NCT01173211

A Randomized, Double-Blind Trial on the Safety and Immunogenicity of Seasonal 2010-2011 Inactivated Trivalent Influenza Vaccine in Pregnant Women

Completed Phase 2 Results posted Last updated 4 December 2014

What this trial tests

Phase 2 trial testing Trivalent inactivated influenza vaccine in Influenza in 183 participants. Completed in 1 November 2011.

Timeline

1 September 2010

Primary endpoint
1 November 2011

1 November 2011

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	183
Start date	1 September 2010
Primary completion	1 November 2011
Estimated completion	1 November 2011
Sites	5 locations across United States

Drugs / interventions tested

• Trivalent inactivated influenza vaccine — full drug profile →
• Trivalent inactivated influenza vaccine — full drug profile →
• Trivalent inactivated influenza vaccine — full drug profile →

Conditions studied

• Influenza — all drugs for Influenza →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 39, female only, with Influenza. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants Reporting Vaccine-associated Unsolicited Non-serious Adverse Events
  Time frame: Day 0 through Day 28 post vaccination
  Unsolicited non-serious adverse events were collected from participants at follow up contacts, either by phone or in clinic, through 28 days after vaccination. Association to vaccination was determined by a clinician licensed to make a medical diagnosis and listed on the site's Federal Drug Administration's Form 1572.
• Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
  Time frame: During the pregnancy and at the time of delivery
  Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.
• Number of Participants Reporting Neonatal Complications
  Time frame: At time of delivery
  Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.
• Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)
  Time frame: Day 0 through Day 180 after vaccination
  Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or requi
• Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination
  Time frame: 8 days after vaccination (Days 0-7).
  Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
• Number of Participants Reporting Solicited Quantitative Local Reactions After Vaccination
  Time frame: 8 days after vaccination (Days 0-7).
  Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety and immunogenicity of three seasonal inactivated influenza vaccines among pregnant women and antibody persistence in their infants.
   Munoz FM, Patel SM, Jackson LA, Swamy GK, et al · · 2020 · cited 22× · PMID 32571718 · DOI 10.1016/j.vaccine.2020.05.059
2. The Global Influenza Initiative recommendations for the vaccination of pregnant women against seasonal influenza.
   Macias AE, Precioso AR, Falsey AR, Global Influenza Initiative. · · 2015 · cited 22× · PMID 26256293 · DOI 10.1111/irv.12320