Trial Outcomes & Findings for Immunogenicity and Safety of Live Attenuated Influenza Vaccine (Flumist) Administered by Nasal and Sublingual Route (NCT NCT01488188)

NCT ID: NCT01488188

Last Updated: 2013-12-23

Results Overview

Passive haemagglutination inhibition titer of serum at 21 days after vaccination.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 40 participants
• Primary outcome timeframe: 21 days after vaccination
• Results posted on: 2013-12-23

Participant Flow

Recruit volunteers at Clinical Trial Center in Seoul National University Hospital

Randomly group assignment

Participant milestones

Measure	Influenza Vaccine -Sublingual Sublingual administration Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route	Influenza Vaccine-Nasal Nasal administration Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunogenicity and Safety of Live Attenuated Influenza Vaccine (Flumist) Administered by Nasal and Sublingual Route

Baseline characteristics by cohort

Measure	Influenza Vaccine -Sublingual n=20 Participants Sublingual administration Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route	Influenza Vaccine-Nasal n=20 Participants Nasal administration Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	25.5 years STANDARD_DEVIATION 5.8 • n=5 Participants	25.9 years STANDARD_DEVIATION 4.5 • n=7 Participants	25.7 years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment Korea, Republic of	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 21 days after vaccination

Passive haemagglutination inhibition titer of serum at 21 days after vaccination.

Outcome measures

Measure	Influenza Vaccine -Sublingual n=20 Participants Sublingual administration Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route	Influenza Vaccine-Nasal n=20 Participants Nasal administration Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route
Passive Haemagglutination Inhibition Titer.	380 Titer Interval 5.0 to 560.0	440 Titer Interval 10.0 to 1120.0

SECONDARY outcome

Timeframe: 7 days after vaccination

Flu virus-specific IgG- and IgA -antibody secreting cells per ml of blood at 7 days after vaccination

Outcome measures

Measure	Influenza Vaccine -Sublingual n=20 Participants Sublingual administration Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route	Influenza Vaccine-Nasal n=20 Participants Nasal administration Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route
Blood Immunoglobulin G (IgG) and Immunoglobulin A (IgA)-Antibody Secreting Cell Number to Flu Virus	8.85 cells/ml Interval 0.0 to 120.0	15.0 cells/ml Interval 0.0 to 53.8

SECONDARY outcome

Timeframe: 21 days after vaccination

Salivary Flu-specific IgA titer at Days 21 after vaccination

Outcome measures

Measure	Influenza Vaccine -Sublingual n=20 Participants Sublingual administration Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route	Influenza Vaccine-Nasal n=19 Participants Nasal administration Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route
Salivary IgA	3550 Titer Interval 1040.0 to 28800.0	3600 Titer Interval 480.0 to 27200.0

SECONDARY outcome

Timeframe: 21 days after vaccination

Interferon gamma production in peripheral blood monocyte (PBMC) after in vitro re-stimulation with influenza virus antigen at 21 days after vaccination.

Outcome measures

Measure	Influenza Vaccine -Sublingual n=20 Participants Sublingual administration Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route	Influenza Vaccine-Nasal n=20 Participants Nasal administration Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route
Cell Mediated Immune Responses	1666 pg/ml Interval 92.0 to 38599.0	1743 pg/ml Interval 4.0 to 11674.0

Adverse Events

Influenza Vaccine -Sublingual

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Influenza Vaccine-Nasal

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Influenza Vaccine -Sublingual n=20 participants at risk Sublingual administration Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route	Influenza Vaccine-Nasal n=20 participants at risk Nasal administration Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route
General disorders Rhinorrhoea	15.0% 3/20 • Number of events 3	0.00% 0/20
General disorders Fatigue	5.0% 1/20 • Number of events 1	5.0% 1/20 • Number of events 1
General disorders Mild fever	10.0% 2/20 • Number of events 2	0.00% 0/20
General disorders Cough	5.0% 1/20 • Number of events 1	0.00% 0/20
General disorders Headache	0.00% 0/20	15.0% 3/20 • Number of events 3
General disorders Pruitis	0.00% 0/20	5.0% 1/20 • Number of events 1
General disorders Constipation	0.00% 0/20	5.0% 1/20 • Number of events 1

Additional Information

Dr. Jae Seung Yang

International Vaccine Institute

Phone: 82-2-881-1198

Email: jsyang@ivi.int

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place