Trial Outcomes & Findings for Study of Live, Attenuated Influenza Vaccination in Preterm and Full-Term Infants (NCT NCT01194297)

Results Overview

Hemagglutinin specific antibody, as measured by hemagglutination inhibition

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

3 participants

Primary outcome timeframe

28-42 days

Results posted on

2014-08-22

Participant Flow

Subjects recruited during influenza season 2010-2011

No significant pre-assignment details

Participant milestones

Participant milestones
Measure	Inactivated Influenza Vaccine One dose of inactivated influenza vaccine, according to routine immunization recommendations Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations	Live Attenuated Influenza Vaccine One dose of live attenuated influenza vaccine, according to routine immunization recommendations Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations
Overall Study STARTED	2	1
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Live, Attenuated Influenza Vaccination in Preterm and Full-Term Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inactivated Influenza Vaccine n=2 Participants One dose of inactivated influenza vaccine, according to routine immunization recommendations Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations	Live Attenuated Influenza Vaccine n=1 Participants One dose of live attenuated influenza vaccine, according to routine immunization recommendations Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 28-42 days

Hemagglutinin specific antibody, as measured by hemagglutination inhibition

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 42 days

Population: Total N

Wheezing that triggers a visit for medical care

Outcome measures

Outcome measures
Measure	Inactivated Influenza Vaccine n=2 Participants One dose of inactivated influenza vaccine, according to routine immunization recommendations Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations	Live Attenuated Influenza Vaccine n=1 Participants One dose of live attenuated influenza vaccine, according to routine immunization recommendations Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations
Medically-attended Wheezing wheezing	0 participants	0 participants
Medically-attended Wheezing medical care	0 participants	0 participants

Adverse Events

Inactivated Influenza Vaccine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Live Attenuated Influenza Vaccine

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

Dr. Carl D'Angio

University of Rochester

Phone: 585-275-2972

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place