Trial Outcomes & Findings for Immunologic Response to Inactivated Vaccine for Novel H1N1 Virus (NCT NCT01023711)

NCT ID: NCT01023711

Last Updated: 2015-05-12

Results Overview

Number of participants with a 4-fold or greater increase in serum HAI antibody from pre- to 28 day post-vaccination

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 107 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2015-05-12

Participant Flow

Subjects were recruited via flyers and advertisments. Recruitment began 12/2009 and ended 10/2010. Subjects were screened via IRB approved Screening script by phone and visit as indicated.

Subjects 18-32 were required to have a serum antibody test done during screening. Their HAI antibody level needed to be less than or = to 1:8. Female subjects of childbearing potential must have a negative pregnancy test at screening.

Participant milestones

Measure	H1N1 Monovalent Influenza Vaccine 0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
Overall Study STARTED	107
Overall Study COMPLETED	107
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunologic Response to Inactivated Vaccine for Novel H1N1 Virus

Baseline characteristics by cohort

Measure	H1N1 Monovalent Influenza Vaccine n=107 Participants 0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=5 Participants
Age, Categorical >=65 years	50 Participants n=5 Participants
Age, Continuous	54.19626 years STANDARD_DEVIATION 21.47638 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants
Region of Enrollment United States	107 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: All subjects who completed Day 28 visit post vaccination were analyzed.

Number of participants with a 4-fold or greater increase in serum HAI antibody from pre- to 28 day post-vaccination

Outcome measures

Measure	H1N1 Monovalent Influenza Vaccine n=55 Participants 0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
Determination of Immune Response to Vaccination.	45 participants

SECONDARY outcome

Timeframe: 7 days

Population: Subjects who completed the 7 day diary card

Number of subjects with reactogenicity events of grade 2 or higher within 7 days of vaccination

Outcome measures

Measure	H1N1 Monovalent Influenza Vaccine n=58 Participants 0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
Assessment of the Reactogenicity Events Post Vaccination.	3 participants

Adverse Events

H1N1 Monovalent Influenza Vaccine

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	H1N1 Monovalent Influenza Vaccine n=107 participants at risk 0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
Respiratory, thoracic and mediastinal disorders UPPER RESPIRATORY INFECTION	7.5% 8/107 • Number of events 8 • Adverse events both non-serious and serious were collected from Day O (day of vaccination thru day 28. Reactogenicity events were collected on a memory aid from day 0 to day 7.
General disorders FATIGUE	2.8% 3/107 • Number of events 3 • Adverse events both non-serious and serious were collected from Day O (day of vaccination thru day 28. Reactogenicity events were collected on a memory aid from day 0 to day 7.
Respiratory, thoracic and mediastinal disorders CONGESTION	2.8% 3/107 • Number of events 4 • Adverse events both non-serious and serious were collected from Day O (day of vaccination thru day 28. Reactogenicity events were collected on a memory aid from day 0 to day 7.

Additional Information

John Treanor, M.D.

University of Rochester

Phone: 585-275-5871

Email: john_treanor@urmc.rochester.edu

Results disclosure agreements

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