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Safety of RIV4 Versus IIV4 in Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03969641
Recruitment Status : Completed
First Posted : May 31, 2019
Results First Posted : December 27, 2022
Last Update Posted : January 11, 2023
Sponsor:
Collaborators:
Children's Hospital Medical Center, Cincinnati
Boston Medical Center
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Safety
Adverse Event Following Immunisation
Birth Outcomes
Interventions Biological: Quadrivalent Recombinant Influenza Vaccine
Biological: Quadrivalent Inactivated Influenza Vaccine
Enrollment 384
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IIV4 RIV4
Hide Arm/Group Description Subjects in this group received an intramuscular injection of 0.5mL standard quadrivalent Inactivated Influenza vaccine (IIV4), Flulaval. Subjects in this group received an intramuscular injection of 0.5mL quadrivalent Recombinant Influenza Vaccine, Flublok (RIV4)
Period Title: Overall Study
Started 193 191
Completed 184 181
Not Completed 9 10
Reason Not Completed
Lost to Follow-up             5             3
Withdrawal by Subject             1             2
Found to be ineligible             1             1
Intrauterine fetal demise (IUFD)             0             2
Spontaneous abortion (SAB)             2             1
Elective termination             0             1
Arm/Group Title RIV4 IIV4 Total
Hide Arm/Group Description Subjects in this group received an intramuscular injection of 0.5mL quadrivalent Recombinant Influenza Vaccine, Flublok (RIV4) Subjects in this group received an intramuscular injection of 0.5mL standard quadrivalent Inactivated Influenza vaccine (IIV4), Flulaval. Total of all reporting groups
Overall Number of Baseline Participants 190 192 382
Hide Baseline Analysis Population Description
Participants who received study product.
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Maternal Age Number Analyzed 190 participants 192 participants 382 participants
31
(18.2 to 43.7)
31
(18.4 to 43.8)
31
(18.2 to 43.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 192 participants 382 participants
Female
190
 100.0%
192
 100.0%
382
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 192 participants 382 participants
Hispanic or Latino
24
  12.6%
25
  13.0%
49
  12.8%
Not Hispanic or Latino
166
  87.4%
163
  84.9%
329
  86.1%
Unknown or Not Reported
0
   0.0%
4
   2.1%
4
   1.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 192 participants 382 participants
American Indian or Alaska Native
1
   0.5%
0
   0.0%
1
   0.3%
Asian
6
   3.2%
1
   0.5%
7
   1.8%
Native Hawaiian or Other Pacific Islander
1
   0.5%
1
   0.5%
2
   0.5%
Black or African American
63
  33.2%
63
  32.8%
126
  33.0%
White
98
  51.6%
114
  59.4%
212
  55.5%
More than one race
12
   6.3%
10
   5.2%
22
   5.8%
Unknown or Not Reported
9
   4.7%
3
   1.6%
12
   3.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 190 participants 192 participants 382 participants
190
 100.0%
192
 100.0%
382
 100.0%
Gestational Age at Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 192 participants 382 participants
less than 20 weeks
65
  34.2%
78
  40.6%
143
  37.4%
20-34 weeks
125
  65.8%
114
  59.4%
239
  62.6%
Receipt of prior influenza season vaccine  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 192 participants 382 participants
143
  75.3%
138
  71.9%
281
  73.6%
1.Primary Outcome
Title Number of Pregnant Women Vaccinated With RIV4 Versus IIV4 With Adverse Birth Outcomes
Hide Description

As measured by the number of women experiencing one of the following:

  • Adverse birth outcome is a composite of occurrence of at least one of the following: preterm birth, spontaneous abortion, fetal death, or neonatal death.

    • Preterm birth- born alive at less than 37 weeks and 0 days gestation
    • Spontaneous abortion (SAB)- pregnancy loss prior to 20 weeks 0 days
    • Fetal death- intrauterine death of fetus at or after 20 weeks 0 days
    • Neonatal death- infant death within first 28 days of life
Time Frame Birth outcomes were monitored within postnatal day 28.
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population- any participant that was enrolled, randomized into the study, and received study vaccine
Arm/Group Title RIV4 IIV4
Hide Arm/Group Description:
Subjects in this group received an intramuscular injection of 0.5mL quadrivalent Recombinant Influenza Vaccine, Flublok (RIV4)
Subjects in this group received an intramuscular injection of 0.5mL standard quadrivalent Inactivated Influenza vaccine (IIV4), Flulaval.
Overall Number of Participants Analyzed 190 192
Measure Type: Count of Participants
Unit of Measure: Participants
17
   8.9%
21
  10.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RIV4, IIV4
Comments The null hypothesis assumes that RIV4 is inferior (i.e., RIV4 will have a higher proportion) to IIV4 in regards to the proportion of pregnant women with adverse birth outcomes.
Type of Statistical Test Non-Inferiority
Comments This objective will be assessed using a one-sided noninferiority test with the alpha level set at 0.025 (1-sided) and a noninferiority margin of 10%.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments The upper bound of a Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used, stratified by site.
Method of Estimation Estimation Parameter Difference in Proportions (RIV4 - IIV4)
Estimated Value -0.0214
Confidence Interval (1-Sided) 97.5%
0.0406
Estimation Comments The directional comparison was the upper bound of the confidence interval using a 10% noninferiority margin.
2.Secondary Outcome
Title Number of Pregnant Women With Preterm Birth After RIV4 Versus IIV4 Vaccination
Hide Description Preterm birth is defined as born alive at less than 37 weeks and 0 days gestation.
Time Frame Birth outcomes were monitored through 36 weeks 6 days gestation.
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population- any participant that was enrolled, randomized into the study, and received study vaccine
Arm/Group Title RIV4 IIV4
Hide Arm/Group Description:
Subjects in this group received an intramuscular injection of 0.5mL quadrivalent Recombinant Influenza Vaccine, Flublok (RIV4)
Subjects in this group received an intramuscular injection of 0.5mL standard quadrivalent Inactivated Influenza vaccine (IIV4), Flulaval.
Overall Number of Participants Analyzed 190 192
Measure Type: Count of Participants
Unit of Measure: Participants
14
   7.4%
19
   9.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RIV4, IIV4
Comments Preterm birth
Type of Statistical Test Superiority
Comments This proportion was compared between the RIV4 group and the IIV4 group using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level. The site adjusted odds ratio and corresponding 95% confidence interval for the proportion of preterm birth was also calculated.
Statistical Test of Hypothesis P-Value 0.4645
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.35 to 1.48
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Pregnant Women With Fetal or Neonatal Death After RIV4 Versus IIV4 Vaccination
Hide Description Fetal death is defined as intrauterine death of fetus at or after 20 weeks 0 days. Neonatal death is defined as infant death within first 28 days of life.
Time Frame Birth outcomes were monitored through postnatal day 28.
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population- any participant that was enrolled, randomized into the study, and received study vaccine
Arm/Group Title RIV4 IIV4
Hide Arm/Group Description:
Subjects in this group received an intramuscular injection of 0.5mL quadrivalent Recombinant Influenza Vaccine, Flublok (RIV4)
Subjects in this group received an intramuscular injection of 0.5mL standard quadrivalent Inactivated Influenza vaccine (IIV4), Flulaval.
Overall Number of Participants Analyzed 190 192
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.1%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RIV4, IIV4
Comments Fetal or neonatal death
Type of Statistical Test Superiority
Comments These proportions were compared between the RIV4 group and the IIV4 group using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level. The site adjusted odds ratio and corresponding 95% confidence interval for the proportions of combined fetal death and neonatal death was also calculated.
Statistical Test of Hypothesis P-Value 0.2447
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.00000031
Confidence Interval (2-Sided) 95%
0.00
The upper limit of this CI is infinity, thus no numeric value can be provided.
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Pregnant Women With Spontaneous Abortion After RIV4 Versus IIV4 Vaccination
Hide Description Spontaneous abortion (SAB) is defined as pregnancy loss prior to 20 weeks 0 days.
Time Frame Birth outcomes were monitored through 19 weeks 6 days gestation.
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population- any participant that was enrolled, randomized into the study, and received study vaccine. By definition, SAB can only occur in women that are at less than 20 weeks 0 days gestational age. All women that were at or over 20 weeks 0 days gestational age were removed from this analysis.
Arm/Group Title RIV4 IIV4
Hide Arm/Group Description:
Subjects in this group received an intramuscular injection of 0.5mL quadrivalent Recombinant Influenza Vaccine, Flublok (RIV4)
Subjects in this group received an intramuscular injection of 0.5mL standard quadrivalent Inactivated Influenza vaccine (IIV4), Flulaval.
Overall Number of Participants Analyzed 62 72
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.6%
2
   2.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RIV4, IIV4
Comments Spontaneous abortion
Type of Statistical Test Superiority
Comments This proportion was compared between the RIV4 group and the IIV4 group using an exact Mantel-Haenszel statistic in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level. The site adjusted odds ratio and corresponding 95% confidence interval for the proportion of spontaneous abortion after vaccination was also calculated. This was a subgroup analysis of only those participants vaccinated at less than 20 weeks gestational age.
Statistical Test of Hypothesis P-Value 0.6235
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
0.04 to 5.47
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Pregnant Women With Moderate/Severe Solicited Reactogenicity Events (Local and Systemic) Within 8 Days After Vaccination With RIV4 Versus IIV4
Hide Description Reactogenicity events include Injection Site Pain, Injection Site Redness, Injection Site Tenderness, Injection Site Swelling, Nausea, Vomiting, Diarrhea, Abdominal Pain, Headache, Chills/Shivering, Body Rash, Fever, Malaise (Fatigue), Myalgia (Body Aches), and Joint Pain.
Time Frame Reactogenicity was measured for 8 days post-vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population- any participant that was enrolled, randomized into the study, and received study vaccine
Arm/Group Title RIV4 IIV4
Hide Arm/Group Description:
Subjects in this group received an intramuscular injection of 0.5mL quadrivalent Recombinant Influenza Vaccine, Flublok (RIV4)
Subjects in this group received an intramuscular injection of 0.5mL standard quadrivalent Inactivated Influenza vaccine (IIV4), Flulaval.
Overall Number of Participants Analyzed 190 192
Measure Type: Count of Participants
Unit of Measure: Participants
Injection Site Pain
16
   8.4%
14
   7.3%
Injection Site Redness
2
   1.1%
1
   0.5%
Injection Site Tenderness
16
   8.4%
22
  11.5%
Injection Site Swelling
0
   0.0%
0
   0.0%
Nausea
7
   3.7%
13
   6.8%
Vomiting
5
   2.6%
8
   4.2%
Diarrhea
6
   3.2%
6
   3.1%
Abdominal Pain
4
   2.1%
5
   2.6%
Headache
11
   5.8%
20
  10.4%
Chills/Shivering
3
   1.6%
3
   1.6%
Body Rash
0
   0.0%
1
   0.5%
Fever
0
   0.0%
0
   0.0%
Malaise (Fatigue)
11
   5.8%
12
   6.3%
Myalgia (Body Aches)
7
   3.7%
8
   4.2%
Joint Pain
5
   2.6%
7
   3.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RIV4, IIV4
Comments Injection Site Pain
Type of Statistical Test Superiority
Comments These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.
Statistical Test of Hypothesis P-Value 0.7029
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.55 to 2.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RIV4, IIV4
Comments Injection Site Redness
Type of Statistical Test Superiority
Comments These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.
Statistical Test of Hypothesis P-Value 0.6217
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.03
Confidence Interval (2-Sided) 95%
0.18 to 22.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RIV4, IIV4
Comments Injection Site Tenderness
Type of Statistical Test Superiority
Comments These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.
Statistical Test of Hypothesis P-Value 0.3848
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.35 to 1.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RIV4, IIV4
Comments Nausea
Type of Statistical Test Superiority
Comments These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.
Statistical Test of Hypothesis P-Value 0.2504
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
0.21 to 1.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RIV4, IIV4
Comments Vomiting
Type of Statistical Test Superiority
Comments These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.
Statistical Test of Hypothesis P-Value 0.5751
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.20 to 1.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection RIV4, IIV4
Comments Diarrhea
Type of Statistical Test Superiority
Comments These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.32 to 3.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection RIV4, IIV4
Comments Abdominal Pain
Type of Statistical Test Superiority
Comments These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.21 to 3.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection RIV4, IIV4
Comments Headache
Type of Statistical Test Superiority
Comments These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.
Statistical Test of Hypothesis P-Value 0.1326
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
0.25 to 1.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection RIV4, IIV4
Comments Chills/Shivering
Type of Statistical Test Superiority
Comments These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.20 to 5.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection RIV4, IIV4
Comments Body Rash
Type of Statistical Test Superiority
Comments These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
0.00
The upper limit of this CI is infinity, thus no numeric value can be provided.
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection RIV4, IIV4
Comments Malaise (Fatigue)
Type of Statistical Test Superiority
Comments These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.39 to 2.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection RIV4, IIV4
Comments Myalgia (Body Aches)
Type of Statistical Test Superiority
Comments These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.31 to 2.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection RIV4, IIV4
Comments Joint Pain
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7704
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.22 to 2.29
Estimation Comments [Not Specified]
Time Frame Adverse events were collected 8 days post vaccination. Serious adverse events were collected up to 90 days post-delivery.
Adverse Event Reporting Description While there were 3 cases of spontaneous abortions, these are not counted as deaths and thus are not entered under "All-Cause Mortality." These are accounted for under "Serious Adverse Events." No pregnant women died during this study. The 2 deaths in the RIV4 group were both fetal deaths.
 
Arm/Group Title RIV4 IIV4
Hide Arm/Group Description Subjects in this group received an intramuscular injection of 0.5mL quadrivalent Recombinant Influenza Vaccine, Flublok (RIV4) Subjects in this group received an intramuscular injection of 0.5mL standard quadrivalent Inactivated Influenza vaccine (IIV4), Flulaval.
All-Cause Mortality
RIV4 IIV4
Affected / at Risk (%) Affected / at Risk (%)
Total   2/190 (1.05%)      0/192 (0.00%)    
Hide Serious Adverse Events
RIV4 IIV4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/190 (7.37%)      12/192 (6.25%)    
Congenital, familial and genetic disorders     
Congenital Fetal Cardiac Defect †  1/190 (0.53%)  1 0/192 (0.00%)  0
Bilateral pyelectasis †  1/190 (0.53%)  1 0/192 (0.00%)  0
Bladder outlet obstruction † [1]  0/190 (0.00%)  0 1/192 (0.52%)  1
ureterocele †  0/190 (0.00%)  0 1/192 (0.52%)  1
Supernumerary Digit- Left Hand †  1/190 (0.53%)  1 0/192 (0.00%)  0
Trisomy 21 †  0/190 (0.00%)  0 1/192 (0.52%)  1
ventricular septal defect †  0/190 (0.00%)  0 2/192 (1.04%)  2
Ectopic kidney †  0/190 (0.00%)  0 1/192 (0.52%)  1
Absent thyroid †  0/190 (0.00%)  0 1/192 (0.52%)  1
Short femur †  0/190 (0.00%)  0 1/192 (0.52%)  1
Atrial septal defect †  0/190 (0.00%)  0 1/192 (0.52%)  1
anomalous S1 hemivertebra †  0/190 (0.00%)  0 1/192 (0.52%)  1
Sagittal Synostosis †  0/190 (0.00%)  0 1/192 (0.52%)  1
Pyloric stenosis †  1/190 (0.53%)  1 0/192 (0.00%)  0
Gastrointestinal disorders     
Vomiting †  1/190 (0.53%)  1 1/192 (0.52%)  1
Appendicitis † [2]  1/190 (0.53%)  1 0/192 (0.00%)  0
Enterocolitis with abdominal abscess †  1/190 (0.53%)  1 0/192 (0.00%)  0
General disorders     
Opioid Dependence Relapse † [3]  1/190 (0.53%)  1 0/192 (0.00%)  0
Infections and infestations     
Infection † [4]  1/190 (0.53%)  1 0/192 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Vaginal Bleeding †  0/190 (0.00%)  0 1/192 (0.52%)  1
Preeclampsia †  5/190 (2.63%)  5 3/192 (1.56%)  3
Spontaneous Abortion †  1/190 (0.53%)  1 2/192 (1.04%)  2
Retained Products of Conception †  0/190 (0.00%)  0 1/192 (0.52%)  1
Chorioamnionitis †  1/190 (0.53%)  1 0/192 (0.00%)  0
Volume Overload †  1/190 (0.53%)  1 0/192 (0.00%)  0
Intrauterine Fetal Demise †  2/190 (1.05%)  2 0/192 (0.00%)  0
Preterm Premature Rupture of Membranes (PPROM) †  0/190 (0.00%)  0 1/192 (0.52%)  1
Respiratory, thoracic and mediastinal disorders     
Shortness of Breath †  0/190 (0.00%)  0 1/192 (0.52%)  1
Bilateral Subsegmental Pulmonary Embolism †  0/190 (0.00%)  0 1/192 (0.52%)  1
Vascular disorders     
Hypertension †  1/190 (0.53%)  1 0/192 (0.00%)  0
Retroperitoneal hematoma †  0/190 (0.00%)  0 1/192 (0.52%)  1
†
Indicates events were collected by systematic assessment
[1]
Including hydronephrosis due to obstruction of bladder, Hydroureter, Chronic kidney disease
[2]
Resulted in a laparoscopic appendectomy
[3]
Hospitalized due to relapse of opioid dependence
[4]
Surgical site infection after laparoscopic appendectomy
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RIV4 IIV4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/190 (11.58%)      22/192 (11.46%)    
Gastrointestinal disorders     
Nausea †  7/190 (3.68%)  7 13/192 (6.77%)  13
General disorders     
Injection Site Pain †  16/190 (8.42%)  16 14/192 (7.29%)  14
Injection Site Tenderness †  16/190 (8.42%)  16 22/192 (11.46%)  22
Headache †  11/190 (5.79%)  11 20/192 (10.42%)  20
Malaise (Fatigue) †  11/190 (5.79%)  11 12/192 (6.25%)  12
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Geeta Swamy
Organization: Duke University
Phone: 919.681.5220
EMail: geeta.swamy@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03969641    
Other Study ID Numbers: Pro00101707
First Submitted: May 28, 2019
First Posted: May 31, 2019
Results First Submitted: September 21, 2022
Results First Posted: December 27, 2022
Last Update Posted: January 11, 2023