Trial Outcomes & Findings for Primary Vaccination Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Vietnam (NCT NCT01153841)
NCT ID: NCT01153841
Last Updated: 2020-01-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
Within the 31-day (Days 0-30) after each dose and across doses
Results posted on
2020-01-02
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
199
|
99
|
|
Overall Study
COMPLETED
|
193
|
99
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Primary Vaccination Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Vietnam
Baseline characteristics by cohort
| Measure |
Synflorix+Infanrix Hexa Group
n=199 Participants
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.
|
Infanrix Hexa Group
n=99 Participants
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.
|
Total
n=298 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.8 Weeks
STANDARD_DEVIATION 1.24 • n=5 Participants
|
8.7 Weeks
STANDARD_DEVIATION 1.11 • n=7 Participants
|
8.77 Weeks
STANDARD_DEVIATION 1.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within the 31-day (Days 0-30) after each dose and across dosesPopulation: 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.
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.
Outcome measures
| Measure |
Synflorix+Infanrix Hexa Group
n=197 Participants
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.
|
Infanrix Hexa Group
n=99 Participants
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.
|
|---|---|---|
|
Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)
Any symptom Dose 1
|
24 Participants
|
3 Participants
|
|
Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)
Any symptom Dose 2
|
18 Participants
|
3 Participants
|
|
Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)
Any symptom Dose 3
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)
Any symptom Across doses
|
32 Participants
|
9 Participants
|
|
Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)
General symptoms Dose 1
|
5 Participants
|
1 Participants
|
|
Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)
General symptoms Dose 2
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)
General symptoms Dose 3
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)
General symptoms Across doses
|
10 Participants
|
3 Participants
|
|
Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)
Local symptoms Dose 1
|
23 Participants
|
2 Participants
|
|
Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)
Local symptoms Dose 2
|
15 Participants
|
2 Participants
|
|
Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)
Local symptoms Dose 3
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)
Local symptoms Across doses
|
28 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dosePopulation: 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.
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.
Outcome measures
| Measure |
Synflorix+Infanrix Hexa Group
n=197 Participants
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.
|
Infanrix Hexa Group
n=99 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain Dose 3
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Pain Dose 1
|
116 Participants
|
34 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain Dose 1
|
22 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Redness Dose 1
|
48 Participants
|
13 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness Dose 1
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Swelling Dose 1
|
47 Participants
|
10 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling Dose 1
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Pain Dose 2
|
101 Participants
|
31 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain Dose 2
|
12 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Redness Dose 2
|
49 Participants
|
19 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness Dose 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Swelling Dose 2
|
44 Participants
|
12 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling Dose 2
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Pain Dose 3
|
68 Participants
|
27 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Redness Dose 3
|
38 Participants
|
12 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness Dose 3
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Swelling Dose 3
|
29 Participants
|
12 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling Dose 3
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dosePopulation: 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.
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.
Outcome measures
| Measure |
Synflorix+Infanrix Hexa Group
n=197 Participants
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.
|
Infanrix Hexa Group
n=99 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Fever Dose 3
|
63 Participants
|
12 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness Dose 1
|
75 Participants
|
19 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness Dose 1
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness Dose 1
|
60 Participants
|
15 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Fever Dose 1
|
147 Participants
|
36 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Fever Dose 1
|
142 Participants
|
34 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Irritability Dose 1
|
155 Participants
|
53 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability Dose 1
|
4 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Irritability Dose 1
|
146 Participants
|
51 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite Dose 1
|
109 Participants
|
40 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite Dose 1
|
86 Participants
|
31 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness Dose 2
|
53 Participants
|
10 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness Dose 2
|
52 Participants
|
8 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Fever Dose 2
|
108 Participants
|
16 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Fever Dose 2
|
105 Participants
|
15 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Irritability Dose 2
|
112 Participants
|
36 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability Dose 2
|
6 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Irritability Dose 2
|
110 Participants
|
32 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite Dose 2
|
94 Participants
|
25 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite Dose 2
|
90 Participants
|
23 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness Dose 3
|
25 Participants
|
5 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness Dose 3
|
21 Participants
|
4 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever Dose 3
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Fever Dose 3
|
60 Participants
|
12 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Irritability Dose 3
|
71 Participants
|
31 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability Dose 3
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Irritability Dose 3
|
69 Participants
|
29 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite Dose 3
|
67 Participants
|
21 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite Dose 3
|
60 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) follow-up period after each dosePopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
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.
Outcome measures
| Measure |
Synflorix+Infanrix Hexa Group
n=199 Participants
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.
|
Infanrix Hexa Group
n=99 Participants
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.
|
|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
|
57 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: 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.
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 |
Synflorix+Infanrix Hexa Group
n=199 Participants
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.
|
Infanrix Hexa Group
n=99 Participants
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.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
9 Participants
|
6 Participants
|
Adverse Events
Synflorix+Infanrix Hexa Group
Serious events: 9 serious events
Other events: 195 other events
Deaths: 0 deaths
Infanrix Hexa Group
Serious events: 6 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Synflorix+Infanrix Hexa Group
n=199 participants at risk
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.
|
Infanrix Hexa Group
n=99 participants at risk
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.
|
|---|---|---|
|
Vascular disorders
Kawasaki's disease
|
0.50%
1/199 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
0.00%
0/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
Blood and lymphatic system disorders
Autoimmune thrombocytopenia
|
0.50%
1/199 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
0.00%
0/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.50%
1/199 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
0.00%
0/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
Nervous system disorders
Convulsion
|
0.50%
1/199 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
0.00%
0/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
Nervous system disorders
Febrile convulsion
|
0.50%
1/199 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
0.00%
0/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.50%
1/199 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
0.00%
0/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.50%
1/199 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
2.0%
2/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.50%
1/199 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
1.0%
1/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
Infections and infestations
Bronchiolitis
|
1.0%
2/199 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
3.0%
3/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
Infections and infestations
Superinfection fungal
|
0.50%
1/199 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
2.0%
2/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
Infections and infestations
Diarrhoea infectious
|
0.50%
1/199 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
0.00%
0/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/199 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
1.0%
1/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.50%
1/199 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
0.00%
0/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/199 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
1.0%
1/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
Infections and infestations
Viral infection
|
0.00%
0/199 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
1.0%
1/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
Other adverse events
| Measure |
Synflorix+Infanrix Hexa Group
n=199 participants at risk
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.
|
Infanrix Hexa Group
n=99 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.50%
1/199 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
5.1%
5/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
General disorders
Pain
|
69.5%
137/197 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
45.5%
45/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
General disorders
Redness
|
45.7%
90/197 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
29.3%
29/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
General disorders
Swelling
|
40.6%
80/197 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
21.2%
21/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
General disorders
Drowsiness
|
48.2%
95/197 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
26.3%
26/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
General disorders
Fever (Axillary)
|
87.3%
172/197 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
50.5%
50/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
General disorders
Irritability
|
84.9%
169/199 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
63.6%
63/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
General disorders
Loss of appetite
|
71.6%
141/197 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
50.5%
50/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
Infections and infestations
Upper respiratory tract infection
|
10.1%
20/199 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
8.1%
8/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
|
Infections and infestations
Bronchiolitis
|
4.5%
9/199 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
9.1%
9/99 • Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
|
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