Trial Outcomes & Findings for Novartis H1N1 Vaccine in Pregnant Women (NCT NCT00992719)

Last Updated: 2013-08-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

84 participants

Primary outcome timeframe

At time of delivery

Results posted on

2013-08-07

Participant Flow

Participants were healthy pregnant and non-pregnant women recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 09Nov2009 and 04May2010.

Participant milestones

Participant milestones
Measure	Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Overall Study STARTED	28	28	28
Overall Study COMPLETED	27	27	28
Overall Study NOT COMPLETED	1	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Novartis H1N1 Vaccine in Pregnant Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine n=28 Participants Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine n=28 Participants Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine n=28 Participants Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Total n=84 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
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	28 Participants n=7 Participants	28 Participants n=5 Participants	84 Participants n=4 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
Age Continuous	30 years STANDARD_DEVIATION 6.0 • n=5 Participants	28.8 years STANDARD_DEVIATION 4.9 • n=7 Participants	30.8 years STANDARD_DEVIATION 5.6 • n=5 Participants	29.9 years STANDARD_DEVIATION 5.5 • n=4 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	28 Participants n=7 Participants	28 Participants n=5 Participants	84 Participants n=4 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
Region of Enrollment United States	28 participants n=5 Participants	28 participants n=7 Participants	28 participants n=5 Participants	84 participants n=4 Participants

PRIMARY outcome

Timeframe: At time of delivery

Population: All participants from whom outcome data were collected are included in the ITT safety population for this outcome measure.

Outcome measures

Outcome measures
Measure	Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine n=27 Participants Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine n=28 Participants Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Stillborn	—	0 participants	0 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Miscarriage	—	0 participants	0 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Gestational diabetes	—	1 participants	2 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Polyhydramnios	—	1 participants	0 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Oligohydramnios	—	1 participants	1 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Pregnancy induced hypertension	—	0 participants	3 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Pre-eclampsia	—	1 participants	3 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Eclampsia	—	0 participants	0 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Fetal Distress	—	2 participants	1 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Abruptio Placenta	—	0 participants	1 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Chorioamnionitis	—	0 participants	0 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Fever	—	2 participants	1 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Anaphylaxis	—	0 participants	0 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Antibiotics prior to delivery	—	12 participants	12 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Fetal abnormalities detected during pregnancy	—	1 participants	0 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Assisted vaginal delivery	—	1 participants	1 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Non-elective Cesarean section	—	6 participants	3 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Abnormal amniotic fluid	—	5 participants	5 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Postpartum fever	—	0 participants	0 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Postpartum endometritis	—	0 participants	0 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Postpartum bleeding	—	2 participants	0 participants
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery Postpartum bacteremia	—	0 participants	0 participants

PRIMARY outcome

Timeframe: At time of delivery

Population: All births are included in this outcome measure. Two participants gave birth to twins and two to triplets, each counted separately.

Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.

Outcome measures

Outcome measures
Measure	Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine n=29 Participants Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine n=32 Participants Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Number of Births With Neonatal Complications Pre-term (less than 37 weeks)	—	5 births	9 births
Number of Births With Neonatal Complications Large for gestational age	—	6 births	2 births
Number of Births With Neonatal Complications Small for gestational age	—	0 births	3 births
Number of Births With Neonatal Complications Abnormal infant exam	—	1 births	4 births
Number of Births With Neonatal Complications Congenital abnormalities	—	0 births	1 births
Number of Births With Neonatal Complications Hematological complications	—	1 births	1 births
Number of Births With Neonatal Complications Infections	—	0 births	0 births
Number of Births With Neonatal Complications Sepsis	—	0 births	0 births
Number of Births With Neonatal Complications Meningitis	—	0 births	0 births
Number of Births With Neonatal Complications Metabolic complications	—	1 births	1 births
Number of Births With Neonatal Complications Respiratory complications	—	5 births	4 births
Number of Births With Neonatal Complications Respiratory support used	—	5 births	4 births
Number of Births With Neonatal Complications Fever 100.4 degrees Fahrenheit or greater	—	0 births	0 births
Number of Births With Neonatal Complications Admission to special nursery/infant intensive care	—	5 births	8 births

PRIMARY outcome

Timeframe: Day 0 through Day 180 after vaccination

Population: All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.

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

Outcome measures
Measure	Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine n=28 Participants Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine n=28 Participants Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine n=28 Participants Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Within 8 days post vaccination (Day 0-7)

Population: All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.

Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.

Outcome measures

Outcome measures
Measure	Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine n=28 Participants Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine n=28 Participants Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine n=28 Participants Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination Pain	6 participants	4 participants	8 participants
Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination Tenderness	14 participants	13 participants	15 participants
Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination Swelling	2 participants	1 participants	2 participants

PRIMARY outcome

Timeframe: Within 8 days post vaccination (Day 0-7)

Population: All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.

Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.

Outcome measures

Outcome measures
Measure	Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine n=28 Participants Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine n=28 Participants Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine n=28 Participants Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Number of Participants Reporting Solicited Quantitative Local Reactions After Vaccination Redness	2 participants	2 participants	2 participants
Number of Participants Reporting Solicited Quantitative Local Reactions After Vaccination Swelling	2 participants	1 participants	1 participants

PRIMARY outcome

Timeframe: Within 8 days post vaccination (Day 0-7)

Population: All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.

Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.

Outcome measures

Outcome measures
Measure	Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine n=28 Participants Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine n=28 Participants Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine n=28 Participants Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination Feverishness	3 participants	0 participants	2 participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination Malaise	4 participants	7 participants	14 participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination Myalgia	4 participants	1 participants	6 participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination Headache	7 participants	8 participants	9 participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination Nausea	3 participants	3 participants	8 participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post vaccination

Population: All participants receiving the vaccination and who reported temperatures are included in the safety cohort. One participant did not report temperatures. Analyses are as treated.

Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.

Outcome measures

Outcome measures
Measure	Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine n=28 Participants Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine n=28 Participants Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine n=27 Participants Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Number of Participants Reporting Fever After Vaccination	0 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: Day 0 prior to and Day 21 after the first vaccination

Population: Participants were included in the analyses if they received the vaccination and had blood collected at both timepoints, with 1 participant excluded due to receipt of non-study vaccines. Participants were analyzed as treated.

Blood was collected from all participants prior to vaccination as well as 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination titer was an increase by 4-fold or more.

Outcome measures

Outcome measures
Measure	Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine n=28 Participants Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine n=26 Participants Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine n=28 Participants Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine	24 participants	18 participants	26 participants

PRIMARY outcome

Timeframe: Day 0 prior to and Day 21 following vaccination

Blood was collected from all participants prior to and at Day 21 post vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Outcome measures
Measure	Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine n=28 Participants Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine n=26 Participants Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine n=28 Participants Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine Day 0	2 participants	5 participants	3 participants
Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine Day 21	26 participants	22 participants	27 participants

SECONDARY outcome

Timeframe: At time of delivery

Population: Pregnant participants were included in the analyses if they had blood collected at delivery, with 1 participant excluded due to receipt of non-study vaccine. Participants were analyzed as treated.

Blood was collected from participants at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Outcome measures
Measure	Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine n=25 Participants Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine n=22 Participants Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in the Maternal Blood at the Time of Delivery	—	17 participants	16 participants

SECONDARY outcome

Timeframe: At time of delivery

Population: Pregnant participants were included in the analyses if they had cord blood collected at delivery, with 1 participant excluded due to receipt of non-study vaccine. Participants were analyzed as treated.

Cord blood was collected at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Outcome measures
Measure	Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine n=22 Participants Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine n=22 Participants Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in Cord Blood	—	17 participants	18 participants

Adverse Events

Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine

Serious events: 8 serious events

Other events: 19 other events

Deaths: 0 deaths

Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine

Serious events: 6 serious events

Other events: 24 other events

Deaths: 0 deaths

Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine n=28 participants at risk Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine n=28 participants at risk Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0	Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine n=28 participants at risk Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Psychiatric disorders Insomnia	0.00% 0/28 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	7.1% 2/28 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/28 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Infections and infestations Upper respiratory tract infection	14.3% 4/28 • Number of events 4 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/28 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	21.4% 6/28 • Number of events 6 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Feeling hot	0.00% 0/28 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	7.1% 2/28 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	10.7% 3/28 • Number of events 3 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Malaise	25.0% 7/28 • Number of events 7 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	50.0% 14/28 • Number of events 14 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	14.3% 4/28 • Number of events 4 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Musculoskeletal and connective tissue disorders Myalgia	3.6% 1/28 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	21.4% 6/28 • Number of events 6 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	14.3% 4/28 • Number of events 4 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Nervous system disorders Headache	28.6% 8/28 • Number of events 8 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	32.1% 9/28 • Number of events 9 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	25.0% 7/28 • Number of events 7 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Gastrointestinal disorders Nausea	10.7% 3/28 • Number of events 3 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	28.6% 8/28 • Number of events 8 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	10.7% 3/28 • Number of events 3 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Injection site pain	14.3% 4/28 • Number of events 4 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	28.6% 8/28 • Number of events 8 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	21.4% 6/28 • Number of events 6 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Tenderness	46.4% 13/28 • Number of events 13 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	53.6% 15/28 • Number of events 15 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	50.0% 14/28 • Number of events 14 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Injection site erythema	7.1% 2/28 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	7.1% 2/28 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	7.1% 2/28 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Injection site swelling (functional grading)	3.6% 1/28 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	7.1% 2/28 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	7.1% 2/28 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Injection site swelling (measured)	3.6% 1/28 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	3.6% 1/28 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	7.1% 2/28 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.

Additional Information

Geeta K. Swamy, M.D.

Department of Obstetrics & Gynecology, Division of Maternal-Fetal Medicine, Duke University School of Medicine

Phone: 919-681-5220

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60