Trial Outcomes & Findings for Innate and Acquired Immunity to Influenza Infection and Immunization (SLVP029) (NCT NCT03028974)
NCT ID: NCT03028974
Last Updated: 2018-12-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
77 participants
Primary outcome timeframe
Day 0 to 28-32 post immunization
Results posted on
2018-12-14
Participant Flow
Participants are presented only in the group in the year in which they received the vaccination. Planned Groups B and C did not enroll in years 2014-2018, Group A did not enroll in 2015-2018 and Group F did not enroll in years 2016-2018 due to LAIV not being recommended.
Participant milestones
| Measure |
Group A: 2-4 yo LAIV4 (Return)
Participants are given quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® . For children requiring 2 doses of vaccine, a second immunization will be given at Day 28-32 after Dose 1. All participants in this group will be asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.
FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray
|
Group B: 2-4 yo LAIV4 (Single Year)
Participants are given LAIV4/ FluMist® and participate for single year. For children requiring 2 doses of vaccine, a second immunization will be given at Day 28-32 after Dose 1.
FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray
|
Group C: 2-4 yo LAIV4 (Swab/Single Yr)
Participants are given LAIV4/ FluMist® and participate for single year. NP swabs are collected; no blood samples will be collected for this group. For children requiring 2 doses of vaccine, a second immunization will be given at least 28 days after Dose 1.
FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray
|
Group D: 6 - 23 Mos Old IIV4 (Returning)
Participants are given a quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® . For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization will be given at Day 28-32 after Dose 1. Participants are asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.
Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine
|
Group E: 6 - 23 Mos Old IIV4 (Single Yr)
Participants are given IIV4/ Fluzone® and participate for a single year. For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization will be given at Day 28-32 after Dose 1.
Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine
|
Group F: 9-13/18-49 yo LAIV4 (Single Yr)
Participants 9-13 year old and 18-49 year old are given LAIV4/ FluMist® . Participants will participate for a single year.
FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray
|
Group G: 9-13/18-49 yo IIV4 (Single Yr)
Participants 9-13 year old and 18-49 year old are given IIV4/ Fluzone® and participate for single year.
Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine
|
|---|---|---|---|---|---|---|---|
|
2014-2015
STARTED
|
1
|
0
|
0
|
3
|
0
|
11
|
13
|
|
2014-2015
COMPLETED
|
1
|
0
|
0
|
3
|
0
|
11
|
13
|
|
2014-2015
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
2015-2016
STARTED
|
0
|
0
|
0
|
6
|
0
|
14
|
20
|
|
2015-2016
COMPLETED
|
0
|
0
|
0
|
6
|
0
|
14
|
20
|
|
2015-2016
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
2016-2017
STARTED
|
0
|
0
|
0
|
4
|
2
|
0
|
18
|
|
2016-2017
COMPLETED
|
0
|
0
|
0
|
4
|
2
|
0
|
18
|
|
2016-2017
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
2017-2018
STARTED
|
0
|
0
|
0
|
5
|
0
|
0
|
5
|
|
2017-2018
COMPLETED
|
0
|
0
|
0
|
5
|
0
|
0
|
5
|
|
2017-2018
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Innate and Acquired Immunity to Influenza Infection and Immunization (SLVP029)
Baseline characteristics by cohort
| Measure |
Group A: 2-4 yo LAIV4 (Return)
n=1 Participants
Participants are given quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® . For children requiring 2 doses of vaccine, a second immunization will be given at Day 28-32 after Dose 1. All participants in this group will be asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.
FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray
|
Group D: 6 - 23 Mos Old IIV4 (Return)
n=6 Participants
Participants are given a quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® . For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization will be given at Day 28-32 after Dose 1. Participants are asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.
Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine
|
Group E: 6 - 23 Mos Old IIV4 (Single Yr)
n=2 Participants
Participants are given IIV4/ Fluzone® and participate for a single year. For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization will be given at Day 28-32 after Dose 1.
Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine
|
Group F: 9-13/18-49 yo LAIV4 (Single Yr)
n=21 Participants
Participants 9-13 year old and 18-49 year old are given LAIV4/ FluMist® . Participants will participate for a single year.
FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray
|
Group G: 9-13/18-49 yo IIV4 (Single Yr)
n=47 Participants
Participants 9-13 year old and 18-49 year old are given IIV4/ Fluzone® and participate for single year.
Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
2 years
STANDARD_DEVIATION 0 • n=5 Participants
|
1.5 years
STANDARD_DEVIATION 00.187 • n=7 Participants
|
1 years
STANDARD_DEVIATION 0 • n=5 Participants
|
20 years
STANDARD_DEVIATION 13.05 • n=4 Participants
|
33.5 years
STANDARD_DEVIATION 1.48 • n=21 Participants
|
21.1 years
STANDARD_DEVIATION 1.64 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
73 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
42 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
2 participants
n=5 Participants
|
21 participants
n=4 Participants
|
47 participants
n=21 Participants
|
77 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 0 to 28-32 post immunizationPopulation: Participants with available data at the respective timepoint are included in the analysis.
Outcome measures
| Measure |
Group A: 2-4 yo LAIV4 (Return)
n=1 Participants
Participants are given quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® . For children requiring 2 doses of vaccine, a second immunization will be given at Day 28-32 after Dose 1. All participants in this group will be asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.
FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray
|
Group D: 6 - 23 Mos Old IIV4 (Returning)
n=7 Participants
Participants are given a quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® . For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization will be given at Day 28-32 after Dose 1. Participants are asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.
Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine
|
Group E: 6 - 23 Mos Old IIV4 (Single Yr)
n=2 Participants
Participants are given IIV4/ Fluzone® and participate for a single year. For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization will be given at Day 28-32 after Dose 1.
Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine
|
Group F: 9-13/18-49 yo LAIV4 (Single Yr)
n=25 Participants
Participants 9-13 year old and 18-49 year old are given LAIV4/ FluMist® . Participants will participate for a single year.
FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray
|
Group G: 9-13/18-49 yo IIV4 (Single Yr)
n=56 Participants
Participants 9-13 year old and 18-49 year old are given IIV4/ Fluzone® and participate for single year.
Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine
|
|---|---|---|---|---|---|
|
Count of Participants From Each Arm Who Received Influenza Vaccine
2014-2015
|
1 Participants
|
3 Participants
|
—
|
11 Participants
|
13 Participants
|
|
Count of Participants From Each Arm Who Received Influenza Vaccine
2015-2016
|
—
|
6 Participants
|
—
|
14 Participants
|
20 Participants
|
|
Count of Participants From Each Arm Who Received Influenza Vaccine
2016-2017
|
—
|
4 Participants
|
2 Participants
|
—
|
18 Participants
|
|
Count of Participants From Each Arm Who Received Influenza Vaccine
2017-2018
|
—
|
5 Participants
|
—
|
—
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 0 to 28-32 post-immunizationOutcome measures
| Measure |
Group A: 2-4 yo LAIV4 (Return)
n=1 Participants
Participants are given quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® . For children requiring 2 doses of vaccine, a second immunization will be given at Day 28-32 after Dose 1. All participants in this group will be asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.
FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray
|
Group D: 6 - 23 Mos Old IIV4 (Returning)
n=7 Participants
Participants are given a quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® . For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization will be given at Day 28-32 after Dose 1. Participants are asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.
Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine
|
Group E: 6 - 23 Mos Old IIV4 (Single Yr)
n=2 Participants
Participants are given IIV4/ Fluzone® and participate for a single year. For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization will be given at Day 28-32 after Dose 1.
Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine
|
Group F: 9-13/18-49 yo LAIV4 (Single Yr)
n=25 Participants
Participants 9-13 year old and 18-49 year old are given LAIV4/ FluMist® . Participants will participate for a single year.
FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray
|
Group G: 9-13/18-49 yo IIV4 (Single Yr)
n=56 Participants
Participants 9-13 year old and 18-49 year old are given IIV4/ Fluzone® and participate for single year.
Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine
|
|---|---|---|---|---|---|
|
Count of Participants With Related Adverse Events
|
0 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
4 Participants
|
Adverse Events
Group A: 2-4 yo LAIV4 (Return)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group D: 6 - 23 Mos Old IIV4 (Returning)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group E: 6 - 23 Mos Old IIV4 (Single Yr)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group F: 9-13/18-49 yo LAIV4 (Single Yr)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group G: 9-13/18-49 yo IIV4 (Single Yr)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A: 2-4 yo LAIV4 (Return)
n=1 participants at risk
Participants were given quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® . For children requiring 2 doses of vaccine, a second immunization was given at Day 28-32 after Dose 1. All participants in this group was asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.
FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray
|
Group D: 6 - 23 Mos Old IIV4 (Returning)
n=7 participants at risk
Participants were given a quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® . For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization was given at Day 28-32 after Dose 1. Participants were asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.
Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine
|
Group E: 6 - 23 Mos Old IIV4 (Single Yr)
n=2 participants at risk
Participants were given IIV4/ Fluzone® and participate for a single year. For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization was given at Day 28-32 after Dose 1.
Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine
|
Group F: 9-13/18-49 yo LAIV4 (Single Yr)
n=25 participants at risk
Participants 9-13-year-old and 18-49-year-old were given LAIV4/ FluMist ®. Participants participated for a single year.
FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray
|
Group G: 9-13/18-49 yo IIV4 (Single Yr)
n=56 participants at risk
Participants 9-13-year-old and 18-49-year-old were given IIV4/ Fluzone® and participated for a single year.
Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/7 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/2 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
16.0%
4/25 • Number of events 4 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/56 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/7 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/2 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
12.0%
3/25 • Number of events 3 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/56 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/7 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/2 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
8.0%
2/25 • Number of events 2 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/56 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
|
General disorders
Mild Headache
|
0.00%
0/1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/7 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/2 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
4.0%
1/25 • Number of events 1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/56 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/7 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/2 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
4.0%
1/25 • Number of events 1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/56 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
14.3%
1/7 • Number of events 1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/2 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/25 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/56 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/7 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/2 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/25 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
1.8%
1/56 • Number of events 1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
|
Surgical and medical procedures
Ecchymosis
|
0.00%
0/1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
14.3%
1/7 • Number of events 1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/2 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/25 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/56 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/7 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/2 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/25 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
1.8%
1/56 • Number of events 1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
|
Surgical and medical procedures
Injection site pain
|
0.00%
0/1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/7 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/2 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/25 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
3.6%
2/56 • Number of events 2 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
|
Surgical and medical procedures
Post procedure bleeding
|
0.00%
0/1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/7 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/2 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
4.0%
1/25 • Number of events 1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/56 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucous drainage
|
0.00%
0/1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/7 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/2 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
4.0%
1/25 • Number of events 1 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
0.00%
0/56 • Day 0 to 28-32 post-immunization
Only related adverse events and related serious adverse events were collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place