Trial Outcomes & Findings for Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age. (NCT NCT00871741)
NCT ID: NCT00871741
Last Updated: 2018-06-06
Results Overview
As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
At Month 3
Results posted on
2018-06-06
Participant Flow
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participant milestones
| Measure |
GSK2202083A Group
Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
|
Infanrix + Menjugate Group
Subjects in this group were to receive three doses of Infanrix hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
| Measure |
GSK2202083A Group
Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
|
Infanrix + Menjugate Group
Subjects in this group were to receive three doses of Infanrix hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
|
|---|---|---|
|
Overall Study
Premature study termination
|
9
|
7
|
Baseline Characteristics
Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.
Baseline characteristics by cohort
| Measure |
GSK2202083A Group
n=9 Participants
Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
|
Infanrix + Menjugate Group
n=7 Participants
Subjects in this group were to receive three doses of Infanrix hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.8 Weeks
STANDARD_DEVIATION 2.28 • n=5 Participants
|
13.9 Weeks
STANDARD_DEVIATION 1.57 • n=7 Participants
|
13.28 Weeks
STANDARD_DEVIATION 2.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 3As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7) post-vaccination period following each dose and across dosesPopulation: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
The solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. Subjects from Control Group did not receive the second study vaccination dose due to study termination.
Outcome measures
| Measure |
GSK2202083A Group
n=9 Participants
Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
|
Infanrix + Menjugate Group
n=7 Participants
Subjects in this group were to receive three doses of Infanrix hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any swelling, Dose 1
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any pain, Dose 1
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 pain, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any redness, Dose 1
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 redness, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 swelling, Dose 1
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any pain, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 pain, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any redness, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 redness, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any swelling, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 swelling, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any pain, Across doses
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 pain, Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any redness, Across doses
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 redness, Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any swelling, Across doses
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 swelling, Across doses
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7) post-vaccination period following each dose and across dosesPopulation: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
The solicited general symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = any general symptom irrespective of intensity grade and relationship to vaccination. Grade 3 Irritability = crying that could not be comforted/prevented normal activity. Grade 3 Drowsiness = drowsiness that prevented normal activity. Grade 3 Loss of Appetite = did not eat at all. Related = symptoms assessed by the investigator as causally related to vaccination. Subjects from Control Group did not receive the second study vaccination dose due to study termination.
Outcome measures
| Measure |
GSK2202083A Group
n=9 Participants
Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
|
Infanrix + Menjugate Group
n=7 Participants
Subjects in this group were to receive three doses of Infanrix hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 irritability, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 loss of appetite, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any temperature, Dose 1
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 temperature (>39.0°C), Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related temperature, Dose 1
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any drowsiness, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 drowsiness, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related temperature, Across doses
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related drowsiness, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any irritability, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 temperature (>39.0°C), Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 irritability, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related irritability, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any loss of appetite, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 loss of appetite, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related loss of appetite, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any temperature, Dose 2
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 temperature (>39.0°C), Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related temperature, Dose 2
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any drowsiness, Across doses
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 drowsiness, Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related drowsiness, Across doses
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any irritability, Across doses
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 irritability, Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related irritability, Across doses
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any loss of appetite, Across doses
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 loss of appetite, Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related loss of appetite, Across doses
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any temperature, Across doses
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related loss of appetite, Dose 1
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any drowsiness, Dose 1
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 drowsiness, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related drowsiness, Dose 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any irritability, Dose 1
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related irritability, Dose 1
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any loss of appetite, Dose 1
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) post-vaccination periodPopulation: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
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.
Outcome measures
| Measure |
GSK2202083A Group
n=9 Participants
Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
|
Infanrix + Menjugate Group
n=7 Participants
Subjects in this group were to receive three doses of Infanrix hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
|
|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events AE(s)
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Month 0 to Month 9)Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
GSK2202083A Group
n=9 Participants
Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
|
Infanrix + Menjugate Group
n=7 Participants
Subjects in this group were to receive three doses of Infanrix hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
Adverse Events
GSK2202083A Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Infanrix + Menjugate Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GSK2202083A Group
n=9 participants at risk
Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
|
Infanrix + Menjugate Group
n=7 participants at risk
Subjects in this group were to receive three doses of Infanrix hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
11.1%
1/9 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
14.3%
1/7 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/9 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
14.3%
1/7 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
|
General disorders
Pain
|
22.2%
2/9 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
28.6%
2/7 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
|
General disorders
Redness
|
44.4%
4/9 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
57.1%
4/7 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
|
General disorders
Swelling
|
33.3%
3/9 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
14.3%
1/7 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
|
General disorders
Drowsiness
|
11.1%
1/9 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
14.3%
1/7 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
|
General disorders
Irritability
|
44.4%
4/9 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
57.1%
4/7 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
|
General disorders
Loss of appetite
|
22.2%
2/9 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
14.3%
1/7 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
|
General disorders
Temperature
|
44.4%
4/9 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
14.3%
1/7 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
|
General disorders
Pyrexia
|
11.1%
1/9 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
0.00%
0/7 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/9 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
14.3%
1/7 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
|
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