Trial Outcomes & Findings for Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity (NCT NCT00710866)
NCT ID: NCT00710866
Last Updated: 2011-08-04
Results Overview
Seroprotection rate: HI titers =\>40
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
262 participants
Primary outcome timeframe
27-46 days after the second dose
Results posted on
2011-08-04
Participant Flow
Participant milestones
| Measure |
0.5mL VAXIGRIP®
2 doses 0.5mL VAXIGRIP® at months 0, 1
|
0.25mL VAXIGRIP®
2 doses 0.25mL VAXIGRIP® at months 0, 1
|
|---|---|---|
|
Overall Study
STARTED
|
133
|
134
|
|
Overall Study
COMPLETED
|
124
|
128
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
| Measure |
0.5mL VAXIGRIP®
2 doses 0.5mL VAXIGRIP® at months 0, 1
|
0.25mL VAXIGRIP®
2 doses 0.25mL VAXIGRIP® at months 0, 1
|
|---|---|---|
|
Overall Study
Protocol Violation
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Failed to meet eligibility
|
1
|
1
|
Baseline Characteristics
Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity
Baseline characteristics by cohort
| Measure |
0.5mL VAXIGRIP®
n=124 Participants
2 doses 0.5mL VAXIGRIP® at months 0, 1
|
0.25mL VAXIGRIP®
n=128 Participants
2 doses 0.25mL VAXIGRIP® at months 0, 1
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
124 Participants
n=99 Participants
|
128 Participants
n=107 Participants
|
252 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age Continuous
|
1.1 years
STANDARD_DEVIATION 0.4 • n=99 Participants
|
1.1 years
STANDARD_DEVIATION 0.4 • n=107 Participants
|
1.1 years
STANDARD_DEVIATION 0.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
124 participants
n=99 Participants
|
128 participants
n=107 Participants
|
252 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 27-46 days after the second dosePopulation: Per Protocol
Seroprotection rate: HI titers =\>40
Outcome measures
| Measure |
0.5mL VAXIGRIP®
n=57 Participants
2 doses 0.5mL VAXIGRIP® at months 0, 1
|
0.25mL VAXIGRIP®
n=63 Participants
2 doses 0.25mL VAXIGRIP® at months 0, 1
|
|---|---|---|
|
Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1)
|
41 participants
Interval 9.8 to 15.2
|
34 participants
Interval 8.2 to 12.7
|
PRIMARY outcome
Timeframe: 27-46 days after the second dosePopulation: Per Protocol
Seroprotection rate: HI titers =\>40
Outcome measures
| Measure |
0.5mL VAXIGRIP®
n=60 Participants
2 doses 0.5mL VAXIGRIP® at months 0, 1
|
0.25mL VAXIGRIP®
n=59 Participants
2 doses 0.25mL VAXIGRIP® at months 0, 1
|
|---|---|---|
|
Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1)
|
54 participants
|
52 participants
|
PRIMARY outcome
Timeframe: 27-46 days after the second dosePopulation: Per Protocol
Seroprotection rate: HI titers =\>40
Outcome measures
| Measure |
0.5mL VAXIGRIP®
n=57 Participants
2 doses 0.5mL VAXIGRIP® at months 0, 1
|
0.25mL VAXIGRIP®
n=63 Participants
2 doses 0.25mL VAXIGRIP® at months 0, 1
|
|---|---|---|
|
Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2)
|
43 participants
|
30 participants
|
PRIMARY outcome
Timeframe: 27-46 days after the second dosePopulation: Per Protocol
Seroprotection rate: HI titers =\>40
Outcome measures
| Measure |
0.5mL VAXIGRIP®
n=60 Participants
2 doses 0.5mL VAXIGRIP® at months 0, 1
|
0.25mL VAXIGRIP®
n=59 Participants
2 doses 0.25mL VAXIGRIP® at months 0, 1
|
|---|---|---|
|
Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2)
|
55 participants
Interval 10.9 to 15.7
|
52 participants
Interval 7.5 to 11.0
|
PRIMARY outcome
Timeframe: 27-46 days after the second dosePopulation: Per Protocol
Outcome measures
| Measure |
0.5mL VAXIGRIP®
n=57 Participants
2 doses 0.5mL VAXIGRIP® at months 0, 1
|
0.25mL VAXIGRIP®
n=63 Participants
2 doses 0.25mL VAXIGRIP® at months 0, 1
|
|---|---|---|
|
Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata)
|
40 participants
Interval 10.8 to 17.1
|
26 participants
Interval 6.7 to 10.6
|
PRIMARY outcome
Timeframe: 27-46 days after the second dosePopulation: Per Protocol
Seroprotection rate: HI titers =\>40
Outcome measures
| Measure |
0.5mL VAXIGRIP®
n=60 Participants
2 doses 0.5mL VAXIGRIP® at months 0, 1
|
0.25mL VAXIGRIP®
n=59 Participants
2 doses 0.25mL VAXIGRIP® at months 0, 1
|
|---|---|---|
|
Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata)
|
54 participants
|
55 participants
|
PRIMARY outcome
Timeframe: 3 days after immunizationPopulation: Per Protocol
Fever defined as temperature \>= 38 C
Outcome measures
| Measure |
0.5mL VAXIGRIP®
n=61 Participants
2 doses 0.5mL VAXIGRIP® at months 0, 1
|
0.25mL VAXIGRIP®
n=65 Participants
2 doses 0.25mL VAXIGRIP® at months 0, 1
|
|---|---|---|
|
Adverse Events: Fever After Either Dose - Infants 6-11 Months
|
1 participants
|
7 participants
|
PRIMARY outcome
Timeframe: 3 days after immunizationPopulation: Per Protocol
Fever defined as temperature \>= 38 C
Outcome measures
| Measure |
0.5mL VAXIGRIP®
n=63 Participants
2 doses 0.5mL VAXIGRIP® at months 0, 1
|
0.25mL VAXIGRIP®
n=61 Participants
2 doses 0.25mL VAXIGRIP® at months 0, 1
|
|---|---|---|
|
Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)-
|
6 participants
|
9 participants
|
Adverse Events
0.5mL VAXIGRIP®
Serious events: 0 serious events
Other events: 108 other events
Deaths: 0 deaths
0.25mL VAXIGRIP®
Serious events: 1 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.5mL VAXIGRIP®
n=124 participants at risk
2 doses 0.5mL VAXIGRIP® at months 0, 1
|
0.25mL VAXIGRIP®
n=126 participants at risk；n=128 participants at risk
2 doses 0.25mL VAXIGRIP® at months 0, 1
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/124 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
0.78%
1/128 • Number of events 1 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
Other adverse events
| Measure |
0.5mL VAXIGRIP®
n=124 participants at risk
2 doses 0.5mL VAXIGRIP® at months 0, 1
|
0.25mL VAXIGRIP®
n=126 participants at risk；n=128 participants at risk
2 doses 0.25mL VAXIGRIP® at months 0, 1
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Redness
|
22.6%
28/124 • Number of events 28 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
20.6%
26/126 • Number of events 26 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
|
Skin and subcutaneous tissue disorders
Swelling
|
15.3%
19/124 • Number of events 19 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
8.7%
11/126 • Number of events 11 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
|
Skin and subcutaneous tissue disorders
Induration
|
13.7%
17/124 • Number of events 17 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
6.3%
8/126 • Number of events 8 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
|
Skin and subcutaneous tissue disorders
Tenderness
|
22.6%
28/124 • Number of events 28 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
26.2%
33/126 • Number of events 33 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
|
General disorders
Fever
|
8.9%
11/124 • Number of events 11 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
15.1%
19/126 • Number of events 19 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
|
General disorders
Irritability
|
59.7%
74/124 • Number of events 74 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
61.1%
77/126 • Number of events 77 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
|
General disorders
Decreased appetite
|
38.7%
48/124 • Number of events 48 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
43.7%
55/126 • Number of events 55 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
|
General disorders
Drowsiness
|
39.5%
49/124 • Number of events 49 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
42.1%
53/126 • Number of events 53 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
|
General disorders
Sleep disturbance
|
54.8%
68/124 • Number of events 68 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
50.8%
64/126 • Number of events 64 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory
|
12.9%
16/124 • Number of events 16 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
11.9%
15/126 • Number of events 15 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
|
Eye disorders
Ocular
|
0.00%
0/124 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
0.79%
1/126 • Number of events 1 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
|
Gastrointestinal disorders
Gastrointestinal
|
6.5%
8/124 • Number of events 8 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
9.5%
12/126 • Number of events 12 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.2%
4/124 • Number of events 4 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
3.2%
4/126 • Number of events 4 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
|
Musculoskeletal and connective tissue disorders
Teething
|
10.5%
13/124 • Number of events 13 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
9.5%
12/126 • Number of events 12 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
|
General disorders
Miscellaneous
|
0.00%
0/124 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
5.6%
7/126 • Number of events 7 • Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
|
Additional Information
Danuta M Skowronski, MD
British Columbia Centre for Disease Control
Phone: 604-660-6067
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place