An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A; Havrix Junior; Prevenar 13; Varivax/ProVarivax; Varilrix
Intervention description: Intramuscular injection; Intramuscular injection administered to subjects aged 12 months or older; Intramuscular injection administered to subjects less than 12 months of age; Intramuscular injection administered to subjects more than 12 months of age; Subcutaneous injection administered to subjects more than 12 months of age
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 12046.0
Sex: All
Minimum age: 6 Months
Maximum age: 35 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine; Seasonal Flu; Efficacy; Children

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 children 6 to 35 months of age. Recruitment will encompass at least 4
      independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort
      in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a
      fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and
      subtropical countries (beginning 2014).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.