Trial Outcomes & Findings for A Prospective Study to Evaluate the Safety of a New Trivalent Intranasal Influenza Vaccine (NCT NCT00677820)
NCT ID: NCT00677820
Last Updated: 2010-10-22
Results Overview
Fever was defined as oral temperature greater than or equal to 101 degrees Fahrenheit.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
300 participants
Primary outcome timeframe
Days 0-7
Results posted on
2010-10-22
Participant Flow
A total of 300 subjects were enrolled and randomized in the study between 09Jun2008 and 10Jun2008 at 3 sites in the USA.
Participant milestones
| Measure |
Trivalent Influenza Virus Vaccine
Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
|
Placebo
Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
|
|---|---|---|
|
Overall Study
STARTED
|
240
|
60
|
|
Overall Study
COMPLETED
|
239
|
60
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Trivalent Influenza Virus Vaccine
Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
|
Placebo
Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Prospective Study to Evaluate the Safety of a New Trivalent Intranasal Influenza Vaccine
Baseline characteristics by cohort
| Measure |
Trivalent Influenza Virus Vaccine
n=240 Participants
Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
|
Placebo
n=60 Participants
Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
31.2 years
STANDARD_DEVIATION 8.3 • n=93 Participants
|
32.0 years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
31.3 years
STANDARD_DEVIATION 8.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
194 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
106 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
39 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
201 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
246 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
5 participants
n=93 Participants
|
2 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 participants
n=93 Participants
|
4 participants
n=4 Participants
|
17 participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
210 participants
n=93 Participants
|
49 participants
n=4 Participants
|
259 participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 participants
n=93 Participants
|
2 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Race (NIH/OMB)
Other
|
6 participants
n=93 Participants
|
2 participants
n=4 Participants
|
8 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
240 participants
n=93 Participants
|
60 participants
n=4 Participants
|
300 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Days 0-7Population: Safety population Evaluable for Solicited Symptoms were subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.
Fever was defined as oral temperature greater than or equal to 101 degrees Fahrenheit.
Outcome measures
| Measure |
Trivalent Influenza Virus Vaccine
n=240 Participants
Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
|
Placebo
n=60 Participants
Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
|
|---|---|---|
|
Number of Subjects Reporting Fever
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 0-7Population: Safety population Evaluable for Solicited Symptoms were subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.
Outcome measures
| Measure |
Trivalent Influenza Virus Vaccine
n=240 Participants
Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
|
Placebo
n=59 Participants
Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
|
|---|---|---|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7
Any solicited symptom
|
101 participants
|
20 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7
Fever > 100F
|
4 participants
|
1 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7
Fever >= 101F
|
3 participants
|
0 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7
Fever > 102F
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7
Fever > 103F
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7
Runny nose
|
52 participants
|
6 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7
Sore throat
|
32 participants
|
7 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7
Cough
|
7 participants
|
2 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7
Vomiting
|
2 participants
|
0 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7
Muscle aches
|
8 participants
|
2 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7
Chills
|
5 participants
|
2 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7
Decreased activity
|
20 participants
|
5 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7
Headache
|
41 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Days 0-7Population: Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.
Outcome measures
| Measure |
Trivalent Influenza Virus Vaccine
n=240 Participants
Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
|
Placebo
n=60 Participants
Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
|
|---|---|---|
|
Number of Subjects Reporting Any Adverse Event (AE) Post-treatment
|
17 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Days 0-14Population: Safety population Evaluable for Solicited Symptoms were subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.
Outcome measures
| Measure |
Trivalent Influenza Virus Vaccine
n=240 Participants
Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
|
Placebo
n=59 Participants
Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
|
|---|---|---|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14
Any solicited symptom
|
108 participants
|
27 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14
Fever > 100F
|
4 participants
|
2 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14
Fever >= 101F
|
3 participants
|
0 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14
Fever > 102F
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14
Fever > 103F
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14
Runny nose
|
58 participants
|
7 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14
Sore throat
|
37 participants
|
8 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14
Cough
|
10 participants
|
4 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14
Vomiting
|
3 participants
|
1 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14
Muscle aches
|
12 participants
|
3 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14
Chills
|
5 participants
|
3 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14
Decreased activity
|
24 participants
|
5 participants
|
|
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14
Headache
|
44 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Days 0-14Population: Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.
Outcome measures
| Measure |
Trivalent Influenza Virus Vaccine
n=240 Participants
Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
|
Placebo
n=60 Participants
Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
|
|---|---|---|
|
Number of Subjects Reporting Any AEs Post Treatment
|
20 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Days 0-28Population: Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.
SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An SNMC was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.
Outcome measures
| Measure |
Trivalent Influenza Virus Vaccine
n=240 Participants
Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
|
Placebo
n=60 Participants
Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC)
Total subjects reporting > 1 SAE
|
1 participants
|
0 participants
|
|
Number of Subjects Reporting Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC)
Total subjects reporting > 1 SNMC
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 0-180Population: Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.
SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An SNMC was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.
Outcome measures
| Measure |
Trivalent Influenza Virus Vaccine
n=240 Participants
Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
|
Placebo
n=60 Participants
Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
|
|---|---|---|
|
Number of Subjects Reporting SAEs and SNMCs
Total subjects reporting > 1 SAE
|
3 participants
|
1 participants
|
|
Number of Subjects Reporting SAEs and SNMCs
Total subjects reporting > 1 SNMC
|
0 participants
|
1 participants
|
Adverse Events
Trivalent Influenza Virus Vaccine
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trivalent Influenza Virus Vaccine
n=240 participants at risk
Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
|
Placebo
n=60 participants at risk
Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.42%
1/240 • Number of events 1 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
0.00%
0/60 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
0.00%
0/240 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
1.7%
1/60 • Number of events 1 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.83%
2/240 • Number of events 2 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
0.00%
0/60 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
Other adverse events
| Measure |
Trivalent Influenza Virus Vaccine
n=240 participants at risk
Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
|
Placebo
n=60 participants at risk
Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
|
|---|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/240 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
1.7%
1/60 • Number of events 1 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/240 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
1.7%
1/60 • Number of events 1 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.83%
2/240 • Number of events 2 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
0.00%
0/60 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.42%
1/240 • Number of events 1 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
1.7%
1/60 • Number of events 1 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
|
Gastrointestinal disorders
Nausea
|
0.83%
2/240 • Number of events 2 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
1.7%
1/60 • Number of events 1 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/240 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
1.7%
1/60 • Number of events 1 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
1.7%
4/240 • Number of events 4 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
1.7%
1/60 • Number of events 1 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.2%
3/240 • Number of events 3 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
0.00%
0/60 • Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
|
Additional Information
Raburn Mallory, MD/ Sr Dir Clinical Development
MedImmune LLC, an affiliate of AstraZeneca
Phone: 301-398-0000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restricion is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER