Trial Outcomes & Findings for Open-Label Study of H5 Vaccine in Participants of Protocol 04-077 (NCT NCT00402649)
NCT ID: NCT00402649
Last Updated: 2011-06-13
Results Overview
Number of subjects reporting solicited Adverse Events collected on Memory Aid for Days 0-7 post each vaccination for all subjects (systematic assessment), for any and severe severities.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Days 0-7 post each vaccination
Results posted on
2011-06-13
Participant Flow
Recruitment was offered to the 23 subjects (aged 2-10 years) who were previously enrolled and assigned to placebo at the three clinical sites in the DMID 04-077 study (NCT00133536), along with up to 32 subjects from a single site who were incorrectly dosed in that study.
Participant milestones
| Measure |
Inactivated Influenza A/H5N1 Vaccine
All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Inactivated Influenza A/H5N1 Vaccine
All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Open-Label Study of H5 Vaccine in Participants of Protocol 04-077
Baseline characteristics by cohort
| Measure |
Inactivated Influenza A/H5N1 Vaccine
n=35 Participants
All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
|
|---|---|
|
Age, Categorical
<=18 years
|
35 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age Continuous
|
7.6 years
STANDARD_DEVIATION 2.3 • n=93 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Days 0-7 post each vaccinationNumber of subjects reporting solicited Adverse Events collected on Memory Aid for Days 0-7 post each vaccination for all subjects (systematic assessment), for any and severe severities.
Outcome measures
| Measure |
Inactivated Influenza A/H5N1 Vaccine
n=35 Participants
All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
|
|---|---|
|
Occurrence of Solicited Adverse Events Among All Subjects
Rash of any severity
|
0 Participants
|
|
Occurrence of Solicited Adverse Events Among All Subjects
Rash - severe
|
0 Participants
|
|
Occurrence of Solicited Adverse Events Among All Subjects
Elevated Oral Temperature of any severity
|
0 Participants
|
|
Occurrence of Solicited Adverse Events Among All Subjects
Elevated Oral Temperature - severe
|
0 Participants
|
|
Occurrence of Solicited Adverse Events Among All Subjects
General Activity of any severity
|
10 Participants
|
|
Occurrence of Solicited Adverse Events Among All Subjects
General Activity - severe
|
1 Participants
|
|
Occurrence of Solicited Adverse Events Among All Subjects
Pain of any severity
|
19 Participants
|
|
Occurrence of Solicited Adverse Events Among All Subjects
Pain - severe
|
0 Participants
|
|
Occurrence of Solicited Adverse Events Among All Subjects
Mobility of any severity
|
5 Participants
|
|
Occurrence of Solicited Adverse Events Among All Subjects
Mobility - severe
|
0 Participants
|
|
Occurrence of Solicited Adverse Events Among All Subjects
Redness of any severity
|
4 Participants
|
|
Occurrence of Solicited Adverse Events Among All Subjects
Redness - severe
|
0 Participants
|
|
Occurrence of Solicited Adverse Events Among All Subjects
Swelling of any severity
|
4 Participants
|
|
Occurrence of Solicited Adverse Events Among All Subjects
Swelling - severe
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 0-7 post each vaccinationPopulation: Solicited symptom of Body Aches was collected from subjects age 6-10 only
Number of subjects reporting solicited Adverse Event of Body Aches, collected on Memory Aid for Days 0-7 post each vaccination for children age 6-10 only (systematic assessment), of any and severe severities.
Outcome measures
| Measure |
Inactivated Influenza A/H5N1 Vaccine
n=26 Participants
All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
|
|---|---|
|
Occurrence of the Solicited Adverse Event of Body Aches, Solicited Only From Children Age 6-10
Body Aches of any severity
|
6 Participants
|
|
Occurrence of the Solicited Adverse Event of Body Aches, Solicited Only From Children Age 6-10
Body Aches - severe
|
0 Participants
|
PRIMARY outcome
Timeframe: Through Day 28 after second vaccinationNumber of subjects with spontaneous reports of Adverse Events of any and severe severities. Events reported by more than 5.6% of subjects in any group are reported by MedDRA Preferred Term.
Outcome measures
| Measure |
Inactivated Influenza A/H5N1 Vaccine
n=35 Participants
All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
|
|---|---|
|
Occurrence of Unsolicited Adverse Events
Vomiting of any severity
|
2 Participants
|
|
Occurrence of Unsolicited Adverse Events
Vomiting - severe
|
0 Participants
|
|
Occurrence of Unsolicited Adverse Events
Gastrointestinal viral of any severity
|
2 Participants
|
|
Occurrence of Unsolicited Adverse Events
Gastrointestinal viral - severe
|
0 Participants
|
|
Occurrence of Unsolicited Adverse Events
Nasopharyngitis of any severity
|
2 Participants
|
|
Occurrence of Unsolicited Adverse Events
Nasopharyngitis - severe
|
0 Participants
|
|
Occurrence of Unsolicited Adverse Events
Upper respiratory tract infection of any severity
|
2 Participants
|
|
Occurrence of Unsolicited Adverse Events
Upper respiratory tract infection - severe
|
0 Participants
|
|
Occurrence of Unsolicited Adverse Events
Headache of any severity
|
2 Participants
|
|
Occurrence of Unsolicited Adverse Events
Headache - severe
|
0 Participants
|
|
Occurrence of Unsolicited Adverse Events
Rhinitis allergic of any severity
|
2 Participants
|
|
Occurrence of Unsolicited Adverse Events
Rhinitis allergic - severe
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 months after the first vaccinationNumber of subjects with Serious Adverse Events during the 6 months after the first vaccination.
Outcome measures
| Measure |
Inactivated Influenza A/H5N1 Vaccine
n=35 Participants
All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
|
|---|---|
|
Occurrence of Serious Adverse Events
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28 after second vaccinationPopulation: Blood draw was optional - blood collected from 16 participants
Number of subjects achieving serum hemagglutination inhibition antibody titer of 1:40 or greater against the influenza A/H5N1 virus after receipt of two doses of vaccine.
Outcome measures
| Measure |
Inactivated Influenza A/H5N1 Vaccine
n=16 Participants
All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
|
|---|---|
|
Number of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Titers of 1:40 or Greater
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 28 after second vaccinationPopulation: Blood draw was optional - blood collected from 16 participants
Geometric mean titer of hemagglutination inhibition antibody titers after receipt of two doses of vaccine.
Outcome measures
| Measure |
Inactivated Influenza A/H5N1 Vaccine
n=16 Participants
All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
|
|---|---|
|
Geometric Mean Titer of Hemagglutination Inhibition Antibody Titers
|
20.9 Titer
Interval 8.4 to 51.9
|
SECONDARY outcome
Timeframe: Day 28 after second vaccinationPopulation: Blood draw was optional - blood collected from 16 participants post vaccination, but missing baseline assessment for 3 of 16 subjects
Number of subjects with a 4-fold or greater increase, relative to baseline, in hemagglutination inhibition antibody titers after receipt of two doses of vaccine.
Outcome measures
| Measure |
Inactivated Influenza A/H5N1 Vaccine
n=13 Participants
All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
|
|---|---|
|
Number of Participants With a Four-fold or Greater Increase in Hemagglutination Inhibition Antibody Titers
|
4 Participants
|
Adverse Events
Inactivated Influenza A/H5N1 Vaccine
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Inactivated Influenza A/H5N1 Vaccine
n=35 participants at risk
All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
5.7%
2/35 • Number of events 2 • Subjects' parents/guardians recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 180.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 8 day period was considered one event.
|
|
Infections and infestations
Gastroenteritis viral
|
5.7%
2/35 • Number of events 2 • Subjects' parents/guardians recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 180.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 8 day period was considered one event.
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
2/35 • Number of events 2 • Subjects' parents/guardians recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 180.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 8 day period was considered one event.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
2/35 • Number of events 2 • Subjects' parents/guardians recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 180.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 8 day period was considered one event.
|
|
Nervous system disorders
Headache
|
5.7%
2/35 • Number of events 3 • Subjects' parents/guardians recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 180.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 8 day period was considered one event.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.7%
2/35 • Number of events 2 • Subjects' parents/guardians recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 180.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 8 day period was considered one event.
|
|
General disorders
Pain - post dose 1
|
14.3%
5/35 • Number of events 5 • Subjects' parents/guardians recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 180.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 8 day period was considered one event.
|
|
General disorders
Pain - post dose 2
|
6.2%
2/32 • Number of events 2 • Subjects' parents/guardians recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 180.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 8 day period was considered one event.
|
|
General disorders
Injection site erythema - post dose 1
|
11.4%
4/35 • Number of events 4 • Subjects' parents/guardians recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 180.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 8 day period was considered one event.
|
|
General disorders
Injection site erythema - post dose 2
|
6.2%
2/32 • Number of events 2 • Subjects' parents/guardians recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 180.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 8 day period was considered one event.
|
|
General disorders
Injection site swelling - post dose 1
|
11.4%
4/35 • Number of events 4 • Subjects' parents/guardians recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 180.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 8 day period was considered one event.
|
|
General disorders
Injection site swelling - post dose 2
|
6.2%
2/32 • Number of events 2 • Subjects' parents/guardians recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 180.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 8 day period was considered one event.
|
|
General disorders
Injection site pain - post dose 1
|
31.4%
11/35 • Number of events 11 • Subjects' parents/guardians recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 180.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 8 day period was considered one event.
|
|
General disorders
Injection site pain - post dose 2
|
46.9%
15/32 • Number of events 15 • Subjects' parents/guardians recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 180.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 8 day period was considered one event.
|
|
General disorders
Decreased activity - post dose 1
|
17.1%
6/35 • Number of events 6 • Subjects' parents/guardians recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 180.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 8 day period was considered one event.
|
|
General disorders
Decreased activity - post dose 2
|
14.3%
5/35 • Number of events 5 • Subjects' parents/guardians recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 180.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 8 day period was considered one event.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased - post dose 1
|
14.3%
5/35 • Number of events 5 • Subjects' parents/guardians recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 180.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 8 day period was considered one event.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased - post dose 2
|
8.6%
3/35 • Number of events 3 • Subjects' parents/guardians recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 180.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 8 day period was considered one event.
|
Additional Information
Ina Stephens, MD
University of Maryland Center for Vaccine Development
Phone: 410-706-1123
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60