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Safety and Immunogenicity of a 10 Valent Pneumococcal Conjugate Vaccine (SIILPCV10) in Healthy Adults, Toddlers, Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02308540
Recruitment Status : Completed
First Posted : December 4, 2014
Results First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
PATH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Pneumococcal Disease
Interventions Biological: SIILPCV10
Biological: Pneumovax 23
Biological: Prevenar 13
Enrollment 346
Recruitment Details  
Pre-assignment Details Adult cohort: 43 screened and 9 screen failures Toddler cohort: 173 screened and 61 screen failures Infant cohort: 262 screened and 62 screen failures
Arm/Group Title Adult SIILPCV10 Adult Pneumovax 23 Toddler SIILPCV10 Toddler Prevenar 13 Infants SIILPCV10 Infants Prevenar 13
Hide Arm/Group Description Single dose of SIILPCV10 on day 0 Single dose of Pneumovax 23 on day 0 Single dose of SIILPCV10 on day 0 Single dose of Prevenar 13 on day 0

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).

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
Period Title: Overall Study
Started 17 17 56 56 100 100
Randomized 17 17 56 56 100 100
Vaccinated 17 17 56 56 100 100
Completed 17 17 56 56 100 99
Not Completed 0 0 0 0 0 1
Reason Not Completed
Lost to Follow-up             0             0             0             0             0             1
Arm/Group Title Adults--PCV 10 Adults--Pneumovax 23 Toddler--PCV 10 Toddler--Prevenar 13 Infant--PCV 10 Infant--Prevenar 13 Infant Boost--PCV 10 Infant Boost--Prevenar 13 Total
Hide Arm/Group Description Single dose of SIILPCV 10 on Day 0 Single dose of Pneumovax 23 on Day 0 Single dose of SIILPCV 10 on Day 0 Single dose of Prevenar 13 on Day 0 A 3-dose series of SIILPCV 10 on Day 0, Day 28, and Day 56. A 3-dose series of Prevenar 13 on Day 0, Day 28, and Day 56. [Subset of infants in main study] Booster dose of SIILPCV 10 at 9 months of age [Subset of infants in main study] Booster dose of Prevenar 13 at 9 months of age Total of all reporting groups
Overall Number of Baseline Participants 17 17 56 56 100 100 49 47 442
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Adults in years Number Analyzed 17 participants 17 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 34 participants
25.9  (4.1) 25.9  (4.4) 25.9  (4.1)
[1]
Measure Analysis Population Description: Only adults are included in this category. Infants and toddlers are included in their own separate categories.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Days
Infants--Age in Days Number Analyzed 0 participants 0 participants 0 participants 0 participants 100 participants 100 participants 0 participants 0 participants 200 participants
47.2  (4) 47.3  (3.8) 47.2  (3.9)
[1]
Measure Analysis Population Description: Only infants are represented here. Adults, toddlers and infants in booster cohort are represented separately.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Toddler--Age in months Number Analyzed 0 participants 0 participants 56 participants 56 participants 0 participants 0 participants 0 participants 0 participants 112 participants
13.3  (0.9) 13.3  (0.8) 13.3  (0.9)
[1]
Measure Analysis Population Description: Only toddlers are represented here. Adults and infants are presented separately.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Infant Booster age in Months Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 49 participants 47 participants 96 participants
11.4  (0.8) 11.5  (0.9) 11.4  (0.8)
[1]
Measure Analysis Population Description: This includes data from infant booster cohort. Data from adults, toddlers and infants are represented separately
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 56 participants 56 participants 100 participants 100 participants 49 participants 47 participants 442 participants
Female
4
  23.5%
4
  23.5%
30
  53.6%
32
  57.1%
52
  52.0%
49
  49.0%
20
  40.8%
20
  42.6%
211
  47.7%
Male
13
  76.5%
13
  76.5%
26
  46.4%
24
  42.9%
48
  48.0%
51
  51.0%
29
  59.2%
27
  57.4%
231
  52.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
African Number Analyzed 17 participants 17 participants 56 participants 56 participants 100 participants 100 participants 49 participants 47 participants 442 participants
17
 100.0%
17
 100.0%
56
 100.0%
56
 100.0%
100
 100.0%
99
  99.0%
49
 100.0%
47
 100.0%
441
  99.8%
Asian Number Analyzed 17 participants 17 participants 56 participants 56 participants 100 participants 100 participants 49 participants 47 participants 442 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Other Number Analyzed 17 participants 17 participants 56 participants 56 participants 100 participants 100 participants 49 participants 47 participants 442 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.0%
0
   0.0%
0
   0.0%
1
   0.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Gambia Number Analyzed 17 participants 17 participants 56 participants 56 participants 100 participants 100 participants 49 participants 47 participants 442 participants
17 17 56 56 100 100 49 47 442
Ethnicity  
Measure Type: Count of Participants
Unit of measure:  Participants
Mandinka Number Analyzed 17 participants 17 participants 56 participants 56 participants 100 participants 100 participants 49 participants 47 participants 442 participants
10
  58.8%
7
  41.2%
28
  50.0%
27
  48.2%
42
  42.0%
55
  55.0%
23
  46.9%
28
  59.6%
220
  49.8%
Wolof Number Analyzed 17 participants 17 participants 56 participants 56 participants 100 participants 100 participants 49 participants 47 participants 442 participants
3
  17.6%
1
   5.9%
4
   7.1%
11
  19.6%
18
  18.0%
10
  10.0%
9
  18.4%
2
   4.3%
58
  13.1%
Fula Number Analyzed 17 participants 17 participants 56 participants 56 participants 100 participants 100 participants 49 participants 47 participants 442 participants
2
  11.8%
4
  23.5%
6
  10.7%
7
  12.5%
12
  12.0%
10
  10.0%
6
  12.2%
5
  10.6%
52
  11.8%
Jola Number Analyzed 17 participants 17 participants 56 participants 56 participants 100 participants 100 participants 49 participants 47 participants 442 participants
1
   5.9%
2
  11.8%
11
  19.6%
3
   5.4%
12
  12.0%
12
  12.0%
5
  10.2%
3
   6.4%
49
  11.1%
Serahule Number Analyzed 17 participants 17 participants 56 participants 56 participants 100 participants 100 participants 49 participants 47 participants 442 participants
0
   0.0%
2
  11.8%
2
   3.6%
2
   3.6%
5
   5.0%
3
   3.0%
1
   2.0%
3
   6.4%
18
   4.1%
Serere Number Analyzed 17 participants 17 participants 56 participants 56 participants 100 participants 100 participants 49 participants 47 participants 442 participants
0
   0.0%
0
   0.0%
3
   5.4%
3
   5.4%
8
   8.0%
5
   5.0%
5
  10.2%
5
  10.6%
29
   6.6%
Manjago Number Analyzed 17 participants 17 participants 56 participants 56 participants 100 participants 100 participants 49 participants 47 participants 442 participants
0
   0.0%
1
   5.9%
1
   1.8%
0
   0.0%
0
   0.0%
1
   1.0%
0
   0.0%
0
   0.0%
3
   0.7%
Other Number Analyzed 17 participants 17 participants 56 participants 56 participants 100 participants 100 participants 49 participants 47 participants 442 participants
1
   5.9%
0
   0.0%
1
   1.8%
3
   5.4%
3
   3.0%
4
   4.0%
0
   0.0%
1
   2.1%
13
   2.9%
1.Primary Outcome
Title Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Hide Description

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).
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least 1 study vaccination and had at least 1 post vaccination safety measurement.
Arm/Group Title Adults--PCV10 Adults--Pneumovax 23 Toddler--PCV 10 Toddler--Prevenar 13
Hide Arm/Group Description:
A single dose of SIILPCV 10 at Day 0
A single dose of Pneumovax 23 at Day 0
A single dose of SIIL PCV 10 at Day 0
A single dose of Prevenar 13 at Day 0
Overall Number of Participants Analyzed 17 17 56 56
Measure Type: Count of Participants
Unit of Measure: Participants
Temperature above 37.5 C Grade 1
0
   0.0%
0
   0.0%
5
   8.9%
6
  10.7%
Grade 2
0
   0.0%
0
   0.0%
2
   3.6%
4
   7.1%
Grade 3
0
   0.0%
0
   0.0%
2
   3.6%
1
   1.8%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None reported/normal (temp)
17
 100.0%
17
 100.0%
47
  83.9%
45
  80.4%
Rash Grade 1
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
Grade 2
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None reported/normal (temp)
17
 100.0%
17
 100.0%
54
  96.4%
56
 100.0%
Fatigue/Malaise/Drowsiness (inf/tod) Grade 1
1
   5.9%
2
  11.8%
5
   8.9%
0
   0.0%
Grade 2
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None reported/normal (temp)
16
  94.1%
15
  88.2%
50
  89.3%
56
 100.0%
Myalgia/Arthralgia (adults only) Grade 1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None reported/normal (temp)
17
 100.0%
17
 100.0%
56
 100.0%
56
 100.0%
Headache (adults only) Grade 1
3
  17.6%
4
  23.5%
0
   0.0%
0
   0.0%
Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None reported/normal (temp)
14
  82.4%
13
  76.5%
56
 100.0%
56
 100.0%
Decreased Appetite Grade 1
0
   0.0%
0
   0.0%
7
  12.5%
6
  10.7%
Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None reported/normal (temp)
17
 100.0%
17
 100.0%
49
  87.5%
50
  89.3%
Pain (adults only) Grade 1
10
  58.8%
9
  52.9%
0
   0.0%
0
   0.0%
Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None reported/normal (temp)
7
  41.2%
8
  47.1%
56
 100.0%
56
 100.0%
Tenderness Grade 1
6
  35.3%
8
  47.1%
10
  17.9%
11
  19.6%
Grade 2
0
   0.0%
0
   0.0%
2
   3.6%
1
   1.8%
Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None reported/normal (temp)
11
  64.7%
9
  52.9%
44
  78.6%
44
  78.6%
Redness Grade 1
0
   0.0%
0
   0.0%
1
   1.8%
2
   3.6%
Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None reported/normal (temp)
17
 100.0%
17
 100.0%
55
  98.2%
54
  96.4%
Swelling Grade 1
0
   0.0%
0
   0.0%
4
   7.1%
1
   1.8%
Grade 2
0
   0.0%
0
   0.0%
2
   3.6%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None reported/normal (temp)
17
 100.0%
17
 100.0%
50
  89.3%
55
  98.2%
Irritability (toddlers only) Grade 1
0
   0.0%
0
   0.0%
4
   7.1%
3
   5.4%
Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None reported/normal (temp)
17
 100.0%
17
 100.0%
52
  92.9%
53
  94.6%
2.Primary Outcome
Title Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Hide Description

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).
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Infant--PCV 10 Infant--Prevenar 13
Hide Arm/Group Description:
Injection of SIIL PCV 10 given on Day 0
Injection of Prevenar 13 on Day 0
Overall Number of Participants Analyzed 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
Temperature Grade 1
29
  29.0%
34
  34.0%
Grade 2
11
  11.0%
7
   7.0%
None
60
  60.0%
59
  59.0%
Irritability Grade 1
33
  33.0%
29
  29.0%
Grade 2
4
   4.0%
2
   2.0%
None
63
  63.0%
69
  69.0%
Drowsiness Grade 1
8
   8.0%
1
   1.0%
Grade 2
0
   0.0%
1
   1.0%
None
92
  92.0%
98
  98.0%
Decreased appetite Grade 1
10
  10.0%
1
   1.0%
Grade 2
0
   0.0%
1
   1.0%
None
90
  90.0%
98
  98.0%
Tenderness at injection site Grade 1
15
  15.0%
12
  12.0%
Grade 2
4
   4.0%
5
   5.0%
None
81
  81.0%
83
  83.0%
Erythema/redness at injection site Grade 1
1
   1.0%
8
   8.0%
Grade 2
0
   0.0%
1
   1.0%
None
99
  99.0%
91
  91.0%
Induration/swelling at injection site Grade 1
4
   4.0%
8
   8.0%
Grade 2
0
   0.0%
2
   2.0%
None
96
  96.0%
90
  90.0%
3.Primary Outcome
Title Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Hide Description

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).
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Infant--PCV 10 Infant--Prevenar 13
Hide Arm/Group Description:
Injection of SIIL PCV 10 given on Days 0 and 28
Injection of Prevenar 13 on Days 0 and 28
Overall Number of Participants Analyzed 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
Temperature Grade 1
11
  11.0%
13
  13.0%
Grade 2
7
   7.0%
6
   6.0%
None
82
  82.0%
81
  81.0%
Irritability Grade 1
35
  35.0%
30
  30.0%
Grade 2
5
   5.0%
3
   3.0%
None
60
  60.0%
67
  67.0%
Drowsiness Grade 1
6
   6.0%
1
   1.0%
Grade 2
0
   0.0%
1
   1.0%
None
94
  94.0%
98
  98.0%
Decreased appetite Grade 1
9
   9.0%
8
   8.0%
Grade 2
1
   1.0%
0
   0.0%
None
90
  90.0%
92
  92.0%
Tenderness at injection site Grade 1
18
  18.0%
26
  26.0%
Grade 2
2
   2.0%
1
   1.0%
None
80
  80.0%
73
  73.0%
Erythema/redness at injection site Grade 1
0
   0.0%
4
   4.0%
Grade 2
1
   1.0%
1
   1.0%
None
99
  99.0%
95
  95.0%
Induration/swelling at injection site Grade 1
7
   7.0%
16
  16.0%
Grade 2
1
   1.0%
2
   2.0%
None
92
  92.0%
82
  82.0%
4.Primary Outcome
Title Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Hide Description

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).
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Infant--PCV 10 Infant--Prevenar 13
Hide Arm/Group Description:
Injection of SIIL PCV 10 given on Days 0, 28, & 56.
Injection of Prevenar 13 on Days 0, 28, & 56.
Overall Number of Participants Analyzed 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
Temperature Grade 1
15
  15.0%
16
  16.0%
Grade 2
4
   4.0%
4
   4.0%
Grade 3
1
   1.0%
0
   0.0%
None
80
  80.0%
80
  80.0%
Irritability Grade 1
33
  33.0%
37
  37.0%
Grade 2
3
   3.0%
4
   4.0%
Grade 3
1
   1.0%
0
   0.0%
None
63
  63.0%
59
  59.0%
Drowsiness Grade 1
2
   2.0%
3
   3.0%
Grade 2
0
   0.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
None
98
  98.0%
97
  97.0%
Decreased appetite Grade 1
6
   6.0%
9
   9.0%
Grade 2
1
   1.0%
2
   2.0%
Grade 3
0
   0.0%
0
   0.0%
None
93
  93.0%
89
  89.0%
Tenderness at injection site Grade 1
21
  21.0%
19
  19.0%
Grade 2
0
   0.0%
2
   2.0%
Grade 3
0
   0.0%
0
   0.0%
None
79
  79.0%
79
  79.0%
Erythema/redness at injection site Grade 1
3
   3.0%
3
   3.0%
Grade 2
0
   0.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
None
97
  97.0%
97
  97.0%
Induration/swelling at injection site Grade 1
11
  11.0%
13
  13.0%
Grade 2
2
   2.0%
1
   1.0%
Grade 3
0
   0.0%
0
   0.0%
None
87
  87.0%
86
  86.0%
5.Primary Outcome
Title Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Hide Description Reported here are only adverse events occurring in 5% or more of subjects; unless specifically stated, AEs were regarded as unrelated.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Adults--PCV 10 Adults--Pneumovax 23 Toddler--PCV 10 Toddler--Prevenar 13
Hide Arm/Group Description:
Single dose of SIILPCV 10 at Day 0
Single dose of Pneumovax 23 at Day 0
Single dose of SIILPCV 10 at Day 0
Single dose of Prevenar 13 at Day 0
Overall Number of Participants Analyzed 17 17 56 56
Measure Type: Count of Participants
Unit of Measure: Participants
Microcytic Anemia (Toddlers) Mild
0
   0.0%
0
   0.0%
1
   1.8%
3
   5.4%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.8%
Severe
0
   0.0%
0
   0.0%
2
   3.6%
0
   0.0%
None
17
 100.0%
17
 100.0%
53
  94.6%
52
  92.9%
Diarrhea (Both) Mild
0
   0.0%
1
   5.9%
7
  12.5%
5
   8.9%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.8%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
16
  94.1%
49
  87.5%
50
  89.3%
Diarrhea--related Mild
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
17
 100.0%
55
  98.2%
56
 100.0%
Pyrexia (Toddlers) Mild
0
   0.0%
0
   0.0%
1
   1.8%
2
   3.6%
Moderate
0
   0.0%
0
   0.0%
1
   1.8%
2
   3.6%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
17
 100.0%
54
  96.4%
52
  92.9%
Furuncle (Toddlers) Mild
0
   0.0%
0
   0.0%
1
   1.8%
5
   8.9%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
17
 100.0%
55
  98.2%
51
  91.1%
Gastroenteritis (Toddlers) Mild
0
   0.0%
0
   0.0%
2
   3.6%
4
   7.1%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.8%
Severe
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
None
17
 100.0%
17
 100.0%
53
  94.6%
51
  91.1%
Nasopharyngitis (Toddlers) Mild
0
   0.0%
0
   0.0%
7
  12.5%
5
   8.9%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
17
 100.0%
49
  87.5%
51
  91.1%
Tinea infection (Toddlers) Mild
0
   0.0%
0
   0.0%
4
   7.1%
1
   1.8%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
17
 100.0%
52
  92.9%
55
  98.2%
Upper respiratory infection (Both) Mild
1
   5.9%
1
   5.9%
6
  10.7%
7
  12.5%
Moderate
0
   0.0%
0
   0.0%
2
   3.6%
2
   3.6%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
16
  94.1%
16
  94.1%
48
  85.7%
47
  83.9%
Abdominal pain (Adults) Mild
1
   5.9%
3
  17.6%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
3
  17.6%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
16
  94.1%
11
  64.7%
56
 100.0%
56
 100.0%
Food poisoning (Adults) Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
16
  94.1%
56
 100.0%
56
 100.0%
Toothache (Adults) Mild
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
Moderate
1
   5.9%
1
   5.9%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
16
  94.1%
15
  88.2%
56
 100.0%
56
 100.0%
Axillary pain (Adults) Mild
1
   5.9%
1
   5.9%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
16
  94.1%
16
  94.1%
56
 100.0%
56
 100.0%
Axillary pain--related Mild
1
   5.9%
1
   5.9%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
16
  94.1%
16
  94.1%
56
 100.0%
56
 100.0%
Vaccination site pruritis (Both) Mild
0
   0.0%
1
   5.9%
0
   0.0%
1
   1.8%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
16
  94.1%
56
 100.0%
55
  98.2%
Vaccination site pruritis--related Mild
0
   0.0%
1
   5.9%
0
   0.0%
1
   1.8%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
16
  94.1%
56
 100.0%
55
  98.2%
Vaccination site swelling (Adults) Mild
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
16
  94.1%
56
 100.0%
56
 100.0%
Vaccination site swelling--related Mild
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
16
  94.1%
56
 100.0%
56
 100.0%
Abscess (Adults) Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
16
  94.1%
56
 100.0%
56
 100.0%
Otitis media (Adults) Mild
1
   5.9%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
16
  94.1%
17
 100.0%
56
 100.0%
56
 100.0%
Tonsillitis (Adults) Mild
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
16
  94.1%
56
 100.0%
56
 100.0%
Urinary tract infection (Adults) Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
16
  94.1%
56
 100.0%
56
 100.0%
Dizziness (Adults) Mild
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
Moderate
1
   5.9%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
16
  94.1%
16
  94.1%
56
 100.0%
56
 100.0%
Dizziness--related Mild
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
16
  94.1%
56
 100.0%
56
 100.0%
6.Primary Outcome
Title Occurrence, Severity and Relatedness of All Adverse Events in Infants
Hide Description 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.
Time Frame 12 weeks post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Infant--PCV 10 Infant--Prevenar 13
Hide Arm/Group Description:
Injection of SIIL PCV 10 given on Days 0, 28, & 56.
Injection of Prevenar 13 on Days 0, 28, & 56.
Overall Number of Participants Analyzed 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
Diarrhea
29
  29.0%
19
  19.0%
Pyrexia
9
   9.0%
3
   3.0%
Vaccination site reaction (routine vaccines)
11
  11.0%
4
   4.0%
Vaccination site swelling (routine vaccines)
55
  55.0%
61
  61.0%
Vaccination site swelling (study vaccine)
1
   1.0%
6
   6.0%
Bronchiolitis
5
   5.0%
6
   6.0%
Conjunctivitis
27
  27.0%
19
  19.0%
Furuncle
8
   8.0%
6
   6.0%
Gastroenteritis
13
  13.0%
10
  10.0%
Impetigo
5
   5.0%
4
   4.0%
Nasopharyngitis
19
  19.0%
17
  17.0%
Otitis media--acute
5
   5.0%
4
   4.0%
Pneumonia
8
   8.0%
8
   8.0%
Tinea infection
31
  31.0%
21
  21.0%
Upper respiratory tract infection
64
  64.0%
48
  48.0%
Cough
12
  12.0%
7
   7.0%
Diaper dermatitis
4
   4.0%
5
   5.0%
Papular rash
5
   5.0%
8
   8.0%
Serious Adverse Event (SAE): Diarrhea
1
   1.0%
0
   0.0%
SAE: Gastroenteritis
1
   1.0%
0
   0.0%
SAE: Bronchiolitis
3
   3.0%
1
   1.0%
SAE: Atypical pneumonia
1
   1.0%
0
   0.0%
SAE: Sepsis
0
   0.0%
1
   1.0%
7.Primary Outcome
Title Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Hide Description 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.
Time Frame 7 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
This table displays vaccinated adults and toddlers only. Infants had laboratory tests only at screening.
Arm/Group Title Adult SIILPCV10 Adult Pneumovax 23 Toddler SIILPCV10 Toddler Prevenar 13
Hide Arm/Group Description:
Single dose of SIILPCV10 on Day 0
Single dose of Pneumovax 23 on Day 0
Single dose of SIILPCV10 on Day 0
Single dose of Prevenar 13 on Day 0
Overall Number of Participants Analyzed 17 17 56 56
Measure Type: Count of Participants
Unit of Measure: Participants
Decreased WBCs--not related Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
1
   5.9%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
None
16
  94.1%
16
  94.1%
56
 100.0%
56
 100.0%
Decreased WBCs--vaccine related Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
16
  94.1%
56
 100.0%
56
 100.0%
Increased WBCs--not related Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
1
   1.8%
1
   1.8%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
17
 100.0%
55
  98.2%
55
  98.2%
Increased WBCs--vaccine related Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
17
 100.0%
55
  98.2%
56
 100.0%
Decreased hemoglobin--not related Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
5
   8.9%
10
  17.9%
None
17
 100.0%
17
 100.0%
51
  91.1%
46
  82.1%
Decreased hemoglobin--vaccine related Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
17
 100.0%
56
 100.0%
56
 100.0%
Increased ALT--not related Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
17
 100.0%
56
 100.0%
56
 100.0%
Increased ALT--vaccine related Mild
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
17
 100.0%
55
  98.2%
56
 100.0%
Decreased platelets--not related Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
17
 100.0%
56
 100.0%
56
 100.0%
Decreased platelets--vaccine related Mild
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.8%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
17
 100.0%
17
 100.0%
56
 100.0%
55
  98.2%
8.Secondary Outcome
Title Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults
Hide Description Serum samples were collected 28 days after the vaccination in adults to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.
Time Frame 4 weeks after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Adults--PCV 10 Adults--Pneumovax 23
Hide Arm/Group Description:
Single dose of SIILPCV 10 on Day 0
Single dose of Pneumovax 23 on Day 0
Overall Number of Participants Analyzed 17 17
Geometric Mean (90% Confidence Interval)
Unit of Measure: µg/mL
PnC-IgG-ELISA type 1 Number Analyzed 17 participants 17 participants
3.96
(2.51 to 6.24)
12.79
(8.34 to 19.61)
PnC-IgG-ELISA type 5 Number Analyzed 17 participants 17 participants
3.56
(2.11 to 6.01)
4.80
(3.07 to 7.51)
PnC-IgG-ELISA type 6A Number Analyzed 16 participants 16 participants
17.09
(9.64 to 30.29)
3.64
(2.59 to 5.12)
PnC-IgG-ELISA type 6B Number Analyzed 12 participants 15 participants
26.87
(15.24 to 47.36)
12.12
(8.12 to 18.07)
PnC-IgG-ELISA type 7F Number Analyzed 17 participants 17 participants
4.62
(3.44 to 6.20)
6.07
(4.10 to 9.0)
PnC-IgG-ELISA type 9V Number Analyzed 17 participants 17 participants
4.92
(3.45 to 7.03)
8.73
(6.70 to 11.37)
PnC-IgG-ELISA type 14 Number Analyzed 14 participants 16 participants
48.23
(31.60 to 73.62)
44.78
(33.13 to 60.52)
PnC-IgG-ELISA type 19A Number Analyzed 17 participants 16 participants
19.47
(12.13 to 31.25)
11.20
(6.26 to 20.05)
PnC-IgG-ELISA type 19F Number Analyzed 17 participants 17 participants
20.72
(14.62 to 29.37)
12.38
(7.53 to 20.37)
PnC-IgG-ELISA type 23F Number Analyzed 17 participants 17 participants
10.09
(6.26 to 16.24)
8.95
(5.61 to 14.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adults--PCV 10, Adults--Pneumovax 23
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value 0.0025
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 1 GMC Ratio
Estimated Value 0.31
Confidence Interval (2-Sided) 90%
0.17 to 0.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adults--PCV 10, Adults--Pneumovax 23
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value 0.4540
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 5 GMC Ratio
Estimated Value 0.74
Confidence Interval (2-Sided) 90%
0.38 to 1.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adults--PCV 10, Adults--Pneumovax 23
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 6A GMC Ratio
Estimated Value 4.69
Confidence Interval (2-Sided) 90%
2.46 to 8.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Adults--PCV 10, Adults--Pneumovax 23
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value 0.0460
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 6B GMC Ratio
Estimated Value 2.22
Confidence Interval (2-Sided) 90%
1.16 to 4.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Adults--PCV 10, Adults--Pneumovax 23
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value 0.3365
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 7F GMC Ratio
Estimated Value 0.76
Confidence Interval (2-Sided) 90%
0.47 to 1.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Adults--PCV 10, Adults--Pneumovax 23
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value 0.0313
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 9V GMC Ratio
Estimated Value 0.56
Confidence Interval (2-Sided) 90%
0.37 to 0.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Adults--PCV 10, Adults--Pneumovax 23
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value 0.8060
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 14 GMC Ratio
Estimated Value 1.08
Confidence Interval (2-Sided) 90%
0.65 to 1.79
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Adults--PCV 10, Adults--Pneumovax 23
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value 0.2044
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 19A GMC Ratio
Estimated Value 1.74
Confidence Interval (2-Sided) 90%
0.84 to 3.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Adults--PCV 10, Adults--Pneumovax 23
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value 0.1490
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 19F GMC Ratio
Estimated Value 1.67
Confidence Interval (2-Sided) 90%
0.93 to 3.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Adults--PCV 10, Adults--Pneumovax 23
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value 0.7565
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 23F GMC Ratio
Estimated Value 1.13
Confidence Interval (2-Sided) 90%
0.59 to 2.15
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
Hide Description Serum samples were collected 28 days after vaccination for toddlers to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.
Time Frame 4 weeks after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Toddler--PCV 10 Toddler--Prevenar 13
Hide Arm/Group Description:
Dose of SIILPCV 10 on Day 0
Dose of Prevenar 13 on Day 0
Overall Number of Participants Analyzed 56 56
Geometric Mean (90% Confidence Interval)
Unit of Measure: µg/mL
PnC-IgG-ELISA type 1: Baseline
0.77
(0.46 to 1.36)
0.92
(0.72 to 1.26)
PnC-IgG-ELISA type 1: Post-vaccination
4.59
(4.03 to 5.67)
6.09
(4.93 to 10.17)
PnC-IgG-ELISA type 5: Baseline
0.60
(0.36 to 1.04)
0.42
(0.32 to 0.51)
PnC-IgG-ELISA type 5: Post-vaccination
2.30
(1.67 to 3.48)
3.35
(2.63 to 5.03)
PnC-IgG-ELISA type 6A: Baseline
1.40
(0.88 to 2.67)
1.29
(0.97 to 1.72)
PnC-IgG-ELISA type 6A: Post-vaccination
13.33
(10.15 to 20.81)
15.83
(12.52 to 25.12)
PnC-IgG-ELISA type 6B: Baseline
2.02
(1.29 to 3.42)
1.95
(1.41 to 2.55)
PnC-IgG-ELISA type 6B: Post-vaccination
15.77
(12.20 to 22.43)
19.16
(15.81 to 28.72)
PnC-IgG-ELISA type 7F: Baseline
1.49
(0.96 to 2.10)
1.46
(0.99 to 1.86)
PnC-IgG-ELISA type 7F: Post-vaccination
9.17
(7.69 to 11.64)
12.35
(9.41 to 18.55)
PnC-IgG-ELISA type 9V: Baseline
0.53
(0.31 to 0.86)
0.41
(0.28 to 0.51)
PnC-IgG-ELISA type 9V: Post-vaccination
2.35
(1.69 to 3.25)
3.90
(2.79 to 5.95)
PnC-IgG-ELISA type 14: Baseline
2.89
(1.60 to 4.40)
2.47
(1.70 to 3.80)
PnC-IgG-ELISA type 14: Post-vaccination
14.55
(9.29 to 20.60)
8.28
(6.49 to 12.55)
PnC-IgG-ELISA type 19A: Baseline
1.17
(0.63 to 1.97)
0.57
(0.34 to 0.72)
PnC-IgG-ELISA type 19A: Post-vaccination
9.76
(7.23 to 12.18)
13.68
(7.12 to 20.02)
PnC-IgG-ELISA type 19F: Baseline
1.75
(0.85 to 3.43)
0.97
(0.65 to 1.58)
PnC-IgG-ELISA type 19F: Post-vaccination
9.75
(7.76 to 12.26)
12.87
(9.08 to 20.75)
PnC-IgG-ELISA type 23F: Baseline
0.71
(0.39 to 1.32)
0.63
(0.44 to 1.05)
PnC-IgG-ELISA type 23F: Post-vaccination
6.84
(4.76 to 10.03)
10.49
(8.21 to 18.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Toddler--PCV 10, Toddler--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).
Statistical Test of Hypothesis P-Value 0.2653
Comments [Not Specified]
Method Two-tailed from z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 1 GMC Ratio
Estimated Value 0.75
Confidence Interval (2-Sided) 90%
0.54 to 1.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Toddler--PCV 10, Toddler--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).
Statistical Test of Hypothesis P-Value 0.2059
Comments [Not Specified]
Method Two-tailed from z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 5 GMC Ratio
Estimated Value 0.69
Confidence Interval (2-Sided) 90%
0.45 to 1.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Toddler--PCV 10, Toddler--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).
Statistical Test of Hypothesis P-Value 0.5664
Comments [Not Specified]
Method Two-tailed from z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 6A GMC Ratio
Estimated Value 0.84
Confidence Interval (2-Sided) 90%
0.55 to 1.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Toddler--PCV 10, Toddler--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).
Statistical Test of Hypothesis P-Value 0.4456
Comments [Not Specified]
Method Two-tailed from z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 6B GMC Ratio
Estimated Value 0.82
Confidence Interval (2-Sided) 90%
0.57 to 1.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Toddler--PCV 10, Toddler--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).
Statistical Test of Hypothesis P-Value 0.2189
Comments [Not Specified]
Method Two-tailed from z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 7F GMC Ratio
Estimated Value 0.74
Confidence Interval (2-Sided) 90%
0.52 to 1.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Toddler--PCV 10, Toddler--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).
Statistical Test of Hypothesis P-Value 0.0970
Comments [Not Specified]
Method Two-tailed from z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 9V GMC Ratio
Estimated Value 0.60
Confidence Interval (2-Sided) 90%
0.38 to 1.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Toddler--PCV 10, Toddler--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).
Statistical Test of Hypothesis P-Value 0.0713
Comments [Not Specified]
Method Two-tailed from z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 14 GMC Ratio
Estimated Value 1.76
Confidence Interval (2-Sided) 90%
1.02 to 2.79
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Toddler--PCV 10, Toddler--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).
Statistical Test of Hypothesis P-Value 0.3443
Comments [Not Specified]
Method Two-tailed from z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 19A GMC Ratio
Estimated Value 0.71
Confidence Interval (2-Sided) 90%
0.42 to 1.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Toddler--PCV 10, Toddler--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).
Statistical Test of Hypothesis P-Value 0.3278
Comments [Not Specified]
Method Two-tailed from z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 19F GMC Ratio
Estimated Value 0.76
Confidence Interval (2-Sided) 90%
0.48 to 1.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Toddler--PCV 10, Toddler--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).
Statistical Test of Hypothesis P-Value 0.2039
Comments [Not Specified]
Method Two-tailed from z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 23F GMC Ratio
Estimated Value 0.65
Confidence Interval (2-Sided) 90%
0.40 to 1.16
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants
Hide Description 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.
Time Frame 4 weeks after the third dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infant--PCV 10 Infant--Prevenar 13
Hide Arm/Group Description:
Dose of SIILPCV 10 on Day 0, 28 and 56
Dose of Prevenar 13 on Day 0, 28 and 56
Overall Number of Participants Analyzed 100 100
Geometric Mean (90% Confidence Interval)
Unit of Measure: µg/mL
PnC-IgG-ELISA type 1 Number Analyzed 100 participants 100 participants
2.99
(2.61 to 3.43)
3.38
(3.02 to 3.78)
PnC-IgG-ELISA type 5 Number Analyzed 100 participants 100 participants
2.09
(1.86 to 2.36)
1.74
(1.53 to 1.98)
PnC-IgG-ELISA type 6A Number Analyzed 100 participants 100 participants
1.02
(0.83 to 1.27)
1.82
(1.53 to 2.17)
PnC-IgG-ELISA type 6B Number Analyzed 100 participants 96 participants
1.57
(1.28 to 1.92)
3.64
(3.01 to 4.42)
PnC-IgG-ELISA type 7F Number Analyzed 100 participants 100 participants
2.19
(1.89 to 2.53)
3.88
(3.44 to 4.38)
PnC-IgG-ELISA type 9V Number Analyzed 100 participants 100 participants
1.07
(0.93 to 1.23)
2.19
(1.91 to 2.50)
PnC-IgG-ELISA type 14 Number Analyzed 100 participants 99 participants
4.96
(4.20 to 5.87)
4.47
(3.62 to 5.53)
PnC-IgG-ELISA type 19A Number Analyzed 100 participants 96 participants
1.49
(1.26 to 1.76)
5.20
(4.37 to 6.20)
PnC-IgG-ELISA type 19F Number Analyzed 100 participants 96 participants
3.87
(3.35 to 4.49)
5.38
(4.79 to 6.05)
PnC-IgG-ELISA type 23F Number Analyzed 100 participants 100 participants
1.56
(1.32 to 1.83)
2.68
(2.28 to 3.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value 0.2550
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 1 GMC Ratio
Estimated Value 0.89
Confidence Interval (2-Sided) 90%
0.74 to 1.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value 0.0865
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 5 GMC Ratio
Estimated Value 1.20
Confidence Interval (2-Sided) 90%
1.01 to 1.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 6A GMC Ratio
Estimated Value 0.56
Confidence Interval (2-Sided) 90%
0.43 to 0.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 6B GMC Ratio
Estimated Value 0.43
Confidence Interval (2-Sided) 90%
0.33 to 0.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 7F GMC Ratio
Estimated Value 0.56
Confidence Interval (2-Sided) 90%
0.47 to 0.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 9V GMC Ratio
Estimated Value 0.49
Confidence Interval (2-Sided) 90%
0.41 to 0.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value 0.5234
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 14 GMC Ratio
Estimated Value 1.11
Confidence Interval (2-Sided) 90%
0.85 to 1.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 19A GMC Ratio
Estimated Value 0.29
Confidence Interval (2-Sided) 90%
0.22 to 0.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value 0.0040
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 19F GMC Ratio
Estimated Value 0.72
Confidence Interval (2-Sided) 90%
0.60 to 0.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pn IgG type 23F GMC Ratio
Estimated Value 0.58
Confidence Interval (2-Sided) 90%
0.46 to 0.73
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype
Hide Description 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.
Time Frame 4 weeks after vaccination (28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable group differs for individual serotypes due to non-reportable results.
Arm/Group Title Toddler--PCV 10 Toddler--Prevenar 13
Hide Arm/Group Description:
Single dose of SIILPCV 10 on Day 0
Single dose of Prevenar 13 on Day 0
Overall Number of Participants Analyzed 17 17
Geometric Mean (90% Confidence Interval)
Unit of Measure: fold change
PnC-IgG-ELISA type 1
5.99
(3.94 to 10.12)
6.59
(5.06 to 11.10)
PnC-IgG-ELISA type 5
3.82
(2.67 to 6.67)
8.00
(6.79 to 12.16)
PnC-IgG-ELISA type 6A
9.91
(6.14 to 19.88)
12.31
(9.81 to 20.31)
PnC-IgG-ELISA type 6B
7.79
(5.02 to 14.78)
9.82
(8.12 to 15.03)
PnC-IgG-ELISA type 7F
6.16
(4.68 to 9.94)
8.44
(6.83 to 13.90)
PnC-IgG-ELISA type 9V
4.43
(3.30 to 6.93)
9.58
(7.81 to 15.35)
PnC-IgG-ELISA type 14
5.04
(3.52 to 7.42)
3.35
(2.41 to 5.12)
PnC-IgG-ELISA type 19A
7.89
(4.56 to 15.32)
24.17
(18.51 to 36.37)
PnC-IgG-ELISA type 19F
5.73
(3.24 to 13.28)
13.26
(9.35 to 21.82)
PnC-IgG-ELISA type 23F
9.67
(6.11 to 17.18)
16.54
(12.53 to 28.13)
12.Secondary Outcome
Title Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype
Hide Description 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.
Time Frame 4 weeks after third dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infant--PCV 10 Infant--Prevenar 13
Hide Arm/Group Description:
Dose of SIILPCV 10 on Days 0, 28 & 56
Dose of Prevenar 13 on Days 0, 28, & 56
Overall Number of Participants Analyzed 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
Pn-IgG-ELISA type 1
99
  99.0%
100
 100.0%
Pn-IgG-ELISA type 5
100
 100.0%
97
  97.0%
Pn-IgG-ELISA type 6A
79
  79.0%
91
  91.0%
Pn-IgG-ELISA type 6B
89
  89.0%
93
  93.0%
Pn-IgG-ELISA type 7F
97
  97.0%
100
 100.0%
Pn-IgG-ELISA type 9V
94
  94.0%
97
  97.0%
Pn-IgG-ELISA type 14
98
  98.0%
96
  96.0%
Pn-IgG-ELISA type 19A
92
  92.0%
94
  94.0%
Pn-IgG-ELISA type 19F
99
  99.0%
97
  97.0%
Pn-IgG-ELISA type 23F
91
  91.0%
97
  97.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.
Method of Estimation Estimation Parameter Absolute Difference for Type 1
Estimated Value -1.0
Confidence Interval (2-Sided) 90%
-5.13 to 2.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.
Method of Estimation Estimation Parameter Absolute Difference for Type 5
Estimated Value 3.0
Confidence Interval (2-Sided) 90%
-1.10 to 7.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.
Method of Estimation Estimation Parameter Absolute Difference for Type 6A
Estimated Value -12.0
Confidence Interval (2-Sided) 90%
-20.94 to -2.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.
Method of Estimation Estimation Parameter Absolute Difference for Type 6B
Estimated Value -7.9
Confidence Interval (2-Sided) 90%
-15.0 to -1.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.
Method of Estimation Estimation Parameter Absolute Difference for Type 7F
Estimated Value -3.0
Confidence Interval (2-Sided) 90%
-7.95 to 1.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.
Method of Estimation Estimation Parameter Absolute Difference for Type 9V
Estimated Value -3.0
Confidence Interval (2-Sided) 90%
-9.17 to 2.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.
Method of Estimation Estimation Parameter Absolute Difference for Type 14
Estimated Value 1.00
Confidence Interval (2-Sided) 90%
-4.00 to 6.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.
Method of Estimation Estimation Parameter Absolute Difference for Type 19A
Estimated Value -5.9
Confidence Interval (2-Sided) 90%
-12.38 to 0.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.
Method of Estimation Estimation Parameter Absolute Difference for Type 19F
Estimated Value 0.0
Confidence Interval (2-Sided) 90%
-4.22 to 4.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Infant--PCV 10, Infant--Prevenar 13
Comments [Not Specified]
Type of Statistical Test Other
Comments Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.
Method of Estimation Estimation Parameter Absolute Difference for Type 23F
Estimated Value -6.0
Confidence Interval (2-Sided) 90%
-12.77 to 0.40
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Functional Antibody (OPA) Geometric Mean Titers
Hide Description 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.
Time Frame 4 weeks after last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Randomly selected subsets of the infant and toddler cohorts and all adult subjects
Arm/Group Title Adults--PCV 10 Adults--Pneumovax 23 Toddler--PCV 10 Toddler--Prevenar 13 Infant--PCV 10 Infant--Prevenar 13
Hide Arm/Group Description:
Single dose of SIILPCV 10 on Day 0
Single dose of Pneumovax 23 on Day 0
Single dose of SIILPCV 10 on Day 0
Single dose of Prevenar 13 on Day 0
Dose of SIILPCV 10 on Days 0, 28 & 56
Dose of Prevenar 13 on Days 0, 28, & 56
Overall Number of Participants Analyzed 17 17 17 17 20 20
Geometric Mean (90% Confidence Interval)
Unit of Measure: titer
MOPA - Pn 1
18.89
(10.14 to 45.59)
85.89
(43.15 to 215.84)
436.31
(365.08 to 582.46)
438.14
(278.73 to 890.17)
50.65
(27.91 to 96.55)
29.42
(15.58 to 68.08)
MOPA - Pn 5
263.06
(138.91 to 499.28)
265.56
(143.22 to 521.05)
1358.22
(960.34 to 2087.48)
1148.43
(929.92 to 1708.67)
113.92
(74.12 to 167.10)
104.83
(64.11 to 181.22)
MOPA - Pn 6A
17161.52
(12378.36 to 23946.20)
4925.68
(3204.91 to 7661.38)
19371.45
(12538.18 to 34268.51)
12001.09
(8229.26 to 21545.31)
1243.88
(942.40 to 1834.30)
3068.16
(2267.85 to 5318.41)
MOPA - 6B
13303.68
(9432.51 to 18190.05)
4221.68
(2890.62 to 5925.09)
8768.08
(5471.57 to 12932.67)
7066.76
(4456.49 to 11894.25)
1530.37
(935.24 to 2368.41)
2267.44
(1175.92 to 3718.87)
MOPA - 7F
7099.73
(4147.20 to 11222.44)
8019.15
(4956.82 to 10917.82)
10723.98
(7151.48 to 16590.09)
12737.21
(8063.57 to 18328.98)
876.58
(616.90 to 1221.31)
3763.17
(2754.89 to 5393.72)
MOPA - 9V
3928.12
(2827.41 to 5629.89)
4443.95
(3275.91 to 6299.32)
3770.19
(2004.45 to 6384.49)
4862.30
(3128.56 to 6953.05)
197.24
(95.09 to 347.56)
752.77
(528.18 to 1024.26)
MOPA - 14
9148.12
(6271.81 to 12407.65)
6707.26
(5098.03 to 7886.64)
8213.23
(4526.63 to 13664.12)
2557.27
(1597.17 to 3868.34)
1243.39
(743.97 to 1912.05)
1108.02
(501.79 to 2097.51)
MOPA - 19A
3170.33
(1906.55 to 4427.88)
2215.22
(1314.65 to 3458.76)
1789.98
(651.04 to 3498.32)
3780.56
(2358.04 to 6045.56)
151.31
(64.25 to 233.45)
765.71
(589.49 to 886.28)
MOPA - 19F
3564.32
(2636.19 to 4898.79)
2481.47
(1623.91 to 3860.16)
3036.60
(2134.81 to 5126.44)
3371.52
(2238.81 to 5853.53)
744.92
(607.87 to 941.74)
498.98
(275.77 to 723.41)
MOPA - 23F
5035.73
(3417.87 to 7587.87)
2844.04
(2123.33 to 3737.09)
12415.92
(8018.97 to 19342.91)
10517.81
(5848.87 to 19460.60)
627.27
(341.95 to 975.77)
921.43
(574.79 to 1419.94)
14.Secondary Outcome
Title Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype
Hide Description 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.
Time Frame 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
Randomly selected subsets of the infant cohort
Arm/Group Title Infant--PCV 10 Infant--Prevenar 13
Hide Arm/Group Description:
Dose of SIILPCV 10 on Days 0, 28 & 56
Dose of Prevenar 13 on Days 0, 28, & 56
Overall Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
MOPA - Pn 1 Number Analyzed 16 participants 13 participants
15
  93.8%
11
  84.6%
MOPA - Pn 5 Number Analyzed 20 participants 20 participants
19
  95.0%
19
  95.0%
MOPA - Pn 6A Number Analyzed 20 participants 19 participants
20
 100.0%
18
  94.7%
MOPA - 6B Number Analyzed 19 participants 20 participants
19
 100.0%
19
  95.0%
MOPA - 7F Number Analyzed 20 participants 20 participants
20
 100.0%
20
 100.0%
MOPA - 9V Number Analyzed 20 participants 20 participants
20
 100.0%
20
 100.0%
MOPA - 14 Number Analyzed 19 participants 19 participants
19
 100.0%
18
  94.7%
MOPA - 19A Number Analyzed 17 participants 20 participants
16
  94.1%
20
 100.0%
MOPA - 19F Number Analyzed 20 participants 20 participants
20
 100.0%
19
  95.0%
MOPA - 23F Number Analyzed 20 participants 20 participants
20
 100.0%