Trial Outcomes & Findings for Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age (NCT NCT00197002)
NCT ID: NCT00197002
Last Updated: 2018-08-06
Results Overview
Cut-off values assessed were greater than or equal to (≥) 15 milli-international units per milliliter (mIU/mL) in the sera of subjects seronegative before vaccination.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
521 participants
Primary outcome timeframe
At one month after Dose 2 of Havrix® vaccine (Month 7-10)
Results posted on
2018-08-06
Participant Flow
Out of a total of 521 subjects enrolled, 88 subjects were not administered a study vaccine dose and thus were not considered to have started the study.
Participant milestones
| Measure |
Havrix Group
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
|
Havrix+Prevnar Group
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
|
Prevnar Havrix Group
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
|
|---|---|---|---|
|
Overall Study
STARTED
|
147
|
137
|
149
|
|
Overall Study
COMPLETED
|
125
|
119
|
132
|
|
Overall Study
NOT COMPLETED
|
22
|
18
|
17
|
Reasons for withdrawal
| Measure |
Havrix Group
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
|
Havrix+Prevnar Group
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
|
Prevnar Havrix Group
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
9
|
5
|
7
|
|
Overall Study
Migrated/moved from study area
|
3
|
5
|
1
|
|
Overall Study
Lost to follow-up (incompl. vaccination)
|
4
|
4
|
5
|
|
Overall Study
Lost to follow-up (compl. vaccination)
|
2
|
2
|
1
|
|
Overall Study
Others
|
3
|
1
|
1
|
Baseline Characteristics
Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age
Baseline characteristics by cohort
| Measure |
Havrix Group
n=147 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
|
Havrix+Prevnar Group
n=137 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
|
Prevnar Havrix Group
n=149 Participants
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
|
Total
n=433 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
15.0 Months
STANDARD_DEVIATION 0.16 • n=5 Participants
|
15.0 Months
STANDARD_DEVIATION 0.09 • n=7 Participants
|
15.0 Months
STANDARD_DEVIATION 0.24 • n=5 Participants
|
15.0 Months
STANDARD_DEVIATION 0.18 • n=4 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
222 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
211 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At one month after Dose 2 of Havrix® vaccine (Month 7-10)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.
Cut-off values assessed were greater than or equal to (≥) 15 milli-international units per milliliter (mIU/mL) in the sera of subjects seronegative before vaccination.
Outcome measures
| Measure |
Havrix Group
n=106 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
|
Havrix+Prevnar Group
n=94 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
|
Prevnar Havrix Group
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
|
|---|---|---|---|
|
Number of Seropositive Subjects for Anti-HAV Antibodies
|
106 Participants
|
94 Participants
|
—
|
PRIMARY outcome
Timeframe: At one month after Dose 2 of Havrix® vaccine (Month 7-10)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.
Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
Havrix Group
n=106 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
|
Havrix+Prevnar Group
n=94 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
|
Prevnar Havrix Group
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
|
|---|---|---|---|
|
Concentrations for Anti-HAV Antibodies
|
1609.9 mIU/mL
Interval 1254.9 to 2065.3
|
1526.4 mIU/mL
Interval 1196.2 to 1947.8
|
—
|
SECONDARY outcome
Timeframe: At one month after Prevnar™ vaccination (Day 30)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.
Antibody concentrations against pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL).
Outcome measures
| Measure |
Havrix Group
n=102 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
|
Havrix+Prevnar Group
n=117 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
|
Prevnar Havrix Group
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
|
|---|---|---|---|
|
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations
Anti-4
|
3.3 μg/mL
Interval 2.8 to 3.9
|
3.1 μg/mL
Interval 2.6 to 3.7
|
—
|
|
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations
Anti-6B
|
7.1 μg/mL
Interval 5.8 to 8.6
|
6.1 μg/mL
Interval 4.8 to 7.6
|
—
|
|
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations
Anti-9V
|
6.8 μg/mL
Interval 5.8 to 7.9
|
7.4 μg/mL
Interval 6.3 to 8.8
|
—
|
|
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations
Anti-14
|
9.8 μg/mL
Interval 8.3 to 11.7
|
11.2 μg/mL
Interval 9.5 to 13.2
|
—
|
|
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations
Anti-23F
|
9.0 μg/mL
Interval 7.4 to 11.0
|
7.9 μg/mL
Interval 6.4 to 9.7
|
—
|
|
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations
Anti-18C
|
5.8 μg/mL
Interval 5.0 to 6.8
|
5.7 μg/mL
Interval 4.7 to 7.0
|
—
|
|
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations
Anti-19F
|
2.8 μg/mL
Interval 2.3 to 3.2
|
2.6 μg/mL
Interval 2.2 to 3.1
|
—
|
SECONDARY outcome
Timeframe: At one month after Prevnar™ vaccination (Day 30)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.
The immune response was defined, with respect to anti-pneumococcal response rates, as an antibody concentration equal to or above (≥) 0.05 μg/mL.
Outcome measures
| Measure |
Havrix Group
n=102 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
|
Havrix+Prevnar Group
n=117 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
|
Prevnar Havrix Group
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
|
|---|---|---|---|
|
Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
Anti-4
|
102 Participants
|
115 Participants
|
—
|
|
Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
Anti-23F
|
100 Participants
|
115 Participants
|
—
|
|
Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
Anti-6B
|
100 Participants
|
115 Participants
|
—
|
|
Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
Anti-9V
|
101 Participants
|
116 Participants
|
—
|
|
Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
Anti-14
|
101 Participants
|
116 Participants
|
—
|
|
Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
Anti-18C
|
101 Participants
|
114 Participants
|
—
|
|
Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
Anti-19F
|
101 Participants
|
116 Participants
|
—
|
SECONDARY outcome
Timeframe: At one month after Dose 1 of Havrix® vaccine (Day 30)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.
Cut-off values assessed were greater than or equal to (≥) 15 mIU/mL in the sera of subjects seronegative before vaccination.
Outcome measures
| Measure |
Havrix Group
n=119 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
|
Havrix+Prevnar Group
n=103 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
|
Prevnar Havrix Group
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
|
|---|---|---|---|
|
Number of Seropositive Subjects for Anti-HAV Antibodies
|
100 Participants
|
91 Participants
|
—
|
SECONDARY outcome
Timeframe: At one month after Dose 1 of Havrix® vaccine (Day 30)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.
Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli international units per milliliter (mIU/mL).
Outcome measures
| Measure |
Havrix Group
n=119 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
|
Havrix+Prevnar Group
n=103 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
|
Prevnar Havrix Group
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
|
|---|---|---|---|
|
Concentrations for Anti-HAV Antibodies
|
48.0 mIU/mL
Interval 39.4 to 58.5
|
61.0 mIU/mL
Interval 49.3 to 75.4
|
—
|
SECONDARY outcome
Timeframe: At one month after Dose 2 of Havrix® vaccine (Month 8-11)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.
Cut-off values assessed were greater than or equal to (≥) 15 mIU/mL in the sera of subjects seronegative before vaccination.
Outcome measures
| Measure |
Havrix Group
n=115 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
|
Havrix+Prevnar Group
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
|
Prevnar Havrix Group
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
|
|---|---|---|---|
|
Number of Seropositive Subjects for Anti-HAV Antibodies
|
113 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At one month after Dose 2 of Havrix® vaccine (Month 8-11)Population: The analysis was performed on the ATP Cohort for Immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.
Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli international units per milliliter (mIU/mL).
Outcome measures
| Measure |
Havrix Group
n=115 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
|
Havrix+Prevnar Group
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
|
Prevnar Havrix Group
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
|
|---|---|---|---|
|
Concentrations for Anti-HAV Antibodies
|
1391.2 mIU/mL
Interval 1092.5 to 1771.4
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after Dose 2 of Havrix® vaccine (Month 7-10/8-10)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.
The vaccine response was defined as: 1. a detectable anti-HAV antibody concentration one month after Dose 2 in subjects who were initially seronegative (antibody concentrations \< 15 mIU/mL for anti-HAV); or 2. a 2-fold increase above the pre-vaccination concentration one month after Dose 2 in subjects who were initially seropositive (antibody concentrations ≥ 15 mIU/mL for anti-HAV).
Outcome measures
| Measure |
Havrix Group
n=102 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
|
Havrix+Prevnar Group
n=90 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
|
Prevnar Havrix Group
n=112 Participants
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
|
|---|---|---|---|
|
Number of Subjects With Vaccine Response to Anti-HAV Antibodies
|
102 Participants
|
89 Participants
|
110 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless 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.
Outcome measures
| Measure |
Havrix Group
n=141 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
|
Havrix+Prevnar Group
n=133 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
|
Prevnar Havrix Group
n=142 Participants
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
|
|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1
|
39 Participants
|
48 Participants
|
61 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
0 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
|
34 Participants
|
34 Participants
|
35 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 3
|
NA Participants
No Dose 3 was administered to this group.
|
NA Participants
No Dose 3 was administered to this group.
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 3
|
NA Participants
No Dose 3 was administered to this group.
|
NA Participants
No Dose 3 was administered to this group.
|
32 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 3
|
NA Participants
No Dose 3 was administered to this group.
|
NA Participants
No Dose 3 was administered to this group.
|
16 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across Doses
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Across Doses
|
45 Participants
|
64 Participants
|
78 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1
|
31 Participants
|
54 Participants
|
64 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
0 Participants
|
7 Participants
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
|
9 Participants
|
39 Participants
|
38 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2
|
30 Participants
|
28 Participants
|
37 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
|
12 Participants
|
18 Participants
|
17 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 3
|
NA Participants
No Dose 3 was administered to this group.
|
NA Participants
No Dose 3 was administered to this group.
|
29 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 3
|
NA Participants
No Dose 3 was administered to this group.
|
NA Participants
No Dose 3 was administered to this group.
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 3
|
NA Participants
No Dose 3 was administered to this group.
|
NA Participants
No Dose 3 was administered to this group.
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Across Doses
|
57 Participants
|
62 Participants
|
76 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Across Doses
|
0 Participants
|
8 Participants
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Across Doses
|
19 Participants
|
47 Participants
|
48 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across Doses
|
0 Participants
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.
Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Havrix Group
n=141 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
|
Havrix+Prevnar Group
n=133 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
|
Prevnar Havrix Group
n=142 Participants
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
|
|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 1
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 1
|
34 Participants
|
34 Participants
|
39 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 1
|
44 Participants
|
44 Participants
|
50 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 1
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 1
|
31 Participants
|
24 Participants
|
27 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 2
|
16 Participants
|
25 Participants
|
25 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 2
|
26 Participants
|
34 Participants
|
40 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 2
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 2
|
14 Participants
|
17 Participants
|
21 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 3
|
NA Participants
No Dose 3 was administered to this group.
|
NA Participants
No Dose 3 was administered to this group.
|
18 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 3
|
NA Participants
No Dose 3 was administered to this group.
|
NA Participants
No Dose 3 was administered to this group.
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Across
|
20 Participants
|
17 Participants
|
26 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Across
|
60 Participants
|
65 Participants
|
82 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Across
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Across
|
37 Participants
|
36 Participants
|
49 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 1
|
40 Participants
|
35 Participants
|
45 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 1
|
12 Participants
|
19 Participants
|
23 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 1
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 1
|
11 Participants
|
11 Participants
|
18 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 1
|
48 Participants
|
47 Participants
|
58 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 1
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 1
|
36 Participants
|
33 Participants
|
35 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 2
|
18 Participants
|
27 Participants
|
28 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 2
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 2
|
12 Participants
|
7 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 2
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 2
|
12 Participants
|
6 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 2
|
28 Participants
|
36 Participants
|
42 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 2
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 2
|
15 Participants
|
20 Participants
|
24 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 3
|
NA Participants
No Dose 3 was administered to this group.
|
NA Participants
No Dose 3 was administered to this group.
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 3
|
NA Participants
No Dose 3 was administered to this group.
|
NA Participants
No Dose 3 was administered to this group.
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 3
|
NA Participants
No Dose 3 was administered to this group.
|
NA Participants
No Dose 3 was administered to this group.
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 3
|
NA Participants
No Dose 3 was administered to this group.
|
NA Participants
No Dose 3 was administered to this group.
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 3
|
NA Participants
No Dose 3 was administered to this group.
|
NA Participants
No Dose 3 was administered to this group.
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 3
|
NA Participants
No Dose 3 was administered to this group.
|
NA Participants
No Dose 3 was administered to this group.
|
27 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 3
|
NA Participants
No Dose 3 was administered to this group.
|
NA Participants
No Dose 3 was administered to this group.
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 3
|
NA Participants
No Dose 3 was administered to this group.
|
NA Participants
No Dose 3 was administered to this group.
|
27 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 3
|
NA Participants
No Dose 3 was administered to this group.
|
NA Participants
No Dose 3 was administered to this group.
|
16 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 3
|
NA Participants
No Dose 3 was administered to this group.
|
NA Participants
No Dose 3 was administered to this group.
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Across
|
48 Participants
|
49 Participants
|
63 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Across
|
2 Participants
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Across
|
41 Participants
|
47 Participants
|
58 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Across
|
21 Participants
|
24 Participants
|
31 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Across
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Across
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Across
|
55 Participants
|
63 Participants
|
79 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Across
|
42 Participants
|
45 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Day 0-30) follow-up periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Havrix Group
n=147 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
|
Havrix+Prevnar Group
n=137 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
|
Prevnar Havrix Group
n=149 Participants
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
|
|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AE(s)
|
3 Participants
|
5 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AE(s)
|
8 Participants
|
8 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AE(s)
|
82 Participants
|
72 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: During the Active Phase (from Day 0 to Day 30 after final vaccine dose for each subject)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study 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. NCIs include autoimmune disorders, asthma, type I diabetes, allergies. MSEs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Outcome measures
| Measure |
Havrix Group
n=147 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
|
Havrix+Prevnar Group
n=137 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
|
Prevnar Havrix Group
n=149 Participants
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs)
Any SAE(s)
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs)
Any NCI(s)
|
NA Participants
New chronic illnesses were only collected in the Extended Safety Follow-up (ESFU) Phase, therefore all the unsolicited AEs throughout the study were reported without identifying which AEs were considered a new chronic illness.
|
NA Participants
New chronic illnesses were only collected in the Extended Safety Follow-up (ESFU) Phase, therefore all the unsolicited AEs throughout the study were reported without identifying which AEs were considered a new chronic illness.
|
NA Participants
New chronic illnesses were only collected in the Extended Safety Follow-up (ESFU) Phase, therefore all the unsolicited AEs throughout the study were reported without identifying which AEs were considered a new chronic illness.
|
|
Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs)
Any MSE(s)
|
NA Participants
Related information about medically significant events was not specifically collected in the Case Report Form, therefore, all the unsolicited AEs throughout the study were reported without identifying which AEs were considered medically significant.
|
NA Participants
Related information about medically significant events was not specifically collected in the Case Report Form, therefore, all the unsolicited AEs throughout the study were reported without identifying which AEs were considered medically significant.
|
NA Participants
Related information about medically significant events was not specifically collected in the Case Report Form, therefore, all the unsolicited AEs throughout the study were reported without identifying which AEs were considered medically significant.
|
SECONDARY outcome
Timeframe: During the Extended Safety Follow-up (ESFU) Phase (from Day 30 to 6 months after final vaccine dose)Population: The analysis was performed on the ESFU cohort, which included all vaccinated subjects for whom safety data were available during the extended safety follow-up period (from Day 30 up to 6 months after last vaccine dose).
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. NCIs include autoimmune disorders, asthma, type I diabetes, allergies. MSEs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Outcome measures
| Measure |
Havrix Group
n=123 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
|
Havrix+Prevnar Group
n=121 Participants
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
|
Prevnar Havrix Group
n=132 Participants
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
|
|---|---|---|---|
|
Number of Subjects With SAEs, NCIs and MSEs
Any SAE(s)
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With SAEs, NCIs and MSEs
Any NCI(s)
|
NA Participants
All the unsolicited AEs throughout the study were reported without identifying which AEs were considered a new chronic illness.
|
NA Participants
All the unsolicited AEs throughout the study were reported without identifying which AEs were considered a new chronic illness.
|
NA Participants
All the unsolicited AEs throughout the study were reported without identifying which AEs were considered a new chronic illness.
|
|
Number of Subjects With SAEs, NCIs and MSEs
Any MSE(s)
|
NA Participants
All the unsolicited AEs throughout the study were reported without identifying which AEs were considered medically significant.
|
NA Participants
All the unsolicited AEs throughout the study were reported without identifying which AEs were considered medically significant.
|
NA Participants
All the unsolicited AEs throughout the study were reported without identifying which AEs were considered medically significant.
|
Adverse Events
Havrix Group
Serious events: 6 serious events
Other events: 107 other events
Deaths: 0 deaths
Havrix+Prevnar Group
Serious events: 8 serious events
Other events: 106 other events
Deaths: 0 deaths
Prevnar Havrix Group
Serious events: 10 serious events
Other events: 121 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Havrix Group
n=147 participants at risk；n=177 participants at risk
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
|
Havrix+Prevnar Group
n=137 participants at risk；n=169 participants at risk
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
|
Prevnar Havrix Group
n=149 participants at risk；n=175 participants at risk
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
|
|---|---|---|---|
|
Infections and infestations
Bronchiolitis (enrollment phase)
|
0.56%
1/177 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/169 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/175 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Injury, poisoning and procedural complications
Burns second degree (enrolllment phase)
|
0.00%
0/177 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/169 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.57%
1/175 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Nervous system disorders
Convulsion (enrollment phase)
|
0.56%
1/177 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.59%
1/169 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/175 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Infections and infestations
Gastroenteritis (enrollment phase)
|
0.56%
1/177 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/169 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/175 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Metabolism and nutrition disorders
Lactose intolerance (enrollment phase)
|
0.00%
0/177 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/169 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.57%
1/175 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Infections and infestations
Otitis media acute (enrollment phase)
|
1.1%
2/177 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/169 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/175 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Infections and infestations
Upper respiratory tract infection (enrollment phase)
|
0.56%
1/177 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/169 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/175 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Nervous system disorders
Convulsion (active phase)
|
0.68%
1/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.67%
1/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Infections and infestations
Croup infectious (active phase)
|
0.68%
1/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.73%
1/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Infections and infestations
Pneumonia (active phase)
|
0.00%
0/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
1.5%
2/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperactivity (active phase)
|
0.00%
0/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.67%
1/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Infections and infestations
Bronchiolitis (active phase)
|
0.00%
0/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.67%
1/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Metabolism and nutrition disorders
Dehydration (active phase)
|
0.00%
0/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.73%
1/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
General disorders
Developmental delay (active phase)
|
0.00%
0/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.73%
1/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Metabolism and nutrition disorders
Diabetes mellitus insulin-dependent (active phase)
|
0.00%
0/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.67%
1/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
General disorders
Gait disturbance (active phase)
|
0.00%
0/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.73%
1/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.67%
1/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Ear and labyrinth disorders
Hearing impaired (active phase)
|
0.00%
0/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.73%
1/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia (active phase)
|
0.00%
0/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.73%
1/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Infections and infestations
Kawasaki's disease (active phase)
|
0.68%
1/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Langerhans' cell granulomatosis (active phase)
|
0.00%
0/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.73%
1/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Metabolism and nutrition disorders
Dehydration (ESFU phase)
|
0.00%
0/123 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/121 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
1.5%
2/132 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Infections and infestations
Gastroenteritis viral (ESFU phase)
|
0.00%
0/123 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.83%
1/121 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.76%
1/132 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Infections and infestations
Kawasaki's disease (ESFU phase)
|
0.00%
0/123 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/121 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.76%
1/132 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Infections and infestations
Pneumonia (ESFU phase)
|
0.00%
0/123 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.83%
1/121 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
0.00%
0/132 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
Other adverse events
| Measure |
Havrix Group
n=147 participants at risk；n=177 participants at risk
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
|
Havrix+Prevnar Group
n=137 participants at risk；n=169 participants at risk
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
|
Prevnar Havrix Group
n=149 participants at risk；n=175 participants at risk
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
|
|---|---|---|---|
|
General disorders
Pain
|
40.4%
57/141 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
46.6%
62/133 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
53.5%
76/142 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
General disorders
Redness
|
31.9%
45/141 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
48.1%
64/133 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
54.9%
78/142 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
General disorders
Swelling
|
13.5%
19/141 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
35.3%
47/133 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
33.8%
48/142 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
General disorders
Drowsiness
|
34.0%
48/141 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
36.8%
49/133 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
44.4%
63/142 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
General disorders
Fever (Axillary)
|
14.9%
21/141 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
18.0%
24/133 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
21.8%
31/142 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
General disorders
Irritability
|
42.6%
60/141 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
48.9%
65/133 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
57.7%
82/142 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
General disorders
Loss of appetite
|
29.8%
42/141 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
33.8%
45/133 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
38.0%
54/142 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Infections and infestations
Upper respiratory tract infection
|
15.0%
22/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
12.4%
17/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
17.4%
26/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Infections and infestations
Otitis media
|
9.5%
14/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
14.6%
20/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
18.1%
27/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
General disorders
Pyrexia
|
6.8%
10/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
5.8%
8/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
8.1%
12/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Gastrointestinal disorders
Diarrhea
|
5.4%
8/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
5.8%
8/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
5.4%
8/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
7/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
3.6%
5/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
5.4%
8/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.68%
1/147 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
2.2%
3/137 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
8.7%
13/149 • Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
|
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