Infections, Streptococcal, Streptococcus Pneumoniae Vaccines
Conditions
Keywords
Pneumococcal vaccine
Brief summary
The purpose of the study is to evaluate the safety and reactogenicity of Synflorix™ (GSK 1024850A) given as a 3-dose primary immunization course when co-administered with Infanrix hexa™ vaccine at 2, 3 and 4 months of age in infants in Vietnam.
Interventions
BIOLOGICALSynflorix™( GSK1024850A)
Intramuscular, 3 doses
BIOLOGICALInfanrix hexa™
Intramuscular, 3 doses
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination. * Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * Written and signed or thumb-printed informed consent obtained from the parent(s)/LAR of the child. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness. * Free of obvious health problems 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. * 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. * Acute disease and/or fever at the time of enrolment. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * History of chronic condition(s) requiring treatment such as cancer or autoimmune disease. * Hypersensitivity to latex. * Previous vaccination against diphtheria, tetanus, pertussis, Hemophilus influenzae type b and/or Streptococcus pneumoniae. Locally recommended EPI vaccines to be given at birth are allowed, but should be administered at least one month before the first dose of the study vaccine is administered. Other locally recommended vaccines are allowed, even if concomitantly administered with the study vaccines, but should be documented in the eCRF.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | Within the 31-day (Days 0-30) after each dose and across doses | The incidence and nature of Grade 3 symptoms (solicited and unsolicited) reported during the 31-day post-vaccination period following each dose and across doses are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | During the 4-day (Days 0-3) post-vaccination period following each dose | Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Days 0-3) post-vaccination period following each dose | Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (\>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Any is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) follow-up period after each dose | An unsolicited AE is 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. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | After the first vaccination up to study end (From Month 0 to Month 3) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
Countries
Vietnam
Participant flow
Pre-assignment details
300 subjects were enrolled in this study. 2 subjects among the 101 subjects in the Infanrix Hexa Group were not vaccinated due to consent withdrawal.
Participants by arm
| Arm | Count |
|---|---|
| Synflorix+Infanrix Hexa Group Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age. | 199 |
| Infanrix Hexa Group Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age. | 99 |
| Total | 298 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Synflorix+Infanrix Hexa Group | Infanrix Hexa Group | Total |
|---|---|---|---|
| Age, Continuous | 8.8 Weeks STANDARD_DEVIATION 1.24 | 8.7 Weeks STANDARD_DEVIATION 1.11 | 8.77 Weeks STANDARD_DEVIATION 1.2 |
| Sex: Female, Male Female | 93 Participants | 37 Participants | 130 Participants |
| Sex: Female, Male Male | 106 Participants | 62 Participants | 168 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 195 / 199 | 91 / 99 |
| serious Total, serious adverse events | 9 / 199 | 6 / 99 |
Outcome results
Primary
Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)
The incidence and nature of Grade 3 symptoms (solicited and unsolicited) reported during the 31-day post-vaccination period following each dose and across doses are presented.
Time frame: Within the 31-day (Days 0-30) after each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with the symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix+Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | Any symptom Dose 2 | 18 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | General symptoms Dose 3 | 1 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | Any symptom Across doses | 32 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | General symptoms Across doses | 10 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | Local symptoms Dose 1 | 23 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | Any symptom Dose 1 | 24 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | Local symptoms Dose 2 | 15 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | General symptoms Dose 1 | 5 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | Local symptoms Dose 3 | 5 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | Any symptom Dose 3 | 6 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | Local symptoms Across doses | 28 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | General symptoms Dose 2 | 7 Participants |
| Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | Local symptoms Across doses | 6 Participants |
| Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | Any symptom Dose 1 | 3 Participants |
| Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | Any symptom Dose 2 | 3 Participants |
| Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | Any symptom Dose 3 | 3 Participants |
| Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | Any symptom Across doses | 9 Participants |
| Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | General symptoms Dose 1 | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | General symptoms Dose 2 | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | General symptoms Dose 3 | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | Local symptoms Dose 1 | 2 Participants |
| Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | Local symptoms Dose 2 | 2 Participants |
| Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | Local symptoms Dose 3 | 2 Participants |
| Infanrix Hexa Group | Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | General symptoms Across doses | 3 Participants |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity.
Time frame: During the 4-day (Days 0-3) post-vaccination period following each dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with the symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 2 | 44 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 1 | 48 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 3 | 4 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 1 | 3 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 2 | 1 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 1 | 3 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 3 | 38 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 2 | 101 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 2 | 49 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 2 | 12 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 1 | 116 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 2 | 2 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 3 | 1 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 3 | 68 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 3 | 29 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 1 | 22 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 3 | 2 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 1 | 47 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 3 | 1 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 1 | 10 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 2 | 19 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 2 | 0 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 2 | 12 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 2 | 0 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 3 | 27 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 3 | 0 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 3 | 12 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 1 | 34 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 1 | 1 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 1 | 13 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 1 | 0 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 1 | 1 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 2 | 31 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 2 | 2 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 3 | 1 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 3 | 12 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (\>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Any is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period following each dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with the symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Dose 1 | 142 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Dose 2 | 110 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 1 | 0 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 2 | 94 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 1 | 147 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 2 | 0 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 1 | 86 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 2 | 90 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Dose 1 | 155 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 3 | 25 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 2 | 53 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 3 | 0 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 1 | 60 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 3 | 21 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Dose 1 | 4 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 3 | 63 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 2 | 52 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Dose 3 | 0 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Dose 1 | 0 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Dose 3 | 60 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 2 | 108 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Dose 3 | 71 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Dose 1 | 146 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Dose 3 | 1 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Dose 2 | 0 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Dose 3 | 69 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 1 | 3 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 3 | 67 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Dose 2 | 105 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 3 | 0 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 1 | 75 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 2 | 0 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 1 | 109 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Dose 2 | 112 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 3 | 60 Participants |
| Synflorix+Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Dose 2 | 6 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 3 | 19 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 1 | 0 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 1 | 15 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 1 | 36 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Dose 1 | 0 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Dose 1 | 34 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Dose 1 | 53 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Dose 1 | 1 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Dose 1 | 51 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 1 | 40 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 1 | 0 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 1 | 31 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 2 | 10 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 2 | 0 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 2 | 8 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 2 | 16 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Dose 2 | 0 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Dose 2 | 15 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Dose 2 | 0 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Dose 2 | 32 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 2 | 25 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 2 | 0 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 2 | 23 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 3 | 5 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 3 | 0 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 3 | 4 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 3 | 12 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Dose 3 | 1 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Dose 3 | 12 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Dose 3 | 31 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Dose 3 | 0 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Dose 3 | 29 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 3 | 21 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Dose 2 | 36 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 3 | 0 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 1 | 19 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
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: After the first vaccination up to study end (From Month 0 to Month 3)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix+Infanrix Hexa Group | Number of Subjects With Serious Adverse Events (SAEs) | 9 Participants |
| Infanrix Hexa Group | Number of Subjects With Serious Adverse Events (SAEs) | 6 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE is 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. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Time frame: During the 31-day (Days 0-30) follow-up period after each dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix+Infanrix Hexa Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 57 Participants |
| Infanrix Hexa Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 37 Participants |