Trial Outcomes & Findings for Development of Childhood Anti-Influenza Immunity (NCT NCT03673345)
NCT ID: NCT03673345
Last Updated: 2022-03-18
Results Overview
Percent of ICOS/PD1+ expressing cells within CXCR5+ CD4 T cell population
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
125 participants
Primary outcome timeframe
Year 2 (Visit 5)
Results posted on
2022-03-18
Participant Flow
Participant milestones
| Measure |
Cohort 1A
0.25 mL dose of IIV-4 administered intramuscularly on days 0 and 28 of study year 1 and on day 0 of study year 2 in children 6-12 months of age who have not previously had an influenza infection or vaccination, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 1B
0.25 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 after primary influenza infection in study year 1 in children 3-12 months of age, who have not previously had an influenza vaccination, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 2A
0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=60
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 2B
0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 3A
0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2006 and 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=30
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 3B
0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2006 and 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 4A
0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2003 and 2006, who have previously received 2 doses of influenza vaccine prior to the study, n=30
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 4B
0.5 mL does of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2003 and 2006, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
57
|
12
|
21
|
7
|
20
|
0
|
|
Overall Study
COMPLETED
|
3
|
3
|
48
|
7
|
19
|
6
|
20
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
9
|
5
|
2
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1A
0.25 mL dose of IIV-4 administered intramuscularly on days 0 and 28 of study year 1 and on day 0 of study year 2 in children 6-12 months of age who have not previously had an influenza infection or vaccination, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 1B
0.25 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 after primary influenza infection in study year 1 in children 3-12 months of age, who have not previously had an influenza vaccination, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 2A
0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=60
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 2B
0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 3A
0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2006 and 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=30
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 3B
0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2006 and 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 4A
0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2003 and 2006, who have previously received 2 doses of influenza vaccine prior to the study, n=30
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 4B
0.5 mL does of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2003 and 2006, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
3
|
3
|
2
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
4
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Development of Childhood Anti-Influenza Immunity
Baseline characteristics by cohort
| Measure |
Cohort 1A
n=5 Participants
0.25 mL dose of IIV-4 administered intramuscularly on days 0 and 28 of study year 1 and on day 0 of study year 2 in children 6-12 months of age who have not previously had an influenza infection or vaccination, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 1B
n=3 Participants
0.25 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 after primary influenza infection in study year 1 in children 3-12 months of age, who have not previously had an influenza vaccination, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 2A
n=57 Participants
0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=60
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 2B
n=12 Participants
0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 3A
n=21 Participants
0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2006 and 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=30
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 3B
n=7 Participants
0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2006 and 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 4A
n=20 Participants
0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2003 and 2006, who have previously received 2 doses of influenza vaccine prior to the study, n=30
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 4B
0.5 mL does of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2003 and 2006, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
9.7 months
STANDARD_DEVIATION 1.6 • n=5 Participants
|
7.2 months
STANDARD_DEVIATION 3.9 • n=7 Participants
|
45.7 months
STANDARD_DEVIATION 25.7 • n=5 Participants
|
39.5 months
STANDARD_DEVIATION 25.2 • n=4 Participants
|
131.5 months
STANDARD_DEVIATION 15.3 • n=21 Participants
|
130.9 months
STANDARD_DEVIATION 20.0 • n=10 Participants
|
167.3 months
STANDARD_DEVIATION 9.1 • n=115 Participants
|
—
|
81.4 months
STANDARD_DEVIATION 57.2 • n=42 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
—
|
68 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
—
|
57 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
—
|
14 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
—
|
110 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
—
|
1 Participants
n=42 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=10 Participants
|
0 Participants
n=115 Participants
|
—
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
—
|
3 Participants
n=42 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=10 Participants
|
0 Participants
n=115 Participants
|
—
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
—
|
22 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
—
|
72 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
—
|
25 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
—
|
3 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Year 2 (Visit 5)Population: Unable to enroll participants into Cohort 4B
Percent of ICOS/PD1+ expressing cells within CXCR5+ CD4 T cell population
Outcome measures
| Measure |
Cohort 1A
n=2 Participants
0.25 mL dose of IIV-4 administered intramuscularly on days 0 and 28 of study year 1 and on day 0 of study year 2 in children 6-12 months of age who have not previously had an influenza infection or vaccination, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 1B
n=3 Participants
0.25 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 after primary influenza infection in study year 1 in children 3-12 months of age, who have not previously had an influenza vaccination, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 2A
n=42 Participants
0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=60
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 2B
n=6 Participants
0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 3A
n=18 Participants
0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2006 and 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=30
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 3B
n=6 Participants
0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2006 and 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 4A
n=17 Participants
0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2003 and 2006, who have previously received 2 doses of influenza vaccine prior to the study, n=30
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
Cohort 4B
0.5 mL does of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2003 and 2006, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
|
|---|---|---|---|---|---|---|---|---|
|
Frequency of CD4 T Cells With a Given Functional Potential
|
0.70 Percentage
Standard Deviation 0.24
|
0.55 Percentage
Standard Deviation 0.31
|
0.52 Percentage
Standard Deviation 0.32
|
0.38 Percentage
Standard Deviation 0.27
|
0.40 Percentage
Standard Deviation 0.37
|
0.34 Percentage
Standard Deviation 0.17
|
0.30 Percentage
Standard Deviation 0.13
|
—
|
Adverse Events
Cohort 1A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 1B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place