Influenza
Conditions
Keywords
GSK2340272A, H1N1 pandemic influenza
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.
Interventions
BIOLOGICALGSK2340272A GSK Biologicals' investigational influenza pandemic vaccine
Two doses; intramuscular administration
BIOLOGICALInfanrix™-IPV/Hib
Routine infant immunisation vaccine, three doses administered intramuscularly
BIOLOGICALPrevenar
Routine infant immunisation vaccine, three doses administered intramuscularly
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Weeks to 12 Weeks
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any Solicited Local or General Symptoms | During the 7-days post-Dose 1 period (Days 0-6) | Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 2-weeks post-Dose 1 period (Days 0-13) | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the 2-weeks post-Dose 1 period (Days 0-13) | SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any Solicited Local or General Symptoms | During the 7-days post-Dose 2 period (Days 28 + 7 days for Group 1; Month 4 + 7 days for Group 2) | Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited AEs | During the 28-day (Days 0-27) follow-up period after each study vaccine administration | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (From Month 0 up to Month 11) | 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. |
Countries
Norway
Participant flow
Recruitment details
Only 8 subjects were enrolled in the study as the study was terminated prematurely for logistic reasons, not related to safety or efficacy of the vaccine.
Pre-assignment details
Subjects who were enrolled completed the study but the lack of data due to the small enrollment number prevented any statistical analyses to be performed. No statistical analyses were performed as per planned in the protocol. All study results summarized below are based solely on individual data listings generated.
Participants by arm
| Arm | Count |
|---|---|
| GSK2340272A Group 1 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. | 5 |
| GSK2340272A Group 2 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. | 3 |
| Total | 8 |
Baseline characteristics
| Characteristic | GSK2340272A Group 2 | Total | GSK2340272A Group 1 |
|---|---|---|---|
| Age, Continuous | 8 Weeks | 8.63 Weeks | 9 Weeks |
| Race/Ethnicity, Customized White-Arabic/North African heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White-Caucasian/European heritage | 3 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 4 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 3 |
| other Total, other adverse events | 5 / 5 | 3 / 3 |
| serious Total, serious adverse events | 0 / 5 | 0 / 3 |
Outcome results
Primary
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.
Time frame: During the 2-weeks post-Dose 1 period (Days 0-13)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group 1 | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 2 Participants |
| GSK2340272A Group 1 | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 0 Participants |
| GSK2340272A Group 1 | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 0 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 2 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 0 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 0 Participants |
Primary
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.
Time frame: During the 7-days post-Dose 1 period (Days 0-6)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group 1 | Number of Subjects With Any Solicited Local or General Symptoms | Loss of appetite | 0 Participants |
| GSK2340272A Group 1 | Number of Subjects With Any Solicited Local or General Symptoms | Pain | 2 Participants |
| GSK2340272A Group 1 | Number of Subjects With Any Solicited Local or General Symptoms | Redness | 2 Participants |
| GSK2340272A Group 1 | Number of Subjects With Any Solicited Local or General Symptoms | Swelling | 2 Participants |
| GSK2340272A Group 1 | Number of Subjects With Any Solicited Local or General Symptoms | Drowsiness | 3 Participants |
| GSK2340272A Group 1 | Number of Subjects With Any Solicited Local or General Symptoms | Fever | 1 Participants |
| GSK2340272A Group 1 | Number of Subjects With Any Solicited Local or General Symptoms | Irritability | 3 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any Solicited Local or General Symptoms | Loss of appetite | 1 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any Solicited Local or General Symptoms | Drowsiness | 1 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any Solicited Local or General Symptoms | Pain | 0 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any Solicited Local or General Symptoms | Irritability | 1 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any Solicited Local or General Symptoms | Redness | 0 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any Solicited Local or General Symptoms | Fever | 0 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any Solicited Local or General Symptoms | Swelling | 0 Participants |
Primary
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.
Time frame: During the 2-weeks post-Dose 1 period (Days 0-13)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group 1 | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| GSK2340272A Group 2 | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
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.
Time frame: During the 28-day (Days 0-27) follow-up period after each study vaccine administration
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group 1 | Number of Subjects With Any, Grade 3 and Related Unsolicited AEs | Any AE(s) | 3 Participants |
| GSK2340272A Group 1 | Number of Subjects With Any, Grade 3 and Related Unsolicited AEs | Grade 3 AE(s) | 0 Participants |
| GSK2340272A Group 1 | Number of Subjects With Any, Grade 3 and Related Unsolicited AEs | Related AE(s) | 0 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any, Grade 3 and Related Unsolicited AEs | Any AE(s) | 2 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any, Grade 3 and Related Unsolicited AEs | Grade 3 AE(s) | 0 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any, Grade 3 and Related Unsolicited AEs | Related AE(s) | 0 Participants |
Secondary
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.
Time frame: During the 7-days post-Dose 2 period (Days 28 + 7 days for Group 1; Month 4 + 7 days for Group 2)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group 1 | Number of Subjects With Any Solicited Local or General Symptoms | Redness | 1 Participants |
| GSK2340272A Group 1 | Number of Subjects With Any Solicited Local or General Symptoms | Drowsiness | 5 Participants |
| GSK2340272A Group 1 | Number of Subjects With Any Solicited Local or General Symptoms | Pain | 3 Participants |
| GSK2340272A Group 1 | Number of Subjects With Any Solicited Local or General Symptoms | Fever | 3 Participants |
| GSK2340272A Group 1 | Number of Subjects With Any Solicited Local or General Symptoms | Swelling | 2 Participants |
| GSK2340272A Group 1 | Number of Subjects With Any Solicited Local or General Symptoms | Irritability | 3 Participants |
| GSK2340272A Group 1 | Number of Subjects With Any Solicited Local or General Symptoms | Loss of appetite | 2 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any Solicited Local or General Symptoms | Irritability | 2 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any Solicited Local or General Symptoms | Loss of appetite | 1 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any Solicited Local or General Symptoms | Pain | 0 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any Solicited Local or General Symptoms | Redness | 1 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any Solicited Local or General Symptoms | Swelling | 3 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any Solicited Local or General Symptoms | Drowsiness | 3 Participants |
| GSK2340272A Group 2 | Number of Subjects With Any Solicited Local or General Symptoms | Fever | 2 Participants |
Secondary
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.
Time frame: During the entire study period (From Month 0 up to Month 11)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group 1 | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| GSK2340272A Group 2 | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |