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Trial Outcomes & Findings for Response to Influenza Vaccine During Pregnancy (NCT NCT03888989)

NCT ID: NCT03888989

Last Updated: 2025-02-17

Results Overview

HAI titer measures immune response to influenza vaccination. An HAI titer is a hemoglobin assay that correlates to protection from influenza infection; an HAI titer of 40 or greater is considered to be protective.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

2 participants

Primary outcome timeframe

Day 7 (after year 1 vaccine administration)

Results posted on

2025-02-17

Participant Flow

Participant milestones

Participant milestones
Measure
Study Phase
Participants will be given the current year's quadrivalent inactivated influenza vaccine (IIV) Quadrivalent inactivated influenza vaccine (IIV): Quadrivalent inactivated influenza vaccine (IIV), Intramuscular Injection
Overall Study
STARTED
2
Overall Study
COMPLETED
2
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Response to Influenza Vaccine During Pregnancy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Inactivated Influenza Vaccine
n=2 Participants
Participants received the annual IIV
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
29 years
n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 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
1 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
2 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Day 7 (after year 1 vaccine administration)

Population: Data were not collected for this outcome measure.

HAI titer measures immune response to influenza vaccination. An HAI titer is a hemoglobin assay that correlates to protection from influenza infection; an HAI titer of 40 or greater is considered to be protective.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline to Day 28 post year 1 vaccine administration

AEs related to IIV

Outcome measures

Outcome measures
Measure
Participants Who Received IIV
n=2 Participants
Participants who received IIV
Number of Participants With Related Adverse Events (Year 1)
0 Participants

PRIMARY outcome

Timeframe: Baseline to Day 28 post year 2 vaccine administration

AEs to IIV

Outcome measures

Outcome measures
Measure
Participants Who Received IIV
n=2 Participants
Participants who received IIV
Number of Participants With Related Adverse Events (Year 2)
0 Participants

PRIMARY outcome

Timeframe: Day 7 (Year 2)

Population: Data were not collected for this outcome measure.

HAI titer measures immune response to influenza vaccination. An HAI titer is a hemoglobin assay that correlates to protection from influenza infection; an HAI titer of 40 or greater is considered to be protective.

Outcome measures

Outcome data not reported

Adverse Events

Study Phase

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

Philip Grant

Stanford University

Phone: 650-521-3540

Results disclosure agreements

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