Trial Outcomes & Findings for 2010-2011 Trivalent Influenza Vaccine (TIV) in Pregnant Women (NCT NCT01173211)
NCT ID: NCT01173211
Last Updated: 2014-12-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
183 participants
Primary outcome timeframe
Day 0 through Day 28 post vaccination
Results posted on
2014-12-24
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 28Sep2010 and 27Apr2011
Participant milestones
| Measure |
Agriflu (Novartis) in Pregnant Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
48
|
45
|
46
|
15
|
16
|
13
|
|
Overall Study
COMPLETED
|
46
|
44
|
44
|
15
|
16
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2010-2011 Trivalent Influenza Vaccine (TIV) in Pregnant Women
Baseline characteristics by cohort
| Measure |
Agriflu (Novartis) in Pregnant Participants
n=48 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=45 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=46 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
n=15 Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
n=16 Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
n=13 Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Total
n=183 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
183 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Continuous
|
30.7 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
29.8 years
STANDARD_DEVIATION 4.1 • n=7 Participants
|
30.7 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
27.5 years
STANDARD_DEVIATION 6.5 • n=4 Participants
|
29.3 years
STANDARD_DEVIATION 6.7 • n=21 Participants
|
29.7 years
STANDARD_DEVIATION 5.2 • n=10 Participants
|
30.0 years
STANDARD_DEVIATION 4.9 • n=115 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
183 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
45 participants
n=7 Participants
|
46 participants
n=5 Participants
|
15 participants
n=4 Participants
|
16 participants
n=21 Participants
|
13 participants
n=10 Participants
|
183 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 0 through Day 28 post vaccinationPopulation: All participants receiving vaccination are included in the safety cohort
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 |
Agriflu (Novartis) in Pregnant Participants
n=48 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=45 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=46 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
n=15 Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
n=16 Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
n=13 Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Vaccine-associated Unsolicited Non-serious Adverse Events
|
2 participants
|
3 participants
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: During the pregnancy and at the time of deliveryPopulation: Pregnant participants receiving vaccination are included in 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 |
Agriflu (Novartis) in Pregnant Participants
n=48 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=45 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=46 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Anaphylaxis
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Stillborn
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Miscarriage
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Gestational Diabetes
|
2 participants
|
2 participants
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Polyhydramnios
|
1 participants
|
0 participants
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Oligohydramnios
|
3 participants
|
3 participants
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Pregnancy induced hypertension
|
3 participants
|
4 participants
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Pre-eclampsia
|
0 participants
|
1 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Eclampsia
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Fetal distress
|
5 participants
|
2 participants
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Abruptio placenta
|
0 participants
|
0 participants
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Chorioamnionitis
|
0 participants
|
1 participants
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Fever greater than 100.4 degrees Fahrenheit
|
3 participants
|
2 participants
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Antibiotics prior to delivery
|
23 participants
|
19 participants
|
20 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Fetal abnormalities detected during pregnancy
|
5 participants
|
0 participants
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Other complications during pregnancy or delivery
|
26 participants
|
28 participants
|
30 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Assisted vaginal delivery
|
3 participants
|
4 participants
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Non-elective Cesarean section
|
6 participants
|
3 participants
|
7 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Abnormal amniotic fluid
|
6 participants
|
11 participants
|
13 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Postpartum fever greater than 100.4 degrees Fahren
|
2 participants
|
1 participants
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Postpartum endometritis
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Postpartum bleeding
|
2 participants
|
3 participants
|
3 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Postpartum bacteremia
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Other postpartum complications
|
3 participants
|
1 participants
|
7 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At time of deliveryPopulation: Pregnant participants receiving vaccination are included in this outcome measure.
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 |
Agriflu (Novartis) in Pregnant Participants
n=48 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=45 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=46 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Neonatal Complications
Pre-term (less than 37 weeks)
|
2 participants
|
4 participants
|
3 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Neonatal Complications
Large for gestational age
|
6 participants
|
3 participants
|
8 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Neonatal Complications
Small for gestational age
|
2 participants
|
1 participants
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Neonatal Complications
Abnormal infant exam
|
5 participants
|
5 participants
|
11 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Neonatal Complications
Congenital abnormalities
|
5 participants
|
0 participants
|
3 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Neonatal Complications
Hematological complications
|
3 participants
|
3 participants
|
4 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Neonatal Complications
Infection
|
0 participants
|
0 participants
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Neonatal Complications
Sepsis
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Neonatal Complications
Meningitis
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Neonatal Complications
Metabolic complications
|
2 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Neonatal Complications
Respiratory complications
|
8 participants
|
7 participants
|
7 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Neonatal Complications
Respiratory support used
|
6 participants
|
5 participants
|
6 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Neonatal Complications
Fever greater than 100.4 degrees Fahrenheit
|
0 participants
|
1 participants
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Neonatal Complications
Admission to special nursery/infant intensive care
|
4 participants
|
4 participants
|
4 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Neonatal Complications
Other clinical problems
|
6 participants
|
5 participants
|
4 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 through Day 180 after vaccinationPopulation: All participants receiving vaccination are included in the 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 |
Agriflu (Novartis) in Pregnant Participants
n=48 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=45 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=46 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
n=15 Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
n=16 Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
n=13 Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 8 days after vaccination (Days 0-7).Population: All participants receiving the vaccination are included in the safety cohort.
Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Outcome measures
| Measure |
Agriflu (Novartis) in Pregnant Participants
n=48 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=45 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=46 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
n=15 Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
n=16 Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
n=13 Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination
Pain
|
19 participants
|
23 participants
|
16 participants
|
5 participants
|
9 participants
|
9 participants
|
|
Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination
Tenderness
|
29 participants
|
37 participants
|
33 participants
|
8 participants
|
11 participants
|
8 participants
|
|
Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination
Swelling
|
5 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 8 days after vaccination (Days 0-7).Population: All participants receiving the vaccination are included in the safety cohort.
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 |
Agriflu (Novartis) in Pregnant Participants
n=48 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=45 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=46 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
n=15 Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
n=16 Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
n=13 Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited Quantitative Local Reactions After Vaccination
Redness
|
7 participants
|
4 participants
|
4 participants
|
2 participants
|
0 participants
|
2 participants
|
|
Number of Participants Reporting Solicited Quantitative Local Reactions After Vaccination
Swelling
|
5 participants
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 8 days after vaccination (Days 0-7).Population: All participants receiving the vaccination are included in the safety cohort.
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 |
Agriflu (Novartis) in Pregnant Participants
n=48 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=45 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=46 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
n=15 Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
n=16 Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
n=13 Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination
Feverishness
|
1 participants
|
1 participants
|
3 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination
Malaise
|
10 participants
|
10 participants
|
13 participants
|
5 participants
|
4 participants
|
2 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination
Myalgia
|
2 participants
|
6 participants
|
5 participants
|
2 participants
|
5 participants
|
2 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination
Headache
|
11 participants
|
17 participants
|
15 participants
|
4 participants
|
5 participants
|
4 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination
Nausea
|
3 participants
|
3 participants
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 8 days after vaccination (Days 0-7).Population: All participants receiving the vaccination are included in the safety cohort.
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 |
Agriflu (Novartis) in Pregnant Participants
n=48 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=45 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=46 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
n=15 Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
n=16 Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
n=13 Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Fever After Vaccination
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 0 prior to and Day 28 following vaccinationPopulation: Subjects who received vaccination and contributed blood samples from which valid results were reported are included. One subject who did not meet eligibility criteria was not included.
Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.
Outcome measures
| Measure |
Agriflu (Novartis) in Pregnant Participants
n=48 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=45 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=45 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
n=15 Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
n=16 Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
n=13 Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
B Antigen - Day 0
|
9.4 Titers
Interval 7.5 to 11.8
|
10.6 Titers
Interval 8.0 to 14.1
|
8.7 Titers
Interval 6.6 to 11.4
|
13.2 Titers
Interval 7.0 to 24.8
|
11.4 Titers
Interval 7.0 to 18.6
|
23.5 Titers
Interval 12.9 to 42.6
|
|
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
H3N2 Antigen - Day 28
|
81.2 Titers
Interval 53.4 to 123.3
|
105.6 Titers
Interval 72.0 to 154.8
|
82.5 Titers
Interval 54.7 to 124.5
|
69.6 Titers
Interval 34.1 to 142.2
|
134.5 Titers
Interval 82.0 to 220.8
|
93.9 Titers
Interval 32.6 to 269.9
|
|
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
H1N1 Antigen - Day 0
|
16.1 Titers
Interval 10.8 to 24.0
|
18.8 Titers
Interval 12.4 to 28.4
|
18.5 Titers
Interval 12.2 to 28.1
|
31.7 Titers
Interval 15.7 to 64.3
|
14.8 Titers
Interval 8.6 to 25.3
|
27.5 Titers
Interval 12.9 to 58.7
|
|
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
B Antigen - Day 28
|
36.7 Titers
Interval 27.4 to 49.1
|
43.9 Titers
Interval 33.3 to 57.8
|
33.8 Titers
Interval 23.3 to 48.8
|
40.0 Titers
Interval 21.3 to 75.3
|
35.1 Titers
Interval 18.6 to 66.3
|
42.2 Titers
Interval 27.3 to 65.2
|
|
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
H3N2 Antigen - Day 0
|
18.6 Titers
Interval 12.6 to 27.4
|
20.6 Titers
Interval 12.9 to 32.9
|
17.4 Titers
Interval 11.7 to 25.8
|
25.2 Titers
Interval 11.9 to 53.3
|
23.8 Titers
Interval 10.5 to 53.7
|
42.2 Titers
Interval 14.0 to 126.9
|
|
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
H1N1 Antigen - Day 28
|
177.0 Titers
Interval 129.0 to 242.8
|
340.3 Titers
Interval 260.9 to 443.9
|
183.8 Titers
Interval 114.3 to 295.6
|
291.8 Titers
Interval 166.8 to 510.5
|
334.2 Titers
Interval 187.2 to 596.6
|
417.8 Titers
Interval 185.5 to 940.8
|
PRIMARY outcome
Timeframe: Day 0 prior to and Day 28 after vaccinationBlood was collected from all participants prior to vaccination as well as 28 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 28 post vaccination titer was 40 or greater, or the Day 0 titer was greater than or equal to 10 and the Day 28 post vaccination titer was an increase by 4-fold or more.
Outcome measures
| Measure |
Agriflu (Novartis) in Pregnant Participants
n=48 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=45 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=45 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
n=15 Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
n=16 Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
n=13 Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Number of Participants With 4-fold or Greater Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
B Antigen
|
19 participants
|
23 participants
|
14 participants
|
4 participants
|
5 participants
|
2 participants
|
|
Number of Participants With 4-fold or Greater Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
H3N2 Antigen
|
24 participants
|
26 participants
|
21 participants
|
5 participants
|
10 participants
|
3 participants
|
|
Number of Participants With 4-fold or Greater Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
H1N1 Antigen
|
37 participants
|
39 participants
|
32 participants
|
9 participants
|
14 participants
|
10 participants
|
PRIMARY outcome
Timeframe: Day 0 prior to and Day 28 after vaccinationPopulation: Subjects who received vaccination and contributed blood samples from which valid results were reported are included. One subject who did not meet eligibility criteria was not included.
Blood was collected from all participants prior to vaccination as well as 28 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.
Outcome measures
| Measure |
Agriflu (Novartis) in Pregnant Participants
n=48 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=45 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=45 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
n=15 Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
n=16 Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
n=13 Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
B Antigen - Day 0
|
5 participants
|
7 participants
|
5 participants
|
4 participants
|
3 participants
|
6 participants
|
|
Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
B Antigen - Day 28
|
26 participants
|
32 participants
|
19 participants
|
10 participants
|
9 participants
|
9 participants
|
|
Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
H3N2 Antigen - Day 0
|
15 participants
|
18 participants
|
11 participants
|
7 participants
|
6 participants
|
7 participants
|
|
Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
H3N2 Antigen - Day 28
|
37 participants
|
37 participants
|
34 participants
|
12 participants
|
16 participants
|
8 participants
|
|
Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
H1N1 Antigen - Day 0
|
14 participants
|
15 participants
|
17 participants
|
9 participants
|
3 participants
|
4 participants
|
|
Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine
H1N1 Antigen - Day 28
|
46 participants
|
44 participants
|
40 participants
|
15 participants
|
16 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Day 180 (approximately 6 months after vaccination)Population: Subjects who received vaccination and contributed blood samples from which valid results were reported are included.
Blood was collected for HAI assay at approximately Day 180 following vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.
Outcome measures
| Measure |
Agriflu (Novartis) in Pregnant Participants
n=45 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=43 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=43 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
n=15 Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
n=16 Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
n=13 Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination
B Antigen
|
19.7 Titer
Interval 14.1 to 27.4
|
23.1 Titer
Interval 17.2 to 31.1
|
23.1 Titer
Interval 15.6 to 34.4
|
24.1 Titer
Interval 11.9 to 48.6
|
18.3 Titer
Interval 10.4 to 32.4
|
21.1 Titer
Interval 12.8 to 34.7
|
|
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination
H3N2 Antigen
|
47.4 Titer
Interval 30.9 to 72.6
|
58.0 Titer
Interval 37.5 to 89.5
|
43.4 Titer
Interval 27.8 to 67.6
|
40.0 Titer
Interval 22.4 to 71.5
|
54.2 Titer
Interval 28.4 to 103.4
|
61.3 Titer
Interval 22.4 to 167.4
|
|
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination
H1N1 Antigen
|
82.5 Titer
Interval 56.9 to 119.6
|
121.6 Titer
Interval 88.7 to 166.9
|
85.3 Titer
Interval 52.5 to 138.7
|
115.8 Titer
Interval 71.8 to 186.8
|
108.3 Titer
Interval 57.6 to 203.9
|
208.9 Titer
Interval 96.2 to 453.4
|
SECONDARY outcome
Timeframe: Day 180 (approximately 6 months after vaccination)Population: Subjects who received vaccination and contributed blood samples from which valid results were reported are included.
Blood was collected from all participants at 180 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 180 post vaccination titer was 40 or greater, or the Day 0 titer was greater than or equal to 10 and the Day 180 post vaccination titer was an increase by 4-fold or more.
Outcome measures
| Measure |
Agriflu (Novartis) in Pregnant Participants
n=45 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=43 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=43 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
n=15 Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
n=16 Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
n=13 Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Number of Participants With 4-fold or Greater Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination
B Antigen
|
11 participants
|
11 participants
|
11 participants
|
3 participants
|
2 participants
|
1 participants
|
|
Number of Participants With 4-fold or Greater Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination
H3N2 Antigen
|
13 participants
|
11 participants
|
9 participants
|
3 participants
|
4 participants
|
1 participants
|
|
Number of Participants With 4-fold or Greater Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination
H1N1 Antigen
|
26 participants
|
30 participants
|
23 participants
|
8 participants
|
10 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Day 180 (approximately 6 months after vaccination)Population: Subjects who received vaccination and contributed blood samples from which valid results were reported are included.
Blood was collected from all participants at 180 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.
Outcome measures
| Measure |
Agriflu (Novartis) in Pregnant Participants
n=45 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=43 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=43 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
n=15 Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
n=16 Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
n=13 Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination
B Antigen - Day 180
|
16 participants
|
19 participants
|
17 participants
|
6 participants
|
6 participants
|
4 participants
|
|
Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination
H3N2 Antigen - Day 180
|
28 participants
|
28 participants
|
24 participants
|
11 participants
|
12 participants
|
8 participants
|
|
Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination
H1N1 Antigen - Day 180
|
35 participants
|
40 participants
|
34 participants
|
14 participants
|
13 participants
|
12 participants
|
SECONDARY outcome
Timeframe: At time of deliveryPopulation: Subjects who contributed blood samples at delivery from which valid results were reported are included.
Maternal blood was collected for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.
Outcome measures
| Measure |
Agriflu (Novartis) in Pregnant Participants
n=44 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=41 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=43 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Maternal HAI GMT Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at Time of Delivery
B Antigen
|
20.0 Titers
Interval 14.3 to 27.9
|
24.1 Titers
Interval 17.7 to 32.7
|
21.7 Titers
Interval 14.5 to 32.4
|
—
|
—
|
—
|
|
Maternal HAI GMT Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at Time of Delivery
H3N2 Antigen
|
46.8 Titers
Interval 30.4 to 72.2
|
61.0 Titers
Interval 37.8 to 98.5
|
44.1 Titers
Interval 28.5 to 68.1
|
—
|
—
|
—
|
|
Maternal HAI GMT Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at Time of Delivery
H1N1 Antigen
|
86.6 Titers
Interval 58.8 to 127.4
|
144.6 Titers
Interval 99.4 to 210.2
|
88.1 Titers
Interval 53.1 to 146.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 prior to vaccination and at time of deliveryPopulation: Subjects who contributed blood samples at delivery from which valid results were reported are included.
Blood was collected from all participants prior to vaccination as well as at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the titer was 40 or greater at delivery, or the Day 0 titer was greater than or equal to 10 and the titer was an increase by 4-fold or more at delivery.
Outcome measures
| Measure |
Agriflu (Novartis) in Pregnant Participants
n=44 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=41 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=43 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Number of Participants With 4-fold or Greater Maternal Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at Time of Delivery
B Antigen
|
10 participants
|
7 participants
|
9 participants
|
—
|
—
|
—
|
|
Number of Participants With 4-fold or Greater Maternal Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at Time of Delivery
H3N2 Antigen
|
13 participants
|
14 participants
|
9 participants
|
—
|
—
|
—
|
|
Number of Participants With 4-fold or Greater Maternal Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at Time of Delivery
H1N1 Antigen
|
26 participants
|
33 participants
|
23 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At time of deliveryPopulation: Subjects who contributed blood samples at delivery from which valid results were reported are included.
Maternal blood was collected for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.
Outcome measures
| Measure |
Agriflu (Novartis) in Pregnant Participants
n=44 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=41 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=43 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Number of Participants With a Maternal Serum HAI Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2010-2011 Inactivated TIV at Time of Delivery.
B Antigen
|
15 participants
|
15 participants
|
14 participants
|
—
|
—
|
—
|
|
Number of Participants With a Maternal Serum HAI Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2010-2011 Inactivated TIV at Time of Delivery.
H3N2 Antigen
|
29 participants
|
29 participants
|
23 participants
|
—
|
—
|
—
|
|
Number of Participants With a Maternal Serum HAI Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2010-2011 Inactivated TIV at Time of Delivery.
H1N1 Antigen
|
34 participants
|
39 participants
|
34 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At time of deliveryPopulation: Subjects from whom cord blood samples were collected at delivery from which valid results were reported are included.
Cord blood was collected at delivery for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.
Outcome measures
| Measure |
Agriflu (Novartis) in Pregnant Participants
n=41 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=41 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=41 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
HAI GMT Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine in Cord Blood Collected at Time of Delivery
B Antigen
|
27.1 Titers
Interval 19.2 to 38.3
|
32.1 Titers
Interval 23.1 to 44.7
|
28.5 Titers
Interval 17.5 to 46.4
|
—
|
—
|
—
|
|
HAI GMT Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine in Cord Blood Collected at Time of Delivery
H3N2 Antigen
|
58.0 Titers
Interval 35.7 to 94.4
|
71.1 Titers
Interval 42.2 to 119.8
|
51.5 Titers
Interval 30.5 to 87.3
|
—
|
—
|
—
|
|
HAI GMT Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine in Cord Blood Collected at Time of Delivery
H1N1 Antigen
|
124.2 Titers
Interval 81.6 to 189.0
|
244.2 Titers
Interval 176.6 to 337.6
|
135.1 Titers
Interval 79.6 to 229.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At time of deliveryPopulation: Subjects from whom cord blood samples were collected at delivery from which valid results were reported are included.
Cord blood was collected at delivery for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.
Outcome measures
| Measure |
Agriflu (Novartis) in Pregnant Participants
n=41 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=41 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=41 Participants
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Number of Participants With HAI Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2010-2011 Inactivated TIV in Cord Blood Collected at Time of Delivery.
B Antigen
|
19 participants
|
23 participants
|
17 participants
|
—
|
—
|
—
|
|
Number of Participants With HAI Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2010-2011 Inactivated TIV in Cord Blood Collected at Time of Delivery.
H3N2 Antigen
|
27 participants
|
27 participants
|
24 participants
|
—
|
—
|
—
|
|
Number of Participants With HAI Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2010-2011 Inactivated TIV in Cord Blood Collected at Time of Delivery.
H1N1 Antigen
|
34 participants
|
39 participants
|
33 participants
|
—
|
—
|
—
|
Adverse Events
Agriflu (Novartis) in Pregnant Participants
Serious events: 16 serious events
Other events: 37 other events
Deaths: 0 deaths
Fluarix (GSK) in Pregnant Participants
Serious events: 18 serious events
Other events: 41 other events
Deaths: 0 deaths
Fluzone (Sanofi Pasteur) in Pregnant Participants
Serious events: 17 serious events
Other events: 40 other events
Deaths: 0 deaths
Agriflu (Novartis) in Non-pregnant Participants
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Fluarix (GSK) in Non-pregnant Participants
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Agriflu (Novartis) in Pregnant Participants
n=48 participants at risk
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=45 participants at risk
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=46 participants at risk
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
n=15 participants at risk
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
n=16 participants at risk
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
n=13 participants at risk
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome
|
2.1%
1/48 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/45 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/46 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/46 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/16 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/46 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/16 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Mastitis
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/45 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/16 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Pneumonia
|
2.1%
1/48 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/16 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
|
Investigations
Blood pressure increased
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/45 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/16 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Convulsion
|
2.1%
1/48 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/16 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Arrested labour
|
2.1%
1/48 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Foetal malpresentation
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/46 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Oligohydramnios
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/45 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Peripartum cardiomyopathy
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/45 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
|
6.2%
3/48 • Number of events 3 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
3/45 • Number of events 3 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
4.3%
2/46 • Number of events 2 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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 delivery
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
3/45 • Number of events 3 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
4.3%
2/46 • Number of events 2 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/46 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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 rupture of membranes
|
2.1%
1/48 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/45 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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 separation of placenta
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/46 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/45 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/46 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/16 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Cholecystectomy
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/46 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/16 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
|
Congenital, familial and genetic disorders
Congenital cardiovascular anomaly
|
2.1%
1/48 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
|
Congenital, familial and genetic disorders
Congenital cerebral cyst
|
2.1%
1/48 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
2.1%
1/48 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
|
Congenital, familial and genetic disorders
Hypospadias
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/46 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
2.1%
1/48 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
|
Congenital, familial and genetic disorders
Pelvic kidney
|
2.1%
1/48 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
|
Congenital, familial and genetic disorders
Trisomy 21
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/46 • Number of events 2 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Vomiting
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/46 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Hypothermia
|
2.1%
1/48 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/45 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Pyrexia
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/45 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
4.3%
2/46 • Number of events 2 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Bronchiolitis
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/45 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Respiratory syncytial virus infection
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
4.4%
2/45 • Number of events 2 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Urosepsis
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/46 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
|
Investigations
Body temperature fluctuation
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/46 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
|
Investigations
Foetal heart rate abnormal
|
2.1%
1/48 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Aqueductal stenosis
|
2.1%
1/48 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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 baby
|
2.1%
1/48 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/46 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/46 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Respiratory distress
|
4.2%
2/48 • Number of events 2 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
4.4%
2/45 • Number of events 2 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
4.3%
2/46 • Number of events 2 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/46 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
—
0/0 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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 |
Agriflu (Novartis) in Pregnant Participants
n=48 participants at risk
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Pregnant Participants
n=45 participants at risk
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Pregnant Participants
n=46 participants at risk
Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
Agriflu (Novartis) in Non-pregnant Participants
n=15 participants at risk
Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
|
Fluarix (GSK) in Non-pregnant Participants
n=16 participants at risk
Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
|
Fluzone (Sanofi Pasteur) in Non-pregnant Participants
n=13 participants at risk
Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
6.2%
1/16 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Cough
|
2.1%
1/48 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/45 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/46 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
6.2%
1/16 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Diarrhoea
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
3/45 • Number of events 3 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/16 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
1/15 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/16 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Gastroenteritis
|
6.2%
3/48 • Number of events 3 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/16 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
6.2%
1/16 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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 haemorrhage
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/45 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/16 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
7.7%
1/13 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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 pruritus
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/16 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
7.7%
1/13 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
6.2%
1/16 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
|
4.2%
2/48 • Number of events 2 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
6/45 • Number of events 6 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
10.9%
5/46 • Number of events 5 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
2/15 • Number of events 2 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
31.2%
5/16 • Number of events 5 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
15.4%
2/13 • Number of events 2 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Nasal congestion
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
3/45 • Number of events 3 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
4.3%
2/46 • Number of events 2 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
6.2%
1/16 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Pain in extremity
|
2.1%
1/48 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/16 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
7.7%
1/13 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Pharyngitis
|
2.1%
1/48 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
3/45 • Number of events 3 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/16 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Toothache
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
1/15 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/16 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
|
16.7%
8/48 • Number of events 8 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
15.6%
7/45 • Number of events 7 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
15.2%
7/46 • Number of events 7 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
20.0%
3/15 • Number of events 3 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
12.5%
2/16 • Number of events 2 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
|
Injury, poisoning and procedural complications
Vaccination site discomfort
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
6.2%
1/16 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Vaccination site haemorrhage
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/45 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/46 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
6.2%
1/16 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Vaccination site paraesthesia
|
0.00%
0/48 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
4.4%
2/45 • Number of events 2 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
6.2%
1/16 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
|
2.1%
1/48 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/45 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
6.5%
3/46 • Number of events 3 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
1/15 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
6.2%
1/16 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
|
20.8%
10/48 • Number of events 10 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
22.2%
10/45 • Number of events 10 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
28.3%
13/46 • Number of events 13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
33.3%
5/15 • Number of events 5 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
25.0%
4/16 • Number of events 4 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
15.4%
2/13 • Number of events 2 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
|
22.9%
11/48 • Number of events 11 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
37.8%
17/45 • Number of events 17 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
32.6%
15/46 • Number of events 15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
26.7%
4/15 • Number of events 4 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
31.2%
5/16 • Number of events 5 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
30.8%
4/13 • Number of events 4 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
|
6.2%
3/48 • Number of events 3 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
3/45 • Number of events 3 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/46 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/15 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
12.5%
2/16 • Number of events 2 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/13 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Vaccination site pain
|
39.6%
19/48 • Number of events 19 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
51.1%
23/45 • Number of events 23 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
34.8%
16/46 • Number of events 16 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
33.3%
5/15 • Number of events 5 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
56.2%
9/16 • Number of events 9 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
69.2%
9/13 • Number of events 9 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
|
60.4%
29/48 • Number of events 29 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
82.2%
37/45 • Number of events 37 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
71.7%
33/46 • Number of events 33 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
53.3%
8/15 • Number of events 8 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
68.8%
11/16 • Number of events 11 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
61.5%
8/13 • Number of events 8 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
|
14.6%
7/48 • Number of events 7 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
8.9%
4/45 • Number of events 4 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
8.7%
4/46 • Number of events 4 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
2/15 • Number of events 2 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/16 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
15.4%
2/13 • Number of events 2 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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 (functional grading)
|
10.4%
5/48 • Number of events 5 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
2.2%
1/45 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
1/15 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/16 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
7.7%
1/13 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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 (measured reaction)
|
10.4%
5/48 • Number of events 5 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
4.4%
2/45 • Number of events 2 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
0/46 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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%
1/15 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
6.2%
1/16 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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.
|
7.7%
1/13 • Number of events 1 • Solicited systemic symptoms and injection site reactions were collected for 8 days (Day 0-7) after vaccination. Unsolicited adverse events were collected for 28 days after vaccination. Serious adverse events were collected for 6 months after vaccination.
For events solicited on the 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60