Tetanus, Poliomyelitis, Neisseria Meningitidis, Haemophilus Influenzae Type b, Diphtheria, Acellular Pertussis, Hepatitis B
Conditions
Keywords
Combined vaccine, Primary vaccination
Brief summary
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.
Interventions
BIOLOGICALGSK2202083A vaccine
Intramuscular, three doses
BIOLOGICALInfanrix hexa
Intramuscular, three doses
BIOLOGICALMenjugate
Intramuscular, two doses
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Weeks to 16 Weeks
Healthy volunteers
Yes
Inclusion criteria
* A male or female infant between, and including, 8 and 16 weeks at the time of the first vaccination. * Born after a gestation period of 36 to 42 weeks inclusive. * Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol. * Written informed consent obtained from the parent or guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs since birth. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Administration of a vaccine not foreseen by the study protocol within 30 days prior to randomisation, or planned administration from randomisation to study Visit 3, or from 30 days before to 30 days after study Visit 4, with the exception of influenza and human rotavirus vaccines. The administration of other vaccines, including conjugated pneumococcal vaccine, is allowed during the period from one day after study Visit 3 to 31 days before study Visit 4. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product * Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib and/or MenC vaccination or disease, including HBV vaccination at birth. * History of seizures or progressive neurological disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). * Major congenital defects or serious chronic illness. The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-PRP Antibody Concentrations ≥ 0.15 mg/mL | At Month 3 | As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | During the 8-day (Days 0-7) post-vaccination period following each dose and across doses | 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. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 8-day (Days 0-7) post-vaccination period following each dose and across doses | 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. |
| Number of Subjects With Unsolicited Adverse Events AE(s) | During the 31-day (Days 0-30) post-vaccination period | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (from Month 0 to Month 9) | 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. |
Countries
Slovakia
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 7 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Premature study termination | 9 | 7 |
Baseline characteristics
| Characteristic | Infanrix + Menjugate Group | Total | GSK2202083A Group |
|---|---|---|---|
| Age, Continuous | 13.9 Weeks STANDARD_DEVIATION 1.57 | 13.28 Weeks STANDARD_DEVIATION 2.02 | 12.8 Weeks STANDARD_DEVIATION 2.28 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 16 Participants | 9 Participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 9 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 7 |
| other Total, other adverse events | 5 / 9 | 5 / 7 |
| serious Total, serious adverse events | 0 / 9 | 0 / 7 |
Outcome results
Primary
Anti-PRP Antibody Concentrations ≥ 0.15 mg/mL
As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done.
Time frame: At Month 3
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
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.
Time frame: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses
Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any drowsiness, Across doses | 1 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any loss of appetite, Dose 1 | 2 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 drowsiness, Across doses | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 drowsiness, Dose 1 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related drowsiness, Across doses | 1 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 loss of appetite, Dose 1 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any irritability, Across doses | 4 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any irritability, Dose 1 | 4 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 irritability, Across doses | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related loss of appetite, Dose 1 | 2 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related irritability, Across doses | 4 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 irritability, Dose 1 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any loss of appetite, Across doses | 2 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any temperature, Dose 1 | 4 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 loss of appetite, Across doses | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any drowsiness, Dose 1 | 1 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related loss of appetite, Across doses | 2 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 temperature (>39.0°C), Dose 1 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any temperature, Across doses | 4 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related irritability, Dose 1 | 4 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 temperature (>39.0°C), Across doses | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related temperature, Dose 1 | 4 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related temperature, Across doses | 4 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related drowsiness, Dose 1 | 1 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any drowsiness, Dose 2 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 drowsiness, Dose 2 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related drowsiness, Dose 2 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any irritability, Dose 2 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 irritability, Dose 2 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related irritability, Dose 2 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any loss of appetite, Dose 2 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 loss of appetite, Dose 2 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related loss of appetite, Dose 2 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any temperature, Dose 2 | 1 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 temperature (>39.0°C), Dose 2 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related temperature, Dose 2 | 1 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related temperature, Across doses | 1 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any drowsiness, Dose 1 | 1 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 drowsiness, Dose 1 | 0 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related drowsiness, Dose 1 | 0 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 irritability, Dose 1 | 0 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related irritability, Dose 1 | 3 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any loss of appetite, Dose 1 | 1 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 loss of appetite, Dose 1 | 0 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related loss of appetite, Dose 1 | 1 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any temperature, Dose 1 | 1 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 temperature (>39.0°C), Dose 1 | 0 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related temperature, Dose 1 | 1 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any drowsiness, Across doses | 1 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 drowsiness, Across doses | 0 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related drowsiness, Across doses | 0 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any irritability, Across doses | 4 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 irritability, Across doses | 0 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related irritability, Across doses | 3 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any loss of appetite, Across doses | 1 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 loss of appetite, Across doses | 0 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related loss of appetite, Across doses | 1 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any temperature, Across doses | 1 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 temperature (>39.0°C), Across doses | 0 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any irritability, Dose 1 | 4 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
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.
Time frame: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses
Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 pain, Dose 2 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any redness, Dose 2 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 redness, Dose 2 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any swelling, Dose 2 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 swelling, Dose 2 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any pain, Across doses | 2 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any redness, Dose 1 | 4 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any redness, Across doses | 4 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 pain, Dose 1 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any swelling, Across doses | 3 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 swelling, Across doses | 1 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 redness, Dose 1 | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any pain, Dose 1 | 2 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any swelling, Dose 1 | 3 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 pain, Across doses | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 swelling, Dose 1 | 1 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 redness, Across doses | 0 Participants |
| GSK2202083A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any pain, Dose 2 | 0 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 swelling, Across doses | 1 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 redness, Across doses | 0 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any swelling, Across doses | 1 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any pain, Dose 1 | 2 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 pain, Dose 1 | 0 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any redness, Dose 1 | 4 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 redness, Dose 1 | 0 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any swelling, Dose 1 | 1 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 swelling, Dose 1 | 1 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 pain, Across doses | 0 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any redness, Across doses | 4 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any pain, Across doses | 2 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2202083A Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events AE(s)
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.
Time frame: During the 31-day (Days 0-30) post-vaccination period
Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2202083A Group | Number of Subjects With Unsolicited Adverse Events AE(s) | 2 Participants |
| Infanrix + Menjugate Group | Number of Subjects With Unsolicited Adverse Events AE(s) | 3 Participants |