Trial Outcomes & Findings for Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13 (NCT NCT05408429)
NCT ID: NCT05408429
Last Updated: 2024-09-19
Results Overview
Local reactions included redness, swelling, and pain at the injection site, recorded by parents/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit = 0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
356 participants
Primary outcome timeframe
Within 7 days after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
Results posted on
2024-09-19
Participant Flow
Participants included in this study were toddlers greater than or equal to (\>=) 12 to less than (\<) 24 months of age who had received 2 doses of 13-valent pneumococcal conjugate vaccine (13vPnC) (Prevenar 13) in infancy (prior to 12 months of age).
A total of 356 participants were enrolled and randomized to receive either 2 dose of 20-valent pneumococcal conjugate vaccine (20vPnC), 1 dose of 20vPnC or 1 dose of 13vPnC.
Participant milestones
| Measure |
2-Dose 20vPnC
Toddlers \>=12 to \<24 months of age were randomized to receive 2 doses of 0.5 milliliter (mL) 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit).
|
1-Dose 20vPnC
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
13vPnC Control
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
|---|---|---|---|
|
Overall Study
STARTED
|
121
|
118
|
117
|
|
Overall Study
COMPLETED
|
115
|
117
|
116
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
1
|
Reasons for withdrawal
| Measure |
2-Dose 20vPnC
Toddlers \>=12 to \<24 months of age were randomized to receive 2 doses of 0.5 milliliter (mL) 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit).
|
1-Dose 20vPnC
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
13vPnC Control
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
1
|
Baseline Characteristics
Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13
Baseline characteristics by cohort
| Measure |
2-Dose 20vPnC
n=121 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 2 doses of 0.5 milliliter (mL) 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit).
|
1-Dose 20vPnC
n=118 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
13vPnC Control
n=117 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
Total
n=356 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.5 months
STANDARD_DEVIATION 1.21 • n=5 Participants
|
12.6 months
STANDARD_DEVIATION 1.52 • n=7 Participants
|
12.7 months
STANDARD_DEVIATION 1.85 • n=5 Participants
|
12.6 months
STANDARD_DEVIATION 1.54 • n=4 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
121 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
356 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
164 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
192 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
86 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
253 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
120 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
350 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data reported after any dose. Here, "Number of Participants Analyzed" signifies the number of participants with any e-diary data reported after the last vaccination.
Local reactions included redness, swelling, and pain at the injection site, recorded by parents/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit = 0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method.
Outcome measures
| Measure |
2-Dose 20vPnC
n=114 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 2 doses of 0.5 milliliter (mL) 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit).
|
1-Dose 20vPnC
n=118 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
13vPnC Control
n=117 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
|---|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination
Swelling: Severe
|
0.9 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 4.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 3.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 3.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination
Pain at Injection Site: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 3.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 3.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 3.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination
Redness: Severe
|
0.9 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 4.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 3.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 3.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination
Swelling: Any
|
23.7 Percentage of participants
95% Confidence Interval 16.2 • Interval 16.2 to 32.6
|
21.2 Percentage of participants
95% Confidence Interval 14.2 • Interval 14.2 to 29.7
|
25.6 Percentage of participants
95% Confidence Interval 18.0 • Interval 18.0 to 34.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination
Redness: Any
|
26.3 Percentage of participants
95% Confidence Interval 18.5 • Interval 18.5 to 35.4
|
29.7 Percentage of participants
95% Confidence Interval 21.6 • Interval 21.6 to 38.8
|
32.5 Percentage of participants
95% Confidence Interval 24.1 • Interval 24.1 to 41.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination
Redness: Mild
|
13.2 Percentage of participants
95% Confidence Interval 7.6 • Interval 7.6 to 20.8
|
18.6 Percentage of participants
95% Confidence Interval 12.1 • Interval 12.1 to 26.9
|
17.9 Percentage of participants
95% Confidence Interval 11.5 • Interval 11.5 to 26.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination
Redness: Moderate
|
12.3 Percentage of participants
95% Confidence Interval 6.9 • Interval 6.9 to 19.7
|
11.0 Percentage of participants
95% Confidence Interval 6.0 • Interval 6.0 to 18.1
|
14.5 Percentage of participants
95% Confidence Interval 8.7 • Interval 8.7 to 22.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination
Swelling: Mild
|
14.0 Percentage of participants
95% Confidence Interval 8.2 • Interval 8.2 to 21.8
|
12.7 Percentage of participants
95% Confidence Interval 7.3 • Interval 7.3 to 20.1
|
16.2 Percentage of participants
95% Confidence Interval 10.1 • Interval 10.1 to 24.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination
Swelling: Moderate
|
8.8 Percentage of participants
95% Confidence Interval 4.3 • Interval 4.3 to 15.5
|
8.5 Percentage of participants
95% Confidence Interval 4.1 • Interval 4.1 to 15.0
|
9.4 Percentage of participants
95% Confidence Interval 4.8 • Interval 4.8 to 16.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination
Pain at Injection Site: Any
|
29.8 Percentage of participants
95% Confidence Interval 21.6 • Interval 21.6 to 39.1
|
28.8 Percentage of participants
95% Confidence Interval 20.8 • Interval 20.8 to 37.9
|
31.6 Percentage of participants
95% Confidence Interval 23.3 • Interval 23.3 to 40.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination
Pain at Injection Site: Mild
|
17.5 Percentage of participants
95% Confidence Interval 11.1 • Interval 11.1 to 25.8
|
17.8 Percentage of participants
95% Confidence Interval 11.4 • Interval 11.4 to 25.9
|
26.5 Percentage of participants
95% Confidence Interval 18.8 • Interval 18.8 to 35.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination
Pain at Injection Site: Moderate
|
12.3 Percentage of participants
95% Confidence Interval 6.9 • Interval 6.9 to 19.7
|
11.0 Percentage of participants
95% Confidence Interval 6.0 • Interval 6.0 to 18.1
|
5.1 Percentage of participants
95% Confidence Interval 1.9 • Interval 1.9 to 10.8
|
PRIMARY outcome
Timeframe: Within 7 days after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. Here, "Number of Participants Analyzed" signifies number of participants with any e-diary data reported after the last vaccination.
Systemic events included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature \>=38.0 degree Celsius (C) and categorized as \>=38.0 to 38.4 degree C,\>38.4 to 38.9 degree C,\>38.9 to 40.0 degree C and \>40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper \& Pearson method.
Outcome measures
| Measure |
2-Dose 20vPnC
n=114 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 2 doses of 0.5 milliliter (mL) 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit).
|
1-Dose 20vPnC
n=118 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
13vPnC Control
n=117 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
|---|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
Fever: >40.0 degrees C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 3.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 3.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 3.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
Decreased appetite: Any
|
25.4 Percentage of participants
95% Confidence Interval 17.7 • Interval 17.7 to 34.4
|
33.1 Percentage of participants
95% Confidence Interval 24.7 • Interval 24.7 to 42.3
|
26.5 Percentage of participants
95% Confidence Interval 18.8 • Interval 18.8 to 35.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
Decreased appetite: Mild
|
14.9 Percentage of participants
95% Confidence Interval 8.9 • Interval 8.9 to 22.8
|
15.3 Percentage of participants
95% Confidence Interval 9.3 • Interval 9.3 to 23.0
|
12.0 Percentage of participants
95% Confidence Interval 6.7 • Interval 6.7 to 19.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
Decreased appetite: Moderate
|
10.5 Percentage of participants
95% Confidence Interval 5.6 • Interval 5.6 to 17.7
|
14.4 Percentage of participants
95% Confidence Interval 8.6 • Interval 8.6 to 22.1
|
13.7 Percentage of participants
95% Confidence Interval 8.0 • Interval 8.0 to 21.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
Drowsiness/increased sleep: Moderate
|
5.3 Percentage of participants
95% Confidence Interval 2.0 • Interval 2.0 to 11.1
|
5.9 Percentage of participants
95% Confidence Interval 2.4 • Interval 2.4 to 11.8
|
10.3 Percentage of participants
95% Confidence Interval 5.4 • Interval 5.4 to 17.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
Drowsiness/increased sleep: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 3.2
|
0.8 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 4.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 3.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
Irritability: Moderate
|
29.8 Percentage of participants
95% Confidence Interval 21.6 • Interval 21.6 to 39.1
|
32.2 Percentage of participants
95% Confidence Interval 23.9 • Interval 23.9 to 41.4
|
29.9 Percentage of participants
95% Confidence Interval 21.8 • Interval 21.8 to 39.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
Irritability: Severe
|
0.9 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 4.8
|
3.4 Percentage of participants
95% Confidence Interval 0.9 • Interval 0.9 to 8.5
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 3.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
Fever: >=38.0 degrees C
|
9.6 Percentage of participants
95% Confidence Interval 4.9 • Interval 4.9 to 16.6
|
15.3 Percentage of participants
95% Confidence Interval 9.3 • Interval 9.3 to 23.0
|
15.4 Percentage of participants
95% Confidence Interval 9.4 • Interval 9.4 to 23.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
Fever: >38.0 degrees C to 38.4 degrees C
|
3.5 Percentage of participants
95% Confidence Interval 1.0 • Interval 1.0 to 8.7
|
6.8 Percentage of participants
95% Confidence Interval 3.0 • Interval 3.0 to 12.9
|
10.3 Percentage of participants
95% Confidence Interval 5.4 • Interval 5.4 to 17.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
Fever: >38.4 degrees C to 38.9 degrees C
|
4.4 Percentage of participants
95% Confidence Interval 1.4 • Interval 1.4 to 9.9
|
3.4 Percentage of participants
95% Confidence Interval 0.9 • Interval 0.9 to 8.5
|
2.6 Percentage of participants
95% Confidence Interval 0.5 • Interval 0.5 to 7.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
Fever: >38.9 degrees C to 40.0 degrees C
|
1.8 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 6.2
|
5.1 Percentage of participants
95% Confidence Interval 1.9 • Interval 1.9 to 10.7
|
2.6 Percentage of participants
95% Confidence Interval 0.5 • Interval 0.5 to 7.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
Decreased appetite: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 3.2
|
3.4 Percentage of participants
95% Confidence Interval 0.9 • Interval 0.9 to 8.5
|
0.9 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 4.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
Drowsiness/increased sleep: Any
|
23.7 Percentage of participants
95% Confidence Interval 16.2 • Interval 16.2 to 32.6
|
32.2 Percentage of participants
95% Confidence Interval 23.9 • Interval 23.9 to 41.4
|
31.6 Percentage of participants
95% Confidence Interval 23.3 • Interval 23.3 to 40.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
Drowsiness/increased sleep: Mild
|
18.4 Percentage of participants
95% Confidence Interval 11.8 • Interval 11.8 to 26.8
|
25.4 Percentage of participants
95% Confidence Interval 17.9 • Interval 17.9 to 34.3
|
21.4 Percentage of participants
95% Confidence Interval 14.3 • Interval 14.3 to 29.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
Irritability: Any
|
55.3 Percentage of participants
95% Confidence Interval 45.7 • Interval 45.7 to 64.6
|
50.8 Percentage of participants
95% Confidence Interval 41.5 • Interval 41.5 to 60.2
|
46.2 Percentage of participants
95% Confidence Interval 36.9 • Interval 36.9 to 55.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
Irritability: Mild
|
24.6 Percentage of participants
95% Confidence Interval 17.0 • Interval 17.0 to 33.5
|
15.3 Percentage of participants
95% Confidence Interval 9.3 • Interval 9.3 to 23.0
|
16.2 Percentage of participants
95% Confidence Interval 10.1 • Interval 10.1 to 24.2
|
PRIMARY outcome
Timeframe: From last vaccination to 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. Here, "Number of Participants Analyzed" signifies the number of participants in the specified group who received the last vaccination.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 95% CI was based on the Clopper and Pearson method. AEs reported in this endpoint excluded local reactions and systemic events collected from an e-diary.
Outcome measures
| Measure |
2-Dose 20vPnC
n=116 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 2 doses of 0.5 milliliter (mL) 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit).
|
1-Dose 20vPnC
n=118 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
13vPnC Control
n=117 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) From Last Vaccination to 1 Month After Last Vaccination
|
22.4 Percentage of participants
95% Confidence Interval 15.2 • Interval 15.2 to 31.1
|
24.6 Percentage of participants
95% Confidence Interval 17.1 • Interval 17.1 to 33.4
|
25.6 Percentage of participants
95% Confidence Interval 18.0 • Interval 18.0 to 34.5
|
PRIMARY outcome
Timeframe: From last vaccination to 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. Here, "Number of Participants Analyzed" signifies the number of participants in the specified group who received the last vaccination.
A SAE was any untoward medical occurrence that: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, was considered serious and other important medical events. 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
2-Dose 20vPnC
n=116 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 2 doses of 0.5 milliliter (mL) 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit).
|
1-Dose 20vPnC
n=118 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
13vPnC Control
n=117 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) From Last Vaccination to 1 Month After Last Vaccination
|
0.9 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 4.7
|
0.8 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 4.6
|
0.9 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 4.7
|
PRIMARY outcome
Timeframe: 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)Population: Evaluable immunogenicity population (EIP) included all participants who were eligible, received vaccinations to which they were randomized, had at least 1 valid immunogenicity result from 1 month after the last assigned vaccination collected within 27 to 56 days after the dose, had no other major protocol deviations as determined by clinician. "Number of Participants analyzed"= participants in EIP. "Number analyzed"= participants with valid IgG results for specified serotype.
Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. The predefined level was 0.35 microgram per milliliter (mcg/mL) for all 7 additional serotypes. 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
2-Dose 20vPnC
n=102 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 2 doses of 0.5 milliliter (mL) 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit).
|
1-Dose 20vPnC
n=108 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
13vPnC Control
n=108 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
|---|---|---|---|
|
Percentage of Participants With Predefined Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes 1 Month After Last Vaccination
Serotype 11A
|
99.0 Percentage of participants
Interval 94.7 to 100.0
|
96.3 Percentage of participants
Interval 90.8 to 99.0
|
13.0 Percentage of participants
Interval 7.3 to 20.8
|
|
Percentage of Participants With Predefined Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes 1 Month After Last Vaccination
Serotype 33F
|
99.0 Percentage of participants
Interval 94.7 to 100.0
|
83.3 Percentage of participants
Interval 74.9 to 89.8
|
3.7 Percentage of participants
Interval 1.0 to 9.2
|
|
Percentage of Participants With Predefined Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes 1 Month After Last Vaccination
Serotype 8
|
100.0 Percentage of participants
Interval 96.4 to 100.0
|
98.1 Percentage of participants
Interval 93.5 to 99.8
|
8.4 Percentage of participants
Interval 3.9 to 15.4
|
|
Percentage of Participants With Predefined Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes 1 Month After Last Vaccination
Serotype 10A
|
99.0 Percentage of participants
Interval 94.7 to 100.0
|
87.0 Percentage of participants
Interval 79.2 to 92.7
|
1.9 Percentage of participants
Interval 0.2 to 6.5
|
|
Percentage of Participants With Predefined Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes 1 Month After Last Vaccination
Serotype 12F
|
91.2 Percentage of participants
Interval 83.9 to 95.9
|
54.6 Percentage of participants
Interval 44.8 to 64.2
|
0.0 Percentage of participants
Interval 0.0 to 3.4
|
|
Percentage of Participants With Predefined Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes 1 Month After Last Vaccination
Serotype 15B
|
100.0 Percentage of participants
Interval 96.4 to 100.0
|
75.9 Percentage of participants
Interval 66.7 to 83.6
|
6.5 Percentage of participants
Interval 2.6 to 12.9
|
|
Percentage of Participants With Predefined Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes 1 Month After Last Vaccination
Serotype 22F
|
100.0 Percentage of participants
Interval 96.4 to 100.0
|
94.4 Percentage of participants
Interval 88.3 to 97.9
|
2.8 Percentage of participants
Interval 0.6 to 7.9
|
SECONDARY outcome
Timeframe: 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)Population: EIP included all participants who were eligible, received vaccinations to which they were randomized, had at least 1 valid immunogenicity result from 1 month after the last assigned vaccination collected within 27 to 56 days after the dose, had no other major protocol deviations as determined by clinician. Here, Number of Participants Analyzed= participants in EIP. "Number Analyzed"= participants with valid IgG assay results for specified serotype.
Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F and 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\*LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, corresponding 2-sided 95% CIs (based on Student's t distribution).
Outcome measures
| Measure |
2-Dose 20vPnC
n=102 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 2 doses of 0.5 milliliter (mL) 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit).
|
1-Dose 20vPnC
n=108 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
13vPnC Control
n=108 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
|---|---|---|---|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 1
|
1.66 mcg/mL
Interval 1.39 to 2.0
|
2.40 mcg/mL
Interval 1.95 to 2.96
|
3.38 mcg/mL
Interval 2.82 to 4.05
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 6A
|
8.55 mcg/mL
Interval 7.25 to 10.07
|
12.45 mcg/mL
Interval 10.16 to 15.27
|
16.28 mcg/mL
Interval 13.48 to 19.66
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 9V
|
3.44 mcg/mL
Interval 2.96 to 3.99
|
3.94 mcg/mL
Interval 3.29 to 4.71
|
5.36 mcg/mL
Interval 4.55 to 6.31
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 19F
|
5.25 mcg/mL
Interval 4.38 to 6.28
|
8.78 mcg/mL
Interval 7.04 to 10.94
|
10.09 mcg/mL
Interval 8.33 to 12.22
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 23F
|
5.06 mcg/mL
Interval 4.23 to 6.05
|
4.45 mcg/mL
Interval 3.58 to 5.53
|
6.32 mcg/mL
Interval 5.07 to 7.89
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 8
|
10.16 mcg/mL
Interval 8.75 to 11.79
|
7.56 mcg/mL
Interval 6.22 to 9.19
|
0.05 mcg/mL
Interval 0.04 to 0.07
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 33F
|
4.94 mcg/mL
Interval 4.04 to 6.03
|
1.68 mcg/mL
Interval 1.21 to 2.34
|
0.02 mcg/mL
Interval 0.01 to 0.02
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 3
|
0.78 mcg/mL
Interval 0.65 to 0.93
|
0.95 mcg/mL
Interval 0.8 to 1.14
|
1.24 mcg/mL
Interval 1.06 to 1.45
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 4
|
3.09 mcg/mL
Interval 2.63 to 3.63
|
4.54 mcg/mL
Interval 3.63 to 5.67
|
5.67 mcg/mL
Interval 4.81 to 6.7
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 5
|
1.61 mcg/mL
Interval 1.36 to 1.92
|
2.03 mcg/mL
Interval 1.64 to 2.51
|
2.46 mcg/mL
Interval 2.04 to 2.95
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 6B
|
5.17 mcg/mL
Interval 4.25 to 6.29
|
4.87 mcg/mL
Interval 3.6 to 6.6
|
6.64 mcg/mL
Interval 5.19 to 8.52
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 7F
|
4.78 mcg/mL
Interval 4.15 to 5.49
|
4.41 mcg/mL
Interval 3.81 to 5.1
|
6.32 mcg/mL
Interval 5.49 to 7.28
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 14
|
5.58 mcg/mL
Interval 4.66 to 6.68
|
7.37 mcg/mL
Interval 5.85 to 9.29
|
8.64 mcg/mL
Interval 7.01 to 10.64
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 18C
|
2.84 mcg/mL
Interval 2.39 to 3.39
|
3.13 mcg/mL
Interval 2.62 to 3.74
|
3.78 mcg/mL
Interval 3.14 to 4.54
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 19A
|
3.31 mcg/mL
Interval 2.8 to 3.9
|
6.36 mcg/mL
Interval 5.22 to 7.74
|
6.89 mcg/mL
Interval 5.76 to 8.23
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 10A
|
6.54 mcg/mL
Interval 5.17 to 8.28
|
1.32 mcg/mL
Interval 0.98 to 1.76
|
0.01 mcg/mL
Interval 0.01 to 0.02
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 11A
|
4.83 mcg/mL
Interval 4.11 to 5.68
|
2.72 mcg/mL
Interval 2.17 to 3.41
|
0.03 mcg/mL
Interval 0.02 to 0.04
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 12F
|
1.72 mcg/mL
Interval 1.4 to 2.12
|
0.33 mcg/mL
Interval 0.25 to 0.45
|
0.01 mcg/mL
Interval 0.01 to 0.01
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 15B
|
11.21 mcg/mL
Interval 9.39 to 13.38
|
0.95 mcg/mL
Interval 0.74 to 1.21
|
0.03 mcg/mL
Interval 0.02 to 0.04
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
Serotype 22F
|
15.45 mcg/mL
Interval 13.24 to 18.03
|
8.66 mcg/mL
Interval 6.27 to 11.98
|
0.01 mcg/mL
Interval 0.0 to 0.01
|
SECONDARY outcome
Timeframe: 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)Population: EIP included all participants who were eligible, received vaccinations to which they were randomized, had at least 1 valid immunogenicity result from 1 month after last assigned vaccination collected within 27 to 56 days after dose, had no other major protocol deviations. Here, Number of Participants Analyzed= participants in EIP. "Number Analyzed"=participants with valid IgG results for specified serotype.
Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes:1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C,19A,19F, 23F. Predefined level was 0.35 mcg/mL for all 13vPnC serotypes except serotypes 5, 6B, and 19A, which had predefined levels of 0.23, 0.10, and 0.12 mcg/mL, respectively. 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
2-Dose 20vPnC
n=102 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 2 doses of 0.5 milliliter (mL) 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit).
|
1-Dose 20vPnC
n=108 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
13vPnC Control
n=108 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
|---|---|---|---|
|
Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination
Serotype 5
|
97.1 Percentage of participants
Interval 91.6 to 99.4
|
96.3 Percentage of participants
Interval 90.8 to 99.0
|
100.0 Percentage of participants
Interval 96.6 to 100.0
|
|
Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination
Serotype 6B
|
100.0 Percentage of participants
Interval 96.4 to 100.0
|
98.1 Percentage of participants
Interval 93.5 to 99.8
|
100.0 Percentage of participants
Interval 96.6 to 100.0
|
|
Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination
Serotype 7F
|
100.0 Percentage of participants
Interval 96.4 to 100.0
|
100.0 Percentage of participants
Interval 96.6 to 100.0
|
100.0 Percentage of participants
Interval 96.6 to 100.0
|
|
Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination
Serotype 9V
|
100.0 Percentage of participants
Interval 96.4 to 100.0
|
99.1 Percentage of participants
Interval 94.9 to 100.0
|
100.0 Percentage of participants
Interval 96.6 to 100.0
|
|
Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination
Serotype 1
|
94.1 Percentage of participants
Interval 87.6 to 97.8
|
94.4 Percentage of participants
Interval 88.3 to 97.9
|
98.1 Percentage of participants
Interval 93.5 to 99.8
|
|
Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination
Serotype 3
|
88.2 Percentage of participants
Interval 80.4 to 93.8
|
87.0 Percentage of participants
Interval 79.2 to 92.7
|
93.5 Percentage of participants
Interval 87.1 to 97.4
|
|
Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination
Serotype 4
|
98.0 Percentage of participants
Interval 93.1 to 99.8
|
99.1 Percentage of participants
Interval 94.9 to 100.0
|
100.0 Percentage of participants
Interval 96.6 to 100.0
|
|
Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination
Serotype 6A
|
100.0 Percentage of participants
Interval 96.4 to 100.0
|
99.1 Percentage of participants
Interval 94.9 to 100.0
|
99.1 Percentage of participants
Interval 94.9 to 100.0
|
|
Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination
Serotype 14
|
100.0 Percentage of participants
Interval 96.4 to 100.0
|
99.1 Percentage of participants
Interval 94.9 to 100.0
|
99.1 Percentage of participants
Interval 94.9 to 100.0
|
|
Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination
Serotype 18C
|
100.0 Percentage of participants
Interval 96.4 to 100.0
|
98.1 Percentage of participants
Interval 93.5 to 99.8
|
99.1 Percentage of participants
Interval 94.9 to 100.0
|
|
Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination
Serotype 19A
|
100.0 Percentage of participants
Interval 96.4 to 100.0
|
100.0 Percentage of participants
Interval 96.6 to 100.0
|
100.0 Percentage of participants
Interval 96.6 to 100.0
|
|
Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination
Serotype 19F
|
100.0 Percentage of participants
Interval 96.4 to 100.0
|
99.1 Percentage of participants
Interval 94.9 to 100.0
|
100.0 Percentage of participants
Interval 96.6 to 100.0
|
|
Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination
Serotype 23F
|
99.0 Percentage of participants
Interval 94.7 to 100.0
|
99.1 Percentage of participants
Interval 94.9 to 100.0
|
97.2 Percentage of participants
Interval 92.1 to 99.4
|
SECONDARY outcome
Timeframe: 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)Population: EIP: eligible participants who received vaccinations as randomized, had at least 1 valid immunogenicity result from 1 month after last dose collected within 27-56 days after dose, had no other major protocol deviation. Number of Participants Analyzed = participants in EIP. OPA titers from randomly selected participants were measured for a subset of the 20 serotypes. Number Analyzed = participants with valid OPA assay result for specified serotype.
OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after last vaccination received. OPA titers below the LLOQ were set to 0.5\*LLOQ. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the Student's t distribution.
Outcome measures
| Measure |
2-Dose 20vPnC
n=102 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 2 doses of 0.5 milliliter (mL) 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit).
|
1-Dose 20vPnC
n=108 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
13vPnC Control
n=108 Participants
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit).
|
|---|---|---|---|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 12F
|
17398 Titers
Interval 11121.0 to 27218.0
|
7346 Titers
Interval 3895.0 to 13855.0
|
64 Titers
Interval 34.0 to 122.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 1
|
46 Titers
Interval 26.0 to 82.0
|
79 Titers
Interval 47.0 to 133.0
|
105 Titers
Interval 68.0 to 162.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 3
|
131 Titers
Interval 106.0 to 163.0
|
101 Titers
Interval 72.0 to 142.0
|
128 Titers
Interval 93.0 to 176.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 5
|
46 Titers
Interval 30.0 to 69.0
|
77 Titers
Interval 52.0 to 114.0
|
73 Titers
Interval 52.0 to 104.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 9V
|
1719 Titers
Interval 928.0 to 3185.0
|
1792 Titers
Interval 1015.0 to 3166.0
|
1930 Titers
Interval 1048.0 to 3556.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 4
|
348 Titers
Interval 178.0 to 681.0
|
425 Titers
Interval 213.0 to 845.0
|
541 Titers
Interval 298.0 to 984.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 6A
|
1470 Titers
Interval 1030.0 to 2096.0
|
1156 Titers
Interval 768.0 to 1739.0
|
1796 Titers
Interval 1286.0 to 2508.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 6B
|
698 Titers
Interval 437.0 to 1114.0
|
452 Titers
Interval 275.0 to 743.0
|
790 Titers
Interval 459.0 to 1357.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 7F
|
1415 Titers
Interval 844.0 to 2371.0
|
1212 Titers
Interval 755.0 to 1945.0
|
1367 Titers
Interval 790.0 to 2365.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 14
|
844 Titers
Interval 474.0 to 1501.0
|
1245 Titers
Interval 837.0 to 1852.0
|
558 Titers
Interval 308.0 to 1011.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 18C
|
1861 Titers
Interval 1115.0 to 3106.0
|
1047 Titers
Interval 583.0 to 1882.0
|
1149 Titers
Interval 684.0 to 1930.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 19A
|
512 Titers
Interval 283.0 to 925.0
|
731 Titers
Interval 401.0 to 1332.0
|
973 Titers
Interval 560.0 to 1688.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 19F
|
473 Titers
Interval 257.0 to 873.0
|
470 Titers
Interval 285.0 to 775.0
|
595 Titers
Interval 363.0 to 975.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 23F
|
727 Titers
Interval 382.0 to 1382.0
|
472 Titers
Interval 255.0 to 876.0
|
721 Titers
Interval 439.0 to 1186.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 8
|
3446 Titers
Interval 2282.0 to 5203.0
|
1609 Titers
Interval 989.0 to 2617.0
|
76 Titers
Interval 42.0 to 137.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 10A
|
6783 Titers
Interval 4555.0 to 10100.0
|
2506 Titers
Interval 1425.0 to 4407.0
|
64 Titers
Interval 40.0 to 104.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 11A
|
3827 Titers
Interval 1975.0 to 7414.0
|
3416 Titers
Interval 1523.0 to 7665.0
|
235 Titers
Interval 99.0 to 562.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 15B
|
10024 Titers
Interval 6200.0 to 16206.0
|
3898 Titers
Interval 1867.0 to 8136.0
|
58 Titers
Interval 24.0 to 143.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 22F
|
11820 Titers
Interval 7993.0 to 17480.0
|
6117 Titers
Interval 3289.0 to 11376.0
|
28 Titers
Interval 13.0 to 61.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
Serotype 33F
|
43671 Titers
Interval 28126.0 to 67809.0
|
15355 Titers
Interval 9431.0 to 24998.0
|
694 Titers
Interval 432.0 to 1115.0
|
Adverse Events
2-Dose 20vPnC (Dose 1 to Dose 2)
Serious events: 4 serious events
Other events: 93 other events
Deaths: 0 deaths
2-Dose 20vPnC (Dose 2 to 1 Month After Dose 2)
Serious events: 1 serious events
Other events: 91 other events
Deaths: 0 deaths
1-Dose 20vPnC (Dose 1 to 1 Month After Dose 1)
Serious events: 1 serious events
Other events: 90 other events
Deaths: 0 deaths
13vPnC Control (Dose 1 to 1 Month After Dose 1)
Serious events: 1 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2-Dose 20vPnC (Dose 1 to Dose 2)
n=121 participants at risk
Toddlers \>=12 to \<24 months of age were randomized to receive 2 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit). This arm reports data from Dose 1 to Dose 2.
|
2-Dose 20vPnC (Dose 2 to 1 Month After Dose 2)
n=116 participants at risk
Toddlers \>=12 to \<24 months of age were randomized to receive 2 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit). This arm reports data From Dose 2 to 1 month after Dose 2.
|
1-Dose 20vPnC (Dose 1 to 1 Month After Dose 1)
n=118 participants at risk
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit). This arm reports data from dose 1 to 1 month after Dose 1.
|
13vPnC Control (Dose 1 to 1 Month After Dose 1)
n=117 participants at risk
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit). This arm reports data from dose 1 to 1 month after Dose 1.
|
|---|---|---|---|---|
|
Nervous system disorders
Febrile convulsion
|
0.83%
1/121 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/116 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/118 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/117 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.83%
1/121 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/116 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/118 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/117 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/121 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/116 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/118 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.85%
1/117 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/121 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.86%
1/116 • Number of events 1 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/118 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/117 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
|
Infections and infestations
Bronchitis
|
0.83%
1/121 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/116 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/118 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/117 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
|
Infections and infestations
Gastroenteritis
|
0.83%
1/121 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/116 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/118 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/117 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.83%
1/121 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.86%
1/116 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/118 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/117 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/121 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/116 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.85%
1/118 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
0.00%
0/117 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
Other adverse events
| Measure |
2-Dose 20vPnC (Dose 1 to Dose 2)
n=121 participants at risk
Toddlers \>=12 to \<24 months of age were randomized to receive 2 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit). This arm reports data from Dose 1 to Dose 2.
|
2-Dose 20vPnC (Dose 2 to 1 Month After Dose 2)
n=116 participants at risk
Toddlers \>=12 to \<24 months of age were randomized to receive 2 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit). This arm reports data From Dose 2 to 1 month after Dose 2.
|
1-Dose 20vPnC (Dose 1 to 1 Month After Dose 1)
n=118 participants at risk
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit). This arm reports data from dose 1 to 1 month after Dose 1.
|
13vPnC Control (Dose 1 to 1 Month After Dose 1)
n=117 participants at risk
Toddlers \>=12 to \<24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit). This arm reports data from dose 1 to 1 month after Dose 1.
|
|---|---|---|---|---|
|
Nervous system disorders
Hypersomnia (INCREASED SLEEP)
|
32.2%
39/121 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
23.3%
27/116 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
32.2%
38/118 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
31.6%
37/117 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
|
Metabolism and nutrition disorders
Decreased appetite (DECREASED APPETITE)
|
30.6%
37/121 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
25.0%
29/116 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
33.1%
39/118 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
26.5%
31/117 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.9%
18/121 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
7.8%
9/116 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
11.0%
13/118 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
7.7%
9/117 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
|
General disorders
Injection site erythema (REDNESS)
|
33.1%
40/121 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
25.9%
30/116 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
29.7%
35/118 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
32.5%
38/117 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
|
General disorders
Injection site pain (PAIN)
|
27.3%
33/121 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
29.3%
34/116 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
28.8%
34/118 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
31.6%
37/117 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
|
General disorders
Injection site swelling (SWELLING)
|
22.3%
27/121 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
23.3%
27/116 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
21.2%
25/118 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
25.6%
30/117 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
|
General disorders
Pyrexia (FEVER)
|
16.5%
20/121 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
9.5%
11/116 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
15.3%
18/118 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
15.4%
18/117 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
|
Psychiatric disorders
Irritability
|
57.9%
70/121 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
54.3%
63/116 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
50.8%
60/118 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
46.2%
54/117 • Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER