Status:
COMPLETED
An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
6-35 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in child...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) can and will comply with the requirements of the protocol.
- A male or female between, and including, 6 and 35 months of age at the time of first vaccination; children are eligible regardless of history of influenza vaccination.
- Written informed consent obtained from the parent(s) /LAR(s) of the subject.
- Subjects in stable health as determined by medical history and clinical examination before entering into the study.
Exclusion
- Participation in a previous FLU-D-QIV-004 study (115345) cohort.
- Child in care.
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Prior receipt of any influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period.
- Children with underlying illness who are at risk of complications of influenza and for whom yearly (seasonal) influenza vaccination is recommended in their respective country.
- Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV), based on medical history and physical examination.
- Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/ or any blood products within 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, non-influenza vaccine comparators and latex; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous vaccination.
- Any contraindication to intramuscular injection.
- Acute disease and/or fever at the time of enrolment.
- Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
- Additional criteria for children ≥ 12 months of age:
- Prior receipt of any licensed varicella vaccine\* or any licensed hepatitis A vaccine or planned use of these vaccines during the study period. Other routine registered childhood vaccinations are permitted.
- \* For countries with varicella vaccine administered as 2-dose schedule, prior receipt of a single dose of a varicella vaccine is allowed if administered at least 2 weeks before the first study vaccination.
- Any history of hepatitis A or varicella diseases.
- Additional criteria for children 6 - 11 months of age in countries without universal mass vaccination recommendation for pneumococcal vaccine:
- Prior receipt of any pneumococcal conjugated vaccine or planned use of this vaccine during the study period. Other routine registered childhood vaccinations are permitted.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2014
Estimated Enrollment :
12046 Patients enrolled
Trial Details
Trial ID
NCT01439360
Start Date
October 1 2011
End Date
December 31 2014
Last Update
September 26 2018
Active Locations (103)
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1
GSK Investigational Site
Dhaka, Bangladesh, 1000
2
GSK Investigational Site
Antwerp, Belgium, 2018
3
GSK Investigational Site
Antwerp, Belgium, 2020
4
GSK Investigational Site
Brussels, Belgium, 1200