Clinical trial NCT01218308: A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children
Official title: Efficacy Study of GSK Biologicals' Quadrivalent Influenza Vaccine, GSK2282512A, (FLU Q-QIV) When Administered in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-10-11
Enrollment: 5220
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to test the efficacy of an investigational influenza vaccine, in children compared to Havrix®, a licensed Hepatitis A virus vaccine.

This study will also evaluate the immunogenicity and safety of the investigational vaccine.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that they and/or their parent(s) or legally acceptable representative(s) can and will comply with the requirements of the protocol.
* A male or female child aged between 3 and 8 years inclusive at the time of the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season. However, subjects who have received any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine will not be enrolled.
* Written informed consent obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
* Written assent obtained from the subject if/as required by local regulations.
* Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
* Access to a consistent means of telephone contact

Exclusion Criteria:

* Child in care.
* Use of an investigational or non-registered product other than the study vaccines within 30 days before study vaccination or planned use during study period. Routine registered childhood vaccinations are permitted.
* Prior receipt of any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period. Prior receipt of more than one dose of a licensed hepatitis A vaccine, with the first dose administered at \>=12 months of age.
* Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
* 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.
* History of Guillain-Barre syndrome within 6 weeks of receipt of prior influenza virus vaccine.
* Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to constituent of vaccine; or a history of severe adverse reaction to a previous influenza vaccine.
* Fever at the time of enrolment.
* Acute disease at the time of enrolment.
* Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Ongoing aspirin therapy.
* Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

Primary outcomes:
measure: Number of Subjects Reporting at Least One Confirmed Occurrence of Influenza A or B.
timeFrame: From Day 14 to Day 180
Secondary outcomes:
measure: Number of Subjects Reporting at Least One Moderate to Severe Occurrence of Influenza A or B.
timeFrame: From Day 14 to Day 180
measure: Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Antigenically Matched Strain.
timeFrame: From Day 14 to Day 180
measure: Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Any Strain.
timeFrame: From Day 14 to Day 180
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
timeFrame: At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]
measure: Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
timeFrame: At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]
measure: Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
timeFrame: At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]
measure: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
timeFrame: At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]
measure: Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains
timeFrame: On Day 0 and at least 6 months after first vaccination (Month 6)
measure: Number of Seroconverted Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.
timeFrame: At least 6 months after first vaccination (Month 6)
measure: Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.
timeFrame: At Day 0 and at least 6 months after first vaccination (Month 6)
measure: Seroconversion Factors for HI Antibodies Against 4 Strains of Influenza Disease.
timeFrame: At least 6 months after first vaccination (Month 6)
measure: Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
timeFrame: During the 7-day (Days 0-6) follow-up period after any vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age.
timeFrame: During the 7-day (Days 0-6) follow-up period after any vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above.
timeFrame: During the 7-day (Days 0-6) follow-up period after any vaccination
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
timeFrame: During the 28-day (Days 0-27) follow-up period after vaccination
measure: Number of Subjects With Any and Related Medically Attended Adverse Events (MAEs).
timeFrame: During the entire study period (Day 0 - Day 180)
measure: Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs).
timeFrame: During the entire study period (Day 0 - Day 180)
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs).
timeFrame: During the entire study period (Day 0 - Day 180)
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: GSK Investigational Site
city: Santo Domingo
country: Dominican Republic
facility: GSK Investigational Site
city: Tegucigalpa
country: Honduras
facility: GSK Investigational Site
city: Beirut
country: Lebanon
facility: GSK Investigational Site
city: Panama
country: Panama
facility: GSK Investigational Site
city: Dasmariñas, Cavite
country: Philippines
facility: GSK Investigational Site
city: Muntinlupa
country: Philippines
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Adana
country: Turkey
facility: GSK Investigational Site
city: Ankara
country: Turkey
facility: GSK Investigational Site
city: Eskisehir
country: Turkey
facility: GSK Investigational Site
city: Izmir
country: Turkey
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Jain VK, Rivera L, Zaman K, Espos RA Jr, Sirivichayakul C, Quiambao BP, Rivera-Medina DM, Kerdpanich P, Ceyhan M, Dinleyici EC, Cravioto A, Yunus M, Chanthavanich P, Limkittikul K, Kurugol Z, Alhan E, Caplanusi A, Durviaux S, Boutet P, Ofori-Anyinam O, Chandrasekaran V, Dbaibo G, Innis BL. Vaccine for prevention of mild and moderate-to-severe influenza in children. N Engl J Med. 2013 Dec 26;369(26):2481-91. doi: 10.1056/NEJMoa1215817. Epub 2013 Dec 11.