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine
|
51 Participants
|
56 Participants
|
PRIMARY outcome
Timeframe: At time of deliveryPopulation: 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 |
15 Mcg H1N1 Vaccine
n=60 Participants
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=60 Participants
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
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
|
1 Participants
|
4 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Oligohydramnios
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Pregnancy induced hypertension
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Pre-eclampsia
|
1 Participants
|
2 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
|
3 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
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Fever
|
2 Participants
|
2 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
|
26 Participants
|
20 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Fetal abnormalities detected during pregnancy
|
3 Participants
|
5 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Assisted vaginal delivery
|
4 Participants
|
3 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Postpartum endometritis
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Postpartum bleeding
|
5 Participants
|
5 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Postpartum bacteremia
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Stillborn
|
1 Participants
|
0 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
Non-elective Cesarean section
|
4 Participants
|
4 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Abnormal amniotic fluid
|
11 Participants
|
12 Participants
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Postpartum fever
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At time of deliveryPopulation: All live births are included in this outcome measure, which excludes 2 participants whose pregnancies ended in miscarriage or stillbirth. Three participants gave birth to twins and one to triplets, 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 |
15 Mcg H1N1 Vaccine
n=61 Participants
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=62 Participants
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
Number of Participants Reporting Neonatal Complications
Pre-term (less than 37 weeks)
|
10 Participants
|
7 Participants
|
|
Number of Participants Reporting Neonatal Complications
Large for gestational age
|
12 Participants
|
3 Participants
|
|
Number of Participants Reporting Neonatal Complications
Small for gestational age
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Neonatal Complications
Abnormal infant exam
|
15 Participants
|
13 Participants
|
|
Number of Participants Reporting Neonatal Complications
Congenital abnormalities
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Neonatal Complications
Hematological complications
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Neonatal Complications
Infection
|
0 Participants
|
0 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
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Neonatal Complications
Fever 100.4 degrees Fahrenheit or greater
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Neonatal Complications
Admission to special nursery/infant intensive care
|
6 Participants
|
6 Participants
|
|
Number of Participants Reporting Neonatal Complications
Respiratory complications
|
6 Participants
|
3 Participants
|
|
Number of Participants Reporting Neonatal Complications
Respiratory support used
|
5 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 0 through Day 180 after last vaccinationPopulation: All participants receiving the first vaccination are included in the ITT safety cohort.
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.
Outcome measures
| Measure |
15 Mcg H1N1 Vaccine
n=60 Participants
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=60 Participants
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At time of deliveryPopulation: Participants were included in the analyses if they had blood collected at delivery, with 22 participants excluded due to receipt of non-study vaccines and 3 due to specimen processing errors at the time of sample collection. Participants were analyzed as treated.
Blood was collected from participants at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Outcome measures
| Measure |
15 Mcg H1N1 Vaccine
n=41 Participants
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=47 Participants
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in the Maternal Blood at the Time of Delivery
|
35 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: At time of deliveryPopulation: Participants were included in the analyses if a cord blood sample was collected at delivery, with 22 participants excluded due to receipt of non-study vaccines and 5 due to specimen processing errors at the time of sample collection.
Cord blood was collected at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Outcome measures
| Measure |
15 Mcg H1N1 Vaccine
n=39 Participants
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=46 Participants
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in Cord Blood
|
34 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Day 0 prior to first vaccination and Day 21 after the second vaccinationPopulation: Participants were included in the analyses if they received both vaccinations within 4 days of the window and had blood collected at both timepoints, with 13 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.
Blood was collected from all participants prior to the initial vaccination as well as 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.
Outcome measures
| Measure |
15 Mcg H1N1 Vaccine
n=38 Participants
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=51 Participants
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following 2 Doses of H1N1 Vaccine
|
36 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Day 21 after the second vaccinationPopulation: Participants were included in the analyses if they received both vaccinations within 4 days of the window and had blood collected at both timepoints, with 13 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.
Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Outcome measures
| Measure |
15 Mcg H1N1 Vaccine
n=38 Participants
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=51 Participants
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following 2 Doses of H1N1 Vaccine
|
36 Participants
|
47 Participants
|
Adverse Events
15 Mcg H1N1 Vaccine
Serious events: 9 serious events
Other events: 53 other events
Deaths: 0 deaths
30 Mcg H1N1 Vaccine
Serious events: 6 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
15 Mcg H1N1 Vaccine
n=60 participants at risk
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=60 participants at risk
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.7%
1/60 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/60 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.7%
1/60 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/60 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
6.7%
4/60 • Number of events 4 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
3.3%
2/60 • Number of events 2 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
1.7%
1/60 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/60 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
1.7%
1/60 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/60 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Surgical and medical procedures
Myomectomy
|
1.7%
1/60 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/60 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
1.7%
1/60 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/60 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Pregnancy, puerperium and perinatal conditions
Caesarean section
|
1.7%
1/60 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/60 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Pregnancy, puerperium and perinatal conditions
Threatened labour
|
0.00%
0/60 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
3.3%
2/60 • Number of events 2 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Pregnancy, puerperium and perinatal conditions
HELLP syndrome
|
0.00%
0/60 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
1.7%
1/60 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Pregnancy, puerperium and perinatal conditions
Retained placenta or membranes
|
0.00%
0/60 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
1.7%
1/60 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy induced hypertension
|
0.00%
0/60 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
1.7%
1/60 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
Other adverse events
| Measure |
15 Mcg H1N1 Vaccine
n=60 participants at risk
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
30 Mcg H1N1 Vaccine
n=60 participants at risk
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/60 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
6.7%
4/60 • Number of events 4 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
4/60 • Number of events 4 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.0%
3/60 • Number of events 3 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/60 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.0%
3/60 • Number of events 4 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.3%
2/60 • Number of events 2 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.0%
3/60 • Number of events 3 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.3%
8/60 • Number of events 8 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
16.7%
10/60 • Number of events 11 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Infections and infestations
Urinary tract infection
|
3.3%
2/60 • Number of events 2 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.0%
3/60 • Number of events 3 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Feeling hot
|
11.7%
7/60 • Number of events 7 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
13.3%
8/60 • Number of events 8 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Malaise
|
38.3%
23/60 • Number of events 27 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
46.7%
28/60 • Number of events 38 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
15/60 • Number of events 15 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
18.3%
11/60 • Number of events 14 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Nervous system disorders
Headache
|
38.3%
23/60 • Number of events 28 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
40.0%
24/60 • Number of events 29 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
10/60 • Number of events 12 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
23.3%
14/60 • Number of events 16 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Injection site pain
|
35.0%
21/60 • Number of events 25 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
51.7%
31/60 • Number of events 41 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Tenderness
|
61.7%
37/60 • Number of events 52 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
73.3%
44/60 • Number of events 74 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Injection site erythema
|
10.0%
6/60 • Number of events 7 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
15.0%
9/60 • Number of events 11 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Injection site swelling
|
8.3%
5/60 • Number of events 5 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
1.7%
1/60 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
Additional Information
Lisa Jackson, MD, MPH
Group Health Research Institute
Phone: 206-442-5216
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60