Trial Outcomes & Findings for 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants (NCT NCT04546425)
NCT ID: NCT04546425
Last Updated: 2024-01-08
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 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
1258 participants
Primary outcome timeframe
Within 7 days after Dose 1
Results posted on
2024-01-08
Participant Flow
For primary study population,1207 participants were enrolled and assigned to receive 3 doses of 20-valent pneumococcal conjugate vaccine (20vPnC) or 13-valent pneumococcal conjugate vaccine (13vPnC) of which 3 participants were not vaccinated, 1204 were vaccinated with 20vPnC or 13vPnC.Additional 51 Russian participants were enrolled, all of whom were vaccinated with 20vPnC or 13vPnC.
Participant milestones
| Measure |
20vPnC: Primary Study Population
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
20vPnC: Russian Cohort
Infants 42 to 70 days of age were enrolled to receive 3 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 60 to 90 days after dose 1 and dose 3 was administered at 11 to 15 months of age.
|
13vPnC: Russian Cohort
Infants 42 to 70 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 60 to 90 days after dose 1 and dose 3 was administered at 11 to 15 months of age.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
601
|
603
|
24
|
27
|
|
Overall Study
Dose 1
|
601
|
603
|
24
|
27
|
|
Overall Study
Dose 2
|
593
|
598
|
24
|
27
|
|
Overall Study
Dose 3
|
588
|
594
|
22
|
25
|
|
Overall Study
COMPLETED
|
583
|
590
|
22
|
25
|
|
Overall Study
NOT COMPLETED
|
18
|
13
|
2
|
2
|
Reasons for withdrawal
| Measure |
20vPnC: Primary Study Population
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
20vPnC: Russian Cohort
Infants 42 to 70 days of age were enrolled to receive 3 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 60 to 90 days after dose 1 and dose 3 was administered at 11 to 15 months of age.
|
13vPnC: Russian Cohort
Infants 42 to 70 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 60 to 90 days after dose 1 and dose 3 was administered at 11 to 15 months of age.
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
3
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
0
|
0
|
|
Overall Study
No Longer met eligibility criteria
|
3
|
3
|
1
|
1
|
|
Overall Study
Withdrawal by parent/guardian
|
6
|
5
|
1
|
1
|
Baseline Characteristics
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
Baseline characteristics by cohort
| Measure |
20vPnC: Primary Study Population
n=601 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=603 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
20vPnC: Russian Cohort
n=24 Participants
Infants 42 to 70 days of age were enrolled to receive 3 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 60 to 90 days after dose 1 and dose 3 was administered at 11 to 15 months of age.
|
13vPnC: Russian Cohort
n=27 Participants
Infants 42 to 70 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 60 to 90 days after dose 1 and dose 3 was administered at 11 to 15 months of age.
|
Total
n=1255 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
577 Participants
n=5 Participants
|
586 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
1210 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
40 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Age, Customized
28 days-23 months
|
601 Participants
n=5 Participants
|
603 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
1255 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
302 Participants
n=5 Participants
|
292 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
622 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
299 Participants
n=5 Participants
|
311 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
633 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
585 Participants
n=5 Participants
|
592 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
1227 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 1Population: 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 with any e-diary data after Dose 1.
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 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 |
20vPnC: Primary Study Population
n=598 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=603 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population
Redness: Mild
|
20.7 Percentage of participants
95% Confidence Interval 17.6 • Interval 17.6 to 24.2
|
22.7 Percentage of participants
95% Confidence Interval 19.4 • Interval 19.4 to 26.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population
Redness: Moderate
|
4.5 Percentage of participants
95% Confidence Interval 3.0 • Interval 3.0 to 6.5
|
4.8 Percentage of participants
95% Confidence Interval 3.2 • Interval 3.2 to 6.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population
Redness: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population
Swelling: Mild
|
12.7 Percentage of participants
95% Confidence Interval 10.1 • Interval 10.1 to 15.6
|
12.9 Percentage of participants
95% Confidence Interval 10.4 • Interval 10.4 to 15.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population
Swelling: Moderate
|
8.7 Percentage of participants
95% Confidence Interval 6.6 • Interval 6.6 to 11.2
|
7.3 Percentage of participants
95% Confidence Interval 5.4 • Interval 5.4 to 9.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population
Swelling: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population
Pain at Injection Site: Mild
|
16.7 Percentage of participants
95% Confidence Interval 13.8 • Interval 13.8 to 20.0
|
17.9 Percentage of participants
95% Confidence Interval 14.9 • Interval 14.9 to 21.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population
Pain at Injection Site: Moderate
|
12.0 Percentage of participants
95% Confidence Interval 9.5 • Interval 9.5 to 14.9
|
11.4 Percentage of participants
95% Confidence Interval 9.0 • Interval 9.0 to 14.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population
Pain at Injection Site: Severe
|
0.3 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 1.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.6
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 2Population: 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 with any e-diary data after Dose 2.
Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>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% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=592 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=594 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population
Redness: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.6
|
0.2 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population
Redness: Mild
|
24.8 Percentage of participants
95% Confidence Interval 21.4 • Interval 21.4 to 28.5
|
22.9 Percentage of participants
95% Confidence Interval 19.6 • Interval 19.6 to 26.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population
Redness: Moderate
|
3.7 Percentage of participants
95% Confidence Interval 2.3 • Interval 2.3 to 5.6
|
5.1 Percentage of participants
95% Confidence Interval 3.4 • Interval 3.4 to 7.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population
Swelling: Mild
|
13.7 Percentage of participants
95% Confidence Interval 11.0 • Interval 11.0 to 16.7
|
14.1 Percentage of participants
95% Confidence Interval 11.4 • Interval 11.4 to 17.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population
Swelling: Moderate
|
8.3 Percentage of participants
95% Confidence Interval 6.2 • Interval 6.2 to 10.8
|
6.2 Percentage of participants
95% Confidence Interval 4.4 • Interval 4.4 to 8.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population
Swelling: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.6
|
0.2 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population
Pain at Injection Site: Mild
|
13.3 Percentage of participants
95% Confidence Interval 10.7 • Interval 10.7 to 16.4
|
16.5 Percentage of participants
95% Confidence Interval 13.6 • Interval 13.6 to 19.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population
Pain at Injection Site: Moderate
|
9.3 Percentage of participants
95% Confidence Interval 7.1 • Interval 7.1 to 11.9
|
7.9 Percentage of participants
95% Confidence Interval 5.9 • Interval 5.9 to 10.4
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population
Pain at Injection Site: Severe
|
0.2 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.9
|
0.2 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.9
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 3Population: 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 with any e-diary data after Dose 3.
Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>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% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=580 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=586 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population
Redness: Mild
|
23.3 Percentage of participants
95% Confidence Interval 19.9 • Interval 19.9 to 26.9
|
25.1 Percentage of participants
95% Confidence Interval 21.6 • Interval 21.6 to 28.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population
Redness: Moderate
|
13.4 Percentage of participants
95% Confidence Interval 10.8 • Interval 10.8 to 16.5
|
8.5 Percentage of participants
95% Confidence Interval 6.4 • Interval 6.4 to 11.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population
Redness: Severe
|
0.2 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 1.0
|
0.2 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population
Swelling: Mild
|
17.8 Percentage of participants
95% Confidence Interval 14.7 • Interval 14.7 to 21.1
|
14.5 Percentage of participants
95% Confidence Interval 11.8 • Interval 11.8 to 17.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population
Swelling: Moderate
|
11.9 Percentage of participants
95% Confidence Interval 9.4 • Interval 9.4 to 14.8
|
9.7 Percentage of participants
95% Confidence Interval 7.5 • Interval 7.5 to 12.4
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population
Swelling: Severe
|
0.2 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 1.0
|
0.3 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 1.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population
Pain at Injection Site: Mild
|
24.7 Percentage of participants
95% Confidence Interval 21.2 • Interval 21.2 to 28.4
|
22.4 Percentage of participants
95% Confidence Interval 19.0 • Interval 19.0 to 25.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population
Pain at Injection Site: Moderate
|
17.4 Percentage of participants
95% Confidence Interval 14.4 • Interval 14.4 to 20.8
|
17.2 Percentage of participants
95% Confidence Interval 14.3 • Interval 14.3 to 20.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population
Pain at Injection Site: Severe
|
0.3 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 1.2
|
0.3 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 1.2
|
PRIMARY outcome
Timeframe: Within 7 Days after Dose 1Population: Safety analysis set: 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 after Dose 1.
Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: was defined as 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: 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: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=598 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=603 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population
Fever: >=38.0 degrees C to 38.4 degrees C
|
7.5 Percentage of participants
95% Confidence Interval 5.5 • Interval 5.5 to 9.9
|
6.8 Percentage of participants
95% Confidence Interval 4.9 • Interval 4.9 to 9.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population
Fever: >38.4 degrees C to 38.9 degrees C
|
1.3 Percentage of participants
95% Confidence Interval 0.6 • Interval 0.6 to 2.6
|
1.3 Percentage of participants
95% Confidence Interval 0.6 • Interval 0.6 to 2.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population
Fever: >38.9 degrees C to 40.0 degrees C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.6
|
0.3 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 1.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population
Fever: >40.0 degrees C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population
Decreased appetite: Mild
|
16.2 Percentage of participants
95% Confidence Interval 13.4 • Interval 13.4 to 19.4
|
13.3 Percentage of participants
95% Confidence Interval 10.7 • Interval 10.7 to 16.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population
Decreased appetite: Moderate
|
7.5 Percentage of participants
95% Confidence Interval 5.5 • Interval 5.5 to 9.9
|
8.8 Percentage of participants
95% Confidence Interval 6.7 • Interval 6.7 to 11.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population
Decreased appetite: Severe
|
1.0 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 2.2
|
0.5 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 1.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population
Drowsiness: Mild
|
46.0 Percentage of participants
95% Confidence Interval 41.9 • Interval 41.9 to 50.1
|
48.6 Percentage of participants
95% Confidence Interval 44.5 • Interval 44.5 to 52.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population
Drowsiness: Moderate
|
14.4 Percentage of participants
95% Confidence Interval 11.7 • Interval 11.7 to 17.5
|
14.3 Percentage of participants
95% Confidence Interval 11.6 • Interval 11.6 to 17.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population
Drowsiness: Severe
|
0.8 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 1.9
|
0.8 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 1.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population
Irritability: Mild
|
17.6 Percentage of participants
95% Confidence Interval 14.6 • Interval 14.6 to 20.8
|
17.4 Percentage of participants
95% Confidence Interval 14.5 • Interval 14.5 to 20.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population
Irritability: Moderate
|
46.2 Percentage of participants
95% Confidence Interval 42.1 • Interval 42.1 to 50.2
|
46.4 Percentage of participants
95% Confidence Interval 42.4 • Interval 42.4 to 50.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population
Irritability: Severe
|
8.2 Percentage of participants
95% Confidence Interval 6.1 • Interval 6.1 to 10.7
|
8.6 Percentage of participants
95% Confidence Interval 6.5 • Interval 6.5 to 11.2
|
PRIMARY outcome
Timeframe: Within 7 Days after Dose 2Population: Safety analysis set: 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 after Dose 2.
Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever: was defined as temperature \>=38.0 degree 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: 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: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=592 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=594 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population
Fever: >=38.0 degrees C to 38.4 degrees C
|
11.7 Percentage of participants
95% Confidence Interval 9.2 • Interval 9.2 to 14.5
|
11.6 Percentage of participants
95% Confidence Interval 9.2 • Interval 9.2 to 14.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population
Fever: >38.4 degrees C to 38.9 degrees C
|
2.5 Percentage of participants
95% Confidence Interval 1.4 • Interval 1.4 to 4.1
|
2.0 Percentage of participants
95% Confidence Interval 1.0 • Interval 1.0 to 3.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population
Fever: >38.9 degrees C to 40.0 degrees C
|
0.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 1.7
|
0.3 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 1.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population
Fever: >40.0 degrees C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.6
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population
Decreased appetite: Mild
|
13.5 Percentage of participants
95% Confidence Interval 10.9 • Interval 10.9 to 16.5
|
12.1 Percentage of participants
95% Confidence Interval 9.6 • Interval 9.6 to 15.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population
Decreased appetite: Moderate
|
10.1 Percentage of participants
95% Confidence Interval 7.8 • Interval 7.8 to 12.9
|
6.4 Percentage of participants
95% Confidence Interval 4.6 • Interval 4.6 to 8.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population
Decreased appetite: Severe
|
1.0 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 2.2
|
0.8 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 2.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population
Drowsiness: Mild
|
37.8 Percentage of participants
95% Confidence Interval 33.9 • Interval 33.9 to 41.9
|
37.0 Percentage of participants
95% Confidence Interval 33.1 • Interval 33.1 to 41.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population
Drowsiness: Moderate
|
13.2 Percentage of participants
95% Confidence Interval 10.6 • Interval 10.6 to 16.2
|
13.5 Percentage of participants
95% Confidence Interval 10.8 • Interval 10.8 to 16.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population
Drowsiness: Severe
|
0.3 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 1.2
|
0.2 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population
Irritability: Mild
|
22.8 Percentage of participants
95% Confidence Interval 19.5 • Interval 19.5 to 26.4
|
21.2 Percentage of participants
95% Confidence Interval 18.0 • Interval 18.0 to 24.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population
Irritability: Moderate
|
43.1 Percentage of participants
95% Confidence Interval 39.0 • Interval 39.0 to 47.2
|
40.6 Percentage of participants
95% Confidence Interval 36.6 • Interval 36.6 to 44.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population
Irritability: Severe
|
5.7 Percentage of participants
95% Confidence Interval 4.0 • Interval 4.0 to 7.9
|
6.6 Percentage of participants
95% Confidence Interval 4.7 • Interval 4.7 to 8.9
|
PRIMARY outcome
Timeframe: Within 7 Days after Dose 3Population: Safety analysis set: 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 after Dose 3.
Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: was defined as temperature \>=38.0 degree 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: mild (decreased interest in eating), moderate (decreased oral intake) \& 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: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=580 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=586 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population
Fever: >=38.0 degrees C to 38.4 degrees C
|
13.4 Percentage of participants
95% Confidence Interval 10.8 • Interval 10.8 to 16.5
|
13.5 Percentage of participants
95% Confidence Interval 10.8 • Interval 10.8 to 16.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population
Fever: >38.4 degrees C to 38.9 degrees C
|
6.9 Percentage of participants
95% Confidence Interval 5.0 • Interval 5.0 to 9.3
|
7.0 Percentage of participants
95% Confidence Interval 5.1 • Interval 5.1 to 9.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population
Fever: >38.9 degrees C to 40.0 degrees C
|
3.6 Percentage of participants
95% Confidence Interval 2.3 • Interval 2.3 to 5.5
|
3.2 Percentage of participants
95% Confidence Interval 2.0 • Interval 2.0 to 5.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population
Fever: >40.0 degrees C
|
0.3 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 1.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population
Decreased appetite: Mild
|
20.0 Percentage of participants
95% Confidence Interval 16.8 • Interval 16.8 to 23.5
|
15.5 Percentage of participants
95% Confidence Interval 12.7 • Interval 12.7 to 18.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population
Decreased appetite: Moderate
|
17.1 Percentage of participants
95% Confidence Interval 14.1 • Interval 14.1 to 20.4
|
18.9 Percentage of participants
95% Confidence Interval 15.8 • Interval 15.8 to 22.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population
Decreased appetite: Severe
|
2.2 Percentage of participants
95% Confidence Interval 1.2 • Interval 1.2 to 3.8
|
2.0 Percentage of participants
95% Confidence Interval 1.1 • Interval 1.1 to 3.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population
Drowsiness: Mild
|
34.8 Percentage of participants
95% Confidence Interval 30.9 • Interval 30.9 to 38.9
|
32.8 Percentage of participants
95% Confidence Interval 29.0 • Interval 29.0 to 36.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population
Drowsiness: Moderate
|
15.3 Percentage of participants
95% Confidence Interval 12.5 • Interval 12.5 to 18.5
|
14.7 Percentage of participants
95% Confidence Interval 11.9 • Interval 11.9 to 17.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population
Drowsiness: Severe
|
0.7 Percentage of participants
95% Confidence Interval 0.2 • Interval 0.2 to 1.8
|
1.2 Percentage of participants
95% Confidence Interval 0.5 • Interval 0.5 to 2.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population
Irritability: Mild
|
23.4 Percentage of participants
95% Confidence Interval 20.1 • Interval 20.1 to 27.1
|
21.3 Percentage of participants
95% Confidence Interval 18.1 • Interval 18.1 to 24.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population
Irritability: Moderate
|
43.4 Percentage of participants
95% Confidence Interval 39.4 • Interval 39.4 to 47.6
|
45.4 Percentage of participants
95% Confidence Interval 41.3 • Interval 41.3 to 49.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population
Irritability: Severe
|
4.1 Percentage of participants
95% Confidence Interval 2.7 • Interval 2.7 to 6.1
|
4.1 Percentage of participants
95% Confidence Interval 2.6 • Interval 2.6 to 6.0
|
PRIMARY outcome
Timeframe: From Dose 1 to 1 month after Dose 2Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=601 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=603 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 2: Primary Study Population
|
13.8 Percentage of participants
95% Confidence Interval 11.2 • Interval 11.2 to 16.8
|
14.4 Percentage of participants
95% Confidence Interval 11.7 • Interval 11.7 to 17.5
|
PRIMARY outcome
Timeframe: From Dose 3 to 1 month after Dose 3Population: 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 who received Dose 3.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=588 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=594 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) From Dose 3 to 1 Month After Dose 3: Primary Study Population
|
15.5 Percentage of participants
95% Confidence Interval 12.6 • Interval 12.6 to 18.7
|
16.5 Percentage of participants
95% Confidence Interval 13.6 • Interval 13.6 to 19.7
|
PRIMARY outcome
Timeframe: From Dose 1 to 1 month after Dose 3Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose.
A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=601 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=603 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 3: Primary Study Population
|
5.7 Percentage of participants
95% Confidence Interval 3.9 • Interval 3.9 to 7.8
|
6.6 Percentage of participants
95% Confidence Interval 4.8 • Interval 4.8 to 8.9
|
PRIMARY outcome
Timeframe: From Dose 1 to 1 month after Dose 3Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose.
A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=601 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=603 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Dose 1 to 1 Month After Dose 3: Primary Study Population
|
1.0 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 2.2
|
1.0 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 2.2
|
PRIMARY outcome
Timeframe: 1 month after Dose 2Population: Dose 2 evaluable immunogenicity population: eligible participants 42-112 days of age at first vaccination, received first 2 doses as randomized, at least 1 valid immunogenicity results from blood collection (27 to 56 days after Dose 2), no other major protocol deviations. "Number of Participants Analyzed"= participants in Dose 2 evaluable immunogenicity population, "Number Analyzed"= participants with valid IgG assay results for specified serotype.
Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 microgram per mL (mcg/mL), for serotype 5: \>=0.23 mcg/mL, for serotype 6B: \>=0.10 mcg/mL and for serotype 19A: \>=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=567 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=562 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 1
|
70.7 Percentage of participants
Interval 66.7 to 74.4
|
84.2 Percentage of participants
Interval 80.9 to 87.1
|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 3
|
58.0 Percentage of participants
Interval 53.8 to 62.1
|
75.8 Percentage of participants
Interval 72.0 to 79.3
|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 4
|
68.6 Percentage of participants
Interval 64.5 to 72.4
|
79.5 Percentage of participants
Interval 76.0 to 82.8
|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 5
|
63.4 Percentage of participants
Interval 59.3 to 67.4
|
76.0 Percentage of participants
Interval 72.2 to 79.5
|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 6A
|
59.5 Percentage of participants
Interval 55.4 to 63.6
|
73.7 Percentage of participants
Interval 69.8 to 77.3
|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 6B
|
20.7 Percentage of participants
Interval 17.5 to 24.3
|
36.5 Percentage of participants
Interval 32.5 to 40.7
|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 7F
|
87.6 Percentage of participants
Interval 84.6 to 90.2
|
90.2 Percentage of participants
Interval 87.5 to 92.5
|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 9V
|
60.2 Percentage of participants
Interval 56.1 to 64.3
|
74.6 Percentage of participants
Interval 70.7 to 78.1
|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 14
|
78.6 Percentage of participants
Interval 75.0 to 81.9
|
81.9 Percentage of participants
Interval 78.4 to 85.0
|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 18C
|
71.0 Percentage of participants
Interval 67.1 to 74.7
|
76.5 Percentage of participants
Interval 72.8 to 80.0
|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 19A
|
92.2 Percentage of participants
Interval 89.7 to 94.3
|
94.0 Percentage of participants
Interval 91.6 to 95.8
|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 19F
|
94.3 Percentage of participants
Interval 92.1 to 96.1
|
95.7 Percentage of participants
Interval 93.7 to 97.2
|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 23F
|
23.5 Percentage of participants
Interval 20.1 to 27.2
|
41.8 Percentage of participants
Interval 37.7 to 46.0
|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 8
|
96.5 Percentage of participants
Interval 94.6 to 97.8
|
2.9 Percentage of participants
Interval 1.6 to 4.6
|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 10A
|
28.9 Percentage of participants
Interval 25.2 to 32.8
|
2.7 Percentage of participants
Interval 1.5 to 4.4
|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 11A
|
94.2 Percentage of participants
Interval 91.9 to 96.0
|
2.0 Percentage of participants
Interval 1.0 to 3.5
|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 12F
|
30.3 Percentage of participants
Interval 26.6 to 34.3
|
0.2 Percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 15B
|
94.3 Percentage of participants
Interval 92.1 to 96.1
|
8.5 Percentage of participants
Interval 6.4 to 11.2
|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 22F
|
94.4 Percentage of participants
Interval 92.1 to 96.1
|
2.0 Percentage of participants
Interval 1.0 to 3.5
|
|
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Serotype 33F
|
46.8 Percentage of participants
Interval 42.6 to 51.0
|
2.7 Percentage of participants
Interval 1.5 to 4.4
|
PRIMARY outcome
Timeframe: 1 month after Dose 2Population: Dose 2 evaluable immunogenicity population: eligible participants 42-112 days of age at first vaccination, received 1st 2 doses as randomized, at least 1 valid immunogenicity result from blood collection (27-56 days after Dose2). "Number of Participants Analyzed"=participants in Dose 2 evaluable immunogenicity population, "Number Analyzed"= participants with valid IgG assay result for specified serotype.
Pneumococcal serotype-specific IgG concentration was measured for serum sample for 13vPnC serotype: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 7 additional serotype: 8, 10A, 11A, 12F, 15B, 22F, 33F. 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). Assay result below LLOQ was set to 0.5\*LLOQ. Geometric mean ratios (GMRs) were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CIs (based on Student's t distribution).
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=567 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=562 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 10A
|
0.16 Microgram per millilitre (mcg/mL)
Interval 0.14 to 0.18
|
0.02 Microgram per millilitre (mcg/mL)
Interval 0.02 to 0.02
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 11A
|
1.62 Microgram per millilitre (mcg/mL)
Interval 1.5 to 1.75
|
0.02 Microgram per millilitre (mcg/mL)
Interval 0.02 to 0.02
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 12F
|
0.15 Microgram per millilitre (mcg/mL)
Interval 0.13 to 0.17
|
0.01 Microgram per millilitre (mcg/mL)
Interval 0.01 to 0.01
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 15B
|
3.33 Microgram per millilitre (mcg/mL)
Interval 3.0 to 3.7
|
0.04 Microgram per millilitre (mcg/mL)
Interval 0.04 to 0.04
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 22F
|
2.25 Microgram per millilitre (mcg/mL)
Interval 2.06 to 2.45
|
0.01 Microgram per millilitre (mcg/mL)
Interval 0.01 to 0.01
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 33F
|
0.31 Microgram per millilitre (mcg/mL)
Interval 0.28 to 0.34
|
0.03 Microgram per millilitre (mcg/mL)
Interval 0.02 to 0.03
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 1
|
0.57 Microgram per millilitre (mcg/mL)
Interval 0.52 to 0.62
|
0.93 Microgram per millilitre (mcg/mL)
Interval 0.86 to 1.01
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 3
|
0.41 Microgram per millilitre (mcg/mL)
Interval 0.38 to 0.45
|
0.58 Microgram per millilitre (mcg/mL)
Interval 0.54 to 0.63
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 4
|
0.55 Microgram per millilitre (mcg/mL)
Interval 0.5 to 0.61
|
0.92 Microgram per millilitre (mcg/mL)
Interval 0.83 to 1.02
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 5
|
0.34 Microgram per millilitre (mcg/mL)
Interval 0.3 to 0.38
|
0.56 Microgram per millilitre (mcg/mL)
Interval 0.5 to 0.62
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 6A
|
0.45 Microgram per millilitre (mcg/mL)
Interval 0.4 to 0.52
|
0.84 Microgram per millilitre (mcg/mL)
Interval 0.73 to 0.95
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 6B
|
0.03 Microgram per millilitre (mcg/mL)
Interval 0.03 to 0.04
|
0.06 Microgram per millilitre (mcg/mL)
Interval 0.05 to 0.07
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 7F
|
1.02 Microgram per millilitre (mcg/mL)
Interval 0.94 to 1.1
|
1.41 Microgram per millilitre (mcg/mL)
Interval 1.3 to 1.53
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 9V
|
0.45 Microgram per millilitre (mcg/mL)
Interval 0.4 to 0.51
|
0.77 Microgram per millilitre (mcg/mL)
Interval 0.68 to 0.87
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 14
|
1.05 Microgram per millilitre (mcg/mL)
Interval 0.94 to 1.18
|
1.28 Microgram per millilitre (mcg/mL)
Interval 1.14 to 1.43
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 18C
|
0.69 Microgram per millilitre (mcg/mL)
Interval 0.62 to 0.77
|
0.87 Microgram per millilitre (mcg/mL)
Interval 0.78 to 0.98
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 19A
|
0.67 Microgram per millilitre (mcg/mL)
Interval 0.61 to 0.74
|
1.13 Microgram per millilitre (mcg/mL)
Interval 1.01 to 1.26
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 19F
|
2.21 Microgram per millilitre (mcg/mL)
Interval 2.04 to 2.4
|
3.06 Microgram per millilitre (mcg/mL)
Interval 2.8 to 3.34
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 23F
|
0.13 Microgram per millilitre (mcg/mL)
Interval 0.12 to 0.15
|
0.25 Microgram per millilitre (mcg/mL)
Interval 0.22 to 0.28
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Serotype 8
|
1.62 Microgram per millilitre (mcg/mL)
Interval 1.51 to 1.74
|
0.02 Microgram per millilitre (mcg/mL)
Interval 0.02 to 0.02
|
PRIMARY outcome
Timeframe: 1 month after Dose 3Population: Dose 3 evaluable immunogenicity population (EIP)=eligible participants 42-112 days of age at first vaccination, received all 3 dose as randomized with 335-386 day of age at Dose 3 at least 1 valid immunogenicity results within 27-56 days after Dose 3, no major protocol deviation "Number of Participants Analyzed"=participants in Dose 3 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, 7 additional serotype: 8, 10A, 11A, 12F, 15B, 22F,33F. GMC and corresponding 2-sided 95% CI were calculated by exponentiating mean logarithm of concentrations and corresponding 2-sided 95% CI (based on Student's t distribution). Assay result below LLOQ were set to 0.5\*LLOQ. GMRs were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CI (based on Student's t distribution).
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=497 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=504 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 19A
|
4.51 Microgram per millilitre (mcg/mL)
Interval 4.11 to 4.94
|
5.49 Microgram per millilitre (mcg/mL)
Interval 5.02 to 6.01
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 19F
|
6.19 Microgram per millilitre (mcg/mL)
Interval 5.68 to 6.75
|
8.08 Microgram per millilitre (mcg/mL)
Interval 7.4 to 8.83
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 23F
|
2.64 Microgram per millilitre (mcg/mL)
Interval 2.4 to 2.91
|
4.40 Microgram per millilitre (mcg/mL)
Interval 3.95 to 4.9
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 8
|
3.57 Microgram per millilitre (mcg/mL)
Interval 3.32 to 3.83
|
0.03 Microgram per millilitre (mcg/mL)
Interval 0.03 to 0.03
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 1
|
1.71 Microgram per millilitre (mcg/mL)
Interval 1.58 to 1.84
|
2.53 Microgram per millilitre (mcg/mL)
Interval 2.33 to 2.75
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 3
|
0.72 Microgram per millilitre (mcg/mL)
Interval 0.67 to 0.78
|
1.09 Microgram per millilitre (mcg/mL)
Interval 1.01 to 1.17
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 4
|
4.11 Microgram per millilitre (mcg/mL)
Interval 3.77 to 4.48
|
5.36 Microgram per millilitre (mcg/mL)
Interval 4.91 to 5.85
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 5
|
1.74 Microgram per millilitre (mcg/mL)
Interval 1.6 to 1.89
|
2.41 Microgram per millilitre (mcg/mL)
Interval 2.21 to 2.64
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 6A
|
7.75 Microgram per millilitre (mcg/mL)
Interval 7.04 to 8.53
|
11.82 Microgram per millilitre (mcg/mL)
Interval 10.66 to 13.11
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 6B
|
2.64 Microgram per millilitre (mcg/mL)
Interval 2.36 to 2.95
|
4.63 Microgram per millilitre (mcg/mL)
Interval 4.09 to 5.25
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 7F
|
3.61 Microgram per millilitre (mcg/mL)
Interval 3.4 to 3.84
|
4.93 Microgram per millilitre (mcg/mL)
Interval 4.63 to 5.24
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 9V
|
3.68 Microgram per millilitre (mcg/mL)
Interval 3.42 to 3.97
|
5.04 Microgram per millilitre (mcg/mL)
Interval 4.67 to 5.43
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 14
|
4.52 Microgram per millilitre (mcg/mL)
Interval 4.08 to 5.0
|
5.66 Microgram per millilitre (mcg/mL)
Interval 5.12 to 6.26
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 18C
|
2.71 Microgram per millilitre (mcg/mL)
Interval 2.52 to 2.93
|
3.61 Microgram per millilitre (mcg/mL)
Interval 3.33 to 3.91
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 10A
|
4.86 Microgram per millilitre (mcg/mL)
Interval 4.41 to 5.36
|
0.01 Microgram per millilitre (mcg/mL)
Interval 0.01 to 0.01
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 11A
|
3.74 Microgram per millilitre (mcg/mL)
Interval 3.44 to 4.07
|
0.02 Microgram per millilitre (mcg/mL)
Interval 0.01 to 0.02
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 12F
|
1.86 Microgram per millilitre (mcg/mL)
Interval 1.71 to 2.01
|
0.01 Microgram per millilitre (mcg/mL)
Interval 0.01 to 0.01
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 15B
|
13.09 Microgram per millilitre (mcg/mL)
Interval 12.1 to 14.15
|
0.02 Microgram per millilitre (mcg/mL)
Interval 0.02 to 0.03
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 22F
|
9.27 Microgram per millilitre (mcg/mL)
Interval 8.52 to 10.08
|
0.00 Microgram per millilitre (mcg/mL)
Interval 0.0 to 0.0
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 33F
|
6.37 Microgram per millilitre (mcg/mL)
Interval 5.83 to 6.95
|
0.01 Microgram per millilitre (mcg/mL)
Interval 0.01 to 0.01
|
PRIMARY outcome
Timeframe: 1 month after Dose 3Population: Dose 3 EIP = eligible participants 42-112 days of age at first vaccination, received all 3 doses as randomized with 335-386 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. "Number of Participants Analyzed"= participants in Dose 3 EIP and "Number Analyzed"= participants with valid assay results for specified concomitant vaccine antigen.
Diphtheria and tetanus toxoids: concentration of antibody (AB) (in international units \[IU\]) to diphtheria \& tetanus toxoid (prespecified level\>=0.1 IU/mL); Pertussis antigens-pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN): prespecified level \>=observed Anti pertussis Antibody concentration achieved by 95% of 13vPnC recipient; HBsAg prespecified level \>=10 milli-IU per mL (mIU/mL); Poliovirus strains (types 1, 2 and 3): prespecified level: \>=1:8; Hemophilus influenzae type b(Hib): prespecified level \>=0.15 microgram per millilitre (mcg/mL) polyribosylribitol phosphate (anti-PRP) in mcg/mL. Concomitant vaccine response was assessed from subset of randomly selected study participants.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=497 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=504 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population
Diphtheria toxoid
|
99.6 Percentage of participants
Interval 98.5 to 100.0
|
99.8 Percentage of participants
Interval 98.9 to 100.0
|
|
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population
Tetanus toxoid
|
99.4 Percentage of participants
Interval 98.2 to 99.9
|
100.0 Percentage of participants
Interval 99.3 to 100.0
|
|
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population
Pertussis: PT
|
92.9 Percentage of participants
Interval 90.3 to 95.0
|
95.2 Percentage of participants
Interval 92.9 to 96.9
|
|
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population
Pertussis: FHA
|
95.3 Percentage of participants
Interval 93.1 to 97.0
|
95.2 Percentage of participants
Interval 92.9 to 96.9
|
|
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population
Pertussis: PRN
|
96.8 Percentage of participants
Interval 94.8 to 98.1
|
95.2 Percentage of participants
Interval 92.9 to 96.9
|
|
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population
Hepatitis B
|
100.0 Percentage of participants
Interval 97.9 to 100.0
|
98.9 Percentage of participants
Interval 96.0 to 99.9
|
|
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population
Poliovirus: Type 1
|
100.0 Percentage of participants
Interval 95.5 to 100.0
|
100.0 Percentage of participants
Interval 95.9 to 100.0
|
|
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population
Poliovirus: Type 2
|
100.0 Percentage of participants
Interval 95.5 to 100.0
|
100.0 Percentage of participants
Interval 95.9 to 100.0
|
|
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population
Poliovirus: Type 3
|
100.0 Percentage of participants
Interval 95.5 to 100.0
|
100.0 Percentage of participants
Interval 95.9 to 100.0
|
|
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population
Hemophilus influenzae type b
|
100.0 Percentage of participants
Interval 98.0 to 100.0
|
100.0 Percentage of participants
Interval 97.8 to 100.0
|
PRIMARY outcome
Timeframe: 1 month after Dose 3Population: Dose 3 evaluable immunogenicity population = eligible participants 42-112 days of age at first vaccination, received all 3 doses as randomized with 335-386 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. Here, "Number of Participants Analyzed"= participants in Dose 3 evaluable immunogenicity population, received measles vaccine and had valid assay results for measle vaccine antigen.
Pre-specified vaccine antigen (measles) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=128 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=132 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
GMC of Measles Virus Antibody 1 Month After Dose 3: Primary Study Population
|
228.63 Arbitrary units per millilitre
95% Confidence Interval 186.34 • Interval 186.34 to 280.52
|
216.72 Arbitrary units per millilitre
95% Confidence Interval 174.92 • Interval 174.92 to 268.52
|
PRIMARY outcome
Timeframe: 1 month after Dose 3Population: Dose 3 evaluable immunogenicity population = eligible participants 42-112 days of age at first vaccination, received all 3 doses as randomized with 335-386 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. Here, "Number of Participants Analyzed"= participants in Dose 3 evaluable immunogenicity population, received mumps vaccine and had valid assay results for mumps vaccine antigen.
Pre-specified vaccine antigen (mumps) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=128 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=133 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
GMC of Mumps Virus Antibody 1 Month After Dose 3: Primary Study Population
|
36.81 Arbitrary units per millilitre
95% Confidence Interval 29.12 • Interval 29.12 to 46.54
|
35.25 Arbitrary units per millilitre
95% Confidence Interval 28.14 • Interval 28.14 to 44.17
|
PRIMARY outcome
Timeframe: 1 month after Dose 3Population: Dose 3 evaluable immunogenicity population = eligible participants 42-112 days of age at first vaccination, received all 3 doses as randomized with 335-386 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. Here, "Number of Participants Analyzed"= participants in Dose 3 evaluable immunogenicity population, received rubella vaccine and had valid assay results for rubella vaccine antigen.
Pre-specified vaccine antigen (rubella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=128 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=132 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
GMC of Rubella Virus Antibody 1 Month After Dose 3: Primary Study Population
|
31.81 International units per millilitre
95% Confidence Interval 25.54 • Interval 25.54 to 39.62
|
38.20 International units per millilitre
95% Confidence Interval 32.10 • Interval 32.1 to 45.45
|
PRIMARY outcome
Timeframe: 1 month after Dose 3Population: Dose 3 evaluable immunogenicity population = eligible participants 42-112 days of age at first vaccination, received all 3 doses as randomized with 335-386 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. Here, "Number of Participants Analyzed"= participants in Dose 3 evaluable immunogenicity population, received varicella vaccine and had valid assay results varicella vaccine antigen.
Pre-specified vaccine antigen (varicella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=128 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=132 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
GMC of Varicella Virus Antibody 1 Month After Dose 3: Primary Study Population
|
195.58 Milli-international units per millilitre
95% Confidence Interval 165.14 • Interval 165.14 to 231.62
|
157.60 Milli-international units per millilitre
95% Confidence Interval 133.57 • Interval 133.57 to 185.95
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 1Population: 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 after Dose 1
Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>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% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=24 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=27 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort
Redness: Mild
|
4.2 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.1
|
7.4 Percentage of participants
95% Confidence Interval 0.9 • Interval 0.9 to 24.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort
Redness: Moderate
|
4.2 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.1
|
3.7 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 19.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort
Redness: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort
Swelling: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort
Swelling: Moderate
|
4.2 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort
Swelling: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort
Pain at Injection Site: Mild
|
8.3 Percentage of participants
95% Confidence Interval 1.0 • Interval 1.0 to 27.0
|
7.4 Percentage of participants
95% Confidence Interval 0.9 • Interval 0.9 to 24.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort
Pain at Injection Site: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
3.7 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 19.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort
Pain at Injection Site: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 2Population: 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 with any e-diary data after Dose 2.
Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>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% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=23 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=27 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort
Redness: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
3.7 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 19.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort
Redness: Moderate
|
4.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort
Redness: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort
Swelling: Mild
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
7.4 Percentage of participants
95% Confidence Interval 0.9 • Interval 0.9 to 24.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort
Swelling: Moderate
|
8.7 Percentage of participants
95% Confidence Interval 1.1 • Interval 1.1 to 28.0
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort
Swelling: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort
Pain at Injection Site: Mild
|
8.7 Percentage of participants
95% Confidence Interval 1.1 • Interval 1.1 to 28.0
|
7.4 Percentage of participants
95% Confidence Interval 0.9 • Interval 0.9 to 24.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort
Pain at Injection Site: Moderate
|
4.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort
Pain at Injection Site: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 3Population: 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 with any e-diary data after Dose 3.
Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>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% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=22 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=25 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort
Redness: Mild
|
0 Percentage of participants
Interval 0.0 to 15.4
|
4.0 Percentage of participants
Interval 0.1 to 20.4
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort
Redness: Moderate
|
4.5 Percentage of participants
Interval 0.1 to 22.8
|
0 Percentage of participants
Interval 0.0 to 13.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 15.4
|
4.0 Percentage of participants
Interval 0.1 to 20.4
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort
Swelling: Mild
|
0 Percentage of participants
Interval 0.0 to 15.4
|
0 Percentage of participants
Interval 0.0 to 13.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort
Pain at Injection Site: Moderate
|
0 Percentage of participants
Interval 0.0 to 15.4
|
0 Percentage of participants
Interval 0.0 to 13.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort
Swelling: Moderate
|
9.1 Percentage of participants
Interval 1.1 to 29.2
|
0 Percentage of participants
Interval 0.0 to 13.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 15.4
|
4.0 Percentage of participants
Interval 0.1 to 20.4
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort
Pain at Injection Site: Mild
|
13.6 Percentage of participants
Interval 2.9 to 34.9
|
8.0 Percentage of participants
Interval 1.0 to 26.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort
Pain at Injection Site: Severe
|
0 Percentage of participants
Interval 0.0 to 15.4
|
0 Percentage of participants
Interval 0.0 to 13.7
|
PRIMARY outcome
Timeframe: Within 7 Days after Dose 1Population: Safety analysis set: all participants who received at least 1 dose of 20vPnC or 13vPnC \& had safety data assessed after any dose. Here, "Number of Participants Analyzed" signifies number of participants with any e-diary data after Dose 1.
Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using e-diary. Fever: temperature \>=38.0 degree C \& 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: 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 |
20vPnC: Primary Study Population
n=24 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=27 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort
Fever: >=38.0 degrees C to 38.4 degrees C
|
4.2 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort
Fever: >38.4 degrees C to 38.9 degrees C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort
Fever: >38.9 degrees C to 40.0 degrees C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort
Fever: >40.0 degrees C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort
Decreased appetite: Mild
|
16.7 Percentage of participants
95% Confidence Interval 4.7 • Interval 4.7 to 37.4
|
14.8 Percentage of participants
95% Confidence Interval 4.2 • Interval 4.2 to 33.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort
Decreased appetite: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
3.7 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 19.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort
Decreased appetite: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort
Drowsiness: Mild
|
20.8 Percentage of participants
95% Confidence Interval 7.1 • Interval 7.1 to 42.2
|
18.5 Percentage of participants
95% Confidence Interval 6.3 • Interval 6.3 to 38.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort
Drowsiness: Moderate
|
8.3 Percentage of participants
95% Confidence Interval 1.0 • Interval 1.0 to 27.0
|
11.1 Percentage of participants
95% Confidence Interval 2.4 • Interval 2.4 to 29.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort
Drowsiness: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort
Irritability: Mild
|
12.5 Percentage of participants
95% Confidence Interval 2.7 • Interval 2.7 to 32.4
|
7.4 Percentage of participants
95% Confidence Interval 0.9 • Interval 0.9 to 24.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort
Irritability: Moderate
|
8.3 Percentage of participants
95% Confidence Interval 1.0 • Interval 1.0 to 27.0
|
14.8 Percentage of participants
95% Confidence Interval 4.2 • Interval 4.2 to 33.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort
Irritability: Severe
|
4.2 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.1
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
PRIMARY outcome
Timeframe: Within 7 Days after Dose 2Population: Safety analysis set: all participants who received at least 1 dose of 20vPnC or 13vPnC \& had safety data assessed after any dose. Here," Number of Participants Analyzed": number of participants with any e-diary data after Dose 2
Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature \>=38.0 degree 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: 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: 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 |
20vPnC: Primary Study Population
n=23 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=27 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort
Fever: >=38.0 degrees C to 38.4 degrees C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
11.1 Percentage of participants
95% Confidence Interval 2.4 • Interval 2.4 to 29.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort
Fever: >38.4 degrees C to 38.9 degrees C
|
4.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.9
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort
Fever: >38.9 degrees C to 40.0 degrees C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort
Fever: >40.0 degrees C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort
Decreased appetite: Mild
|
4.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.9
|
7.4 Percentage of participants
95% Confidence Interval 0.9 • Interval 0.9 to 24.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort
Decreased appetite: Moderate
|
4.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.9
|
3.7 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 19.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort
Decreased appetite: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort
Drowsiness: Mild
|
4.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.9
|
3.7 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 19.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort
Drowsiness: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
3.7 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 19.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort
Drowsiness: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 12.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort
Irritability: Mild
|
13.0 Percentage of participants
95% Confidence Interval 2.8 • Interval 2.8 to 33.6
|
22.2 Percentage of participants
95% Confidence Interval 8.6 • Interval 8.6 to 42.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort
Irritability: Moderate
|
4.3 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 21.9
|
18.5 Percentage of participants
95% Confidence Interval 6.3 • Interval 6.3 to 38.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort
Irritability: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 14.8
|
3.7 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 19.0
|
PRIMARY outcome
Timeframe: Within 7 Days after Dose 3Population: Safety analysis set: all participants who received at least 1 dose of 20vPnC or 13vPnC \& had safety data assessed after any dose. Here," Number of Participants Analyzed": number of participants with any e-diary data after Dose 3.
Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature \>=38.0 degree 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: 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: 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 |
20vPnC: Primary Study Population
n=22 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=25 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort
Fever: >=38.0 degrees C to 38.4 degrees C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 13.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort
Fever: >38.4 degrees C to 38.9 degrees C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
4.0 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 20.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort
Fever: >38.9 degrees C to 40.0 degrees C
|
4.5 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 22.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 13.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort
Fever: >40.0 degrees C
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 13.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort
Decreased appetite: Mild
|
9.1 Percentage of participants
95% Confidence Interval 1.1 • Interval 1.1 to 29.2
|
8.0 Percentage of participants
95% Confidence Interval 1.0 • Interval 1.0 to 26.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort
Decreased appetite: Moderate
|
9.1 Percentage of participants
95% Confidence Interval 1.1 • Interval 1.1 to 29.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 13.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort
Decreased appetite: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 13.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort
Drowsiness: Mild
|
13.6 Percentage of participants
95% Confidence Interval 2.9 • Interval 2.9 to 34.9
|
20.0 Percentage of participants
95% Confidence Interval 6.8 • Interval 6.8 to 40.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort
Drowsiness: Moderate
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
4.0 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 20.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort
Drowsiness: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 13.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort
Irritability: Mild
|
27.3 Percentage of participants
95% Confidence Interval 10.7 • Interval 10.7 to 50.2
|
16.0 Percentage of participants
95% Confidence Interval 4.5 • Interval 4.5 to 36.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort
Irritability: Moderate
|
9.1 Percentage of participants
95% Confidence Interval 1.1 • Interval 1.1 to 29.2
|
8.0 Percentage of participants
95% Confidence Interval 1.0 • Interval 1.0 to 26.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort
Irritability: Severe
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 15.4
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 13.7
|
PRIMARY outcome
Timeframe: From Dose 1 to 1 month after Dose 2Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=24 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=27 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With AEs From Dose 1 to 1 Month After Dose 2: Russian Cohort
|
8.3 Percentage of participants
95% Confidence Interval 1.0 • Interval 1.0 to 27.0
|
3.7 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 19.0
|
PRIMARY outcome
Timeframe: From Dose 3 to 1 month after Dose 3Population: 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 who received Dose 3.
An AE was any untoward medical occurrence in a participants, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=22 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=25 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With AEs From Dose 3 to 1 Month After Dose 3: Russian Cohort
|
4.5 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 22.8
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 13.7
|
PRIMARY outcome
Timeframe: From Dose 1 to 1 month after Dose 3Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose.
A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=24 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=27 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With SAEs From Dose 1 to 1 Month After Dose 3: Russian Cohort
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 12.8
|
PRIMARY outcome
Timeframe: From Dose 1 to 1 month after Dose 3Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose.
A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=24 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=27 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With NDCMC From Dose 1 to 1 Month After Dose 3: Russian Cohort
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 12.8
|
PRIMARY outcome
Timeframe: 1 month after Dose 2Population: Dose 2 evaluable immunogenicity population: eligible participants 42-70 days of age at first vaccination, received first 2 doses as randomized, at least 1 valid immunogenicity results within 27 to 56 days after Dose 2, no other major protocol deviations. "Number of Participants Analyzed"= participants in Dose 2 evaluable immunogenicity population; "Number Analyzed"= participants with valid IgG results for specified serotype.
Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 mcg/mL, for serotype 5: \>=0.23 mcg/mL, for serotype 6B. \>=0.10 mcg/mL and for serotype 19A: \>=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=24 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=27 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 33F
|
45.8 Percentage of participants
95% Confidence Interval 25.6 • Interval 25.6 to 67.2
|
25.9 Percentage of participants
95% Confidence Interval 11.1 • Interval 11.1 to 46.3
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 8
|
75.0 Percentage of participants
95% Confidence Interval 53.3 • Interval 53.3 to 90.2
|
33.3 Percentage of participants
95% Confidence Interval 16.5 • Interval 16.5 to 54.0
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 10A
|
41.7 Percentage of participants
95% Confidence Interval 22.1 • Interval 22.1 to 63.4
|
18.5 Percentage of participants
95% Confidence Interval 6.3 • Interval 6.3 to 38.1
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 11A
|
83.3 Percentage of participants
95% Confidence Interval 62.6 • Interval 62.6 to 95.3
|
18.5 Percentage of participants
95% Confidence Interval 6.3 • Interval 6.3 to 38.1
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 12F
|
12.5 Percentage of participants
95% Confidence Interval 2.7 • Interval 2.7 to 32.4
|
14.8 Percentage of participants
95% Confidence Interval 4.2 • Interval 4.2 to 33.7
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 1
|
70.8 Percentage of participants
95% Confidence Interval 48.9 • Interval 48.9 to 87.4
|
77.8 Percentage of participants
95% Confidence Interval 57.7 • Interval 57.7 to 91.4
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 3
|
37.5 Percentage of participants
95% Confidence Interval 18.8 • Interval 18.8 to 59.4
|
59.3 Percentage of participants
95% Confidence Interval 38.8 • Interval 38.8 to 77.6
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 4
|
75.0 Percentage of participants
95% Confidence Interval 53.3 • Interval 53.3 to 90.2
|
74.1 Percentage of participants
95% Confidence Interval 53.7 • Interval 53.7 to 88.9
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 5
|
66.7 Percentage of participants
95% Confidence Interval 44.7 • Interval 44.7 to 84.4
|
81.5 Percentage of participants
95% Confidence Interval 61.9 • Interval 61.9 to 93.7
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 6A
|
54.2 Percentage of participants
95% Confidence Interval 32.8 • Interval 32.8 to 74.4
|
81.5 Percentage of participants
95% Confidence Interval 61.9 • Interval 61.9 to 93.7
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 6B
|
20.8 Percentage of participants
95% Confidence Interval 7.1 • Interval 7.1 to 42.2
|
59.3 Percentage of participants
95% Confidence Interval 38.8 • Interval 38.8 to 77.6
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 7F
|
95.8 Percentage of participants
95% Confidence Interval 78.9 • Interval 78.9 to 99.9
|
92.6 Percentage of participants
95% Confidence Interval 75.7 • Interval 75.7 to 99.1
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 9V
|
41.7 Percentage of participants
95% Confidence Interval 22.1 • Interval 22.1 to 63.4
|
81.5 Percentage of participants
95% Confidence Interval 61.9 • Interval 61.9 to 93.7
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 14
|
83.3 Percentage of participants
95% Confidence Interval 62.6 • Interval 62.6 to 95.3
|
85.2 Percentage of participants
95% Confidence Interval 66.3 • Interval 66.3 to 95.8
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 18C
|
66.7 Percentage of participants
95% Confidence Interval 44.7 • Interval 44.7 to 84.4
|
81.5 Percentage of participants
95% Confidence Interval 61.9 • Interval 61.9 to 93.7
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 19A
|
87.5 Percentage of participants
95% Confidence Interval 67.6 • Interval 67.6 to 97.3
|
92.6 Percentage of participants
95% Confidence Interval 75.7 • Interval 75.7 to 99.1
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 19F
|
79.2 Percentage of participants
95% Confidence Interval 57.8 • Interval 57.8 to 92.9
|
96.3 Percentage of participants
95% Confidence Interval 81.0 • Interval 81.0 to 99.9
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 23F
|
37.5 Percentage of participants
95% Confidence Interval 18.8 • Interval 18.8 to 59.4
|
70.4 Percentage of participants
95% Confidence Interval 49.8 • Interval 49.8 to 86.2
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 15B
|
66.7 Percentage of participants
95% Confidence Interval 44.7 • Interval 44.7 to 84.4
|
33.3 Percentage of participants
95% Confidence Interval 16.5 • Interval 16.5 to 54.0
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 22F
|
66.7 Percentage of participants
95% Confidence Interval 44.7 • Interval 44.7 to 84.4
|
14.8 Percentage of participants
95% Confidence Interval 4.2 • Interval 4.2 to 33.7
|
PRIMARY outcome
Timeframe: 1 month after Dose 2Population: Dose 2 evaluable immunogenicity population: eligible participants 42-70days of age at first vaccination, received first 2 doses as randomized, at least 1 valid immunogenicity results within 27 to 56 days after Dose 2, no other major protocol deviations. "Number of Participants Analyzed"= Participants in Dose 2 evaluable immunogenicity population; "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, and 23F and 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. Assay results below the LLOQ were set to 0.5 \* LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, and the corresponding 2-sided 95% CIs (based on Student's t distribution).
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=24 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=27 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 1
|
0.76 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.49 • Interval 0.49 to 1.19
|
1.04 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.64 • Interval 0.64 to 1.69
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 3
|
0.28 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.19 • Interval 0.19 to 0.42
|
0.47 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.31 • Interval 0.31 to 0.72
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 4
|
0.67 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.45 • Interval 0.45 to 1.0
|
1.00 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.58 • Interval 0.58 to 1.71
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 5
|
0.53 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.31 • Interval 0.31 to 0.92
|
0.75 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.40 • Interval 0.4 to 1.4
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 6A
|
0.45 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.20 • Interval 0.2 to 1.03
|
1.57 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.80 • Interval 0.8 to 3.1
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 6B
|
0.07 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.03 • Interval 0.03 to 0.16
|
0.27 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.12 • Interval 0.12 to 0.63
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 7F
|
1.06 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.68 • Interval 0.68 to 1.65
|
1.89 Microgram per millilitre (mcg/mL)
95% Confidence Interval 1.32 • Interval 1.32 to 2.71
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 9V
|
0.44 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.23 • Interval 0.23 to 0.84
|
1.22 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.73 • Interval 0.73 to 2.06
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 14
|
1.56 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.88 • Interval 0.88 to 2.75
|
2.66 Microgram per millilitre (mcg/mL)
95% Confidence Interval 1.46 • Interval 1.46 to 4.86
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 18C
|
0.94 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.46 • Interval 0.46 to 1.91
|
0.94 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.50 • Interval 0.5 to 1.78
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 19A
|
1.15 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.47 • Interval 0.47 to 2.82
|
1.21 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.59 • Interval 0.59 to 2.49
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 19F
|
1.51 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.84 • Interval 0.84 to 2.72
|
3.32 Microgram per millilitre (mcg/mL)
95% Confidence Interval 2.03 • Interval 2.03 to 5.44
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 23F
|
0.25 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.11 • Interval 0.11 to 0.55
|
0.73 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.37 • Interval 0.37 to 1.42
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 8
|
0.79 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.37 • Interval 0.37 to 1.69
|
0.07 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.03 • Interval 0.03 to 0.18
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 10A
|
0.31 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.10 • Interval 0.1 to 0.94
|
0.04 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.01 • Interval 0.01 to 0.1
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 11A
|
0.83 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.43 • Interval 0.43 to 1.6
|
0.04 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.02 • Interval 0.02 to 0.09
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 12F
|
0.06 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.03 • Interval 0.03 to 0.11
|
0.02 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.01 • Interval 0.01 to 0.04
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 15B
|
1.19 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.46 • Interval 0.46 to 3.05
|
0.16 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.05 • Interval 0.05 to 0.5
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 22F
|
0.48 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.16 • Interval 0.16 to 1.47
|
0.02 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.01 • Interval 0.01 to 0.06
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Serotype 33F
|
0.40 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.18 • Interval 0.18 to 0.88
|
0.07 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.03 • Interval 0.03 to 0.16
|
PRIMARY outcome
Timeframe: 1 month after Dose 3Population: Dose 3 evaluable immunogenicity population = eligible participants 42-70 days of age at first vaccination, received all 3 doses as randomized with 335-455 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. Here, "Number of Participants Analyzed"= participants in Dose 3 evaluable immunogenicity population; "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, and 23F and additional serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Assay results below the LLOQ were set to 0.5 \* LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, and the corresponding 2-sided 95% CIs (based on Student's t distribution).
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=22 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=24 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 4
|
3.05 Microgram per millilitre (mcg/mL)
95% Confidence Interval 1.50 • Interval 1.5 to 6.2
|
3.04 Microgram per millilitre (mcg/mL)
95% Confidence Interval 1.72 • Interval 1.72 to 5.36
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 5
|
1.50 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.80 • Interval 0.8 to 2.82
|
1.72 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.90 • Interval 0.9 to 3.29
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 6A
|
6.63 Microgram per millilitre (mcg/mL)
95% Confidence Interval 2.96 • Interval 2.96 to 14.86
|
5.63 Microgram per millilitre (mcg/mL)
95% Confidence Interval 2.96 • Interval 2.96 to 10.72
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 6B
|
1.94 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.82 • Interval 0.82 to 4.56
|
1.49 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.67 • Interval 0.67 to 3.32
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 7F
|
3.53 Microgram per millilitre (mcg/mL)
95% Confidence Interval 1.97 • Interval 1.97 to 6.33
|
4.14 Microgram per millilitre (mcg/mL)
95% Confidence Interval 2.73 • Interval 2.73 to 6.26
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 9V
|
2.32 Microgram per millilitre (mcg/mL)
95% Confidence Interval 1.28 • Interval 1.28 to 4.19
|
2.27 Microgram per millilitre (mcg/mL)
95% Confidence Interval 1.19 • Interval 1.19 to 4.35
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 14
|
4.01 Microgram per millilitre (mcg/mL)
95% Confidence Interval 1.64 • Interval 1.64 to 9.77
|
5.06 Microgram per millilitre (mcg/mL)
95% Confidence Interval 3.04 • Interval 3.04 to 8.4
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 1
|
1.61 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.93 • Interval 0.93 to 2.78
|
1.65 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.94 • Interval 0.94 to 2.9
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 3
|
0.84 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.44 • Interval 0.44 to 1.6
|
0.57 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.32 • Interval 0.32 to 1.01
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 18C
|
2.60 Microgram per millilitre (mcg/mL)
95% Confidence Interval 1.24 • Interval 1.24 to 5.44
|
2.64 Microgram per millilitre (mcg/mL)
95% Confidence Interval 1.49 • Interval 1.49 to 4.69
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 19A
|
4.81 Microgram per millilitre (mcg/mL)
95% Confidence Interval 2.07 • Interval 2.07 to 11.16
|
2.69 Microgram per millilitre (mcg/mL)
95% Confidence Interval 1.12 • Interval 1.12 to 6.45
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 19F
|
4.97 Microgram per millilitre (mcg/mL)
95% Confidence Interval 2.30 • Interval 2.3 to 10.76
|
4.58 Microgram per millilitre (mcg/mL)
95% Confidence Interval 2.36 • Interval 2.36 to 8.9
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 23F
|
3.52 Microgram per millilitre (mcg/mL)
95% Confidence Interval 1.68 • Interval 1.68 to 7.38
|
2.96 Microgram per millilitre (mcg/mL)
95% Confidence Interval 1.33 • Interval 1.33 to 6.56
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 8
|
1.33 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.50 • Interval 0.5 to 3.56
|
0.09 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.04 • Interval 0.04 to 0.24
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 10A
|
1.99 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.63 • Interval 0.63 to 6.29
|
0.03 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.01 • Interval 0.01 to 0.09
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 11A
|
1.50 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.58 • Interval 0.58 to 3.87
|
0.06 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.02 • Interval 0.02 to 0.16
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 12F
|
0.17 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.05 • Interval 0.05 to 0.56
|
0.02 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.01 • Interval 0.01 to 0.03
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 15B
|
4.90 Microgram per millilitre (mcg/mL)
95% Confidence Interval 1.67 • Interval 1.67 to 14.37
|
0.07 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.03 • Interval 0.03 to 0.2
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 22F
|
1.52 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.38 • Interval 0.38 to 6.03
|
0.02 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.01 • Interval 0.01 to 0.08
|
|
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 33F
|
1.38 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.53 • Interval 0.53 to 3.59
|
0.04 Microgram per millilitre (mcg/mL)
95% Confidence Interval 0.02 • Interval 0.02 to 0.1
|
SECONDARY outcome
Timeframe: 1 Month after Dose 3Population: Dose 3 evaluable immunogenicity population = eligible participants 42-112 days of age at first vaccination, received all 3 doses as randomized with 335-386 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. "Number of Participants Analyzed"= participants in Dose 3 evaluable immunogenicity population; "Number Analyzed"= participants with valid IgG results for specified serotype.
Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 mcg/mL, for serotype 5: \>=0.23 mcg/mL, for serotype 6B: \>=0.10 mcg/mL and for serotype 19A: \>=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=497 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=504 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 18C
|
99.2 Percentage of participants
Interval 97.9 to 99.8
|
98.2 Percentage of participants
Interval 96.6 to 99.2
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 19A
|
99.6 Percentage of participants
Interval 98.5 to 100.0
|
99.6 Percentage of participants
Interval 98.6 to 100.0
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 19F
|
99.6 Percentage of participants
Interval 98.5 to 100.0
|
99.4 Percentage of participants
Interval 98.3 to 99.9
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 23F
|
96.4 Percentage of participants
Interval 94.3 to 97.8
|
97.2 Percentage of participants
Interval 95.4 to 98.5
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 8
|
99.2 Percentage of participants
Interval 97.9 to 99.8
|
3.6 Percentage of participants
Interval 2.1 to 5.6
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 10A
|
97.8 Percentage of participants
Interval 96.1 to 98.9
|
1.6 Percentage of participants
Interval 0.7 to 3.1
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 11A
|
98.4 Percentage of participants
Interval 96.8 to 99.3
|
4.6 Percentage of participants
Interval 2.9 to 6.8
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 12F
|
96.6 Percentage of participants
Interval 94.6 to 98.0
|
0.2 Percentage of participants
Interval 0.0 to 1.1
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 15B
|
99.4 Percentage of participants
Interval 98.2 to 99.9
|
4.8 Percentage of participants
Interval 3.1 to 7.0
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 22F
|
99.2 Percentage of participants
Interval 97.9 to 99.8
|
1.4 Percentage of participants
Interval 0.6 to 2.9
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 33F
|
98.6 Percentage of participants
Interval 97.1 to 99.4
|
1.8 Percentage of participants
Interval 0.8 to 3.4
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 1
|
97.2 Percentage of participants
Interval 95.3 to 98.4
|
98.2 Percentage of participants
Interval 96.6 to 99.2
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 3
|
82.6 Percentage of participants
Interval 79.0 to 85.8
|
93.2 Percentage of participants
Interval 90.7 to 95.3
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 4
|
99.2 Percentage of participants
Interval 97.9 to 99.8
|
99.2 Percentage of participants
Interval 98.0 to 99.8
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 5
|
98.4 Percentage of participants
Interval 96.8 to 99.3
|
98.0 Percentage of participants
Interval 96.4 to 99.0
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 6A
|
98.8 Percentage of participants
Interval 97.4 to 99.6
|
98.8 Percentage of participants
Interval 97.4 to 99.6
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 6B
|
98.4 Percentage of participants
Interval 96.8 to 99.3
|
97.6 Percentage of participants
Interval 95.9 to 98.8
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 7F
|
99.6 Percentage of participants
Interval 98.5 to 100.0
|
100.0 Percentage of participants
Interval 99.3 to 100.0
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 9V
|
99.2 Percentage of participants
Interval 97.9 to 99.8
|
98.8 Percentage of participants
Interval 97.4 to 99.6
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Serotype 14
|
96.6 Percentage of participants
Interval 94.5 to 98.0
|
98.0 Percentage of participants
Interval 96.4 to 99.0
|
SECONDARY outcome
Timeframe: 1 month after Dose 2Population: Dose 2 evaluable immunogenicity population: eligible participants 42-112 days of age at first vaccination, received first 2 doses as randomized, at least 1 valid immunogenicity results within 27 to 56 days after Dose 2, no other major protocol deviations. "Number of Participants Analyzed"= participants in Dose 2 evaluable immunogenicity population, "Number Analyzed"= participants with valid OPA assay results 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 Dose 2. Results were expressed as OPA titers. 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 |
20vPnC: Primary Study Population
n=567 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=562 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 1
|
14 Titers
Interval 12.0 to 16.0
|
23 Titers
Interval 19.0 to 28.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 3
|
31 Titers
Interval 26.0 to 36.0
|
40 Titers
Interval 34.0 to 47.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 4
|
333 Titers
Interval 270.0 to 413.0
|
391 Titers
Interval 314.0 to 486.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 5
|
21 Titers
Interval 18.0 to 23.0
|
27 Titers
Interval 23.0 to 31.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 6A
|
347 Titers
Interval 273.0 to 441.0
|
409 Titers
Interval 318.0 to 527.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 6B
|
54 Titers
Interval 42.0 to 71.0
|
105 Titers
Interval 76.0 to 144.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 7F
|
858 Titers
Interval 736.0 to 1000.0
|
895 Titers
Interval 781.0 to 1027.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 9V
|
233 Titers
Interval 182.0 to 298.0
|
285 Titers
Interval 228.0 to 358.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 14
|
287 Titers
Interval 215.0 to 383.0
|
360 Titers
Interval 264.0 to 489.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 18C
|
588 Titers
Interval 467.0 to 741.0
|
719 Titers
Interval 590.0 to 876.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 19A
|
57 Titers
Interval 43.0 to 75.0
|
91 Titers
Interval 69.0 to 121.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 19F
|
97 Titers
Interval 81.0 to 116.0
|
117 Titers
Interval 94.0 to 146.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 23F
|
59 Titers
Interval 42.0 to 84.0
|
68 Titers
Interval 48.0 to 96.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 8
|
164 Titers
Interval 133.0 to 203.0
|
17 Titers
Interval 15.0 to 18.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 10A
|
855 Titers
Interval 610.0 to 1199.0
|
39 Titers
Interval 34.0 to 44.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 11A
|
327 Titers
Interval 253.0 to 423.0
|
49 Titers
Interval 47.0 to 51.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 12F
|
4788 Titers
Interval 3779.0 to 6067.0
|
26 Titers
Interval 23.0 to 28.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 15B
|
846 Titers
Interval 605.0 to 1183.0
|
17 Titers
Interval 15.0 to 19.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 22F
|
4444 Titers
Interval 3666.0 to 5386.0
|
10 Titers
Interval 9.0 to 11.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Serotype 33F
|
2373 Titers
Interval 1759.0 to 3202.0
|
178 Titers
Interval 163.0 to 195.0
|
SECONDARY outcome
Timeframe: 1 Month after Dose 3Population: Dose 3 evaluable immunogenicity population = eligible participants 42-112 days of age at first vaccination, received all 3 doses as randomized with 335-386 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. "Number of Participants Analyzed"= participants in Dose 3 evaluable immunogenicity population; "Number Analyzed"= participants with valid assay results for specified OPA 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 Dose 3. Results were expressed as OPA titers. 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 |
20vPnC: Primary Study Population
n=497 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=504 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 12F
|
5501 Titers
Interval 4499.0 to 6725.0
|
29 Titers
Interval 25.0 to 35.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 15B
|
2676 Titers
Interval 1948.0 to 3677.0
|
23 Titers
Interval 18.0 to 30.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 22F
|
6523 Titers
Interval 4848.0 to 8777.0
|
17 Titers
Interval 13.0 to 24.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 33F
|
11315 Titers
Interval 8107.0 to 15794.0
|
708 Titers
Interval 545.0 to 920.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 1
|
54 Titers
Interval 43.0 to 69.0
|
101 Titers
Interval 79.0 to 129.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 3
|
99 Titers
Interval 84.0 to 117.0
|
129 Titers
Interval 111.0 to 150.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 4
|
904 Titers
Interval 752.0 to 1086.0
|
992 Titers
Interval 777.0 to 1266.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 5
|
60 Titers
Interval 50.0 to 72.0
|
82 Titers
Interval 66.0 to 101.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 6A
|
1101 Titers
Interval 897.0 to 1350.0
|
1304 Titers
Interval 1018.0 to 1671.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 6B
|
537 Titers
Interval 408.0 to 706.0
|
864 Titers
Interval 664.0 to 1125.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 7F
|
1811 Titers
Interval 1553.0 to 2112.0
|
2197 Titers
Interval 1905.0 to 2533.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 9V
|
3254 Titers
Interval 2596.0 to 4079.0
|
4544 Titers
Interval 3681.0 to 5610.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 14
|
738 Titers
Interval 606.0 to 899.0
|
926 Titers
Interval 751.0 to 1142.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 18C
|
1296 Titers
Interval 1048.0 to 1602.0
|
1870 Titers
Interval 1489.0 to 2348.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 19A
|
754 Titers
Interval 627.0 to 907.0
|
707 Titers
Interval 558.0 to 896.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 19F
|
183 Titers
Interval 140.0 to 237.0
|
258 Titers
Interval 192.0 to 347.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 23F
|
697 Titers
Interval 530.0 to 917.0
|
975 Titers
Interval 734.0 to 1296.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 8
|
1398 Titers
Interval 1088.0 to 1796.0
|
31 Titers
Interval 25.0 to 39.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 10A
|
3403 Titers
Interval 2600.0 to 4455.0
|
69 Titers
Interval 52.0 to 91.0
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Serotype 11A
|
2966 Titers
Interval 2212.0 to 3978.0
|
66 Titers
Interval 51.0 to 85.0
|
SECONDARY outcome
Timeframe: Before Dose 3 to 1 month after Dose 3Population: Dose 3 evaluable immunogenicity population = eligible participants 42-112 days of age at first vaccination, received all 3 doses as randomized with 335-386 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. "Number of Participants Analyzed"= participants in Dose 3 evaluable immunogenicity population; "Number Analysed"= participants in Dose 3 EIP at both timepoints.
20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student's t distribution).
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=497 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=504 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 1
|
13.9 Fold rise
Interval 12.7 to 15.3
|
13.9 Fold rise
Interval 12.8 to 15.1
|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 3
|
13.7 Fold rise
Interval 12.4 to 15.1
|
15.2 Fold rise
Interval 13.9 to 16.7
|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 4
|
29.8 Fold rise
Interval 27.0 to 32.9
|
27.7 Fold rise
Interval 25.0 to 30.6
|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 5
|
14.0 Fold rise
Interval 12.9 to 15.2
|
13.6 Fold rise
Interval 12.6 to 14.7
|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 6A
|
26.9 Fold rise
Interval 24.2 to 30.0
|
28.7 Fold rise
Interval 25.9 to 31.7
|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 6B
|
36.8 Fold rise
Interval 33.3 to 40.6
|
40.2 Fold rise
Interval 36.8 to 44.0
|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 7F
|
8.5 Fold rise
Interval 7.9 to 9.2
|
9.3 Fold rise
Interval 8.6 to 10.0
|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 9V
|
22.5 Fold rise
Interval 20.4 to 24.7
|
19.9 Fold rise
Interval 18.3 to 21.6
|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 14
|
9.7 Fold rise
Interval 8.7 to 10.8
|
8.4 Fold rise
Interval 7.6 to 9.4
|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 18C
|
15.8 Fold rise
Interval 14.5 to 17.1
|
17.0 Fold rise
Interval 15.7 to 18.4
|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 19A
|
39.3 Fold rise
Interval 34.6 to 44.7
|
40.7 Fold rise
Interval 36.4 to 45.5
|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 19F
|
20.5 Fold rise
Interval 18.4 to 22.9
|
21.4 Fold rise
Interval 19.4 to 23.7
|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 23F
|
32.3 Fold rise
Interval 29.2 to 35.7
|
38.3 Fold rise
Interval 34.7 to 42.4
|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 8
|
12.7 Fold rise
Interval 11.6 to 13.9
|
1.4 Fold rise
Interval 1.3 to 1.5
|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 10A
|
14.8 Fold rise
Interval 13.3 to 16.4
|
1.1 Fold rise
Interval 1.0 to 1.2
|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 11A
|
13.8 Fold rise
Interval 12.4 to 15.3
|
1.1 Fold rise
Interval 1.0 to 1.2
|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 12F
|
16.5 Fold rise
Interval 15.0 to 18.0
|
1.0 Fold rise
Interval 1.0 to 1.1
|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 15B
|
13.4 Fold rise
Interval 11.9 to 15.1
|
1.3 Fold rise
Interval 1.2 to 1.4
|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 22F
|
12.8 Fold rise
Interval 11.5 to 14.3
|
1.3 Fold rise
Interval 1.1 to 1.4
|
|
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Serotype 33F
|
12.9 Fold rise
Interval 11.6 to 14.3
|
1.1 Fold rise
Interval 1.0 to 1.2
|
SECONDARY outcome
Timeframe: 1 month after Dose 2Population: Dose 2 EIP=eligible participants 42-112 days of age at first vaccine, received 2 dose as randomized, at least 1 valid immunogenicity result from blood collection (27 to 56 days after Dose 2), no other major protocol deviations. "Number of Participants Analyzed"= participants in Dose 2 evaluable immunogenicity population; "Number Analyzed"= participants with valid assay results for specified concomitant vaccine antigen.
Pre-specified vaccines were administered concomitantly with 20vPnC or 13vPnC and responses assessed using pre-defined levels as follows: Diphtheria and tetanus toxoids: concentration of antibody (in international units \[IU\]) to diphtheria and tetanus toxoid (prespecified level \>= observed anti-pertussis antibody concentration achieved by 95% of 13vPnC recipients); Poliomyelitis: NA titers to poliovirus types 1, 2, and 3 (prespecified level NA titer \>=1:8); and Hib: concentration of antibody to Hib (PRP) in mcg/mL (prespecified level \>=0.15 mcg/mL anti-PRP). 2-sided 95% CI was based on Clopper and Pearson method. The assays were performed on randomly selected subsets.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=567 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=562 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population
Diphtheria toxoid
|
85.0 Percentage of participants
Interval 79.3 to 89.6
|
89.5 Percentage of participants
Interval 84.4 to 93.4
|
|
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population
Tetanus toxoid
|
95.5 Percentage of participants
Interval 91.6 to 97.9
|
98.5 Percentage of participants
Interval 95.7 to 99.7
|
|
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population
Pertussis: PT
|
94.5 Percentage of participants
Interval 90.4 to 97.2
|
95.0 Percentage of participants
Interval 91.0 to 97.6
|
|
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population
Pertussis: FHA
|
93.5 Percentage of participants
Interval 89.1 to 96.5
|
95.0 Percentage of participants
Interval 91.0 to 97.6
|
|
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population
Pertussis: PRN
|
93.5 Percentage of participants
Interval 89.1 to 96.5
|
95.0 Percentage of participants
Interval 91.0 to 97.6
|
|
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population
Poliovirus: Type 1
|
94.8 Percentage of participants
Interval 88.3 to 98.3
|
98.1 Percentage of participants
Interval 93.2 to 99.8
|
|
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population
Poliovirus: Type 2
|
88.5 Percentage of participants
Interval 80.4 to 94.1
|
91.3 Percentage of participants
Interval 84.2 to 96.0
|
|
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population
Poliovirus: Type 3
|
95.8 Percentage of participants
Interval 89.7 to 98.9
|
100.0 Percentage of participants
Interval 96.5 to 100.0
|
|
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population
Hemophilus influenzae type b
|
100.0 Percentage of participants
Interval 98.2 to 100.0
|
100.0 Percentage of participants
Interval 98.1 to 100.0
|
SECONDARY outcome
Timeframe: 1 Month after Dose 3Population: Dose 3 evaluable immunogenicity population = eligible participants 42-70 days of age at first vaccination, received all 3 doses as randomized with 335-455 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. Here, "Number of Participants Analyzed"= participants in Dose 3 evaluable immunogenicity population; "Number Analyzed"= participants with valid IgG results for specified serotype.
Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 mcg/mL, for serotype 5: \>=0.23 mcg/mL, for serotype 6B: \>=0.10 mcg/mL and for serotype 19A: \>=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC: Primary Study Population
n=22 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=24 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 1
|
90.9 Percentage of participants
Interval 70.8 to 98.9
|
83.3 Percentage of participants
Interval 62.6 to 95.3
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 3
|
68.2 Percentage of participants
Interval 45.1 to 86.1
|
50.0 Percentage of participants
Interval 29.1 to 70.9
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 4
|
95.5 Percentage of participants
Interval 77.2 to 99.9
|
100.0 Percentage of participants
Interval 85.8 to 100.0
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 5
|
90.9 Percentage of participants
Interval 70.8 to 98.9
|
91.7 Percentage of participants
Interval 73.0 to 99.0
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 6A
|
95.5 Percentage of participants
Interval 77.2 to 99.9
|
100.0 Percentage of participants
Interval 85.8 to 100.0
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 6B
|
90.9 Percentage of participants
Interval 70.8 to 98.9
|
91.7 Percentage of participants
Interval 73.0 to 99.0
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 7F
|
95.5 Percentage of participants
Interval 77.2 to 99.9
|
100.0 Percentage of participants
Interval 85.8 to 100.0
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 9V
|
100.0 Percentage of participants
Interval 84.6 to 100.0
|
83.3 Percentage of participants
Interval 62.6 to 95.3
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 14
|
90.9 Percentage of participants
Interval 70.8 to 98.9
|
100.0 Percentage of participants
Interval 85.8 to 100.0
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 18C
|
90.9 Percentage of participants
Interval 70.8 to 98.9
|
95.8 Percentage of participants
Interval 78.9 to 99.9
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 19A
|
100.0 Percentage of participants
Interval 84.6 to 100.0
|
95.8 Percentage of participants
Interval 78.9 to 99.9
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 19F
|
100.0 Percentage of participants
Interval 84.6 to 100.0
|
91.7 Percentage of participants
Interval 73.0 to 99.0
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 23F
|
90.9 Percentage of participants
Interval 70.8 to 98.9
|
79.2 Percentage of participants
Interval 57.8 to 92.9
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 8
|
68.2 Percentage of participants
Interval 45.1 to 86.1
|
25.0 Percentage of participants
Interval 9.8 to 46.7
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 10A
|
68.2 Percentage of participants
Interval 45.1 to 86.1
|
16.7 Percentage of participants
Interval 4.7 to 37.4
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 11A
|
77.3 Percentage of participants
Interval 54.6 to 92.2
|
20.8 Percentage of participants
Interval 7.1 to 42.2
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 12F
|
36.4 Percentage of participants
Interval 17.2 to 59.3
|
4.2 Percentage of participants
Interval 0.1 to 21.1
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 15B
|
90.9 Percentage of participants
Interval 70.8 to 98.9
|
20.8 Percentage of participants
Interval 7.1 to 42.2
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 22F
|
63.6 Percentage of participants
Interval 40.7 to 82.8
|
12.5 Percentage of participants
Interval 2.7 to 32.4
|
|
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Serotype 33F
|
72.7 Percentage of participants
Interval 49.8 to 89.3
|
20.8 Percentage of participants
Interval 7.1 to 42.2
|
SECONDARY outcome
Timeframe: 1 month after Dose 2Population: Dose 2 evaluable immunogenicity population: eligible participants 42-70 days of age at first vaccination, received first 2 doses as randomized, at least 1 valid immunogenicity results from blood collection (27 to 56 days after Dose 2), no other major protocol deviations. "Number of participants Analyzed"= participants in Dose 2 evaluable immunogenicity population, ""Number Analyzed"= participants with valid OPA assay results 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 Dose 2. Results were expressed as OPA titers. 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 |
20vPnC: Primary Study Population
n=24 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=27 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 9V
|
218 Titers
Interval 70.0 to 676.0
|
293 Titers
Interval 85.0 to 1008.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 1
|
17 Titers
Interval 7.0 to 40.0
|
33 Titers
Interval 10.0 to 105.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 3
|
79 Titers
Interval 42.0 to 149.0
|
31 Titers
Interval 13.0 to 73.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 4
|
166 Titers
Interval 38.0 to 736.0
|
163 Titers
Interval 32.0 to 840.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 5
|
28 Titers
Interval 11.0 to 76.0
|
31 Titers
Interval 14.0 to 71.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 6A
|
222 Titers
Interval 32.0 to 1553.0
|
247 Titers
Interval 60.0 to 1011.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 6B
|
314 Titers
Interval 27.0 to 3584.0
|
216 Titers
Interval 39.0 to 1186.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 7F
|
809 Titers
Interval 481.0 to 1361.0
|
717 Titers
Interval 246.0 to 2084.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 14
|
984 Titers
Interval 492.0 to 1970.0
|
247 Titers
Interval 69.0 to 886.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 18C
|
968 Titers
Interval 403.0 to 2326.0
|
268 Titers
Interval 43.0 to 1655.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 19A
|
314 Titers
Interval 68.0 to 1443.0
|
31 Titers
Interval 8.0 to 118.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 19F
|
120 Titers
Interval 27.0 to 529.0
|
230 Titers
Interval 48.0 to 1097.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 23F
|
35 Titers
Interval 6.0 to 196.0
|
56 Titers
Interval 9.0 to 346.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 8
|
203 Titers
Interval 19.0 to 2155.0
|
38 Titers
Interval 9.0 to 161.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 10A
|
559 Titers
Interval 50.0 to 6233.0
|
232 Titers
Interval 8.0 to 6478.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 11A
|
3537 Titers
Interval 863.0 to 14497.0
|
2717 Titers
Interval 470.0 to 15716.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 12F
|
698 Titers
Interval 77.0 to 6301.0
|
198 Titers
Interval 41.0 to 960.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 15B
|
142 Titers
Interval 9.0 to 2269.0
|
242 Titers
Interval 18.0 to 3267.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 22F
|
413 Titers
Interval 32.0 to 5406.0
|
499 Titers
Interval 28.0 to 8837.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Serotype 33F
|
3508 Titers
Interval 349.0 to 35250.0
|
3961 Titers
Interval 706.0 to 22238.0
|
SECONDARY outcome
Timeframe: 1 Month after Dose 3Population: Dose 3 evaluable immunogenicity population = eligible participants 42-70 days of age at first vaccination, received all 3 doses as randomized with 335-455 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. "Number of participants Analyzed"= participants in Dose 3 evaluable immunogenicity population; "Number Analyzed"= participants with valid OPA assay results 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 Dose 3. Results were expressed as OPA titers. 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 |
20vPnC: Primary Study Population
n=22 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=24 Participants
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
|---|---|---|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 11A
|
7137 Titers
Interval 1036.0 to 49164.0
|
1789 Titers
Interval 36.0 to 89068.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 1
|
85 Titers
Interval 17.0 to 421.0
|
93 Titers
Interval 22.0 to 394.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 3
|
126 Titers
Interval 41.0 to 383.0
|
107 Titers
Interval 37.0 to 309.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 4
|
310 Titers
Interval 86.0 to 1123.0
|
429 Titers
Interval 38.0 to 4863.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 5
|
116 Titers
Interval 28.0 to 476.0
|
108 Titers
Interval 26.0 to 456.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 6A
|
2922 Titers
Interval 311.0 to 27459.0
|
1580 Titers
Interval 393.0 to 6351.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 6B
|
4417 Titers
Interval 998.0 to 19951.0
|
1397 Titers
Interval 150.0 to 12967.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 7F
|
1039 Titers
Interval 509.0 to 2122.0
|
1411 Titers
Interval 373.0 to 5340.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 9V
|
1574 Titers
Interval 369.0 to 6711.0
|
1067 Titers
Interval 150.0 to 7583.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 14
|
1151 Titers
Interval 321.0 to 4132.0
|
628 Titers
Interval 137.0 to 2890.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 18C
|
583 Titers
Interval 149.0 to 2284.0
|
973 Titers
Interval 89.0 to 10606.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 19A
|
652 Titers
Interval 131.0 to 3234.0
|
435 Titers
Interval 14.0 to 13833.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 19F
|
1570 Titers
Interval 239.0 to 10337.0
|
701 Titers
Interval 124.0 to 3958.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 23F
|
152 Titers
Interval 24.0 to 966.0
|
410 Titers
Interval 22.0 to 7594.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 8
|
368 Titers
Interval 11.0 to 12078.0
|
149 Titers
Interval 9.0 to 2337.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 10A
|
2851 Titers
Interval 1309.0 to 6210.0
|
117 Titers
Interval 15.0 to 916.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 12F
|
757 Titers
Interval 15.0 to 37522.0
|
241 Titers
Interval 16.0 to 3734.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 15B
|
822 Titers
Interval 42.0 to 16070.0
|
147 Titers
Interval 10.0 to 2214.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 22F
|
1983 Titers
Interval 390.0 to 10085.0
|
1635 Titers
Interval 165.0 to 16157.0
|
|
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Serotype 33F
|
5903 Titers
Interval 53.0 to 657862.0
|
3619 Titers
Interval 948.0 to 13817.0
|
Adverse Events
20vPnC: Primary Study Population
Serious events: 34 serious events
Other events: 589 other events
Deaths: 0 deaths
13vPnC: Primary Study Population
Serious events: 40 serious events
Other events: 593 other events
Deaths: 0 deaths
20vPnC: Russian Cohort
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
13vPnC: Russian Cohort
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
20vPnC: Primary Study Population
n=601 participants at risk
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=603 participants at risk
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
20vPnC: Russian Cohort
n=24 participants at risk
Infants 42 to 70 days of age were enrolled to receive 3 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 60 to 90 days after dose 1 and dose 3 was administered at 11 to 15 months of age.
|
13vPnC: Russian Cohort
n=27 participants at risk
Infants 42 to 70 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 60 to 90 days after dose 1 and dose 3 was administered at 11 to 15 months of age.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Blood and lymphatic system disorders
Thymus enlargement
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Congenital, familial and genetic disorders
Aorticopulmonary septal defect
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Congenital, familial and genetic disorders
Bronchogenic cyst
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Bacterial infection
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Bronchiolitis
|
0.33%
2/601 • Number of events 3 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.33%
2/603 • Number of events 2 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Bronchitis
|
0.17%
1/601 • Number of events 2 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
COVID-19
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Erythema infectiosum
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.33%
2/603 • Number of events 2 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Gastroenteritis
|
0.67%
4/601 • Number of events 4 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.83%
5/603 • Number of events 5 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Gastrointestinal infection
|
0.33%
2/601 • Number of events 2 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.33%
2/603 • Number of events 2 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Herpangina
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Laryngitis
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.33%
2/603 • Number of events 2 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Meningitis
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Meningitis enteroviral
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Otitis media
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Pneumonia
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.50%
3/603 • Number of events 3 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Pyelonephritis
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Pyelonephritis acute
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.33%
2/601 • Number of events 2 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Skin infection
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Urinary tract infection
|
0.67%
4/601 • Number of events 4 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.66%
4/603 • Number of events 5 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Viral infection
|
0.50%
3/601 • Number of events 3 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Injury, poisoning and procedural complications
Foreign body aspiration
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Metabolism and nutrition disorders
Feeding disorder
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.50%
3/603 • Number of events 3 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Metabolism and nutrition disorders
Poor feeding infant
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Metabolism and nutrition disorders
Underweight
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Nervous system disorders
Febrile convulsion
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Nervous system disorders
Seizure
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/601 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.17%
1/603 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
General disorders
Inflammation
|
0.17%
1/601 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/603 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
Other adverse events
| Measure |
20vPnC: Primary Study Population
n=601 participants at risk
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
13vPnC: Primary Study Population
n=603 participants at risk
Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age.
|
20vPnC: Russian Cohort
n=24 participants at risk
Infants 42 to 70 days of age were enrolled to receive 3 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 60 to 90 days after dose 1 and dose 3 was administered at 11 to 15 months of age.
|
13vPnC: Russian Cohort
n=27 participants at risk
Infants 42 to 70 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 60 to 90 days after dose 1 and dose 3 was administered at 11 to 15 months of age.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite (DECREASED APPETITE)
|
57.4%
345/601 • Number of events 522 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
53.6%
323/603 • Number of events 465 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
37.5%
9/24 • Number of events 10 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
29.6%
8/27 • Number of events 10 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Nervous system disorders
Hypersomnia (INCREASED SLEEP)
|
82.4%
495/601 • Number of events 965 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
84.9%
512/603 • Number of events 970 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
33.3%
8/24 • Number of events 11 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
40.7%
11/27 • Number of events 16 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Psychiatric disorders
Irritability (IRRITABILITY)
|
92.0%
553/601 • Number of events 1266 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
92.2%
556/603 • Number of events 1258 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
54.2%
13/24 • Number of events 18 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
55.6%
15/27 • Number of events 24 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
General disorders
Injection site erythema (REDNESS)
|
55.1%
331/601 • Number of events 534 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
55.2%
333/603 • Number of events 531 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
12.5%
3/24 • Number of events 4 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
14.8%
4/27 • Number of events 6 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
General disorders
Injection site pain (PAIN)
|
57.1%
343/601 • Number of events 555 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
57.5%
347/603 • Number of events 557 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
29.2%
7/24 • Number of events 8 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
22.2%
6/27 • Number of events 7 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
General disorders
Injection site swelling (SWELLING)
|
43.3%
260/601 • Number of events 431 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
41.6%
251/603 • Number of events 388 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
16.7%
4/24 • Number of events 5 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
11.1%
3/27 • Number of events 3 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
General disorders
Pyrexia (FEVER)
|
35.3%
212/601 • Number of events 282 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
35.5%
214/603 • Number of events 273 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
8.3%
2/24 • Number of events 3 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
14.8%
4/27 • Number of events 4 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
21/601 • Number of events 21 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
5.8%
35/603 • Number of events 40 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
4.2%
1/24 • Number of events 1 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
0.00%
0/27 • Local reactions and Systemic events (systematic assessment): Within 7 days after Dose 1, 2, or 3; SAEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 3 and other AEs (non-systematic assessment): From Dose 1 up to 1 month after Dose 2 and from Dose 3 up to 1 month after Dose 3
Same event may appear as both SAE and non-SAE. However, 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 evaluated. MedDRA 25.0 was used for primary cohorts and 26.0 was used for Russian cohort.
|
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