Status:
COMPLETED
A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and Children
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
6-49 years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to demonstrate the acceptable safety profile and the immunological non-inferiority of the FLU D-QIV vaccine manufactured with this investigational process (FLU D-QIV Inves...
Detailed Description
This study will enroll 3 age cohorts: Adults: 18-49 years, Children: 3-17 years and 6-35 months of age.
Eligibility Criteria
Inclusion
- Adults 18-49 years cohort:
- A male or female between, and including, 18 and 49 years of age at the time of vaccination.
- Subjects who the investigator believes that they/their parent(s)/Legally Acceptable Representatives (LAR(s)) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject/parent(s)/LAR(s) of the subject.
- Written informed assent obtained from the subject if/as required by local regulations.
- Healthy subjects or those with chronic well-controlled disease as established by medical history and clinical examination before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy.
- Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception for 2 months after vaccination.
- Pediatric cohort:
- United States:
- • A male or female subject between, and including, the ages of 3 and 17 years in the United States.
- Rest of the World:
- • A male or female subject between, and including, the ages of 6 months to 17 years all countries with the exception of the United States.
- All participating countries:
- Subjects who the investigator believes that they/their parent(s)/Legally Acceptable Representatives (LAR(s)) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject/parent(s)/LAR(s) of the subject.
- Written informed assent obtained from the subject if/as required by local regulations.
- Healthy subjects or those with chronic well-controlled disease as established by medical history and clinical examination before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy.
- Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion
- Adults aged 18-49 years cohort:
- Child in care.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical or device).
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
- Administration of an influenza vaccine during the 6 months preceding entry into the study.
- Administration of a vaccine not foreseen by the study protocol within 30 days before vaccination or planned administration during the study period.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- Acute or un-controlled, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
- Any history of Guillain-Barré Syndrome.
- Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥ 38.0ºC/100.4ºF.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of chronic alcohol consumption and/or drug abuse.
- Any contra-indication to intramuscular administration of influenza vaccines.
- Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- Pediatric cohort
- Child in care.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical or device).
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccination dose. Inhaled and topical steroids are allowed.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
- Administration of an influenza vaccine during the 6 months preceding entry into the study.
- Administration of a vaccine not foreseen by the study protocol within 30 days before vaccination or planned administration during the study period.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- Acute or un-controlled, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
- Any history of Guillain-Barré Syndrome.
- Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥ 38.0ºC/100.4ºF.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of chronic alcohol consumption and/or drug abuse.
- Any contra-indication to intramuscular administration of influenza vaccines.
- Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Key Trial Info
Start Date :
August 18 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2015
Estimated Enrollment :
1886 Patients enrolled
Trial Details
Trial ID
NCT02207413
Start Date
August 18 2014
End Date
April 18 2015
Last Update
June 6 2018
Active Locations (53)
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1
GSK Investigational Site
Wichita, Kansas, United States, 67207
2
GSK Investigational Site
Rochester, New York, United States, 14609
3
GSK Investigational Site
Warwick, Rhode Island, United States, 02886
4
GSK Investigational Site
Nashville, Tennessee, United States, 37203