InfluenzaPhase 4NCT01514708

The Safety and Immune Response to Influenza Vaccination in Pregnant Women

A Phase 4 study testing AdimFlu-S Influenza Vaccine in people with Influenza, run by Adimmune Corporation at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: AdimFlu-S Influenza Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteTaiwan
Study dates: Nov 2011to Aug 2012
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 12Show fewer

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;

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

National Taiwan University Hospital
Taipei, 100

Other trials in Taiwan

About this study

Conditions: Influenza
Being tested: AdimFlu-S Influenza Vaccine
Keywords: Influenza, Vaccination, Vaccine, Pregnancy
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AdimFlu-S Influenza VaccineBiological
Suspension for injection

Study groups in NCT01514708
Study group	Role	What they receive
AdimFlu-S Influenza Vaccine, 0.5mL/dose, receive 1 dose	Experimental	Not described Receives: Biological: AdimFlu-S Influenza Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Safety outcomes include immediate reactions at the time of vaccination, solicited local and systemic reactions for 7 days, unsolicited adverse events until the first post-vaccination serum collected (Day 28), and serious adverse events and adverse events of special interest until 8 weeks after the delivery.
Measured: The safety information is collected from the day of vaccination to 8 weeks after the delivery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Aug 2012

First posted23 Jan 2012 (estimated)
Study startNov 2011
Primary completionJun 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01514708
Sponsor's protocol ID: FLU11T12P
Status last verified: Dec 2012
First submitted: 18 Jan 2012
Last updated: 16 Jul 2018
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 23762229

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Safety and Immune Response to Influenza Vaccination in Pregnant Women
ClinicalTrials.gov ID: NCT01514708
Acronym / sponsor ID: FLU11T12P
Conditions: Influenza
Keywords: Influenza, Vaccination, Vaccine, Pregnancy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Adimmune CorporationIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Jun 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 23 Jan 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AdimFlu-S Influenza Vaccine, 0.5mL/dose, receive 1 dose	Experimental	Biological: AdimFlu-S Influenza Vaccine

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (12 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AdimFlu-S Influenza VaccineSuspension for injection	Biological	AdimFlu-S Influenza Vaccine, 0.5mL/dose, receive 1 dose

Primary outcome

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.
Time frame: 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.
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.

1 secondary outcome

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.
Time frame: The safety information is collected from the day of vaccination to 8 weeks after the delivery.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
Derived from this study: PubMed 23762229Lin 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.

Related trials for Influenza

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing AdimFlu-S Influenza Vaccine in people with Influenza, run by Adimmune Corporation at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01514708, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018.