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

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 8 to 12 Weeks

Conditions
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Influenza

Intervention / Treatment
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* Biological: GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine
* Biological: Infanrix™-IPV/Hib
* Biological: Prevenar


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSK2340272A Group 1<br>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. | Biological: GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine<br>* Two doses; intramuscular administration<br>Biological: Infanrix™-IPV/Hib<br>* Routine infant immunisation vaccine, three doses administered intramuscularly<br>Biological: Prevenar<br>* Routine infant immunisation vaccine, three doses administered intramuscularly<br>|
| Experimental: GSK2340272A Group 2<br>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. | Biological: GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine<br>* Two doses; intramuscular administration<br>Biological: Infanrix™-IPV/Hib<br>* Routine infant immunisation vaccine, three doses administered intramuscularly<br>Biological: Prevenar<br>* Routine infant immunisation vaccine, three doses administered intramuscularly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Any Solicited Local or General Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. | During the 7-days post-Dose 1 period (Days 0-6) | 
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities/crying that cannot be comforted. Related = AE assessed by the investigator as related to the vaccination. | During the 2-weeks post-Dose 1 period (Days 0-13) | 
| Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. | During the 2-weeks post-Dose 1 period (Days 0-13) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Any Solicited Local or General Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. | During the 7-days post-Dose 2 period (Days 28 + 7 days for Group 1; Month 4 + 7 days for Group 2) | 
| Number of Subjects With Any, Grade 3 and Related Unsolicited AEs | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited AE. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities/crying that cannot be comforted. Related = AE assessed by the investigator as related to the vaccination. Results about unsolicited AEs for this endpoint were based on individual listings. | During the 28-day (Days 0-27) follow-up period after each study vaccine administration | 
| Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Results about SAEs were based on individual listings. | During the entire study period (From Month 0 up to Month 11) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GSK2340272A, H1N1 pandemic influenza