Trial Outcomes & Findings for Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children (NCT NCT01003418)
NCT ID: NCT01003418
Last Updated: 2019-02-15
Results Overview
Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
During the 7-days post-Dose 1 period (Days 0-6)
Results posted on
2019-02-15
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children
Baseline characteristics by cohort
| Measure |
GSK2340272A Group 1
n=5 Participants
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.
|
GSK2340272A Group 2
n=3 Participants
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.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9 Weeks
n=5 Participants
|
8 Weeks
n=7 Participants
|
8.63 Weeks
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White-Arabic/North African heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White-Caucasian/European heritage
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
GSK2340272A Group 1
n=5 Participants
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.
|
GSK2340272A Group 2
n=3 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any Solicited Local or General Symptoms
Pain
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local or General Symptoms
Redness
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local or General Symptoms
Swelling
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local or General Symptoms
Drowsiness
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any Solicited Local or General Symptoms
Fever
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local or General Symptoms
Irritability
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any Solicited Local or General Symptoms
Loss of appetite
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
GSK2340272A Group 1
n=5 Participants
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.
|
GSK2340272A Group 2
n=3 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AE(s)
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AE(s)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AE(s)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
GSK2340272A Group 1
n=5 Participants
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.
|
GSK2340272A Group 2
n=3 Participants
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.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
GSK2340272A Group 1
n=5 Participants
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.
|
GSK2340272A Group 2
n=3 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any Solicited Local or General Symptoms
Pain
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local or General Symptoms
Redness
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Solicited Local or General Symptoms
Swelling
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any Solicited Local or General Symptoms
Drowsiness
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Any Solicited Local or General Symptoms
Fever
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any Solicited Local or General Symptoms
Irritability
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any Solicited Local or General Symptoms
Loss of appetite
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During the 28-day (Days 0-27) follow-up period after each study vaccine administrationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
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.
Outcome measures
| Measure |
GSK2340272A Group 1
n=5 Participants
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.
|
GSK2340272A Group 2
n=3 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited AEs
Grade 3 AE(s)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited AEs
Related AE(s)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited AEs
Any AE(s)
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
GSK2340272A Group 1
n=5 Participants
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.
|
GSK2340272A Group 2
n=3 Participants
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.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
Adverse Events
GSK2340272A Group 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
GSK2340272A Group 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GSK2340272A Group 1
n=5 participants at risk
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.
|
GSK2340272A Group 2
n=3 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
33.3%
1/3 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal inflammation
|
20.0%
1/5 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
0.00%
0/3 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
1/5 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
33.3%
1/3 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
|
Infections and infestations
Conjunctivitis
|
20.0%
1/5 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
0.00%
0/3 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
|
General disorders
Pain
|
80.0%
4/5 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
0.00%
0/3 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
|
General disorders
Redness
|
40.0%
2/5 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
33.3%
1/3 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
|
General disorders
Swelling
|
40.0%
2/5 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
100.0%
3/3 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
|
General disorders
Drowsiness
|
100.0%
5/5 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
100.0%
3/3 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
|
General disorders
Fever
|
80.0%
4/5 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
66.7%
2/3 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
|
General disorders
Irritability
|
80.0%
4/5 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
100.0%
3/3 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
|
General disorders
Loss of appetite
|
40.0%
2/5 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
33.3%
1/3 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER