An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: Prevenar 13; Biological: Varilrix; Biological: Havrix Junior; Biological: Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A; Biological: Varivax/ProVarivax

Study type: Interventional

Funder types: Industry

Identifiers

NCT01439360

2011-000758-41 (EudraCT Number)

115345

Details and patient eligibility

About

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).

Enrollment: 12,046 patients

Sex: All

Ages: 6 to 35 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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12,046 participants in 2 patient groups

D-QIV

Experimental group

Description:

Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).

Treatment:

Biological: Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A

Control

Active Comparator group

Description:

In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).

Treatment:

Biological: Prevenar 13

Biological: Varivax/ProVarivax

Biological: Havrix Junior

Biological: Varilrix