Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 2

Conditions: Influenza

Treatments: Biological: Infanrix™-IPV/Hib; Biological: GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine; Biological: Prevenar

Study type: Interventional

Funder types: Industry

Identifiers

NCT01003418

113629

Details and patient eligibility

About

The purpose of this study is to assess the safety and immunogenicity of two doses of the H1N1 candidate vaccine administered in children aged between 8 and 12 weeks at the time of first vaccination.

Enrollment: 8 patients

Sex: All

Ages: 8 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

All subjects must satisfy ALL the following criteria at study entry:

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol
• Children, male or female, aged between 8 and 12 weeks at the time of first study vaccination.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject.
• Healthy children, as established by medical history and clinical examination when entering the study.
• Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
• Born after a gestation period of >= 36 to <= 42 weeks.

Exclusion criteria

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
• Acute disease at the time of enrolment.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
• History of any neurological disorders or seizures.
• A family history of congenital or hereditary immunodeficiency.
• Receipt of systemic glucocorticoids within one month of study enrolment, or any other cytotoxic or immunosuppressive drug since birth.
• Administration of any vaccines within two weeks before study enrolment.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study.
• Previous administration of any H1N1 vaccine, of any seasonal influenza vaccine.
• Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations.
• History of intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b disease.
• Major congenital defects or serious chronic illness.
• Child in care.
• Any known or suspected allergy to any constituent of the influenza, DTPa-IPV/Hib and pneumococcal study vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza, DTPa-IPV/Hib and pneumococcal vaccine.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

GSK2340272A Group 1

Experimental group

Description:

Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (Infanrix™-IPV/Hib) and Prevenar™ vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh.

Treatment:

Biological: GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine

Biological: Prevenar

Biological: Infanrix™-IPV/Hib

GSK2340272A Group 2

Experimental group

Description:

Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (Infanrix™-IPV/Hib) and Prevenar™ vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh.

Treatment:

Biological: GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine

Biological: Prevenar

Biological: Infanrix™-IPV/Hib