The Safety and Immune Response to Influenza Vaccination in Pregnant Women
1 other identifier
interventional
46
1 country
1
Brief Summary
The purpose of this study is to evaluate the antibody response to the influenza vaccine (AdimFlu-S), as measured by hemagglutination inhibition (HAI) at 4 weeks post immunization in pregnant women in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96). Besides, the vaccine safety will also be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 18, 2012
CompletedFirst Posted
Study publicly available on registry
January 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedJuly 16, 2018
December 1, 2012
7 months
January 18, 2012
July 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 1:40. The other immunogenicity endpoints include seroconversion rate and geometric mean folds increase in HAI titer.
The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 1:40. The other immunogenicity endpoints include seroconversion rate and geometric mean folds increase in HAI titer. Immunogenicity profile will be assessed before vaccination, 4 weeks after the vaccination and at the end of gestation period.
Immunogenicity profile was assessed before vaccination, 4 weeks after the vaccination and at the end of gestation period. Moreover, the HAI titer of the cord blood was also measured and compared with the maternal blood sample.
Secondary Outcomes (1)
The secondary endpoint is to evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S.
The safety information is collected from the day of vaccination to 8 weeks after the delivery.
Study Arms (1)
AdimFlu-S Influenza Vaccine, 0.5mL/dose, receive 1 dose
EXPERIMENTALInterventions
Suspension for injection
Eligibility Criteria
You may qualify if:
- Pregnant female aged ≥ 18 years old.
- Subject is pregnant for at least 3 months, inclusive.
- Subject is willing and able to adhere to visit schedules and all study requirements.
- Subject has read and signed the study-specific informed consent.
You may not qualify if:
- Subject with previous complicated pregnancy or preterm delivery, spontaneous or medical abortion;
- Subject with history or concurrent high risk of dangerous gestation such as gestational diabetes mellitus (GDM), pregnant induced hypertension, or preeclampsia;
- Subject received any influenza vaccine within the previous 6 months;
- Subject has a history of hypersensitivity to eggs or egg protein or similar pharmacological effects to study vaccine;
- Subject or her family has the history of Guillain-Barré Syndrome;
- Subject has current upper respiratory illness (URI), including the common cold or nasal congestion within 72 hours;
- Subject with influenza-like illness as defined by the presence of fever (temperature over 38ºC) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
- Subject receive any treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
- Subject has immunodeficiency or is under immunosuppressive treatment.
- Subject received any vaccine within 1 week prior to study vaccination or expected to receive one within 1 week after study vaccination;
- Subject received any blood products, including immunoglobulin, in the past 3 months before consent;
- Subject has underlying condition in the investigators' opinion may interfere with evaluation of the vaccine;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
Related Publications (1)
Lin SY, Wu ET, Lin CH, Shyu MK, Lee CN. The safety and immunogenicity of trivalent inactivated influenza vaccination: a study of maternal-cord blood pairs in Taiwan. PLoS One. 2013 Jun 6;8(6):e62983. doi: 10.1371/journal.pone.0062983. Print 2013.
PMID: 23762229DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2012
First Posted
January 23, 2012
Study Start
November 1, 2011
Primary Completion
June 1, 2012
Study Completion
August 1, 2012
Last Updated
July 16, 2018
Record last verified: 2012-12