Trial Outcomes & Findings for Comparison of the Efficacy of Inflexal V With a Commercially Available Influenza Vaccine in Young Children (NCT NCT01310400)

Results Overview

Seroconversion rate post-immunization. Seroconversion is defined as a post-vaccination titer of ≥1:40 for those with a pre-vaccination HI titer of \<1:10 and as ≥ four-fold increase in HI titer for those with a pre-vaccination HI titer of ≥1:10.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1356 participants

Primary outcome timeframe

3 weeks after the 2nd vaccination

Results posted on

2014-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	Inflexal V 0.5 mL Subjects received 2 doses: 1st dose on Day 0, 2nd dose on Day 28	Inflexal V 0.25 mL Subjects received 2 doses: 1st dose on Day 0, 2nd dose on Day 28	Agrippal 0.25 mL Subjects received 2 doses: 1st dose on Day 0, 2nd dose on Day 28
Overall Study STARTED	452	452	452
Overall Study COMPLETED	424	420	422
Overall Study NOT COMPLETED	28	32	30

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of the Efficacy of Inflexal V With a Commercially Available Influenza Vaccine in Young Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inflexal V 0.5 mL n=452 Participants The safety data are shown for the safety population (N = 452 for this group).	Inflexal V 0.25 mL n=451 Participants The safety data are shown for the safety population (N = 451 for this group).	Agrippal 0.25 mL n=451 Participants The safety data are shown for the safety population (N = 451 for this group).	Total n=1354 Participants Total of all reporting groups
Age, Categorical <=18 years	452 Participants n=5 Participants	451 Participants n=7 Participants	451 Participants n=5 Participants	1354 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	1.8 years STANDARD_DEVIATION 0.7 • n=5 Participants	1.8 years STANDARD_DEVIATION 0.7 • n=7 Participants	1.8 years STANDARD_DEVIATION 0.7 • n=5 Participants	1.8 years STANDARD_DEVIATION 0.7 • n=4 Participants
Sex: Female, Male Female	227 Participants n=5 Participants	215 Participants n=7 Participants	206 Participants n=5 Participants	648 Participants n=4 Participants
Sex: Female, Male Male	225 Participants n=5 Participants	236 Participants n=7 Participants	245 Participants n=5 Participants	706 Participants n=4 Participants
Region of Enrollment China	452 participants n=5 Participants	451 participants n=7 Participants	451 participants n=5 Participants	1354 participants n=4 Participants

PRIMARY outcome

Timeframe: 3 weeks after the 2nd vaccination

Population: According-to-protocol population: subjects who received both doses of influenza vaccine, with available pre- and post-vaccination titers and without major protocol violations

Seroconversion rate post-immunization. Seroconversion is defined as a post-vaccination titer of ≥1:40 for those with a pre-vaccination HI titer of \<1:10 and as ≥ four-fold increase in HI titer for those with a pre-vaccination HI titer of ≥1:10.

Outcome measures

Outcome measures
Measure	Inflexal V 0.5 mL n=423 Participants The immunogenicity results are shown for the per-protocol population (N = 423 for this group).	Inflexal V 0.25 mL n=380 Participants The immunogenicity results are shown for the per-protocol population (N = 380 for this group).	Agrippal 0.25 mL n=384 Participants The immunogenicity results are shown for the per-protocol population (N = 384 for this group).
Immunogenicity, Assessed by the Haemagglutination (HI) Test Percentage of subjects seroconverted: A/H1N1	97.2 percentage of participants Interval 95.1 to 98.5	89.7 percentage of participants Interval 86.2 to 92.6	92.7 percentage of participants Interval 89.6 to 95.1
Immunogenicity, Assessed by the Haemagglutination (HI) Test Percentage of subjects seroconverted: A/H3N2	90.5 percentage of participants Interval 87.4 to 93.2	83.4 percentage of participants Interval 79.3 to 87.0	82.6 percentage of participants Interval 78.4 to 86.2
Immunogenicity, Assessed by the Haemagglutination (HI) Test Percentage of subjects seroconverted: B-strain	57.5 percentage of participants Interval 52.6 to 62.2	47.9 percentage of participants Interval 42.8 to 53.1	37.2 percentage of participants Interval 32.4 to 42.3

SECONDARY outcome

Timeframe: 3 weeks after the 2nd vaccination

GMT-fold increase - calculated as the GMT on Day 49 divided by the baseline GMT value

Outcome measures

Outcome measures
Measure	Inflexal V 0.5 mL n=423 Participants The immunogenicity results are shown for the per-protocol population (N = 423 for this group).	Inflexal V 0.25 mL n=380 Participants The immunogenicity results are shown for the per-protocol population (N = 380 for this group).	Agrippal 0.25 mL n=384 Participants The immunogenicity results are shown for the per-protocol population (N = 384 for this group).
Fold Increase in Geometric Mean Titer (GMT) GMT fold increase from baseline: A/H1N1	36.6 Fold (ratio)	25.9 Fold (ratio)	25.4 Fold (ratio)
Fold Increase in Geometric Mean Titer (GMT) GMT fold increase from baseline: A/H3N2	72.5 Fold (ratio)	48.8 Fold (ratio)	54.2 Fold (ratio)
Fold Increase in Geometric Mean Titer (GMT) GMT fold increase from baseline: B-strain	9.2 Fold (ratio)	7.0 Fold (ratio)	5.3 Fold (ratio)

SECONDARY outcome

Timeframe: 3 weeks after the 2nd vaccination

Seroprotection rate, defined as a post-vaccination HI titer of 1:40.

Outcome measures

Outcome measures
Measure	Inflexal V 0.5 mL n=423 Participants The immunogenicity results are shown for the per-protocol population (N = 423 for this group).	Inflexal V 0.25 mL n=380 Participants The immunogenicity results are shown for the per-protocol population (N = 380 for this group).	Agrippal 0.25 mL n=384 Participants The immunogenicity results are shown for the per-protocol population (N = 384 for this group).
Seroprotection Percentage of subjects seroprotected: A/H3N2	91.3 percentage seroprotected subjects Interval 88.1 to 93.8	84.5 percentage seroprotected subjects Interval 80.4 to 88.0	82.8 percentage seroprotected subjects Interval 78.7 to 86.5
Seroprotection Percentage of subjects seroprotected: A/H1N1	97.6 percentage seroprotected subjects Interval 95.7 to 98.9	92.1 percentage seroprotected subjects Interval 88.9 to 94.6	93.2 percentage seroprotected subjects Interval 90.2 to 95.5
Seroprotection Percentage of subjects seroprotected: B-strain	60.3 percentage seroprotected subjects Interval 55.4 to 65.0	51.3 percentage seroprotected subjects Interval 46.2 to 56.5	39.6 percentage seroprotected subjects Interval 34.7 to 44.7

SECONDARY outcome

Timeframe: Solicited AEs: Days 1-4 and 28-31, and Days 28 and 49; unsolicited AEs: until study end

Safety assessements were made by the investigator at baseline and on Days 28 and 49, as well as by the subjects themselves (in Subjects Diaries) for the 4-day period following each vaccination.

Outcome measures

Outcome measures
Measure	Inflexal V 0.5 mL n=452 Participants The immunogenicity results are shown for the per-protocol population (N = 423 for this group).	Inflexal V 0.25 mL n=451 Participants The immunogenicity results are shown for the per-protocol population (N = 380 for this group).	Agrippal 0.25 mL n=451 Participants The immunogenicity results are shown for the per-protocol population (N = 384 for this group).
Safety: Incidence of Solicited and Unsolicited Adverse Events Subjects with at least one AE	38.5 percentage of subjects with AEs	33.0 percentage of subjects with AEs	35.7 percentage of subjects with AEs
Safety: Incidence of Solicited and Unsolicited Adverse Events Subjects with at least one solicited AE	32.3 percentage of subjects with AEs	29.1 percentage of subjects with AEs	29.5 percentage of subjects with AEs
Safety: Incidence of Solicited and Unsolicited Adverse Events Subjects with at least one unsolicited AE	12.6 percentage of subjects with AEs	8.2 percentage of subjects with AEs	12.2 percentage of subjects with AEs

Adverse Events

Inflexal V 0.5 mL

Serious events: 0 serious events

Other events: 57 other events

Deaths: 0 deaths

Inflexal V 0.25 mL

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Agrippal 0.25 mL

Serious events: 1 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Inflexal V 0.5 mL n=452 participants at risk The safety data are shown for the safety population (N = 452 for this group).	Inflexal V 0.25 mL n=451 participants at risk The safety data are shown for the safety population (N = 451 for this group).	Agrippal 0.25 mL n=451 participants at risk The safety data are shown for the safety population (N = 451 for this group).
Gastrointestinal disorders Diarrhea	0.00% 0/452	0.22% 1/451 • Number of events 1	0.00% 0/451
General disorders Pyrexia	0.00% 0/452	0.00% 0/451	0.22% 1/451 • Number of events 1

Other adverse events

Other adverse events
Measure	Inflexal V 0.5 mL n=452 participants at risk The safety data are shown for the safety population (N = 452 for this group).	Inflexal V 0.25 mL n=451 participants at risk The safety data are shown for the safety population (N = 451 for this group).	Agrippal 0.25 mL n=451 participants at risk The safety data are shown for the safety population (N = 451 for this group).
Gastrointestinal disorders Diarrhea	2.4% 11/452 • Number of events 11	2.0% 9/451 • Number of events 9	1.8% 8/451 • Number of events 8
Respiratory, thoracic and mediastinal disorders Cough	3.8% 17/452 • Number of events 17	2.4% 11/451 • Number of events 11	5.1% 23/451 • Number of events 23
Respiratory, thoracic and mediastinal disorders Rhinorrhea	3.1% 14/452 • Number of events 14	2.0% 9/451 • Number of events 9	3.8% 17/451 • Number of events 17
Gastrointestinal disorders Vomiting	3.5% 16/452 • Number of events 16	2.4% 11/451 • Number of events 11	2.7% 12/451 • Number of events 12
General disorders Pyrexia (body temp. >=38°C)	9.5% 43/452 • Number of events 43	6.9% 31/451 • Number of events 31	8.4% 38/451 • Number of events 38

Additional Information

Medical Affairs Director

Crucell Switzerland AG

Phone: +41(0)319806111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release. A time period for this review is not specified in the study protocol.
Publication restrictions are in place

Restriction type: OTHER