Trial Outcomes & Findings for Immune Responses to the Flu Shot During Pregnancy (NCT NCT02148874)

NCT ID: NCT02148874

Last Updated: 2019-09-24

Results Overview

Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay

Recruitment status

COMPLETED

Target enrollment

287 participants

Primary outcome timeframe

30-days after influenza vaccination

Results posted on

2019-09-24

Participant Flow

We enrolled 287 pregnant women between October 2013 and March 2017 at The Ohio State University Wexner Medical Center. Participants were recruited through prenatal clinics at Ohio State, campus newsletters and advertisements, and community online advertisements.

Participant milestones

Participant milestones
Measure	Non-Obese Pregnant women with a pre-pregnancy BMI 18.5-29.9.	Obese Pregnant women with a pre-pregnancy BMI 30.0-50.0
Overall Study STARTED	201	86
Overall Study COMPLETED	194	84
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immune Responses to the Flu Shot During Pregnancy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-Obese n=201 Participants Pregnant women with a pre-pregnancy BMI 18.5-29.9.	Obese n=86 Participants Pregnant women with a pre-pregnancy BMI 30.0-50.0	Total n=287 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	201 Participants n=5 Participants	86 Participants n=7 Participants	287 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	201 Participants n=5 Participants	86 Participants n=7 Participants	287 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	195 Participants n=5 Participants	82 Participants n=7 Participants	277 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	38 Participants n=5 Participants	33 Participants n=7 Participants	71 Participants n=5 Participants
Race (NIH/OMB) White	150 Participants n=5 Participants	49 Participants n=7 Participants	199 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	201 participants n=5 Participants	86 participants n=7 Participants	287 participants n=5 Participants

PRIMARY outcome

Timeframe: 30-days after influenza vaccination

Population: Pregnant women with antibody titer data at 30 days post vaccination. Analyses include all women with available antibody titer data at the necessary time points.

Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay

Outcome measures

Outcome measures
Measure	Non-Obese n=188 Participants Pregnant women with a pre-pregnancy BMI 18.5-29.9.	Obese n=75 Participants Pregnant women with a pre-pregnancy BMI 30.0-50.0
Maternal HAI Antibody Titers A/H1N1 Strain	55.9 Titer Interval 43.0 to 72.5	59.8 Titer Interval 41.1 to 87.0
Maternal HAI Antibody Titers A/H3N2 Strain	78.5 Titer Interval 60.9 to 101.1	74.0 Titer Interval 48.9 to 112.1
Maternal HAI Antibody Titers B/Massachusetts Strain	17.3 Titer Interval 13.9 to 21.6	22.3 Titer Interval 15.2 to 32.8
Maternal HAI Antibody Titers B/Brisbane Strain	17.8 Titer Interval 14.4 to 22.1	20.8 Titer Interval 14.1 to 30.6

PRIMARY outcome

Timeframe: at delivery

Population: Pregnant women with antibody titer data at delivery. Analyses include all women with available antibody titer data at the necessary time points.

Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay

Outcome measures

Outcome measures
Measure	Non-Obese n=181 Participants Pregnant women with a pre-pregnancy BMI 18.5-29.9.	Obese n=79 Participants Pregnant women with a pre-pregnancy BMI 30.0-50.0
Maternal HAI Antibody Titers A/H3N2 Strain	31.6 Titer Interval 24.8 to 40.4	32.7 Titer Interval 22.3 to 47.8
Maternal HAI Antibody Titers B/Massachusetts Strain	10.3 Titer Interval 8.6 to 12.3	16.3 Titer Interval 11.9 to 22.2
Maternal HAI Antibody Titers B/Brisbane Strain	8.4 Titer Interval 7.2 to 9.9	11.4 Titer Interval 8.5 to 15.4
Maternal HAI Antibody Titers A/H1N1 Strain	23.5 Titer Interval 18.5 to 29.8	32.5 Titer Interval 22.6 to 46.8

SECONDARY outcome

Timeframe: cord blood at delivery

Population: Cord blood from participating pregnant women with cord blood data available. There was only one cord blood sample per participant in this study.

Infant influenza antibody titers from hemagglutination inhibition (HAI) assay

Outcome measures

Outcome measures
Measure	Non-Obese n=165 Participants Pregnant women with a pre-pregnancy BMI 18.5-29.9.	Obese n=69 Participants Pregnant women with a pre-pregnancy BMI 30.0-50.0
Infant HAI Antibody Titers A/H1N1 Strain	95.4 Titer Interval 78.6 to 115.7	78.4 Titer Interval 54.7 to 112.4
Infant HAI Antibody Titers A/H3N2 Strain	155.5 Titer Interval 125.2 to 192.9	118.2 Titer Interval 80.8 to 172.8
Infant HAI Antibody Titers B/Massachusetts Strain	139.0 Titer Interval 113.0 to 170.9	157.0 Titer Interval 114.1 to 215.9
Infant HAI Antibody Titers B/Brisbane Strain	128.8 Titer Interval 106.2 to 156.3	99.1 Titer Interval 68.5 to 143.3

Adverse Events

Non-Obese

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Obese

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

Lisa Christian, PhD

The Ohio State University Wexner Medical Center

Phone: 614-293-0936

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place