Immunogenocity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine When Administered in Children

NCT01196988

Influenza

COMPLETED PHASE3

Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age

NCT00858468

Influenza

COMPLETED PHASE1/PHASE2

Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine

NCT02222870

Influenza

COMPLETED PHASE4

Study to Evaluate Safety and Immunogenicity of Butantan Seasonal Influenza Vaccine - FLU-02-IB

NCT02819180

Influenza

COMPLETED

Safety and Immunogenicity of the 2015-2016 Formulation of Fluzone® Quadrivalent (Influenza Vaccine) Among Healthy Children

NCT02539108

Influenza

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Too see percentage of subjects with HI titer \>= 1:40, 28 days after two doses in infants and children (6 months-8 years old) and one dose in children 9-11 years old for each strain.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vaccine

Vaccine

Flubio (Influenza HA) vaccine

2 doses for infants and children (6 months - 8 years old)

1 doses for children (9-11 years old)

The vaccine will be given intramuscularly

Group Type EXPERIMENTAL

Vaccine

Intervention Type BIOLOGICAL

Flubio (Influenza HA) Vaccine

The vaccine will be given intramuscularly.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vaccine

Flubio (Influenza HA) Vaccine

The vaccine will be given intramuscularly.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Flubio

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy
* Parents have been informed properly regarding the study and signed the informed consent form
* Parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial

Exclusion Criteria

* Subjects concomitantly enrolled or scheduled to be enrolled in another trial
* Evolving mild, moderate, or severe illness, especially infectious diseases or fever (axillary temperature \>=37oC)
* Known history of allergy to egg and/or chicken protein or any other component of the vaccines
* Known history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
* Subject who has received a treatment likely to alter the immune response in the previous 4 weeks (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\>2 weeks)).
* Any abnormality or chronic disease justified by investigator that might interfere assessment of the trial objectives.
* Subjects has been immunized with influenza vaccine within 1 year
* Subjects receives any vaccination within 1 months before and after immunization of Flubio.

Minimum Eligible Age

6 Months

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes