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2010-2011 Trivalent Influenza Vaccine (TIV) in Pregnant Women

NCT01173211 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2014-12-24

Study results available
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Summary

The purpose of this study is to see how much antibody (proteins produced by the immune system that help fight infections) the body makes after getting a flu vaccine. Researchers will also look at how the body reacts to the flu vaccine and how it affects the babies of pregnant women. The study will enroll approximately 240 women ages 18-39 years, including 180 pregnant women in their second or third trimester of pregnancy (at least 14 weeks pregnant) and 60 non-pregnant women. Participants will be randomly (by chance) assigned to 1 of 3 vaccine groups. Each participant will receive one shot of a 2010-2011 flu season licensed vaccine. The vaccine will be given as an intramuscular injection (shot in the muscle) in the upper arm. Study procedures include pregnancy testing, blood draws, and memory aids. Patient participation may be up to 8 months. The information from this study will help guide researchers in developing flu vaccines for pregnant women.

Conditions

Interventions

BIOLOGICAL

Trivalent inactivated influenza vaccine

Three licensed 2010-2011 seasonal inactivated trivalent influenza vaccines. Single intramuscular 0.5 mL dose. Each vaccine is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose. Thimerosal is a preservative used in some vaccines. Fluzone, Agriflu and Fluarix do not contain thimerosal. For Fluarix, the tip cap and rubber plunger of the needleless prefilled syringes contain dry natural latex rubber.

BIOLOGICAL

Trivalent inactivated influenza vaccine

Three licensed 2010-2011 seasonal inactivated trivalent influenza vaccines. Single intramuscular 0.5 mL dose. Each vaccine is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose. Thimerosal is a preservative used in some vaccines. Fluzone, Agriflu and Fluarix do not contain thimerosal. For Fluarix, the tip cap and rubber plunger of the needleless prefilled syringes contain dry natural latex rubber..

BIOLOGICAL

Trivalent inactivated influenza vaccine

Three licensed 2010-2011 seasonal inactivated trivalent influenza vaccines. Single intramuscular 0.5 mL dose. Each vaccine is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose. Thimerosal is a preservative used in some vaccines. Fluzone®, Agriflu® and Fluarix® do not contain thimerosal. For Fluarix, the tip cap and rubber plunger of the needleless prefilled syringes contain dry natural latex rubber.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01173211 on ClinicalTrials.gov