Trial Outcomes & Findings for Safety and Immunogenicity of a 10 Valent Pneumococcal Conjugate Vaccine (SIILPCV10) in Healthy Adults, Toddlers, Infants (NCT NCT02308540)
NCT ID: NCT02308540
Last Updated: 2019-08-02
Results Overview
Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on Day 7 (+3) following each vaccination (Visit 2 for adults and toddlers).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
346 participants
Primary outcome timeframe
7 days
Results posted on
2019-08-02
Participant Flow
Adult cohort: 43 screened and 9 screen failures Toddler cohort: 173 screened and 61 screen failures Infant cohort: 262 screened and 62 screen failures
Participant milestones
| Measure |
Adult SIILPCV10
Single dose of SIILPCV10 on day 0
|
Adult Pneumovax 23
Single dose of Pneumovax 23 on day 0
|
Toddler SIILPCV10
Single dose of SIILPCV10 on day 0
|
Toddler Prevenar 13
Single dose of Prevenar 13 on day 0
|
Infants SIILPCV10
A three-dose series of SIILPCV10 on day 0, day 28, and day 56; Booster dose of SIILPCV 10 at 9 months of age.
SIILPCV10: 10-valent Pneumococcal Conjugate Vaccine (SIILPCV10) at a dosage of 2 µg for each serotype polysaccharide, except 4 µg for 6B serotype, conjugated to a carrier protein (CRM197), with adjuvant (aluminum phosphate \[alum\]) and preservative (thiomersal).
|
Infants Prevenar 13
A three-dose series of Prevenar 13 on day 0, day 28, and day 56
Prevenar 13: 13-valent Pneumococcal Conjugate Vaccine (Prevenar 13; Pfizer-Wyeth) for the toddler and infant cohorts
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
56
|
56
|
100
|
100
|
|
Overall Study
Randomized
|
17
|
17
|
56
|
56
|
100
|
100
|
|
Overall Study
Vaccinated
|
17
|
17
|
56
|
56
|
100
|
100
|
|
Overall Study
COMPLETED
|
17
|
17
|
56
|
56
|
100
|
99
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Adult SIILPCV10
Single dose of SIILPCV10 on day 0
|
Adult Pneumovax 23
Single dose of Pneumovax 23 on day 0
|
Toddler SIILPCV10
Single dose of SIILPCV10 on day 0
|
Toddler Prevenar 13
Single dose of Prevenar 13 on day 0
|
Infants SIILPCV10
A three-dose series of SIILPCV10 on day 0, day 28, and day 56; Booster dose of SIILPCV 10 at 9 months of age.
SIILPCV10: 10-valent Pneumococcal Conjugate Vaccine (SIILPCV10) at a dosage of 2 µg for each serotype polysaccharide, except 4 µg for 6B serotype, conjugated to a carrier protein (CRM197), with adjuvant (aluminum phosphate \[alum\]) and preservative (thiomersal).
|
Infants Prevenar 13
A three-dose series of Prevenar 13 on day 0, day 28, and day 56
Prevenar 13: 13-valent Pneumococcal Conjugate Vaccine (Prevenar 13; Pfizer-Wyeth) for the toddler and infant cohorts
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Only adults are included in this category. Infants and toddlers are included in their own separate categories.
Baseline characteristics by cohort
| Measure |
Adults--PCV 10
n=17 Participants
Single dose of SIILPCV 10 on Day 0
|
Adults--Pneumovax 23
n=17 Participants
Single dose of Pneumovax 23 on Day 0
|
Toddler--PCV 10
n=56 Participants
Single dose of SIILPCV 10 on Day 0
|
Toddler--Prevenar 13
n=56 Participants
Single dose of Prevenar 13 on Day 0
|
Infant--PCV 10
n=100 Participants
A 3-dose series of SIILPCV 10 on Day 0, Day 28, and Day 56.
|
Infant--Prevenar 13
n=100 Participants
A 3-dose series of Prevenar 13 on Day 0, Day 28, and Day 56.
|
Infant Boost--PCV 10
n=49 Participants
\[Subset of infants in main study\] Booster dose of SIILPCV 10 at 9 months of age
|
Infant Boost--Prevenar 13
n=47 Participants
\[Subset of infants in main study\] Booster dose of Prevenar 13 at 9 months of age
|
Total
n=442 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Adults in years
|
25.9 years
STANDARD_DEVIATION 4.1 • n=17 Participants • Only adults are included in this category. Infants and toddlers are included in their own separate categories.
|
25.9 years
STANDARD_DEVIATION 4.4 • n=17 Participants • Only adults are included in this category. Infants and toddlers are included in their own separate categories.
|
—
|
—
|
—
|
—
|
—
|
—
|
25.9 years
STANDARD_DEVIATION 4.1 • n=34 Participants • Only adults are included in this category. Infants and toddlers are included in their own separate categories.
|
|
Age, Continuous
Infants--Age in Days
|
—
|
—
|
—
|
—
|
47.2 Days
STANDARD_DEVIATION 4 • n=100 Participants • Only infants are represented here. Adults, toddlers and infants in booster cohort are represented separately.
|
47.3 Days
STANDARD_DEVIATION 3.8 • n=100 Participants • Only infants are represented here. Adults, toddlers and infants in booster cohort are represented separately.
|
—
|
—
|
47.2 Days
STANDARD_DEVIATION 3.9 • n=200 Participants • Only infants are represented here. Adults, toddlers and infants in booster cohort are represented separately.
|
|
Age, Continuous
Toddler--Age in months
|
—
|
—
|
13.3 Months
STANDARD_DEVIATION 0.9 • n=56 Participants • Only toddlers are represented here. Adults and infants are presented separately.
|
13.3 Months
STANDARD_DEVIATION 0.8 • n=56 Participants • Only toddlers are represented here. Adults and infants are presented separately.
|
—
|
—
|
—
|
—
|
13.3 Months
STANDARD_DEVIATION 0.9 • n=112 Participants • Only toddlers are represented here. Adults and infants are presented separately.
|
|
Age, Continuous
Infant Booster age in Months
|
—
|
—
|
—
|
—
|
—
|
—
|
11.4 months
STANDARD_DEVIATION 0.8 • n=49 Participants • This includes data from infant booster cohort. Data from adults, toddlers and infants are represented separately
|
11.5 months
STANDARD_DEVIATION 0.9 • n=47 Participants • This includes data from infant booster cohort. Data from adults, toddlers and infants are represented separately
|
11.4 months
STANDARD_DEVIATION 0.8 • n=96 Participants • This includes data from infant booster cohort. Data from adults, toddlers and infants are represented separately
|
|
Sex: Female, Male
Female
|
4 Participants
n=17 Participants
|
4 Participants
n=17 Participants
|
30 Participants
n=56 Participants
|
32 Participants
n=56 Participants
|
52 Participants
n=100 Participants
|
49 Participants
n=100 Participants
|
20 Participants
n=49 Participants
|
20 Participants
n=47 Participants
|
211 Participants
n=442 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=17 Participants
|
13 Participants
n=17 Participants
|
26 Participants
n=56 Participants
|
24 Participants
n=56 Participants
|
48 Participants
n=100 Participants
|
51 Participants
n=100 Participants
|
29 Participants
n=49 Participants
|
27 Participants
n=47 Participants
|
231 Participants
n=442 Participants
|
|
Race/Ethnicity, Customized
African
|
17 Participants
n=17 Participants
|
17 Participants
n=17 Participants
|
56 Participants
n=56 Participants
|
56 Participants
n=56 Participants
|
100 Participants
n=100 Participants
|
99 Participants
n=100 Participants
|
49 Participants
n=49 Participants
|
47 Participants
n=47 Participants
|
441 Participants
n=442 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=442 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=100 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=47 Participants
|
1 Participants
n=442 Participants
|
|
Region of Enrollment
Gambia
|
17 participants
n=17 Participants
|
17 participants
n=17 Participants
|
56 participants
n=56 Participants
|
56 participants
n=56 Participants
|
100 participants
n=100 Participants
|
100 participants
n=100 Participants
|
49 participants
n=49 Participants
|
47 participants
n=47 Participants
|
442 participants
n=442 Participants
|
|
Ethnicity
Mandinka
|
10 Participants
n=17 Participants
|
7 Participants
n=17 Participants
|
28 Participants
n=56 Participants
|
27 Participants
n=56 Participants
|
42 Participants
n=100 Participants
|
55 Participants
n=100 Participants
|
23 Participants
n=49 Participants
|
28 Participants
n=47 Participants
|
220 Participants
n=442 Participants
|
|
Ethnicity
Wolof
|
3 Participants
n=17 Participants
|
1 Participants
n=17 Participants
|
4 Participants
n=56 Participants
|
11 Participants
n=56 Participants
|
18 Participants
n=100 Participants
|
10 Participants
n=100 Participants
|
9 Participants
n=49 Participants
|
2 Participants
n=47 Participants
|
58 Participants
n=442 Participants
|
|
Ethnicity
Fula
|
2 Participants
n=17 Participants
|
4 Participants
n=17 Participants
|
6 Participants
n=56 Participants
|
7 Participants
n=56 Participants
|
12 Participants
n=100 Participants
|
10 Participants
n=100 Participants
|
6 Participants
n=49 Participants
|
5 Participants
n=47 Participants
|
52 Participants
n=442 Participants
|
|
Ethnicity
Jola
|
1 Participants
n=17 Participants
|
2 Participants
n=17 Participants
|
11 Participants
n=56 Participants
|
3 Participants
n=56 Participants
|
12 Participants
n=100 Participants
|
12 Participants
n=100 Participants
|
5 Participants
n=49 Participants
|
3 Participants
n=47 Participants
|
49 Participants
n=442 Participants
|
|
Ethnicity
Serahule
|
0 Participants
n=17 Participants
|
2 Participants
n=17 Participants
|
2 Participants
n=56 Participants
|
2 Participants
n=56 Participants
|
5 Participants
n=100 Participants
|
3 Participants
n=100 Participants
|
1 Participants
n=49 Participants
|
3 Participants
n=47 Participants
|
18 Participants
n=442 Participants
|
|
Ethnicity
Serere
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
3 Participants
n=56 Participants
|
3 Participants
n=56 Participants
|
8 Participants
n=100 Participants
|
5 Participants
n=100 Participants
|
5 Participants
n=49 Participants
|
5 Participants
n=47 Participants
|
29 Participants
n=442 Participants
|
|
Ethnicity
Manjago
|
0 Participants
n=17 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=100 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=47 Participants
|
3 Participants
n=442 Participants
|
|
Ethnicity
Other
|
1 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=56 Participants
|
3 Participants
n=56 Participants
|
3 Participants
n=100 Participants
|
4 Participants
n=100 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=47 Participants
|
13 Participants
n=442 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: All subjects who received at least 1 study vaccination and had at least 1 post vaccination safety measurement.
Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on Day 7 (+3) following each vaccination (Visit 2 for adults and toddlers).
Outcome measures
| Measure |
Adults--PCV10
n=17 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=17 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
n=56 Participants
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
n=56 Participants
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Temperature above 37.5 C · Grade 1
|
0 Participants
|
0 Participants
|
5 Participants
|
6 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Temperature above 37.5 C · Grade 2
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Temperature above 37.5 C · Grade 3
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Temperature above 37.5 C · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Temperature above 37.5 C · None reported/normal (temp)
|
17 Participants
|
17 Participants
|
47 Participants
|
45 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Rash · Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Rash · Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Rash · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Rash · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Rash · None reported/normal (temp)
|
17 Participants
|
17 Participants
|
54 Participants
|
56 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Fatigue/Malaise/Drowsiness (inf/tod) · Grade 1
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Fatigue/Malaise/Drowsiness (inf/tod) · Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Fatigue/Malaise/Drowsiness (inf/tod) · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Fatigue/Malaise/Drowsiness (inf/tod) · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Fatigue/Malaise/Drowsiness (inf/tod) · None reported/normal (temp)
|
16 Participants
|
15 Participants
|
50 Participants
|
56 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Myalgia/Arthralgia (adults only) · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Myalgia/Arthralgia (adults only) · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Myalgia/Arthralgia (adults only) · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Myalgia/Arthralgia (adults only) · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Myalgia/Arthralgia (adults only) · None reported/normal (temp)
|
17 Participants
|
17 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Headache (adults only) · Grade 1
|
3 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Headache (adults only) · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Headache (adults only) · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Headache (adults only) · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Headache (adults only) · None reported/normal (temp)
|
14 Participants
|
13 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Decreased Appetite · Grade 1
|
0 Participants
|
0 Participants
|
7 Participants
|
6 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Decreased Appetite · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Decreased Appetite · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Decreased Appetite · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Decreased Appetite · None reported/normal (temp)
|
17 Participants
|
17 Participants
|
49 Participants
|
50 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Pain (adults only) · Grade 1
|
10 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Pain (adults only) · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Pain (adults only) · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Pain (adults only) · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Pain (adults only) · None reported/normal (temp)
|
7 Participants
|
8 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Tenderness · Grade 1
|
6 Participants
|
8 Participants
|
10 Participants
|
11 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Tenderness · Grade 2
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Tenderness · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Tenderness · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Tenderness · None reported/normal (temp)
|
11 Participants
|
9 Participants
|
44 Participants
|
44 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Redness · Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Redness · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Redness · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Redness · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Redness · None reported/normal (temp)
|
17 Participants
|
17 Participants
|
55 Participants
|
54 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Swelling · Grade 1
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Swelling · Grade 2
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Swelling · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Swelling · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Swelling · None reported/normal (temp)
|
17 Participants
|
17 Participants
|
50 Participants
|
55 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Irritability (toddlers only) · Grade 1
|
0 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Irritability (toddlers only) · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Irritability (toddlers only) · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Irritability (toddlers only) · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Irritability (toddlers only) · None reported/normal (temp)
|
17 Participants
|
17 Participants
|
52 Participants
|
53 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Safety population
Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following each vaccination (Visit 2, 4, and 6 for infants).
Outcome measures
| Measure |
Adults--PCV10
n=100 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=100 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Temperature · Grade 1
|
29 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Temperature · Grade 2
|
11 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Temperature · None
|
60 Participants
|
59 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Irritability · Grade 1
|
33 Participants
|
29 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Irritability · Grade 2
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Irritability · None
|
63 Participants
|
69 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Drowsiness · Grade 1
|
8 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Drowsiness · Grade 2
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Drowsiness · None
|
92 Participants
|
98 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Decreased appetite · Grade 1
|
10 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Decreased appetite · Grade 2
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Decreased appetite · None
|
90 Participants
|
98 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Tenderness at injection site · Grade 1
|
15 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Tenderness at injection site · Grade 2
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Tenderness at injection site · None
|
81 Participants
|
83 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Erythema/redness at injection site · Grade 1
|
1 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Erythema/redness at injection site · Grade 2
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Erythema/redness at injection site · None
|
99 Participants
|
91 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Induration/swelling at injection site · Grade 1
|
4 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Induration/swelling at injection site · Grade 2
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Induration/swelling at injection site · None
|
96 Participants
|
90 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Safety population
Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following each vaccination (Visit 2, 4, and 6 for infants).
Outcome measures
| Measure |
Adults--PCV10
n=100 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=100 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Temperature · Grade 1
|
11 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Temperature · Grade 2
|
7 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Temperature · None
|
82 Participants
|
81 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Irritability · Grade 1
|
35 Participants
|
30 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Irritability · Grade 2
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Irritability · None
|
60 Participants
|
67 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Drowsiness · Grade 1
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Drowsiness · Grade 2
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Drowsiness · None
|
94 Participants
|
98 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Decreased appetite · Grade 1
|
9 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Decreased appetite · Grade 2
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Decreased appetite · None
|
90 Participants
|
92 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Tenderness at injection site · Grade 1
|
18 Participants
|
26 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Tenderness at injection site · Grade 2
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Tenderness at injection site · None
|
80 Participants
|
73 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Erythema/redness at injection site · Grade 1
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Erythema/redness at injection site · Grade 2
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Erythema/redness at injection site · None
|
99 Participants
|
95 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Induration/swelling at injection site · Grade 1
|
7 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Induration/swelling at injection site · Grade 2
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Induration/swelling at injection site · None
|
92 Participants
|
82 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Safety population
Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following each vaccination (Visit 2, 4, and 6 for infants).
Outcome measures
| Measure |
Adults--PCV10
n=100 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=100 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Decreased appetite · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Temperature · Grade 1
|
15 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Temperature · Grade 2
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Temperature · Grade 3
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Temperature · None
|
80 Participants
|
80 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Irritability · Grade 1
|
33 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Irritability · Grade 2
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Irritability · Grade 3
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Irritability · None
|
63 Participants
|
59 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Drowsiness · Grade 1
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Drowsiness · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Drowsiness · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Drowsiness · None
|
98 Participants
|
97 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Decreased appetite · Grade 1
|
6 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Decreased appetite · Grade 2
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Decreased appetite · None
|
93 Participants
|
89 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Tenderness at injection site · Grade 1
|
21 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Tenderness at injection site · Grade 2
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Tenderness at injection site · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Tenderness at injection site · None
|
79 Participants
|
79 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Erythema/redness at injection site · Grade 1
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Erythema/redness at injection site · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Erythema/redness at injection site · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Erythema/redness at injection site · None
|
97 Participants
|
97 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Induration/swelling at injection site · Grade 1
|
11 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Induration/swelling at injection site · Grade 2
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Induration/swelling at injection site · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Induration/swelling at injection site · None
|
87 Participants
|
86 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 daysPopulation: All subjects who received at least 1 study vaccination and had at least 1 post vaccination safety measurement and experienced an AE at a rate of 5% or more.
Reported here are only adverse events occurring in 5% or more of subjects; unless specifically stated, AEs were regarded as unrelated.
Outcome measures
| Measure |
Adults--PCV10
n=17 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=17 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
n=56 Participants
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
n=56 Participants
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Diarrhea (Both) · None
|
17 Participants
|
16 Participants
|
49 Participants
|
50 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Diarrhea--related · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Diarrhea--related · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Diarrhea--related · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Diarrhea--related · None
|
17 Participants
|
17 Participants
|
55 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Microcytic Anemia (Toddlers) · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Microcytic Anemia (Toddlers) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Microcytic Anemia (Toddlers) · Severe
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Microcytic Anemia (Toddlers) · None
|
17 Participants
|
17 Participants
|
53 Participants
|
52 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Diarrhea (Both) · Mild
|
0 Participants
|
1 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Diarrhea (Both) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Diarrhea (Both) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Pyrexia (Toddlers) · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Pyrexia (Toddlers) · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Pyrexia (Toddlers) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Pyrexia (Toddlers) · None
|
17 Participants
|
17 Participants
|
54 Participants
|
52 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Furuncle (Toddlers) · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Furuncle (Toddlers) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Furuncle (Toddlers) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Furuncle (Toddlers) · None
|
17 Participants
|
17 Participants
|
55 Participants
|
51 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Gastroenteritis (Toddlers) · Mild
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Gastroenteritis (Toddlers) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Gastroenteritis (Toddlers) · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Gastroenteritis (Toddlers) · None
|
17 Participants
|
17 Participants
|
53 Participants
|
51 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Nasopharyngitis (Toddlers) · Mild
|
0 Participants
|
0 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Nasopharyngitis (Toddlers) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Nasopharyngitis (Toddlers) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Nasopharyngitis (Toddlers) · None
|
17 Participants
|
17 Participants
|
49 Participants
|
51 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Tinea infection (Toddlers) · Mild
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Tinea infection (Toddlers) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Tinea infection (Toddlers) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Tinea infection (Toddlers) · None
|
17 Participants
|
17 Participants
|
52 Participants
|
55 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Upper respiratory infection (Both) · Mild
|
1 Participants
|
1 Participants
|
6 Participants
|
7 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Upper respiratory infection (Both) · Moderate
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Upper respiratory infection (Both) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Upper respiratory infection (Both) · None
|
16 Participants
|
16 Participants
|
48 Participants
|
47 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Abdominal pain (Adults) · Mild
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Abdominal pain (Adults) · Moderate
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Abdominal pain (Adults) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Abdominal pain (Adults) · None
|
16 Participants
|
11 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Food poisoning (Adults) · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Food poisoning (Adults) · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Food poisoning (Adults) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Food poisoning (Adults) · None
|
17 Participants
|
16 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Toothache (Adults) · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Toothache (Adults) · Moderate
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Toothache (Adults) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Toothache (Adults) · None
|
16 Participants
|
15 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Axillary pain (Adults) · Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Axillary pain (Adults) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Axillary pain (Adults) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Axillary pain (Adults) · None
|
16 Participants
|
16 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Axillary pain--related · Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Axillary pain--related · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Axillary pain--related · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Axillary pain--related · None
|
16 Participants
|
16 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Vaccination site pruritis (Both) · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Vaccination site pruritis (Both) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Vaccination site pruritis (Both) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Vaccination site pruritis (Both) · None
|
17 Participants
|
16 Participants
|
56 Participants
|
55 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Vaccination site pruritis--related · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Vaccination site pruritis--related · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Vaccination site pruritis--related · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Vaccination site pruritis--related · None
|
17 Participants
|
16 Participants
|
56 Participants
|
55 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Vaccination site swelling (Adults) · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Vaccination site swelling (Adults) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Vaccination site swelling (Adults) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Vaccination site swelling (Adults) · None
|
17 Participants
|
16 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Vaccination site swelling--related · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Vaccination site swelling--related · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Vaccination site swelling--related · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Vaccination site swelling--related · None
|
17 Participants
|
16 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Abscess (Adults) · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Abscess (Adults) · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Abscess (Adults) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Abscess (Adults) · None
|
17 Participants
|
16 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Otitis media (Adults) · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Otitis media (Adults) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Otitis media (Adults) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Otitis media (Adults) · None
|
16 Participants
|
17 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Tonsillitis (Adults) · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Tonsillitis (Adults) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Tonsillitis (Adults) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Tonsillitis (Adults) · None
|
17 Participants
|
16 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Urinary tract infection (Adults) · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Urinary tract infection (Adults) · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Urinary tract infection (Adults) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Urinary tract infection (Adults) · None
|
17 Participants
|
16 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Dizziness (Adults) · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Dizziness (Adults) · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Dizziness (Adults) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Dizziness (Adults) · None
|
16 Participants
|
16 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Dizziness--related · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Dizziness--related · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Dizziness--related · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Dizziness--related · None
|
17 Participants
|
16 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 weeks post last vaccinationPopulation: Safety population
Reported here are adverse events that occurred in 5% or more of the infant cohort. Booster dose safety results are reported separately. Unless stated, AEs are regarded as unrelated.
Outcome measures
| Measure |
Adults--PCV10
n=100 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=100 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Upper respiratory tract infection
|
64 Participants
|
48 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Diarrhea
|
29 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Pyrexia
|
9 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Vaccination site reaction (routine vaccines)
|
11 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Vaccination site swelling (routine vaccines)
|
55 Participants
|
61 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Vaccination site swelling (study vaccine)
|
1 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Bronchiolitis
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Conjunctivitis
|
27 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Furuncle
|
8 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Gastroenteritis
|
13 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Impetigo
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Nasopharyngitis
|
19 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Otitis media--acute
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Pneumonia
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Tinea infection
|
31 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Cough
|
12 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Diaper dermatitis
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Papular rash
|
5 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Serious Adverse Event (SAE): Diarrhea
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
SAE: Gastroenteritis
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
SAE: Bronchiolitis
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
SAE: Atypical pneumonia
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence, Severity and Relatedness of All Adverse Events in Infants
SAE: Sepsis
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 days after vaccinationPopulation: This table displays vaccinated adults and toddlers only. Infants had laboratory tests only at screening.
Blood samples were collected for safety hematology and clinical chemistry evaluations, organ function tests, and, for adults, coagulation panel evaluation. Laboratory assessments were only performed at baseline for infants. Testing for HIV was undertaken only following pre-test counseling of the subject/subject's parent as to the implications of the test result. Post test counseling was also undertaken, and on the basis of a positive result the subject and subject's parents would have been referred on for HIV care according to normal local practice in The Gambia.
Outcome measures
| Measure |
Adults--PCV10
n=17 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=17 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
n=56 Participants
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
n=56 Participants
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Increased ALT--not related · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Increased ALT--not related · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased WBCs--not related · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased WBCs--not related · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased WBCs--not related · None
|
16 Participants
|
16 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased WBCs--vaccine related · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased WBCs--vaccine related · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased WBCs--vaccine related · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased WBCs--vaccine related · None
|
17 Participants
|
16 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Increased WBCs--not related · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Increased WBCs--not related · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Increased WBCs--not related · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Increased WBCs--not related · None
|
17 Participants
|
17 Participants
|
55 Participants
|
55 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Increased WBCs--vaccine related · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Increased WBCs--vaccine related · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Increased WBCs--vaccine related · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Increased WBCs--vaccine related · None
|
17 Participants
|
17 Participants
|
55 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased hemoglobin--not related · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased hemoglobin--not related · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased hemoglobin--not related · Severe
|
0 Participants
|
0 Participants
|
5 Participants
|
10 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased hemoglobin--not related · None
|
17 Participants
|
17 Participants
|
51 Participants
|
46 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased hemoglobin--vaccine related · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased hemoglobin--vaccine related · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased hemoglobin--vaccine related · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased hemoglobin--vaccine related · None
|
17 Participants
|
17 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Increased ALT--not related · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Increased ALT--not related · None
|
17 Participants
|
17 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Increased ALT--vaccine related · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Increased ALT--vaccine related · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Increased ALT--vaccine related · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Increased ALT--vaccine related · None
|
17 Participants
|
17 Participants
|
55 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased platelets--not related · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased platelets--not related · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased platelets--not related · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased platelets--not related · None
|
17 Participants
|
17 Participants
|
56 Participants
|
56 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased platelets--vaccine related · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased platelets--vaccine related · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased platelets--vaccine related · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased platelets--vaccine related · None
|
17 Participants
|
17 Participants
|
56 Participants
|
55 Participants
|
—
|
—
|
|
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Decreased WBCs--not related · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after vaccinationPopulation: All subjects who received the study vaccine per the assigned treatment group, and had post-dose immunogenicity measurement(s) with no major protocol violations that were determined to potentially interfere with immune response to the study vaccine.
Serum samples were collected 28 days after the vaccination in adults to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.
Outcome measures
| Measure |
Adults--PCV10
n=17 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=17 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults
PnC-IgG-ELISA type 1
|
3.96 µg/mL
Interval 2.51 to 6.24
|
12.79 µg/mL
Interval 8.34 to 19.61
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults
PnC-IgG-ELISA type 5
|
3.56 µg/mL
Interval 2.11 to 6.01
|
4.80 µg/mL
Interval 3.07 to 7.51
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults
PnC-IgG-ELISA type 6A
|
17.09 µg/mL
Interval 9.64 to 30.29
|
3.64 µg/mL
Interval 2.59 to 5.12
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults
PnC-IgG-ELISA type 6B
|
26.87 µg/mL
Interval 15.24 to 47.36
|
12.12 µg/mL
Interval 8.12 to 18.07
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults
PnC-IgG-ELISA type 7F
|
4.62 µg/mL
Interval 3.44 to 6.2
|
6.07 µg/mL
Interval 4.1 to 9.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults
PnC-IgG-ELISA type 9V
|
4.92 µg/mL
Interval 3.45 to 7.03
|
8.73 µg/mL
Interval 6.7 to 11.37
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults
PnC-IgG-ELISA type 14
|
48.23 µg/mL
Interval 31.6 to 73.62
|
44.78 µg/mL
Interval 33.13 to 60.52
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults
PnC-IgG-ELISA type 19A
|
19.47 µg/mL
Interval 12.13 to 31.25
|
11.20 µg/mL
Interval 6.26 to 20.05
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults
PnC-IgG-ELISA type 19F
|
20.72 µg/mL
Interval 14.62 to 29.37
|
12.38 µg/mL
Interval 7.53 to 20.37
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults
PnC-IgG-ELISA type 23F
|
10.09 µg/mL
Interval 6.26 to 16.24
|
8.95 µg/mL
Interval 5.61 to 14.28
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after vaccinationPopulation: All subjects who received the study vaccine per the assigned treatment group, and had post-dose immunogenicity measurement(s) with no major protocol violations that were determined to potentially interfere with immune response to the study vaccine.
Serum samples were collected 28 days after vaccination for toddlers to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.
Outcome measures
| Measure |
Adults--PCV10
n=56 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=56 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 1: Baseline
|
0.77 µg/mL
Interval 0.46 to 1.36
|
0.92 µg/mL
Interval 0.72 to 1.26
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 1: Post-vaccination
|
4.59 µg/mL
Interval 4.03 to 5.67
|
6.09 µg/mL
Interval 4.93 to 10.17
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 5: Baseline
|
0.60 µg/mL
Interval 0.36 to 1.04
|
0.42 µg/mL
Interval 0.32 to 0.51
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 5: Post-vaccination
|
2.30 µg/mL
Interval 1.67 to 3.48
|
3.35 µg/mL
Interval 2.63 to 5.03
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 6A: Baseline
|
1.40 µg/mL
Interval 0.88 to 2.67
|
1.29 µg/mL
Interval 0.97 to 1.72
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 6A: Post-vaccination
|
13.33 µg/mL
Interval 10.15 to 20.81
|
15.83 µg/mL
Interval 12.52 to 25.12
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 6B: Baseline
|
2.02 µg/mL
Interval 1.29 to 3.42
|
1.95 µg/mL
Interval 1.41 to 2.55
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 6B: Post-vaccination
|
15.77 µg/mL
Interval 12.2 to 22.43
|
19.16 µg/mL
Interval 15.81 to 28.72
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 7F: Baseline
|
1.49 µg/mL
Interval 0.96 to 2.1
|
1.46 µg/mL
Interval 0.99 to 1.86
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 7F: Post-vaccination
|
9.17 µg/mL
Interval 7.69 to 11.64
|
12.35 µg/mL
Interval 9.41 to 18.55
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 9V: Baseline
|
0.53 µg/mL
Interval 0.31 to 0.86
|
0.41 µg/mL
Interval 0.28 to 0.51
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 9V: Post-vaccination
|
2.35 µg/mL
Interval 1.69 to 3.25
|
3.90 µg/mL
Interval 2.79 to 5.95
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 14: Baseline
|
2.89 µg/mL
Interval 1.6 to 4.4
|
2.47 µg/mL
Interval 1.7 to 3.8
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 14: Post-vaccination
|
14.55 µg/mL
Interval 9.29 to 20.6
|
8.28 µg/mL
Interval 6.49 to 12.55
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 19A: Baseline
|
1.17 µg/mL
Interval 0.63 to 1.97
|
0.57 µg/mL
Interval 0.34 to 0.72
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 19A: Post-vaccination
|
9.76 µg/mL
Interval 7.23 to 12.18
|
13.68 µg/mL
Interval 7.12 to 20.02
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 19F: Baseline
|
1.75 µg/mL
Interval 0.85 to 3.43
|
0.97 µg/mL
Interval 0.65 to 1.58
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 19F: Post-vaccination
|
9.75 µg/mL
Interval 7.76 to 12.26
|
12.87 µg/mL
Interval 9.08 to 20.75
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 23F: Baseline
|
0.71 µg/mL
Interval 0.39 to 1.32
|
0.63 µg/mL
Interval 0.44 to 1.05
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
PnC-IgG-ELISA type 23F: Post-vaccination
|
6.84 µg/mL
Interval 4.76 to 10.03
|
10.49 µg/mL
Interval 8.21 to 18.16
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after the third dosePopulation: All subjects who received all study vaccines per the assigned treatment group, and had post-dose immunogenicity measurement(s) with no major protocol violations that were determined to potentially interfere with immune response to the study vaccine.
Serum samples were collected 28 days after the third vaccination for infants to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.
Outcome measures
| Measure |
Adults--PCV10
n=100 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=100 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants
PnC-IgG-ELISA type 7F
|
2.19 µg/mL
Interval 1.89 to 2.53
|
3.88 µg/mL
Interval 3.44 to 4.38
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants
PnC-IgG-ELISA type 9V
|
1.07 µg/mL
Interval 0.93 to 1.23
|
2.19 µg/mL
Interval 1.91 to 2.5
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants
PnC-IgG-ELISA type 1
|
2.99 µg/mL
Interval 2.61 to 3.43
|
3.38 µg/mL
Interval 3.02 to 3.78
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants
PnC-IgG-ELISA type 5
|
2.09 µg/mL
Interval 1.86 to 2.36
|
1.74 µg/mL
Interval 1.53 to 1.98
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants
PnC-IgG-ELISA type 6A
|
1.02 µg/mL
Interval 0.83 to 1.27
|
1.82 µg/mL
Interval 1.53 to 2.17
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants
PnC-IgG-ELISA type 6B
|
1.57 µg/mL
Interval 1.28 to 1.92
|
3.64 µg/mL
Interval 3.01 to 4.42
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants
PnC-IgG-ELISA type 14
|
4.96 µg/mL
Interval 4.2 to 5.87
|
4.47 µg/mL
Interval 3.62 to 5.53
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants
PnC-IgG-ELISA type 19A
|
1.49 µg/mL
Interval 1.26 to 1.76
|
5.20 µg/mL
Interval 4.37 to 6.2
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants
PnC-IgG-ELISA type 19F
|
3.87 µg/mL
Interval 3.35 to 4.49
|
5.38 µg/mL
Interval 4.79 to 6.05
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants
PnC-IgG-ELISA type 23F
|
1.56 µg/mL
Interval 1.32 to 1.83
|
2.68 µg/mL
Interval 2.28 to 3.15
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after vaccination (28 days)Population: The evaluable group differs for individual serotypes due to non-reportable results.
Serum samples were collected before the first vaccination and 28 days after the last vaccination for adults and toddlers and 28 days after the completion of the primary series for infants to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10. Blood samples were also collected for immunogenicity testing before and 28 days after the booster dose for infants. Baseline serum samples for infants and adults were not assayed. The IgG concentration was also determined for each component of the co administered pentavalent vaccine (DTwP-HepB-Hib) in sera from the infant cohort. If there were limitations to blood volumes, appropriate subsets and priorities for immune testing were established with the immunology laboratories to ensure measurements were unbiased and representative of the entire cohort.
Outcome measures
| Measure |
Adults--PCV10
n=17 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=17 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype
PnC-IgG-ELISA type 1
|
5.99 fold change
Interval 3.94 to 10.12
|
6.59 fold change
Interval 5.06 to 11.1
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype
PnC-IgG-ELISA type 5
|
3.82 fold change
Interval 2.67 to 6.67
|
8.00 fold change
Interval 6.79 to 12.16
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype
PnC-IgG-ELISA type 6A
|
9.91 fold change
Interval 6.14 to 19.88
|
12.31 fold change
Interval 9.81 to 20.31
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype
PnC-IgG-ELISA type 6B
|
7.79 fold change
Interval 5.02 to 14.78
|
9.82 fold change
Interval 8.12 to 15.03
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype
PnC-IgG-ELISA type 7F
|
6.16 fold change
Interval 4.68 to 9.94
|
8.44 fold change
Interval 6.83 to 13.9
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype
PnC-IgG-ELISA type 9V
|
4.43 fold change
Interval 3.3 to 6.93
|
9.58 fold change
Interval 7.81 to 15.35
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype
PnC-IgG-ELISA type 14
|
5.04 fold change
Interval 3.52 to 7.42
|
3.35 fold change
Interval 2.41 to 5.12
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype
PnC-IgG-ELISA type 19A
|
7.89 fold change
Interval 4.56 to 15.32
|
24.17 fold change
Interval 18.51 to 36.37
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype
PnC-IgG-ELISA type 19F
|
5.73 fold change
Interval 3.24 to 13.28
|
13.26 fold change
Interval 9.35 to 21.82
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype
PnC-IgG-ELISA type 23F
|
9.67 fold change
Interval 6.11 to 17.18
|
16.54 fold change
Interval 12.53 to 28.13
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after third dosePopulation: All subjects who received all study vaccines per the assigned treatment group, and had post-dose immunogenicity measurement(s) with no major protocol violations that were determined to potentially interfere with immune response to the study vaccine.
Seroresponse was defined as ≥ 0.35 µg/mL. In infants, serum samples were collected 28 days after receipt of three doses of the vaccine to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.
Outcome measures
| Measure |
Adults--PCV10
n=100 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=100 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype
Pn-IgG-ELISA type 1
|
99 Participants
|
100 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype
Pn-IgG-ELISA type 5
|
100 Participants
|
97 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype
Pn-IgG-ELISA type 6A
|
79 Participants
|
91 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype
Pn-IgG-ELISA type 6B
|
89 Participants
|
93 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype
Pn-IgG-ELISA type 7F
|
97 Participants
|
100 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype
Pn-IgG-ELISA type 9V
|
94 Participants
|
97 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype
Pn-IgG-ELISA type 14
|
98 Participants
|
96 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype
Pn-IgG-ELISA type 19A
|
92 Participants
|
94 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype
Pn-IgG-ELISA type 19F
|
99 Participants
|
97 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype
Pn-IgG-ELISA type 23F
|
91 Participants
|
97 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after last vaccinationPopulation: Randomly selected subsets of the infant and toddler cohorts and all adult subjects
The functional activity of the IgG response to the 10 serotypes contained in SIILPCV10 was determined in randomly selected subsets of the infant and toddler cohorts and all adult subjects in the same serum samples collected 28 days after the last vaccinations. This activity was determined using the 4-fold multiplexed OPA developed at the University of Alabama at Birmingham.
Outcome measures
| Measure |
Adults--PCV10
n=17 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=17 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
n=17 Participants
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
n=17 Participants
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
n=20 Participants
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
n=20 Participants
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Functional Antibody (OPA) Geometric Mean Titers
MOPA - Pn 1
|
18.89 titer
Interval 10.14 to 45.59
|
85.89 titer
Interval 43.15 to 215.84
|
436.31 titer
Interval 365.08 to 582.46
|
438.14 titer
Interval 278.73 to 890.17
|
50.65 titer
Interval 27.91 to 96.55
|
29.42 titer
Interval 15.58 to 68.08
|
|
Functional Antibody (OPA) Geometric Mean Titers
MOPA - Pn 5
|
263.06 titer
Interval 138.91 to 499.28
|
265.56 titer
Interval 143.22 to 521.05
|
1358.22 titer
Interval 960.34 to 2087.48
|
1148.43 titer
Interval 929.92 to 1708.67
|
113.92 titer
Interval 74.12 to 167.1
|
104.83 titer
Interval 64.11 to 181.22
|
|
Functional Antibody (OPA) Geometric Mean Titers
MOPA - Pn 6A
|
17161.52 titer
Interval 12378.36 to 23946.2
|
4925.68 titer
Interval 3204.91 to 7661.38
|
19371.45 titer
Interval 12538.18 to 34268.51
|
12001.09 titer
Interval 8229.26 to 21545.31
|
1243.88 titer
Interval 942.4 to 1834.3
|
3068.16 titer
Interval 2267.85 to 5318.41
|
|
Functional Antibody (OPA) Geometric Mean Titers
MOPA - 6B
|
13303.68 titer
Interval 9432.51 to 18190.05
|
4221.68 titer
Interval 2890.62 to 5925.09
|
8768.08 titer
Interval 5471.57 to 12932.67
|
7066.76 titer
Interval 4456.49 to 11894.25
|
1530.37 titer
Interval 935.24 to 2368.41
|
2267.44 titer
Interval 1175.92 to 3718.87
|
|
Functional Antibody (OPA) Geometric Mean Titers
MOPA - 7F
|
7099.73 titer
Interval 4147.2 to 11222.44
|
8019.15 titer
Interval 4956.82 to 10917.82
|
10723.98 titer
Interval 7151.48 to 16590.09
|
12737.21 titer
Interval 8063.57 to 18328.98
|
876.58 titer
Interval 616.9 to 1221.31
|
3763.17 titer
Interval 2754.89 to 5393.72
|
|
Functional Antibody (OPA) Geometric Mean Titers
MOPA - 9V
|
3928.12 titer
Interval 2827.41 to 5629.89
|
4443.95 titer
Interval 3275.91 to 6299.32
|
3770.19 titer
Interval 2004.45 to 6384.49
|
4862.30 titer
Interval 3128.56 to 6953.05
|
197.24 titer
Interval 95.09 to 347.56
|
752.77 titer
Interval 528.18 to 1024.26
|
|
Functional Antibody (OPA) Geometric Mean Titers
MOPA - 14
|
9148.12 titer
Interval 6271.81 to 12407.65
|
6707.26 titer
Interval 5098.03 to 7886.64
|
8213.23 titer
Interval 4526.63 to 13664.12
|
2557.27 titer
Interval 1597.17 to 3868.34
|
1243.39 titer
Interval 743.97 to 1912.05
|
1108.02 titer
Interval 501.79 to 2097.51
|
|
Functional Antibody (OPA) Geometric Mean Titers
MOPA - 19A
|
3170.33 titer
Interval 1906.55 to 4427.88
|
2215.22 titer
Interval 1314.65 to 3458.76
|
1789.98 titer
Interval 651.04 to 3498.32
|
3780.56 titer
Interval 2358.04 to 6045.56
|
151.31 titer
Interval 64.25 to 233.45
|
765.71 titer
Interval 589.49 to 886.28
|
|
Functional Antibody (OPA) Geometric Mean Titers
MOPA - 19F
|
3564.32 titer
Interval 2636.19 to 4898.79
|
2481.47 titer
Interval 1623.91 to 3860.16
|
3036.60 titer
Interval 2134.81 to 5126.44
|
3371.52 titer
Interval 2238.81 to 5853.53
|
744.92 titer
Interval 607.87 to 941.74
|
498.98 titer
Interval 275.77 to 723.41
|
|
Functional Antibody (OPA) Geometric Mean Titers
MOPA - 23F
|
5035.73 titer
Interval 3417.87 to 7587.87
|
2844.04 titer
Interval 2123.33 to 3737.09
|
12415.92 titer
Interval 8018.97 to 19342.91
|
10517.81 titer
Interval 5848.87 to 19460.6
|
627.27 titer
Interval 341.95 to 975.77
|
921.43 titer
Interval 574.79 to 1419.94
|
SECONDARY outcome
Timeframe: 84 daysPopulation: Randomly selected subsets of the infant cohort
The functional activity of the immune response to the 10 serotypes contained in SIILPCV10 was determined in randomly selected subsets of the infant cohort in the same serum samples collected 28 days after the completion of the primary series. This activity was determined using the 4-fold multiplexed OPA developed at the University of Alabama at Birmingham.
Outcome measures
| Measure |
Adults--PCV10
n=20 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=20 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype
MOPA - Pn 1
|
15 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype
MOPA - Pn 5
|
19 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype
MOPA - Pn 6A
|
20 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype
MOPA - 6B
|
19 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype
MOPA - 7F
|
20 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype
MOPA - 9V
|
20 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype
MOPA - 14
|
19 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype
MOPA - 19A
|
16 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype
MOPA - 19F
|
20 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype
MOPA - 23F
|
20 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 84 daysPopulation: All subjects who receive all study vaccines per the assigned treatment group, and had post-dose immunogenicity measurement(s) with no major protocol violations that were determined to potentially interfere with immune response to the study vaccine.
Serum samples were collected 28 days after the third vaccination for infants to determine the ELISA IgG concentration for each component of the co administered pentavalent vaccine (DTwP-HepB-Hib) . Seroresponse was defined as equal to or greater concentrations for: * Diptheria toxoid: 0.1 IU/mL * Hepatitis B: 10 milli-International unit (mIU) /mL * Hib: 0.15 mcg/mL * Tetanus toxoid: 0.1 IU/mL
Outcome measures
| Measure |
Adults--PCV10
n=100 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=100 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Number and Percentage of Immunoglobulin G (IgG) Seroresponders Against Pentavalent Vaccine Components
Diphtheria toxoid
|
100 Participants
|
100 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Immunoglobulin G (IgG) Seroresponders Against Pentavalent Vaccine Components
Hepatitis B
|
100 Participants
|
100 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Immunoglobulin G (IgG) Seroresponders Against Pentavalent Vaccine Components
Hib (anti-PRP antibodies)
|
100 Participants
|
99 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Immunoglobulin G (IgG) Seroresponders Against Pentavalent Vaccine Components
Tetanus toxoid
|
100 Participants
|
100 Participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 daysPopulation: A subset of the infant cohort who were eligible for the booster phase, had not yet received the Prevenar 13 booster that was offered to infants in the SIILPCV10 group as part of the primary phase of the study and who contributed at least some safety and/or immunogenicity data.
Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 30 (± 10) minutes following booster vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following the vaccination
Outcome measures
| Measure |
Adults--PCV10
n=49 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=47 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Temperature above 37 C · Grade 1
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Temperature above 37 C · Grade 2
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Temperature above 37 C · Grade 3
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Temperature above 37 C · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Temperature above 37 C · None reported/normal (temp)
|
43 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Cutaneous Rash · Grade 1
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Cutaneous Rash · Grade 2
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Cutaneous Rash · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Cutaneous Rash · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Cutaneous Rash · None reported/normal (temp)
|
48 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Irritability · Grade 1
|
5 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Irritability · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Irritability · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Irritability · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Irritability · None reported/normal (temp)
|
44 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Drowsiness · Grade 1
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Drowsiness · Grade 2
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Drowsiness · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Drowsiness · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Drowsiness · None reported/normal (temp)
|
48 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Decreased appetite · Grade 1
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Decreased appetite · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Decreased appetite · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Decreased appetite · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Decreased appetite · None reported/normal (temp)
|
47 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Injection site tenderness · Grade 1
|
8 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Injection site tenderness · Grade 2
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Injection site tenderness · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Injection site tenderness · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Injection site tenderness · None reported/normal (temp)
|
40 Participants
|
36 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Erythema · Grade 1
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Erythema · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Erythema · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Erythema · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Erythema · None reported/normal (temp)
|
48 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Induration/Swelling · Grade 1
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Induration/Swelling · Grade 2
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Induration/Swelling · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Induration/Swelling · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Induration/Swelling · None reported/normal (temp)
|
43 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeks (28 days)Population: A subset of the infant cohort PP\_IMM who were eligible for the booster phase, had not yet received the Prevenar 13 booster that was offered to infants in the SIILPCV10 group as part of the primary phase of the study and who contributed at least some safety and/or immunogenicity data.
Unsolicited adverse events following a booster dose of SIILPCV10 occurring in 5% or greater of study participants. Unless specifically stated, AEs are considered unrelated.
Outcome measures
| Measure |
Adults--PCV10
n=49 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=47 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Upper respiratory tract infection · Grade 1
|
14 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Upper respiratory tract infection · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Upper respiratory tract infection · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Upper respiratory tract infection · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Upper respiratory tract infection · None reported
|
35 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Dermatitis · Grade 1
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Dermatitis · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Dermatitis · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Dermatitis · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Dermatitis · None reported
|
45 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Diarrhea · Grade 1
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Diarrhea · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Diarrhea · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Diarrhea · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Diarrhea · None reported
|
47 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Impetigo · Grade 1
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Impetigo · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Impetigo · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Impetigo · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Impetigo · None reported
|
46 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Rash pustular · Grade 1
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Rash pustular · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Rash pustular · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Rash pustular · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Rash pustular · None reported
|
48 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Pyrexia · Grade 1
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Pyrexia · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Pyrexia · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Pyrexia · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Pyrexia · None reported
|
48 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
SAE--severe malaria with severe anemia · Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
SAE--severe malaria with severe anemia · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
SAE--severe malaria with severe anemia · Grade 3
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
SAE--severe malaria with severe anemia · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
SAE--severe malaria with severe anemia · None reported
|
48 Participants
|
47 Participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeks (28 days)Population: This is the population of infants who received a booster dose of either PCV-10 or Prevenar-13. The evaluable group differs for individual serotypes due to NR results.
Using enzyme-linked immunosorbent assay (ELISA). Blood samples were collected for immunogenicity testing at 4 weeks post vaccination 3, and before and 28 days after the booster dose for infants.
Outcome measures
| Measure |
Adults--PCV10
n=49 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=47 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
n=96 Participants
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 1: 4 weeks post Vac 3
|
2.67 µg/mL
Interval 2.22 to 3.21
|
3.23 µg/mL
Interval 2.76 to 3.78
|
0.83 µg/mL
Interval 0.65 to 1.05
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 1: Pre Booster
|
0.27 µg/mL
Interval 0.22 to 0.33
|
0.32 µg/mL
Interval 0.27 to 0.4
|
0.83 µg/mL
Interval 0.63 to 1.1
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 1: Post Booster
|
6.24 µg/mL
Interval 4.62 to 8.42
|
5.11 µg/mL
Interval 3.96 to 6.6
|
1.22 µg/mL
Interval 0.83 to 1.81
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 5: 4 weeks post Vac 3
|
2.01 µg/mL
Interval 1.7 to 2.38
|
1.45 µg/mL
Interval 1.18 to 1.79
|
1.38 µg/mL
Interval 1.06 to 1.8
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 5: Pre Booster
|
0.16 µg/mL
Interval 0.13 to 0.18
|
0.25 µg/mL
Interval 0.21 to 0.3
|
0.62 µg/mL
Interval 0.48 to 0.78
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
ELISA Type 5: Post Booster
|
2.30 µg/mL
Interval 1.88 to 2.81
|
2.57 µg/mL
Interval 2.1 to 3.13
|
0.90 µg/mL
Interval 0.68 to 1.19
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 6A: 4 weeks post Vac 3
|
1.06 µg/mL
Interval 0.8 to 1.42
|
1.56 µg/mL
Interval 1.17 to 2.06
|
0.68 µg/mL
Interval 0.46 to 1.02
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 6A: Pre Booster
|
0.46 µg/mL
Interval 0.38 to 0.56
|
0.53 µg/mL
Interval 0.43 to 0.66
|
0.87 µg/mL
Interval 0.65 to 1.16
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 6A: Post Booster
|
9.50 µg/mL
Interval 6.94 to 12.99
|
12.06 µg/mL
Interval 9.98 to 14.56
|
0.79 µg/mL
Interval 0.55 to 1.13
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 6B: 4 weeks post Vac 3
|
1.39 µg/mL
Interval 1.03 to 1.87
|
3.67 µg/mL
Interval 2.74 to 4.93
|
0.38 µg/mL
Interval 0.25 to 0.57
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 6B: Pre Booster
|
0.73 µg/mL
Interval 0.59 to 0.9
|
0.50 µg/mL
Interval 0.42 to 0.6
|
1.45 µg/mL
Interval 1.1 to 1.9
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 6B: Post Booster
|
12.72 µg/mL
Interval 9.79 to 16.54
|
14.06 µg/mL
Interval 11.55 to 17.11
|
0.91 µg/mL
Interval 0.65 to 1.26
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 7F: 4 weeks post Vac 3
|
1.99 µg/mL
Interval 1.59 to 2.49
|
3.43 µg/mL
Interval 2.81 to 4.18
|
0.58 µg/mL
Interval 0.43 to 0.78
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 7F: Pre Booster
|
0.49 µg/mL
Interval 0.39 to 0.62
|
0.81 µg/mL
Interval 0.68 to 0.97
|
0.61 µg/mL
Interval 0.45 to 0.81
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 7F: Post Booster
|
6.76 µg/mL
Interval 5.49 to 8.32
|
8.51 µg/mL
Interval 7.05 to 10.26
|
0.79 µg/mL
Interval 0.6 to 1.05
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 9V: 4 weeks post Vac 3
|
1.06 µg/mL
Interval 0.89 to 1.26
|
2.22 µg/mL
Interval 1.84 to 2.68
|
0.48 µg/mL
Interval 0.37 to 0.62
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 9V: Pre Booster
|
0.18 µg/mL
Interval 0.15 to 0.21
|
0.22 µg/mL
Interval 0.16 to 0.28
|
0.83 µg/mL
Interval 0.6 to 1.14
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 9V: Post Booster
|
2.44 µg/mL
Interval 2.02 to 2.95
|
3.23 µg/mL
Interval 2.76 to 3.79
|
0.76 µg/mL
Interval 0.59 to 0.97
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 14: 4 weeks post Vac 3
|
4.38 µg/mL
Interval 3.51 to 5.46
|
3.71 µg/mL
Interval 2.67 to 5.16
|
1.18 µg/mL
Interval 0.8 to 1.74
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 14: Pre Booster
|
0.81 µg/mL
Interval 0.64 to 1.03
|
1.52 µg/mL
Interval 1.18 to 1.97
|
0.53 µg/mL
Interval 0.38 to 0.76
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 14: Post Booster
|
8.16 µg/mL
Interval 6.19 to 10.77
|
7.60 µg/mL
Interval 5.82 to 9.93
|
1.07 µg/mL
Interval 0.73 to 1.57
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 19A: 4 weeks post Vac 3
|
1.35 µg/mL
Interval 1.05 to 1.74
|
5.12 µg/mL
Interval 3.92 to 6.68
|
0.26 µg/mL
Interval 0.18 to 0.38
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 19A: Pre Booster
|
0.29 µg/mL
Interval 0.22 to 0.38
|
0.59 µg/mL
Interval 0.43 to 0.8
|
0.49 µg/mL
Interval 0.33 to 0.74
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 19A: Post Booster
|
6.72 µg/mL
Interval 4.87 to 9.25
|
15.20 µg/mL
Interval 11.83 to 19.54
|
0.44 µg/mL
Interval 0.29 to 0.66
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 19F: 4 weeks post Vac 3
|
3.70 µg/mL
Interval 3.03 to 4.53
|
4.61 µg/mL
Interval 3.86 to 5.51
|
0.80 µg/mL
Interval 0.61 to 1.05
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 19F: Pre Booster
|
0.63 µg/mL
Interval 0.49 to 0.8
|
0.59 µg/mL
Interval 0.45 to 0.75
|
1.07 µg/mL
Interval 0.76 to 1.52
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 19F: Post Booster
|
7.73 µg/mL
Interval 5.96 to 10.03
|
11.85 µg/mL
Interval 9.41 to 14.92
|
0.65 µg/mL
Interval 0.46 to 0.92
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 23F: 4 weeks post Vac 3
|
1.35 µg/mL
Interval 1.06 to 1.73
|
2.18 µg/mL
Interval 1.67 to 2.87
|
0.62 µg/mL
Interval 0.43 to 0.89
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 23F: Pre Booster
|
0.23 µg/mL
Interval 0.17 to 0.3
|
0.17 µg/mL
Interval 0.14 to 0.22
|
1.32 µg/mL
Interval 0.93 to 1.87
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
PnC-IgG-ELISA Type 23F: Post Booster
|
5.11 µg/mL
Interval 3.93 to 6.65
|
5.28 µg/mL
Interval 4.04 to 6.9
|
0.97 µg/mL
Interval 0.67 to 1.4
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeks (28 days)Population: This population is infants who had a booster vaccination of either PCV-10 or Prevenar-13. The evaluable group differs for individual serotypes due to NR results.
Using enzyme-linked immunosorbent assay (ELISA). Blood samples were collected for immunogenicity testing before and 28 days after the booster dose for infants.
Outcome measures
| Measure |
Adults--PCV10
n=48 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=47 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
n=95 Participants
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 1
|
22.52 fold change
Interval 17.6 to 28.82
|
15.75 fold change
Interval 12.16 to 20.41
|
1.43 fold change
Interval 1.0 to 2.04
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 5
|
14.83 fold change
Interval 12.32 to 17.85
|
10.17 fold change
Interval 8.62 to 11.99
|
1.46 fold change
Interval 1.14 to 1.86
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 6A
|
20.70 fold change
Interval 16.13 to 26.56
|
22.98 fold change
Interval 17.88 to 29.54
|
0.90 fold change
Interval 0.63 to 1.28
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 6B
|
17.81 fold change
Interval 14.55 to 21.8
|
28.66 fold change
Interval 23.43 to 35.05
|
0.62 fold change
Interval 0.47 to 0.82
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 7F
|
13.37 fold change
Interval 10.86 to 16.45
|
10.44 fold change
Interval 8.59 to 12.7
|
1.28 fold change
Interval 0.96 to 1.7
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 9V
|
13.48 fold change
Interval 11.26 to 16.13
|
15.02 fold change
Interval 11.73 to 19.23
|
0.90 fold change
Interval 0.66 to 1.21
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 14
|
10.03 fold change
Interval 7.38 to 13.63
|
4.99 fold change
Interval 3.78 to 6.6
|
2.01 fold change
Interval 1.33 to 3.03
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose
PnC-IgG-ELISA Type 19A
|
23.20 fold change
Interval 15.67 to 34.36
|
25.73 fold change
Interval 18.25 to 36.28
|
0.90 fold change
Interval 0.54 to 1.51
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose
PnC-IgG-ELISA Type 19F
|
12.44 fold change
Interval 8.74 to 17.72
|
20.60 fold change
Interval 14.68 to 28.92
|
0.60 fold change
Interval 0.37 to 0.98
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose
PnC-IgG-ELISA Type 23F
|
22.10 fold change
Interval 17.3 to 28.23
|
30.75 fold change
Interval 23.34 to 40.52
|
0.72 fold change
Interval 0.5 to 1.03
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 20-23 weeksPopulation: This population is infants who had a booster vaccination of either PCV-10 or Prevenar-13. The evaluable group differs for individual serotypes due to non-reportable results.
Defined as the ratio of IgG geometric mean concentration (GMC) measured prior to the infant booster dose, to GMC measured 4 weeks after the 3-dose primary series. Infants received the booster dose at least four weeks after they received routine Expanded Program on Immunization (EPI) vaccines, which occurred at 9 months of age. Thus, the time frame was at least 20 weeks but may have been longer.
Outcome measures
| Measure |
Adults--PCV10
n=49 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=47 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 1
|
0.10 concentration ratio
Interval 0.08 to 0.13
|
0.10 concentration ratio
Interval 0.08 to 0.13
|
—
|
—
|
—
|
—
|
|
Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 5
|
0.08 concentration ratio
Interval 0.06 to 0.1
|
0.17 concentration ratio
Interval 0.13 to 0.23
|
—
|
—
|
—
|
—
|
|
Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 6A
|
0.43 concentration ratio
Interval 0.3 to 0.61
|
0.34 concentration ratio
Interval 0.24 to 0.49
|
—
|
—
|
—
|
—
|
|
Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 6B
|
0.52 concentration ratio
Interval 0.36 to 0.75
|
0.14 concentration ratio
Interval 0.1 to 0.19
|
—
|
—
|
—
|
—
|
|
Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 7F
|
0.25 concentration ratio
Interval 0.18 to 0.34
|
0.24 concentration ratio
Interval 0.18 to 0.31
|
—
|
—
|
—
|
—
|
|
Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 9V
|
0.17 concentration ratio
Interval 0.13 to 0.22
|
0.10 concentration ratio
Interval 0.07 to 0.13
|
—
|
—
|
—
|
—
|
|
Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 14
|
0.19 concentration ratio
Interval 0.13 to 0.26
|
0.41 concentration ratio
Interval 0.27 to 0.62
|
—
|
—
|
—
|
—
|
|
Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose
PnC-IgG-ELISA Type 19A
|
0.22 concentration ratio
Interval 0.15 to 0.31
|
0.12 concentration ratio
Interval 0.08 to 0.17
|
—
|
—
|
—
|
—
|
|
Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose
PnC-IgG-ELISA Type 19F
|
0.17 concentration ratio
Interval 0.12 to 0.23
|
0.13 concentration ratio
Interval 0.09 to 0.17
|
—
|
—
|
—
|
—
|
|
Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose
PnC-IgG-ELISA Type 23F
|
0.17 concentration ratio
Interval 0.12 to 0.24
|
0.08 concentration ratio
Interval 0.06 to 0.11
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-26 weeksPopulation: This population is infants who had a booster vaccination of either PCV-10 or Prevenar-13. The evaluable group differs for individual serotypes due to non-reportable results.
Defined as the ratio of IgG geometric mean concentration (GMC) measured 4 weeks post-infant booster dose, to GMC measured 4 weeks after the 3-dose primary series. Infants received the booster dose at least four weeks after they received routine Expanded Program on Immunization (EPI) vaccines, which occurred at 9 months of age. Thus, the time frame was at least 24 weeks but may have been longer.
Outcome measures
| Measure |
Adults--PCV10
n=49 Participants
A single dose of SIILPCV 10 at Day 0
|
Adults--Pneumovax 23
n=47 Participants
A single dose of Pneumovax 23 at Day 0
|
Toddler--PCV 10
A single dose of SIIL PCV 10 at Day 0
|
Toddler--Prevenar 13
A single dose of Prevenar 13 at Day 0
|
Infant--PCV 10
Dose of SIILPCV 10 on Days 0, 28 \& 56
|
Infant--Prevenar 13
Dose of Prevenar 13 on Days 0, 28, \& 56
|
|---|---|---|---|---|---|---|
|
Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 1
|
2.34 concentration ratio
Interval 1.65 to 3.31
|
1.58 concentration ratio
Interval 1.17 to 2.13
|
—
|
—
|
—
|
—
|
|
Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 5
|
1.14 concentration ratio
Interval 0.88 to 1.48
|
1.77 concentration ratio
Interval 1.33 to 2.35
|
—
|
—
|
—
|
—
|
|
Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 6A
|
8.93 concentration ratio
Interval 5.86 to 13.62
|
7.75 concentration ratio
Interval 5.53 to 10.85
|
—
|
—
|
—
|
—
|
|
Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 6B
|
9.18 concentration ratio
Interval 6.18 to 13.63
|
3.83 concentration ratio
Interval 2.7 to 5.43
|
—
|
—
|
—
|
—
|
|
Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 7F
|
3.40 concentration ratio
Interval 2.51 to 4.59
|
2.48 concentration ratio
Interval 1.89 to 3.25
|
—
|
—
|
—
|
—
|
|
Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 9V
|
2.31 concentration ratio
Interval 1.79 to 2.98
|
1.46 concentration ratio
Interval 1.14 to 1.86
|
—
|
—
|
—
|
—
|
|
Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose
PnC-IgG-ELISA type 14
|
1.87 concentration ratio
Interval 1.31 to 2.65
|
2.05 concentration ratio
Interval 1.35 to 3.12
|
—
|
—
|
—
|
—
|
|
Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose
PnC-IgG-ELISA Type 19A
|
4.96 concentration ratio
Interval 3.32 to 7.41
|
2.97 concentration ratio
Interval 2.07 to 4.27
|
—
|
—
|
—
|
—
|
|
Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose
PnC-IgG-ELISA Type 19F
|
2.09 concentration ratio
Interval 1.51 to 2.89
|
2.57 concentration ratio
Interval 1.93 to 3.42
|
—
|
—
|
—
|
—
|
|
Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose
PnC-IgG-ELISA Type 23F
|
3.78 concentration ratio
Interval 2.65 to 5.4
|
2.42 concentration ratio
Interval 1.66 to 3.52
|
—
|
—
|
—
|
—
|
Adverse Events
Adult SIILPCV 10
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Adult Pneumovax 23
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Toddler SIILPCV 10
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Toddler Prevenar 13
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Infants SIILPCV 10
Serious events: 6 serious events
Other events: 97 other events
Deaths: 0 deaths
Infants Prevenar 13
Serious events: 2 serious events
Other events: 96 other events
Deaths: 0 deaths
Booster Infants SIILPCV 10
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Booster Infants Prevenar 13
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adult SIILPCV 10
n=17 participants at risk
Single dose of SIILPCV10 on Day 0
|
Adult Pneumovax 23
n=17 participants at risk
Single dose of Pneumovax 23 on Day 0
|
Toddler SIILPCV 10
n=56 participants at risk
Single dose of SIILPCV10 on Day 0
|
Toddler Prevenar 13
n=56 participants at risk
Single dose of Prevenar 13 on Day 0
|
Infants SIILPCV 10
n=100 participants at risk
A 3-dose series of SIILPCV 10 on Days 0, 28, \& 56
|
Infants Prevenar 13
n=100 participants at risk
A 3-dose series of Prevenar 13 on Days 0, 28, \& 56
|
Booster Infants SIILPCV 10
n=49 participants at risk
Booster dose of SIILPCV 10 at 9 months of age
|
Booster Infants Prevenar 13
n=47 participants at risk
Booster dose of Prevenar 13 at 9 months of age
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
1.8%
1/56 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
1.8%
1/56 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
6.0%
6/100 • Number of events 6 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
2.0%
2/100 • Number of events 2 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Infections and infestations
Malaria
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
2.0%
1/49 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
2.0%
1/49 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
Other adverse events
| Measure |
Adult SIILPCV 10
n=17 participants at risk
Single dose of SIILPCV10 on Day 0
|
Adult Pneumovax 23
n=17 participants at risk
Single dose of Pneumovax 23 on Day 0
|
Toddler SIILPCV 10
n=56 participants at risk
Single dose of SIILPCV10 on Day 0
|
Toddler Prevenar 13
n=56 participants at risk
Single dose of Prevenar 13 on Day 0
|
Infants SIILPCV 10
n=100 participants at risk
A 3-dose series of SIILPCV 10 on Days 0, 28, \& 56
|
Infants Prevenar 13
n=100 participants at risk
A 3-dose series of Prevenar 13 on Days 0, 28, \& 56
|
Booster Infants SIILPCV 10
n=49 participants at risk
Booster dose of SIILPCV 10 at 9 months of age
|
Booster Infants Prevenar 13
n=47 participants at risk
Booster dose of Prevenar 13 at 9 months of age
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
5.9%
1/17 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
23.5%
4/17 • Number of events 4 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
5.9%
1/17 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
12.5%
7/56 • Number of events 7 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
8.9%
5/56 • Number of events 6 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
29.0%
29/100 • Number of events 34 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
22.0%
22/100 • Number of events 22 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
4.1%
2/49 • Number of events 2 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
10.6%
5/47 • Number of events 5 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
5.9%
1/17 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Gastrointestinal disorders
Toothache
|
5.9%
1/17 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
17.6%
3/17 • Number of events 3 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
General disorders
Axillary pain
|
5.9%
1/17 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
5.9%
1/17 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
General disorders
Vaccination site pruritis
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
5.9%
1/17 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
General disorders
Vaccination site swelling
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
5.9%
1/17 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
55.0%
55/100 • Number of events 72 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
61.0%
61/100 • Number of events 77 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Infections and infestations
Abscess
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
5.9%
1/17 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Infections and infestations
Otitis media
|
5.9%
1/17 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
5.9%
1/17 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
1/17 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
5.9%
1/17 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
14.3%
8/56 • Number of events 8 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
16.1%
9/56 • Number of events 9 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
64.0%
64/100 • Number of events 90 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
48.0%
48/100 • Number of events 72 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
28.6%
14/49 • Number of events 16 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
12.8%
6/47 • Number of events 6 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
5.9%
1/17 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
5.9%
1/17 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
General disorders
Pyrexia
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
3.6%
2/56 • Number of events 2 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
7.1%
4/56 • Number of events 4 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
9.0%
9/100 • Number of events 9 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
3.0%
3/100 • Number of events 3 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
2.0%
1/49 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
6.4%
3/47 • Number of events 3 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Infections and infestations
Impetigo
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
6.1%
3/49 • Number of events 3 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
6.4%
3/47 • Number of events 3 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Infections and infestations
Rash Pustular
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
2.0%
1/49 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
8.5%
4/47 • Number of events 4 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
8.2%
4/49 • Number of events 4 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
6.4%
3/47 • Number of events 4 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
General disorders
Vaccination site reaction
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
11.0%
11/100 • Number of events 12 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
4.0%
4/100 • Number of events 4 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
5.0%
5/100 • Number of events 8 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
6.0%
6/100 • Number of events 6 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
27.0%
27/100 • Number of events 29 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
19.0%
19/100 • Number of events 20 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Infections and infestations
Furuncle
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
1.8%
1/56 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
8.9%
5/56 • Number of events 5 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
8.0%
8/100 • Number of events 8 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
6.0%
6/100 • Number of events 7 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
12.5%
7/56 • Number of events 7 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
8.9%
5/56 • Number of events 5 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
19.0%
19/100 • Number of events 20 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
17.0%
17/100 • Number of events 21 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
8.0%
8/100 • Number of events 8 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
8.0%
8/100 • Number of events 8 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
7.1%
4/56 • Number of events 4 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
1.8%
1/56 • Number of events 1 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
31.0%
31/100 • Number of events 35 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
21.0%
21/100 • Number of events 24 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Infections and infestations
Cough
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
12.0%
12/100 • Number of events 12 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
7.0%
7/100 • Number of events 7 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Skin and subcutaneous tissue disorders
Papular rash
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/56 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
5.0%
5/100 • Number of events 5 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
8.0%
8/100 • Number of events 9 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Blood and lymphatic system disorders
Microcytic anemia
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
5.4%
3/56 • Number of events 3 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
7.1%
4/56 • Number of events 4 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/17 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
5.4%
3/56 • Number of events 3 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
8.9%
5/56 • Number of events 5 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/100 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/49 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
0.00%
0/47 • All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place