Clinical trial NCT01514708: The Safety and Immune Response to Influenza Vaccination in Pregnant Women
Official title: The Safety and Immune Response to Influenza Vaccination in Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza
Vaccination
Vaccine
Pregnancy
Lead sponsor: Adimmune Corporation
Sponsor class: INDUSTRY
First posted: 2012-01-23
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Pregnant female aged ≥ 18 years old.
2. Subject is pregnant for at least 3 months, inclusive.
3. Subject is willing and able to adhere to visit schedules and all study requirements.
4. Subject has read and signed the study-specific informed consent.

Exclusion Criteria:

1. Subject with previous complicated pregnancy or preterm delivery, spontaneous or medical abortion;
2. Subject with history or concurrent high risk of dangerous gestation such as gestational diabetes mellitus (GDM), pregnant induced hypertension, or preeclampsia;
3. Subject received any influenza vaccine within the previous 6 months;
4. Subject has a history of hypersensitivity to eggs or egg protein or similar pharmacological effects to study vaccine;
5. Subject or her family has the history of Guillain-Barré Syndrome;
6. Subject has current upper respiratory illness (URI), including the common cold or nasal congestion within 72 hours;
7. 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;
8. Subject receive any treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
9. Subject has immunodeficiency or is under immunosuppressive treatment.
10. Subject received any vaccine within 1 week prior to study vaccination or expected to receive one within 1 week after study vaccination;
11. Subject received any blood products, including immunoglobulin, in the past 3 months before consent;
12. Subject has underlying condition in the investigators' opinion may interfere with evaluation of the vaccine;

Primary outcomes:
measure: 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.
timeFrame: 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:
measure: 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.
timeFrame: The safety information is collected from the day of vaccination to 8 weeks after the delivery.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
citation: 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.