Trial Outcomes & Findings for Pilot Study in Young Adults to Examine the Kinetics of Changes in the B-cell Repertoire Following TIV Immunization (NCT NCT02987374)

NCT ID: NCT02987374

Last Updated: 2017-04-21

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

Day 0 to 180 post-immunization

Results posted on

2017-04-21

Participant Flow

During spring and early summer (prior to June 30) of 2012, 11 participants were consented to participate. One participant was found to be ineligible and was therefore withdrawn prior to any interventions.

Participant milestones

Participant milestones
Measure	2011-2012 Fluzone IIV3 (IM) 2011-2012 Fluzone IIV3 NDC No 49281-011-50 2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study in Young Adults to Examine the Kinetics of Changes in the B-cell Repertoire Following TIV Immunization

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2011-2012 Fluzone IIV3 (IM) n=10 Participants 2011-2012 Fluzone IIV3 NDC No 49281-011-50 2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)
Age, Customized Between 18 and 30 years old	10 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 to 180 post-immunization

Population: 10 participants received the 2011-2012 Fluzone IIV3 vaccine

Outcome measures

Outcome measures
Measure	2011-2012 Fluzone IIV3 (IM) n=10 Participants 2011-2012 Fluzone IIV3 NDC No 49281-011-50 2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)
Number of Participants Who Received Influenza Vaccine	10 Participants

SECONDARY outcome

Timeframe: Day 0 to 180 post-immunization

Population: Number of participants with related adverse events up to 180 days post immunization

Outcome measures

Outcome measures
Measure	2011-2012 Fluzone IIV3 (IM) n=10 Participants 2011-2012 Fluzone IIV3 NDC No 49281-011-50 2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)
Number of Participants With Related Adverse Events	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day -5 to 180 post-immunization

Proteomic analysis: Identification, production, and characterization of Influenza A specific antibodies and their CDRH3 amino-acid sequences.

Outcome measures

Outcome data not reported

Adverse Events

2011-2012 Fluzone IIV3 (IM)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	2011-2012 Fluzone IIV3 (IM) n=10 participants at risk 2011-2012 Fluzone IIV3 NDC No 49281-011-50 2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)
Musculoskeletal and connective tissue disorders Low Back Pain	10.0% 1/10 • Number of events 1 • 180 days post immunization
Infections and infestations Upper respiratory infection	10.0% 1/10 • Number of events 1 • 180 days post immunization
Skin and subcutaneous tissue disorders Abrasion LT upper leg	10.0% 1/10 • Number of events 1 • 180 days post immunization

Additional Information

Dr Cornelia Dekker

Stanford University School of Medicine, Dept. of Pediatrics

Phone: 650-724-4437

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place