Clinical trial NCT01003418: Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children
Official title: Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 8 to 12 Weeks
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Influenza
Keywords: GSK2340272A
H1N1 pandemic influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-10-28
Enrollment: 8
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With Any Solicited Local or General Symptoms
timeFrame: During the 7-days post-Dose 1 period (Days 0-6)
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: During the 2-weeks post-Dose 1 period (Days 0-13)
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the 2-weeks post-Dose 1 period (Days 0-13)
Secondary outcomes:
measure: Number of Subjects With Any Solicited Local or General Symptoms
timeFrame: During the 7-days post-Dose 2 period (Days 28 + 7 days for Group 1; Month 4 + 7 days for Group 2)
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited AEs
timeFrame: During the 28-day (Days 0-27) follow-up period after each study vaccine administration
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (From Month 0 up to Month 11)
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: GSK Investigational Site
city: Hønefoss
country: Norway
facility: GSK Investigational Site
city: Lierskogen
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: