Trial Outcomes & Findings for Evaluating Immune Response to Seasonal FluMist in Healthy Adults (NCT NCT01673425)

NCT ID: NCT01673425

Last Updated: 2021-01-27

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

Change from baseline in antibody titer at 6 weeks

Results posted on

2021-01-27

Participant Flow

Participant milestones

Participant milestones
Measure
Experimental: Live Attenuated Influenza Vaccine
Single intervention study; all participants receive LAIV
Overall Study
STARTED
5
Overall Study
COMPLETED
4
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating Immune Response to Seasonal FluMist in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Live Attenuated Influenza Vaccine Study
n=5 Participants
This study was terminated due to poor enrollment and inconclusive nasal wash samples. No analyses were performed.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
Region of Enrollment
United States
5 participants
n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline in antibody titer at 6 weeks

Population: This study was terminated due to poor enrollment. Analyses were not conducted due to inconclusive nasal wash samples.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline in serum antibody response at 6 weeks

Outcome measures

Outcome data not reported

Adverse Events

Study Enrollment

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

Lewis Radonovich

VA National Center for Occupational Health & Infection Control

Phone: 352-376-1611

Results disclosure agreements

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