Trial Outcomes & Findings for 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants (NCT NCT04382326)
NCT ID: NCT04382326
Last Updated: 2023-12-06
Results Overview
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1997 participants
Primary outcome timeframe
Within 7 days after Dose 1
Results posted on
2023-12-06
Participant Flow
A total of 1997 participants were enrolled and assigned to receive 4 doses of 20-valent pneumococcal conjugate vaccine (20vPnC) or 13vPnC of which 6 participants were not vaccinated and 1991 were vaccinated with either 20vPnC or 13vPnC.
Participant milestones
| Measure |
20vPnC
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Overall Study
STARTED
|
1001
|
987
|
|
Overall Study
COMPLETED
|
821
|
799
|
|
Overall Study
NOT COMPLETED
|
180
|
188
|
Reasons for withdrawal
| Measure |
20vPnC
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Overall Study
Adverse Event, not serious
|
1
|
2
|
|
Overall Study
Other
|
1
|
0
|
|
Overall Study
Withdrawal By Parent/Guardian
|
50
|
54
|
|
Overall Study
No Longer Meets Eligibility Criteria
|
50
|
44
|
|
Overall Study
Protocol Violation
|
29
|
23
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
48
|
63
|
|
Overall Study
Adverse Event, non-fatal
|
1
|
1
|
Baseline Characteristics
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
Baseline characteristics by cohort
| Measure |
20vPnC
n=1001 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=987 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
Total
n=1988 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 Days
STANDARD_DEVIATION 7.98 • n=5 Participants
|
65.6 Days
STANDARD_DEVIATION 7.12 • n=7 Participants
|
65.8 Days
STANDARD_DEVIATION 7.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
483 Participants
n=5 Participants
|
482 Participants
n=7 Participants
|
965 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
518 Participants
n=5 Participants
|
505 Participants
n=7 Participants
|
1023 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
312 Participants
n=5 Participants
|
293 Participants
n=7 Participants
|
605 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
661 Participants
n=5 Participants
|
659 Participants
n=7 Participants
|
1320 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
110 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
754 Participants
n=5 Participants
|
742 Participants
n=7 Participants
|
1496 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
68 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
47 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 1Population: Safety population included all the participants who received at least 1 dose of the investigational product (IP) with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any electronic diary (e-diary) data reported after Dose 1.
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 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).
Outcome measures
| Measure |
20vPnC
n=993 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=974 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Redness: Any
|
25.5 Percentage of participants
Interval 22.8 to 28.3
|
24.6 Percentage of participants
Interval 22.0 to 27.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Redness: Mild
|
21.5 Percentage of participants
Interval 18.9 to 24.1
|
22.3 Percentage of participants
Interval 19.7 to 25.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Redness: Moderate
|
4.0 Percentage of participants
Interval 2.9 to 5.4
|
2.4 Percentage of participants
Interval 1.5 to 3.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 0.4
|
0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Swelling: Any
|
16.4 Percentage of participants
Interval 14.2 to 18.9
|
18.8 Percentage of participants
Interval 16.4 to 21.4
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Swelling: Mild
|
11.5 Percentage of participants
Interval 9.6 to 13.6
|
14.7 Percentage of participants
Interval 12.5 to 17.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Swelling: Moderate
|
4.8 Percentage of participants
Interval 3.6 to 6.4
|
4.1 Percentage of participants
Interval 2.9 to 5.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Swelling: Severe
|
0.1 Percentage of participants
Interval 0.0 to 0.6
|
0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Pain at the injection site: Any
|
49.1 Percentage of participants
Interval 46.0 to 52.3
|
45.3 Percentage of participants
Interval 42.1 to 48.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Pain at the injection site: Mild
|
30.6 Percentage of participants
Interval 27.8 to 33.6
|
30.4 Percentage of participants
Interval 27.5 to 33.4
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Pain at the injection site: Moderate
|
18.4 Percentage of participants
Interval 16.1 to 21.0
|
14.9 Percentage of participants
Interval 12.7 to 17.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Pain at the injection site: Severe
|
0.1 Percentage of participants
Interval 0.0 to 0.6
|
0 Percentage of participants
Interval 0.0 to 0.4
|
PRIMARY outcome
Timeframe: Within 7 Days After Dose 2Population: Safety population included all the participants who received at least 1 dose of the investigational product (IP) with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any electronic diary (e-diary) data reported after Dose 2.
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 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).
Outcome measures
| Measure |
20vPnC
n=940 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=924 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Percentage of Participants With Local Reaction Within 7 Days After Dose 2
Redness: Any
|
23.2 Percentage of participants
Interval 20.5 to 26.0
|
26.4 Percentage of participants
Interval 23.6 to 29.4
|
|
Percentage of Participants With Local Reaction Within 7 Days After Dose 2
Redness: Mild
|
21.2 Percentage of participants
Interval 18.6 to 23.9
|
23.1 Percentage of participants
Interval 20.4 to 25.9
|
|
Percentage of Participants With Local Reaction Within 7 Days After Dose 2
Redness: Moderate
|
2.0 Percentage of participants
Interval 1.2 to 3.1
|
3.4 Percentage of participants
Interval 2.3 to 4.7
|
|
Percentage of Participants With Local Reaction Within 7 Days After Dose 2
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 0.4
|
0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Local Reaction Within 7 Days After Dose 2
Swelling: Any
|
15.5 Percentage of participants
Interval 13.3 to 18.0
|
17.3 Percentage of participants
Interval 14.9 to 19.9
|
|
Percentage of Participants With Local Reaction Within 7 Days After Dose 2
Swelling: Mild
|
11.5 Percentage of participants
Interval 9.5 to 13.7
|
13.5 Percentage of participants
Interval 11.4 to 15.9
|
|
Percentage of Participants With Local Reaction Within 7 Days After Dose 2
Swelling: Moderate
|
4.0 Percentage of participants
Interval 2.9 to 5.5
|
3.8 Percentage of participants
Interval 2.7 to 5.2
|
|
Percentage of Participants With Local Reaction Within 7 Days After Dose 2
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 0.4
|
0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Local Reaction Within 7 Days After Dose 2
Pain at the injection site: Any
|
44.0 Percentage of participants
Interval 40.8 to 47.3
|
41.7 Percentage of participants
Interval 38.5 to 44.9
|
|
Percentage of Participants With Local Reaction Within 7 Days After Dose 2
Pain at the injection site: Mild
|
29.3 Percentage of participants
Interval 26.4 to 32.3
|
27.7 Percentage of participants
Interval 24.8 to 30.7
|
|
Percentage of Participants With Local Reaction Within 7 Days After Dose 2
Pain at the injection site: Moderate
|
14.8 Percentage of participants
Interval 12.6 to 17.2
|
14.0 Percentage of participants
Interval 11.8 to 16.4
|
|
Percentage of Participants With Local Reaction Within 7 Days After Dose 2
Pain at the injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 0.4
|
0 Percentage of participants
Interval 0.0 to 0.4
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 3Population: Safety population included all the participants who received at least 1 dose of the investigational product (IP) with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any electronic diary (e-diary) data reported after Dose 3.
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 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).
Outcome measures
| Measure |
20vPnC
n=914 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=901 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Redness: Any
|
25.4 Percentage of participants
Interval 22.6 to 28.3
|
27.2 Percentage of participants
Interval 24.3 to 30.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Redness: Mild
|
21.1 Percentage of participants
Interval 18.5 to 23.9
|
23.5 Percentage of participants
Interval 20.8 to 26.4
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Redness: Moderate
|
4.3 Percentage of participants
Interval 3.1 to 5.8
|
3.7 Percentage of participants
Interval 2.5 to 5.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 0.4
|
0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Swelling: Any
|
17.1 Percentage of participants
Interval 14.7 to 19.7
|
17.6 Percentage of participants
Interval 15.2 to 20.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Swelling: Mild
|
12.5 Percentage of participants
Interval 10.4 to 14.8
|
13.8 Percentage of participants
Interval 11.6 to 16.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Swelling: Moderate
|
4.6 Percentage of participants
Interval 3.3 to 6.2
|
3.8 Percentage of participants
Interval 2.6 to 5.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 0.4
|
0.1 Percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Pain at the injection site: Any
|
38.6 Percentage of participants
Interval 35.5 to 41.9
|
39.0 Percentage of participants
Interval 35.8 to 42.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Pain at the injection site: Mild
|
25.7 Percentage of participants
Interval 22.9 to 28.7
|
25.5 Percentage of participants
Interval 22.7 to 28.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Pain at the injection site: Moderate
|
12.9 Percentage of participants
Interval 10.8 to 15.3
|
13.4 Percentage of participants
Interval 11.3 to 15.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Pain at the injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 0.4
|
0 Percentage of participants
Interval 0.0 to 0.4
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 4Population: Safety population included all the participants who received at least 1 dose of the investigational product (IP) with safety follow up after any dose. Here, 'Number of Participants Analyzed' = number of participants with any electronic diary (e-diary) data reported after Dose 4.
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 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
n=826 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=815 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Redness: Any
|
23.5 Percentage of participants
Interval 20.6 to 26.5
|
26.6 Percentage of participants
Interval 23.6 to 29.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Redness: Mild
|
19.6 Percentage of participants
Interval 17.0 to 22.5
|
22.0 Percentage of participants
Interval 19.2 to 25.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Redness: Moderate
|
3.9 Percentage of participants
Interval 2.7 to 5.4
|
4.7 Percentage of participants
Interval 3.3 to 6.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 0.4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Swelling: Any
|
14.9 Percentage of participants
Interval 12.5 to 17.5
|
17.3 Percentage of participants
Interval 14.8 to 20.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Swelling: Mild
|
10.7 Percentage of participants
Interval 8.6 to 13.0
|
13.6 Percentage of participants
Interval 11.3 to 16.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Swelling: Moderate
|
4.2 Percentage of participants
Interval 3.0 to 5.8
|
3.7 Percentage of participants
Interval 2.5 to 5.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 0.4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Pain at the injection site: Any
|
35.7 Percentage of participants
Interval 32.4 to 39.1
|
35.8 Percentage of participants
Interval 32.5 to 39.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Pain at the injection site: Mild
|
24.1 Percentage of participants
Interval 21.2 to 27.2
|
27.1 Percentage of participants
Interval 24.1 to 30.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Pain at the injection site: Moderate
|
11.3 Percentage of participants
Interval 9.2 to 13.6
|
8.7 Percentage of participants
Interval 6.9 to 10.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Pain at the injection site: Severe
|
0.4 Percentage of participants
Interval 0.1 to 1.1
|
0 Percentage of participants
Interval 0.0 to 0.5
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 1Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any e-diary data reported after Dose 1.
Systemic events included 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 greater than or equal to (\>=) 38.0 degrees Celsius (C) and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees 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 or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC
n=993 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=974 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Fever: >=38.0 degree C
|
10.3 Percentage of participants
Interval 8.5 to 12.3
|
7.5 Percentage of participants
Interval 5.9 to 9.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Fever: >=38.0 degree C to 38.4 degree C
|
7.3 Percentage of participants
Interval 5.7 to 9.0
|
6.3 Percentage of participants
Interval 4.8 to 8.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Fever: >38.4 degree C to 38.9 degree C
|
2.2 Percentage of participants
Interval 1.4 to 3.3
|
0.9 Percentage of participants
Interval 0.4 to 1.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Fever: >38.9 degree C to 40.0 degree C
|
0.7 Percentage of participants
Interval 0.3 to 1.4
|
0.3 Percentage of participants
Interval 0.1 to 0.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Fever: >40.0 degree C
|
0.1 Percentage of participants
Interval 0.0 to 0.6
|
0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Decreased appetite: Any
|
24.4 Percentage of participants
Interval 21.7 to 27.2
|
23.9 Percentage of participants
Interval 21.3 to 26.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Decreased appetite: Mild
|
14.5 Percentage of participants
Interval 12.4 to 16.8
|
16.1 Percentage of participants
Interval 13.9 to 18.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Decreased appetite: Moderate
|
9.7 Percentage of participants
Interval 7.9 to 11.7
|
7.5 Percentage of participants
Interval 5.9 to 9.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Decreased appetite: Severe
|
0.2 Percentage of participants
Interval 0.0 to 0.7
|
0.3 Percentage of participants
Interval 0.1 to 0.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Drowsiness: Any
|
67.2 Percentage of participants
Interval 64.2 to 70.1
|
66.0 Percentage of participants
Interval 62.9 to 69.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Drowsiness: Mild
|
50.2 Percentage of participants
Interval 47.0 to 53.3
|
49.3 Percentage of participants
Interval 46.1 to 52.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Drowsiness: Moderate
|
16.1 Percentage of participants
Interval 13.9 to 18.5
|
15.6 Percentage of participants
Interval 13.4 to 18.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Drowsiness: Severe
|
0.9 Percentage of participants
Interval 0.4 to 1.7
|
1.1 Percentage of participants
Interval 0.6 to 2.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Irritability: Any
|
70.9 Percentage of participants
Interval 68.0 to 73.7
|
71.7 Percentage of participants
Interval 68.7 to 74.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Irritability: Mild
|
23.4 Percentage of participants
Interval 20.8 to 26.1
|
21.6 Percentage of participants
Interval 19.0 to 24.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Irritability: Moderate
|
43.0 Percentage of participants
Interval 39.9 to 46.1
|
46.2 Percentage of participants
Interval 43.0 to 49.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Irritability: Severe
|
4.5 Percentage of participants
Interval 3.3 to 6.0
|
3.9 Percentage of participants
Interval 2.8 to 5.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Use of antipyretic or pain medication
|
35.1 Percentage of participants
Interval 32.2 to 38.2
|
33.8 Percentage of participants
Interval 30.8 to 36.8
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 2Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any e-diary data reported after Dose 2.
Systemic events included 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 degrees C and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees 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 or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC
n=940 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=924 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Fever: >=38.0 degree C
|
17.3 Percentage of participants
Interval 15.0 to 19.9
|
16.3 Percentage of participants
Interval 14.0 to 18.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Fever: >=38.0 degree C to 38.4 degree C
|
10.9 Percentage of participants
Interval 8.9 to 13.0
|
10.0 Percentage of participants
Interval 8.1 to 12.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Fever: >38.4 degree C to 38.9 degree C
|
4.0 Percentage of participants
Interval 2.9 to 5.5
|
4.2 Percentage of participants
Interval 3.0 to 5.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Use of antipyretic or pain medication
|
40.7 Percentage of participants
Interval 37.6 to 44.0
|
41.0 Percentage of participants
Interval 37.8 to 44.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Fever: >38.9 degree C to 40.0 degree C
|
2.2 Percentage of participants
Interval 1.4 to 3.4
|
2.2 Percentage of participants
Interval 1.3 to 3.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Fever: >40.0 degree C
|
0.2 Percentage of participants
Interval 0.0 to 0.8
|
0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Decreased appetite: Any
|
26.4 Percentage of participants
Interval 23.6 to 29.3
|
23.5 Percentage of participants
Interval 20.8 to 26.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Decreased appetite: Mild
|
16.4 Percentage of participants
Interval 14.1 to 18.9
|
15.3 Percentage of participants
Interval 13.0 to 17.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Decreased appetite: Moderate
|
9.8 Percentage of participants
Interval 8.0 to 11.9
|
7.7 Percentage of participants
Interval 6.0 to 9.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Decreased appetite: Severe
|
0.2 Percentage of participants
Interval 0.0 to 0.8
|
0.5 Percentage of participants
Interval 0.2 to 1.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Drowsiness: Any
|
54.7 Percentage of participants
Interval 51.4 to 57.9
|
55.6 Percentage of participants
Interval 52.4 to 58.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Drowsiness: Mild
|
37.0 Percentage of participants
Interval 33.9 to 40.2
|
36.9 Percentage of participants
Interval 33.8 to 40.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Drowsiness: Moderate
|
16.9 Percentage of participants
Interval 14.6 to 19.5
|
17.9 Percentage of participants
Interval 15.4 to 20.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Drowsiness: Severe
|
0.7 Percentage of participants
Interval 0.3 to 1.5
|
0.9 Percentage of participants
Interval 0.4 to 1.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Irritability: Any
|
71.6 Percentage of participants
Interval 68.6 to 74.5
|
68.8 Percentage of participants
Interval 65.7 to 71.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Irritability: Mild
|
22.9 Percentage of participants
Interval 20.2 to 25.7
|
21.2 Percentage of participants
Interval 18.6 to 24.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Irritability: Moderate
|
44.7 Percentage of participants
Interval 41.5 to 47.9
|
43.4 Percentage of participants
Interval 40.2 to 46.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Irritability: Severe
|
4.0 Percentage of participants
Interval 2.9 to 5.5
|
4.2 Percentage of participants
Interval 3.0 to 5.7
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 3Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any e-diary data reported after Dose 3.
Systemic events included 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 degrees C and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees 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 or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC
n=914 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=901 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Irritability: Mild
|
25.2 Percentage of participants
Interval 22.4 to 28.1
|
21.6 Percentage of participants
Interval 19.0 to 24.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Irritability: Moderate
|
37.5 Percentage of participants
Interval 34.4 to 40.8
|
39.2 Percentage of participants
Interval 36.0 to 42.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Irritability: Severe
|
1.8 Percentage of participants
Interval 1.0 to 2.8
|
2.2 Percentage of participants
Interval 1.4 to 3.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Use of antipyretic/pain medication
|
36.3 Percentage of participants
Interval 33.2 to 39.5
|
36.1 Percentage of participants
Interval 32.9 to 39.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Fever: >=38.0 degree C
|
12.6 Percentage of participants
Interval 10.5 to 14.9
|
13.7 Percentage of participants
Interval 11.5 to 16.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Fever: >=38.0 degree C to 38.4 degree C
|
7.7 Percentage of participants
Interval 6.0 to 9.6
|
7.9 Percentage of participants
Interval 6.2 to 9.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Fever: >38.4 degree C to 38.9 degree C
|
3.4 Percentage of participants
Interval 2.3 to 4.8
|
3.9 Percentage of participants
Interval 2.7 to 5.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Fever: >38.9 degree C to 40.0 degree C
|
1.4 Percentage of participants
Interval 0.8 to 2.4
|
1.9 Percentage of participants
Interval 1.1 to 3.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Fever: >40.0 degree C
|
0.1 Percentage of participants
Interval 0.0 to 0.6
|
0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Decreased appetite: Any
|
20.6 Percentage of participants
Interval 18.0 to 23.3
|
22.4 Percentage of participants
Interval 19.7 to 25.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Decreased appetite: Mild
|
13.5 Percentage of participants
Interval 11.3 to 15.8
|
13.9 Percentage of participants
Interval 11.7 to 16.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Decreased appetite: Moderate
|
6.7 Percentage of participants
Interval 5.1 to 8.5
|
8.2 Percentage of participants
Interval 6.5 to 10.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Decreased appetite: Severe
|
0.4 Percentage of participants
Interval 0.1 to 1.1
|
0.3 Percentage of participants
Interval 0.1 to 1.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Drowsiness: Any
|
44.1 Percentage of participants
Interval 40.8 to 47.4
|
44.1 Percentage of participants
Interval 40.8 to 47.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Drowsiness: Mild
|
31.1 Percentage of participants
Interval 28.1 to 34.2
|
30.1 Percentage of participants
Interval 27.1 to 33.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Drowsiness: Moderate
|
12.5 Percentage of participants
Interval 10.4 to 14.8
|
13.1 Percentage of participants
Interval 11.0 to 15.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Drowsiness: Severe
|
0.5 Percentage of participants
Interval 0.2 to 1.3
|
0.9 Percentage of participants
Interval 0.4 to 1.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Irritability: Any
|
64.4 Percentage of participants
Interval 61.2 to 67.5
|
63.0 Percentage of participants
Interval 59.8 to 66.2
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 4Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any e-diary data reported after Dose 4.
Systemic events included 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 degrees C and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees 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 or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC
n=826 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=815 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Fever: >= 38.0 degree C
|
14.5 Percentage of participants
Interval 12.2 to 17.1
|
14.0 Percentage of participants
Interval 11.7 to 16.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Fever: >=38.0 degree C to 38.4 degree C
|
6.5 Percentage of participants
Interval 4.9 to 8.4
|
7.7 Percentage of participants
Interval 6.0 to 9.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Fever: >38.4 degree C to 38.9 degree C
|
5.1 Percentage of participants
Interval 3.7 to 6.8
|
3.2 Percentage of participants
Interval 2.1 to 4.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Fever: >38.9 degree C to 40.0 degree C
|
2.7 Percentage of participants
Interval 1.7 to 4.0
|
2.9 Percentage of participants
Interval 1.9 to 4.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Fever: >40.0 degree C
|
0.2 Percentage of participants
Interval 0.0 to 0.9
|
0.1 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Decreased appetite: Any
|
24.8 Percentage of participants
Interval 21.9 to 27.9
|
25.2 Percentage of participants
Interval 22.2 to 28.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Decreased appetite: Mild
|
15.9 Percentage of participants
Interval 13.4 to 18.5
|
16.1 Percentage of participants
Interval 13.6 to 18.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Decreased appetite: Moderate
|
8.6 Percentage of participants
Interval 6.8 to 10.7
|
8.3 Percentage of participants
Interval 6.5 to 10.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Decreased appetite: Severe
|
0.4 Percentage of participants
Interval 0.1 to 1.1
|
0.7 Percentage of participants
Interval 0.3 to 1.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Drowsiness: Any
|
39.5 Percentage of participants
Interval 36.1 to 42.9
|
39.5 Percentage of participants
Interval 36.1 to 43.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Drowsiness: Mild
|
27.8 Percentage of participants
Interval 24.8 to 31.0
|
28.2 Percentage of participants
Interval 25.2 to 31.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Drowsiness: Moderate
|
11.0 Percentage of participants
Interval 9.0 to 13.4
|
10.7 Percentage of participants
Interval 8.6 to 13.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Drowsiness: Severe
|
0.6 Percentage of participants
Interval 0.2 to 1.4
|
0.6 Percentage of participants
Interval 0.2 to 1.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Irritability: Any
|
61.0 Percentage of participants
Interval 57.6 to 64.4
|
61.1 Percentage of participants
Interval 57.7 to 64.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Irritability: Mild
|
23.4 Percentage of participants
Interval 20.5 to 26.4
|
21.8 Percentage of participants
Interval 19.0 to 24.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Irritability: Moderate
|
35.0 Percentage of participants
Interval 31.7 to 38.3
|
37.9 Percentage of participants
Interval 34.6 to 41.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Irritability: Severe
|
2.7 Percentage of participants
Interval 1.7 to 4.0
|
1.3 Percentage of participants
Interval 0.7 to 2.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Use of antipyretic/pain medication
|
37.5 Percentage of participants
Interval 34.2 to 40.9
|
36.7 Percentage of participants
Interval 33.4 to 40.1
|
PRIMARY outcome
Timeframe: From Dose 1 to 1 Month after Dose 3Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, 'Number of Participants Analyzed' = number of participants who received Dose 1.
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.
Outcome measures
| Measure |
20vPnC
n=1001 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=987 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3
|
36.6 Percentage of participants
Interval 33.6 to 39.6
|
39.4 Percentage of participants
Interval 36.3 to 42.5
|
PRIMARY outcome
Timeframe: From Dose 4 to 1 month after Dose 4Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, 'Number of Participants Analyzed' = number of participants who received Dose 4 and had safety follow up after Dose 4.
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.
Outcome measures
| Measure |
20vPnC
n=853 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=841 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4
|
15.1 Percentage of participants
Interval 12.8 to 17.7
|
15.0 Percentage of participants
Interval 12.6 to 17.6
|
PRIMARY outcome
Timeframe: From Dose 1 to 6 months following Dose 4Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, 'Number of Participants Analyzed' = number of participants who received Dose 1.
A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
20vPnC
n=1001 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=987 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 6 Months Following Dose 4
|
4.5 Percentage of participants
Interval 3.3 to 6.0
|
3.1 Percentage of participants
Interval 2.1 to 4.4
|
PRIMARY outcome
Timeframe: From Dose 1 to 6 months following Dose 4Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, 'Number of Participants Analyzed' = number of participants who received Dose 1.
An NDCMC was defined as a significant 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
n=1001 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=987 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 6 Months Following Dose 4
|
5.0 Percentage of participants
Interval 3.7 to 6.5
|
5.9 Percentage of participants
Interval 4.5 to 7.5
|
PRIMARY outcome
Timeframe: 1 month after Dose 3Population: Dose 3 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received the first 3 doses randomized, had at least 1 valid immunogenicity result 27 to 56 days post Dose 3, and had no major protocol deviations. "Number of Participants Analyzed"= participants in Dose 3 evaluable immunogenicity population, "Number Analyzed" = number of participants with valid IgG concentrations for the specified serotype reported at 1 month after Dose 3.
Pre-specified levels of serotypes 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
n=833 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=803 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 1
|
79.8 percentage of participants
Interval 76.9 to 82.5
|
88.4 percentage of participants
Interval 86.0 to 90.5
|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 3
|
52.1 percentage of participants
Interval 48.6 to 55.5
|
67.6 percentage of participants
Interval 64.2 to 70.8
|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 4
|
79.7 percentage of participants
Interval 76.8 to 82.4
|
88.2 percentage of participants
Interval 85.7 to 90.3
|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 5
|
82.5 percentage of participants
Interval 79.7 to 85.0
|
86.8 percentage of participants
Interval 84.2 to 89.1
|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 6A
|
93.5 percentage of participants
Interval 91.6 to 95.1
|
95.9 percentage of participants
Interval 94.3 to 97.2
|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 6B
|
88.3 percentage of participants
Interval 85.9 to 90.4
|
92.4 percentage of participants
Interval 90.3 to 94.1
|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 7F
|
96.6 percentage of participants
Interval 95.2 to 97.8
|
97.6 percentage of participants
Interval 96.3 to 98.6
|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 9V
|
81.9 percentage of participants
Interval 79.1 to 84.4
|
89.8 percentage of participants
Interval 87.5 to 91.8
|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 14
|
93.4 percentage of participants
Interval 91.5 to 95.0
|
94.1 percentage of participants
Interval 92.3 to 95.7
|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 18C
|
92.6 percentage of participants
Interval 90.6 to 94.2
|
93.1 percentage of participants
Interval 91.2 to 94.8
|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 19A
|
97.1 percentage of participants
Interval 95.7 to 98.1
|
98.1 percentage of participants
Interval 96.9 to 98.9
|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 19F
|
96.9 percentage of participants
Interval 95.5 to 98.0
|
96.6 percentage of participants
Interval 95.1 to 97.8
|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 23F
|
77.9 percentage of participants
Interval 74.9 to 80.7
|
85.5 percentage of participants
Interval 82.9 to 87.9
|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 8
|
96.8 percentage of participants
Interval 95.3 to 97.9
|
85.5 percentage of participants
Interval 82.9 to 87.9
|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 10A
|
82.2 percentage of participants
Interval 79.5 to 84.8
|
85.5 percentage of participants
Interval 82.9 to 87.9
|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 11A
|
92.7 percentage of participants
Interval 90.7 to 94.4
|
85.5 percentage of participants
Interval 82.9 to 87.9
|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 12F
|
67.5 percentage of participants
Interval 64.2 to 70.6
|
85.5 percentage of participants
Interval 82.9 to 87.9
|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 15B
|
98.2 percentage of participants
Interval 97.0 to 99.0
|
85.5 percentage of participants
Interval 82.9 to 87.9
|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 22F
|
98.3 percentage of participants
Interval 97.2 to 99.1
|
85.5 percentage of participants
Interval 82.9 to 87.9
|
|
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Serotype 33F
|
86.7 percentage of participants
Interval 84.2 to 88.9
|
85.5 percentage of participants
Interval 82.9 to 87.9
|
PRIMARY outcome
Timeframe: From Dose 1 to 6 months following Dose 4Population: Dose 4 evaluable immunogenicity population: aged 42-98 days on Dose 1, received the first 4 doses randomized, had at least 1 valid immunogenicity result 27 to 56 days after Dose 4, had no major protocol deviations. "Number of Participants Analyzed"= participants in Dose 4 evaluable immunogenicity population, "Number Analyzed" = number of participants with valid IgG concentrations for the specified serotype reported at 1 month after Dose 4.
Concentrations of anticapsular IgG 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 all participants at 1 month after Dose 4 using the Luminex assay. Results were expressed as IgG concentrations. GMCs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the 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
n=755 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=745 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 1
|
1.47 microgram per milliliter (μg/mL)
Interval 1.37 to 1.57
|
2.12 microgram per milliliter (μg/mL)
Interval 1.97 to 2.27
|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 3
|
0.56 microgram per milliliter (μg/mL)
Interval 0.53 to 0.6
|
0.85 microgram per milliliter (μg/mL)
Interval 0.8 to 0.9
|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 4
|
3.77 microgram per milliliter (μg/mL)
Interval 3.52 to 4.04
|
4.84 microgram per milliliter (μg/mL)
Interval 4.5 to 5.22
|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 5
|
1.87 microgram per milliliter (μg/mL)
Interval 1.74 to 2.0
|
2.51 microgram per milliliter (μg/mL)
Interval 2.33 to 2.7
|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 6A
|
9.01 microgram per milliliter (μg/mL)
Interval 8.45 to 9.61
|
11.69 microgram per milliliter (μg/mL)
Interval 10.91 to 12.53
|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 6B
|
4.01 microgram per milliliter (μg/mL)
Interval 3.7 to 4.35
|
5.74 microgram per milliliter (μg/mL)
Interval 5.27 to 6.24
|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 7F
|
3.91 microgram per milliliter (μg/mL)
Interval 3.7 to 4.35
|
5.18 microgram per milliliter (μg/mL)
Interval 4.88 to 5.49
|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 9V
|
3.44 microgram per milliliter (μg/mL)
Interval 3.23 to 3.67
|
4.30 microgram per milliliter (μg/mL)
Interval 4.02 to 4.59
|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 14
|
5.68 microgram per milliliter (μg/mL)
Interval 5.27 to 6.12
|
6.34 microgram per milliliter (μg/mL)
Interval 5.88 to 6.83
|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 18C
|
3.46 microgram per milliliter (μg/mL)
Interval 3.24 to 3.7
|
4.69 microgram per milliliter (μg/mL)
Interval 4.34 to 5.05
|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 19A
|
3.53 microgram per milliliter (μg/mL)
Interval 3.3 to 3.77
|
4.13 microgram per milliliter (μg/mL)
Interval 3.84 to 4.45
|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 19F
|
5.01 microgram per milliliter (μg/mL)
Interval 4.68 to 5.36
|
5.79 microgram per milliliter (μg/mL)
Interval 5.36 to 6.25
|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 23F
|
3.95 microgram per milliliter (μg/mL)
Interval 3.63 to 4.31
|
6.18 microgram per milliliter (μg/mL)
Interval 5.66 to 6.75
|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 8
|
3.97 microgram per milliliter (μg/mL)
Interval 3.73 to 4.22
|
0.03 microgram per milliliter (μg/mL)
Interval 0.03 to 0.04
|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 10A
|
6.22 microgram per milliliter (μg/mL)
Interval 5.75 to 6.72
|
0.01 microgram per milliliter (μg/mL)
Interval 0.01 to 0.01
|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 11A
|
3.53 microgram per milliliter (μg/mL)
Interval 3.31 to 3.78
|
0.02 microgram per milliliter (μg/mL)
Interval 0.02 to 0.02
|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 12F
|
1.85 microgram per milliliter (μg/mL)
Interval 1.73 to 1.99
|
0.01 microgram per milliliter (μg/mL)
Interval 0.01 to 0.01
|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 15B
|
12.59 microgram per milliliter (μg/mL)
Interval 11.78 to 13.45
|
0.02 microgram per milliliter (μg/mL)
Interval 0.02 to 0.03
|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 22F
|
10.60 microgram per milliliter (μg/mL)
Interval 9.92 to 11.33
|
0.00 microgram per milliliter (μg/mL)
Interval 0.0 to 0.01
|
|
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Serotype 33F
|
9.31 microgram per milliliter (μg/mL)
Interval 8.71 to 9.96
|
0.01 microgram per milliliter (μg/mL)
Interval 0.01 to 0.01
|
PRIMARY outcome
Timeframe: 1 month after Dose 3Population: Dose 3 evaluable population: eligible participants aged 42-98 days on Dose 1, received the first 3 doses randomized, had at least 1 valid immunogenicity result 27 to 56 days post Dose 3, had no major protocol deviations. "Number of Participants Analyzed"=participants in Dose 3 evaluable immunogenicity population, "Number Analyzed" = number of participants with valid assay results for the specified antigen at 1 month after Dose 3.
Concentration of antibody to diphtheria toxoid (predefined level ≥0.1 IU/mL), tetanus toxoid (predefined level ≥0.1 IU/mL), IgG antibodies to pertussis antigens (pertussis toxin, filamentous hemagglutinin and pertactin, each with the predefined level as the 5th percentile observed in the 13vPnC group), hepatitis B antibody (in milli-international units per mL \[mIU/mL\]) (predefined level ≥10 mIU/mL), neutralizing antibody (NA) titers to poliovirus types 1, 2, and 3 (predefined level NA titer ≥1:8), Haemophilus influenzae type b (Hib) (≥0.15 μg/mL) were determined on subsets of sera collected at the immunogenicity time point 1 month after Dose 3. The antibody levels were measured by a validated multiplex Luminex immunoassay. The concomitant immune responses were measured on random subsets.
Outcome measures
| Measure |
20vPnC
n=833 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=803 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Percentage of Participants With Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens 1 Month After Dose 3
Tetanus
|
99.7 percentage of participants
Interval 98.5 to 100.0
|
99.4 percentage of participants
Interval 98.0 to 99.9
|
|
Percentage of Participants With Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens 1 Month After Dose 3
Pertussis (PT)
|
94.9 percentage of participants
Interval 92.1 to 96.9
|
95.0 percentage of participants
Interval 92.3 to 97.0
|
|
Percentage of Participants With Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens 1 Month After Dose 3
Pertussis (FHA)
|
95.7 percentage of participants
Interval 93.1 to 97.5
|
95.0 percentage of participants
Interval 92.3 to 97.0
|
|
Percentage of Participants With Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens 1 Month After Dose 3
Pertussis (PRN)
|
93.8 percentage of participants
Interval 90.8 to 96.0
|
95.0 percentage of participants
Interval 92.3 to 97.0
|
|
Percentage of Participants With Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens 1 Month After Dose 3
hepatitis B surface antigen (HBsAg)
|
100.0 percentage of participants
Interval 96.9 to 100.0
|
100.0 percentage of participants
Interval 97.1 to 100.0
|
|
Percentage of Participants With Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens 1 Month After Dose 3
Poliovirus (Type 1)
|
100.0 percentage of participants
Interval 96.7 to 100.0
|
100.0 percentage of participants
Interval 96.9 to 100.0
|
|
Percentage of Participants With Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens 1 Month After Dose 3
Poliovirus (Type 2)
|
100.0 percentage of participants
Interval 96.8 to 100.0
|
99.2 percentage of participants
Interval 95.4 to 100.0
|
|
Percentage of Participants With Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens 1 Month After Dose 3
Poliovirus (Type 3)
|
100.0 percentage of participants
Interval 96.8 to 100.0
|
100.0 percentage of participants
Interval 97.0 to 100.0
|
|
Percentage of Participants With Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens 1 Month After Dose 3
Hib ≥0.15 μg/mL
|
100.0 percentage of participants
Interval 97.1 to 100.0
|
100.0 percentage of participants
Interval 97.1 to 100.0
|
|
Percentage of Participants With Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens 1 Month After Dose 3
Diphtheria
|
93.5 percentage of participants
Interval 90.5 to 95.8
|
97.8 percentage of participants
Interval 95.7 to 99.0
|
SECONDARY outcome
Timeframe: 1 month after Dose 3Population: Dose 3 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received the first 3 doses randomized, had at least 1 valid immunogenicity result 27 to 56 days post Dose 3, and had no major protocol deviations. "Number of Participants Analyzed"= participants in Dose 3 evaluable immunogenicity population, "Number Analyzed" = number of participants with valid IgG concentrations for the specified serotype reported at 1 month after Dose 3.
Pneumococcal IgG antibody against each of 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) was measured using direct binding Luminex assay. Results were expressed as IgG concentrations. GMCs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the 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). 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
n=833 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=803 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 1
|
0.74 μg/mL
Interval 0.7 to 0.79
|
1.14 μg/mL
Interval 1.06 to 1.22
|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 3
|
0.36 μg/mL
Interval 0.33 to 0.38
|
0.51 μg/mL
Interval 0.48 to 0.55
|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 4
|
0.75 μg/mL
Interval 0.7 to 0.81
|
1.08 μg/mL
Interval 1.0 to 1.17
|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 5
|
0.66 μg/mL
Interval 0.61 to 0.71
|
0.96 μg/mL
Interval 0.88 to 1.04
|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 6A
|
1.95 μg/mL
Interval 1.81 to 2.1
|
2.69 μg/mL
Interval 2.48 to 2.92
|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 6B
|
0.61 μg/mL
Interval 0.55 to 0.68
|
1.02 μg/mL
Interval 0.91 to 1.14
|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 7F
|
1.71 μg/mL
Interval 1.62 to 1.81
|
2.29 μg/mL
Interval 2.16 to 2.43
|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 9V
|
0.87 μg/mL
Interval 0.81 to 0.93
|
1.21 μg/mL
Interval 1.12 to 1.3
|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 14
|
2.16 μg/mL
Interval 2.01 to 2.33
|
2.72 μg/mL
Interval 2.51 to 2.95
|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 18C
|
1.31 μg/mL
Interval 1.23 to 1.39
|
1.71 μg/mL
Interval 1.59 to 1.84
|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 19A
|
0.72 μg/mL
Interval 0.67 to 0.76
|
0.91 μg/mL
Interval 0.85 to 0.97
|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 19F
|
1.59 μg/mL
Interval 1.5 to 1.67
|
2.00 μg/mL
Interval 1.88 to 2.12
|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 23F
|
0.82 μg/mL
Interval 0.75 to 0.9
|
1.25 μg/mL
Interval 1.14 to 1.37
|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 8
|
1.80 μg/mL
Interval 1.7 to 1.91
|
0.02 μg/mL
Interval 0.02 to 0.02
|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 10A
|
1.21 μg/mL
Interval 1.09 to 1.33
|
0.01 μg/mL
Interval 0.01 to 0.01
|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 11A
|
1.39 μg/mL
Interval 1.3 to 1.48
|
0.02 μg/mL
Interval 0.01 to 0.02
|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 12F
|
0.55 μg/mL
Interval 0.5 to 0.6
|
0.01 μg/mL
Interval 0.01 to 0.01
|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 15B
|
4.40 μg/mL
Interval 4.11 to 4.71
|
0.03 μg/mL
Interval 0.02 to 0.03
|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 22F
|
3.71 μg/mL
Interval 3.45 to 3.99
|
0.01 μg/mL
Interval 0.0 to 0.01
|
|
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Serotype 33F
|
1.49 μg/mL
Interval 1.36 to 1.64
|
0.02 μg/mL
Interval 0.01 to 0.02
|
SECONDARY outcome
Timeframe: 1 month after Dose 4Population: Dose 4 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received all 4 doses as randomized, had at least 1 valid immunogenicity result within 27 to 56 days after Dose 4, and had no other major protocol deviations. "Number of Participants Analyzed"=participants in Dose 4 evaluable immunogenicity population, "Number Analyzed" = number of participants with valid IgG concentrations for the specified serotype reported at 1 month after Dose 4.
Pre-specified levels of serotypes 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
n=755 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=745 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 1
|
94.3 percentage of participants
Interval 92.4 to 95.8
|
97.2 percentage of participants
Interval 95.7 to 98.2
|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 3
|
73.6 percentage of participants
Interval 70.3 to 76.8
|
85.8 percentage of participants
Interval 83.1 to 88.2
|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 4
|
98.9 percentage of participants
Interval 97.9 to 99.5
|
99.1 percentage of participants
Interval 98.1 to 99.6
|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 5
|
97.9 percentage of participants
Interval 96.6 to 98.8
|
97.7 percentage of participants
Interval 96.4 to 98.7
|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 6A
|
99.5 percentage of participants
Interval 98.6 to 99.9
|
99.7 percentage of participants
Interval 99.0 to 100.0
|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 6B
|
99.1 percentage of participants
Interval 98.1 to 99.6
|
99.5 percentage of participants
Interval 98.6 to 99.9
|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 7F
|
99.5 percentage of participants
Interval 98.6 to 99.9
|
99.9 percentage of participants
Interval 99.3 to 100.0
|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 9V
|
98.5 percentage of participants
Interval 97.4 to 99.3
|
98.9 percentage of participants
Interval 97.9 to 99.5
|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 14
|
98.9 percentage of participants
Interval 97.9 to 99.5
|
99.5 percentage of participants
Interval 98.6 to 99.9
|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 18C
|
98.9 percentage of participants
Interval 97.9 to 99.5
|
99.5 percentage of participants
Interval 98.6 to 99.9
|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 19A
|
99.9 percentage of participants
Interval 99.3 to 100.0
|
99.7 percentage of participants
Interval 99.0 to 100.0
|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 19F
|
98.8 percentage of participants
Interval 97.7 to 99.5
|
98.9 percentage of participants
Interval 97.9 to 99.5
|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 23F
|
97.2 percentage of participants
Interval 95.8 to 98.3
|
98.1 percentage of participants
Interval 96.9 to 99.0
|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 8
|
99.5 percentage of participants
Interval 98.6 to 99.9
|
4.7 percentage of participants
Interval 3.3 to 6.5
|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 10A
|
97.7 percentage of participants
Interval 96.4 to 98.7
|
2.0 percentage of participants
Interval 1.1 to 3.3
|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 11A
|
98.8 percentage of participants
Interval 97.7 to 99.5
|
4.2 percentage of participants
Interval 2.8 to 5.9
|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 12F
|
95.2 percentage of participants
Interval 93.5 to 96.6
|
0.3 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 15B
|
99.7 percentage of participants
Interval 99.0 to 100.0
|
4.6 percentage of participants
Interval 3.2 to 6.3
|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 22F
|
99.6 percentage of participants
Interval 98.8 to 99.9
|
1.5 percentage of participants
Interval 0.7 to 2.6
|
|
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Serotype 33F
|
99.5 percentage of participants
Interval 98.6 to 99.9
|
1.7 percentage of participants
Interval 0.9 to 3.0
|
SECONDARY outcome
Timeframe: 1 month after Dose 3Population: Dose 3 evaluable immunogenicity population: aged 42-98 days on Dose 1, received the first 3 doses randomized, had at least 1 valid immunogenicity result 27 to 56 days after Dose 3, had no protocol deviations. "Number of Participants Analyzed" = Dose 3 evaluable immunogenicity populations. "Number Analyzed" = number of participants with valid OPA titers for the specified serotype reported at 1 month after Dose 3.
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 randomized 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 concentrations and the corresponding CIs based on the Student's t distribution. OPA titers were determined in randomized subsets of participants at 1 month after Dose 3.
Outcome measures
| Measure |
20vPnC
n=833 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=803 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 1
|
26 Titers
Interval 21.0 to 33.0
|
34 Titers
Interval 27.0 to 42.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 3
|
51 Titers
Interval 43.0 to 61.0
|
63 Titers
Interval 53.0 to 76.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 4
|
339 Titers
Interval 252.0 to 455.0
|
280 Titers
Interval 207.0 to 378.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 5
|
32 Titers
Interval 27.0 to 39.0
|
39 Titers
Interval 32.0 to 47.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 6A
|
910 Titers
Interval 763.0 to 1084.0
|
936 Titers
Interval 757.0 to 1156.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 6B
|
318 Titers
Interval 242.0 to 419.0
|
516 Titers
Interval 409.0 to 651.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 7F
|
1222 Titers
Interval 1020.0 to 1465.0
|
1149 Titers
Interval 926.0 to 1424.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 9V
|
661 Titers
Interval 482.0 to 906.0
|
594 Titers
Interval 421.0 to 838.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 14
|
415 Titers
Interval 323.0 to 535.0
|
420 Titers
Interval 330.0 to 535.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 18C
|
1153 Titers
Interval 910.0 to 1460.0
|
996 Titers
Interval 754.0 to 1317.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 19A
|
108 Titers
Interval 78.0 to 149.0
|
109 Titers
Interval 79.0 to 151.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 19F
|
84 Titers
Interval 67.0 to 105.0
|
116 Titers
Interval 90.0 to 149.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 23F
|
255 Titers
Interval 186.0 to 350.0
|
295 Titers
Interval 215.0 to 406.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 8
|
665 Titers
Interval 503.0 to 880.0
|
18 Titers
Interval 17.0 to 20.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 10A
|
2558 Titers
Interval 1869.0 to 3501.0
|
37 Titers
Interval 33.0 to 42.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 11A
|
289 Titers
Interval 212.0 to 395.0
|
50 Titers
Interval 46.0 to 55.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 12F
|
7677 Titers
Interval 5952.0 to 9901.0
|
28 Titers
Interval 24.0 to 33.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 15B
|
1560 Titers
Interval 1090.0 to 2233.0
|
18 Titers
Interval 16.0 to 22.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 22F
|
6797 Titers
Interval 5170.0 to 8936.0
|
9 Titers
Interval 9.0 to 9.0
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Serotype 33F
|
7388 Titers
Interval 4803.0 to 11365.0
|
198 Titers
Interval 177.0 to 220.0
|
SECONDARY outcome
Timeframe: 1 month after Dose 4Population: Dose 4 evaluable immunogenicity population: aged 42-98 days on Dose 1, received the first 4 doses randomized, had at least 1 valid immunogenicity result 27 to 56 days after Dose 4, had no major protocol deviations. "Number of Participants Analyzed" = Dose 4 evaluable immunogenicity populations. "Number Analyzed" = number of participants with valid OPA titers for the specified serotype reported at 1 month after Dose 4.
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 randomized subsets of participants at 1 month after Dose 4. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution. OPA titers were determined in randomized subsets of participants at 1 month after Dose 4.
Outcome measures
| Measure |
20vPnC
n=755 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=745 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 12F
|
9320 Titers
Interval 7037.0 to 12343.0
|
31 Titers
Interval 26.0 to 37.0
|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 15B
|
3035 Titers
Interval 2138.0 to 4308.0
|
23 Titers
Interval 17.0 to 30.0
|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 22F
|
11077 Titers
Interval 7956.0 to 15422.0
|
15 Titers
Interval 11.0 to 20.0
|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 33F
|
19216 Titers
Interval 13193.0 to 27990.0
|
363 Titers
Interval 292.0 to 451.0
|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 1
|
36 Titers
Interval 27.0 to 48.0
|
66 Titers
Interval 50.0 to 87.0
|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 3
|
62 Titers
Interval 49.0 to 78.0
|
102 Titers
Interval 86.0 to 120.0
|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 4
|
621 Titers
Interval 435.0 to 887.0
|
961 Titers
Interval 714.0 to 1294.0
|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 5
|
55 Titers
Interval 45.0 to 67.0
|
69 Titers
Interval 54.0 to 87.0
|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 6A
|
1384 Titers
Interval 1092.0 to 1753.0
|
1767 Titers
Interval 1329.0 to 2348.0
|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 6B
|
666 Titers
Interval 489.0 to 906.0
|
1211 Titers
Interval 861.0 to 1703.0
|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 7F
|
2022 Titers
Interval 1673.0 to 2444.0
|
2099 Titers
Interval 1741.0 to 2531.0
|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 9V
|
2609 Titers
Interval 1913.0 to 3558.0
|
3210 Titers
Interval 2500.0 to 4123.0
|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 14
|
667 Titers
Interval 523.0 to 850.0
|
593 Titers
Interval 462.0 to 761.0
|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 18C
|
1973 Titers
Interval 1472.0 to 2643.0
|
2425 Titers
Interval 1914.0 to 3072.0
|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 19A
|
844 Titers
Interval 622.0 to 1145.0
|
1357 Titers
Interval 1007.0 to 1829.0
|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 19F
|
246 Titers
Interval 179.0 to 337.0
|
373 Titers
Interval 272.0 to 513.0
|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 23F
|
827 Titers
Interval 554.0 to 1235.0
|
1532 Titers
Interval 1118.0 to 2100.0
|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 8
|
1228 Titers
Interval 901.0 to 1673.0
|
26 Titers
Interval 21.0 to 31.0
|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 10A
|
3674 Titers
Interval 2746.0 to 4916.0
|
57 Titers
Interval 44.0 to 74.0
|
|
Serotype-specific OPA GMTs at 1 Month After Dose 4
Serotype 11A
|
2728 Titers
Interval 1975.0 to 3768.0
|
69 Titers
Interval 53.0 to 89.0
|
SECONDARY outcome
Timeframe: 1 month after Dose 3 to before Dose 4Population: Dose 3 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received the first 3 doses as randomized, had at least 1 valid immunogenicity result 27 to 56 days after Dose 3, and had no major protocol deviations. "Number of Participants Analyzed"= participants in Dose 3 evaluable immunogenicity population; "Number Analyzed"= number of participants with valid IgG concentrations at both timepoints for the specified serotype.
GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F. The GMFR from 1 month after Dose 3 to before Dose 4 were reported from Dose 3 evaluable immunogenicity participant.
Outcome measures
| Measure |
20vPnC
n=758 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=733 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 1
|
0.3 Fold rise
Interval 0.3 to 0.3
|
0.3 Fold rise
Interval 0.2 to 0.3
|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 3
|
0.2 Fold rise
Interval 0.2 to 0.2
|
0.2 Fold rise
Interval 0.2 to 0.2
|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 4
|
0.3 Fold rise
Interval 0.3 to 0.4
|
0.3 Fold rise
Interval 0.3 to 0.3
|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 5
|
0.3 Fold rise
Interval 0.3 to 0.3
|
0.3 Fold rise
Interval 0.3 to 0.3
|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 6A
|
0.3 Fold rise
Interval 0.3 to 0.3
|
0.3 Fold rise
Interval 0.3 to 0.3
|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 6B
|
0.4 Fold rise
Interval 0.4 to 0.4
|
0.3 Fold rise
Interval 0.3 to 0.3
|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 7F
|
0.4 Fold rise
Interval 0.4 to 0.6
|
0.4 Fold rise
Interval 0.3 to 0.4
|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 9V
|
0.3 Fold rise
Interval 0.3 to 0.4
|
0.3 Fold rise
Interval 0.3 to 0.3
|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 14
|
0.5 Fold rise
Interval 0.4 to 0.5
|
0.5 Fold rise
Interval 0.4 to 0.5
|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 18C
|
0.2 Fold rise
Interval 0.2 to 0.2
|
0.2 Fold rise
Interval 0.2 to 0.2
|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 19A
|
0.2 Fold rise
Interval 0.2 to 0.2
|
0.2 Fold rise
Interval 0.2 to 0.2
|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 19F
|
0.2 Fold rise
Interval 0.2 to 0.3
|
0.2 Fold rise
Interval 0.2 to 0.2
|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 23F
|
0.3 Fold rise
Interval 0.3 to 0.3
|
0.3 Fold rise
Interval 0.2 to 0.3
|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 8
|
0.2 Fold rise
Interval 0.2 to 0.3
|
1.4 Fold rise
Interval 1.3 to 1.5
|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 10A
|
0.7 Fold rise
Interval 0.6 to 0.7
|
0.9 Fold rise
Interval 0.9 to 1.0
|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 11A
|
0.3 Fold rise
Interval 0.2 to 0.3
|
1.1 Fold rise
Interval 1.0 to 1.2
|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 12F
|
0.3 Fold rise
Interval 0.3 to 0.4
|
1.0 Fold rise
Interval 1.0 to 1.1
|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 15B
|
0.4 Fold rise
Interval 0.3 to 0.4
|
0.8 Fold rise
Interval 0.7 to 0.8
|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 22F
|
0.3 Fold rise
Interval 0.3 to 0.4
|
0.8 Fold rise
Interval 0.7 to 0.9
|
|
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Serotype 33F
|
0.7 Fold rise
Interval 0.7 to 0.8
|
0.8 Fold rise
Interval 0.7 to 0.8
|
SECONDARY outcome
Timeframe: From 1 month before to 1 month after Dose 4Population: Dose 4 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received all 4 doses as randomized, had at least 1 valid immunogenicity result 27 to 56 days after Dose 4, and had no major protocol deviations. "Number of Participants Analyzed"= participants in Dose 4 evaluable immunogenicity population; "Number Analyzed"= number of participants with valid IgG concentrations at both timepoints for the specified serotype.
GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F. The GMFR from 1 month before Dose 4 to 1 month after Dose 4 were reported from Dose 4 evaluable immunogenicity participants.
Outcome measures
| Measure |
20vPnC
n=732 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=721 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 1
|
7.3 Fold rise
Interval 6.9 to 7.8
|
7.1 Fold rise
Interval 6.7 to 7.6
|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 3
|
8.5 Fold rise
Interval 7.9 to 9.1
|
9.0 Fold rise
Interval 8.4 to 9.6
|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 4
|
15.4 Fold rise
Interval 14.3 to 16.6
|
14.2 Fold rise
Interval 13.1 to 15.3
|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 6A
|
15.2 Fold rise
Interval 14.3 to 16.2
|
14.5 Fold rise
Interval 13.1 to 15.3
|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 6B
|
18.0 Fold rise
Interval 16.8 to 19.3
|
17.0 Fold rise
Interval 15.8 to 18.2
|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 7F
|
6.0 Fold rise
Interval 5.7 to 6.3
|
6.4 Fold rise
Interval 6.0 to 6.8
|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 9V
|
11.8 Fold rise
Interval 11.1 to 12.6
|
11.2 Fold rise
Interval 10.5 to 11.9
|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 14
|
5.9 Fold rise
Interval 5.4 to 6.3
|
5.0 Fold rise
Interval 4.6 to 5.3
|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 5
|
8.9 Fold rise
Interval 8.4 to 9.5
|
8.5 Fold rise
Interval 8.0 to 9.0
|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 18C
|
11.3 Fold rise
Interval 10.6 to 12.0
|
11.4 Fold rise
Interval 10.7 to 12.1
|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 19A
|
25.6 Fold rise
Interval 23.8 to 27.6
|
25.6 Fold rise
Interval 23.6 to 27.7
|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 19F
|
13.1 Fold rise
Interval 12.2 to 14.1
|
12.5 Fold rise
Interval 11.6 to 13.5
|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 23F
|
18.1 Fold rise
Interval 16.8 to 19.5
|
19.2 Fold rise
Interval 17.9 to 20.6
|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 8
|
9.1 Fold rise
Interval 8.5 to 9.8
|
1.3 Fold rise
Interval 1.2 to 1.4
|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 10A
|
8.1 Fold rise
Interval 7.6 to 8.7
|
1.1 Fold rise
Interval 1.0 to 1.1
|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 11A
|
9.8 Fold rise
Interval 9.1 to 10.6
|
1.1 Fold rise
Interval 1.0 to 1.2
|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 12F
|
10.0 Fold rise
Interval 9.4 to 10.6
|
1.0 Fold rise
Interval 1.0 to 1.1
|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 15B
|
8.1 Fold rise
Interval 7.5 to 8.7
|
1.2 Fold rise
Interval 1.2 to 1.3
|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 22F
|
8.4 Fold rise
Interval 7.9 to 9.1
|
1.2 Fold rise
Interval 1.1 to 1.3
|
|
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Serotype 33F
|
8.8 Fold rise
Interval 8.2 to 9.4
|
1.1 Fold rise
Interval 1.0 to 1.1
|
SECONDARY outcome
Timeframe: from 1 month after Dose 3 to 1 month after Dose 4Population: Dose 3 and Dose 4 evaluable population: participants aged 42-98 days on Dose 1, received the first 3 doses and 4 doses, had at least 1 valid immunogenicity result 27 to 56 days post Dose 3 or Dose 4. "Number of Participants Analyzed"= maximum number of participants in both Dose 3 and Dose 4 evaluable immuno populations that had a valid IgG concentration at both timepoints. "Number Analyzed"= number of participants with valid IgG concentrations at both timepoints for the specified serotype.
GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F. The GMFR from 1 month after Dose 3 to 1 month after Dose 4 were reported from participants in both Dose 3 and Dose 4 evaluable immunogenicity populations.
Outcome measures
| Measure |
20vPnC
n=704 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=687 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 1
|
2.0 Fold rise
Interval 1.9 to 2.1
|
1.8 Fold rise
Interval 1.7 to 1.9
|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 3
|
1.6 Fold rise
Interval 1.5 to 1.7
|
1.7 Fold rise
Interval 1.6 to 1.8
|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 4
|
5.1 Fold rise
Interval 4.8 to 5.5
|
4.4 Fold rise
Interval 4.1 to 4.8
|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 5
|
2.9 Fold rise
Interval 2.7 to 3.1
|
2.6 Fold rise
Interval 2.4 to 2.8
|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 6A
|
4.7 Fold rise
Interval 4.4 to 5.0
|
4.3 Fold rise
Interval 4.0 to 4.6
|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 6B
|
6.8 Fold rise
Interval 6.2 to 7.4
|
5.5 Fold rise
Interval 5.0 to 6.0
|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 7F
|
2.3 Fold rise
Interval 2.2 to 2.4
|
2.2 Fold rise
Interval 2.1 to 2.3
|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 9V
|
4.0 Fold rise
Interval 3.7 to 4.3
|
3.4 Fold rise
Interval 3.2 to 3.7
|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 14
|
2.6 Fold rise
Interval 2.4 to 2.9
|
2.2 Fold rise
Interval 2.0 to 2.5
|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 18C
|
2.7 Fold rise
Interval 2.5 to 2.8
|
2.6 Fold rise
Interval 2.5 to 2.8
|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 19A
|
4.9 Fold rise
Interval 4.6 to 5.2
|
4.6 Fold rise
Interval 4.2 to 4.9
|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 19F
|
3.2 Fold rise
Interval 3.0 to 3.4
|
2.9 Fold rise
Interval 2.7 to 3.1
|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 23F
|
4.9 Fold rise
Interval 4.5 to 5.3
|
4.9 Fold rise
Interval 4.5 to 5.3
|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 8
|
2.2 Fold rise
Interval 2.0 to 2.3
|
1.8 Fold rise
Interval 1.6 to 2.0
|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 10A
|
5.3 Fold rise
Interval 4.9 to 5.8
|
1.0 Fold rise
Interval 0.9 to 1.1
|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 11A
|
2.6 Fold rise
Interval 2.4 to 2.8
|
1.1 Fold rise
Interval 1.0 to 1.3
|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 12F
|
3.3 Fold rise
Interval 3.1 to 3.6
|
1.0 Fold rise
Interval 1.0 to 1.1
|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 15B
|
2.8 Fold rise
Interval 2.6 to 3.0
|
1.0 Fold rise
Interval 0.9 to 1.1
|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 22F
|
2.9 Fold rise
Interval 2.7 to 3.1
|
1.0 Fold rise
Interval 0.9 to 1.1
|
|
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Serotype 33F
|
6.4 Fold rise
Interval 5.9 to 7.0
|
0.8 Fold rise
Interval 0.8 to 0.9
|
SECONDARY outcome
Timeframe: 1 month after Dose 3Population: Dose 3 evaluable population: eligible participants aged 42-98 days on Dose 1, received the first 3 doses, had at least 1 valid immunogenicity result within 27 to 56 days post Dose 3, and had no other major protocol deviations. "Number of Participant Analyzed" = Dose 3 evaluable immunogenicity population with valid Hib antibody level. "Number Analyzed" = number of participants with valid Hib antibody level.
Antibody concentration to the Hib vaccine antigens were determined on sera collected from a randomly selected subset of participants with sufficient sera volumes. Percentage of participants with alternative prespecified Hib antibody (≥1.0 μg/mL) were reported from Dose 3 evaluable immunogenicity participants.
Outcome measures
| Measure |
20vPnC
n=124 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=125 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Percentage of Participants With Alternative Prespecified Hib Antibody Level 1 Month After Dose 3
|
75.0 percentage of participants
Interval 66.4 to 82.3
|
72.0 percentage of participants
Interval 63.3 to 79.7
|
SECONDARY outcome
Timeframe: 1 month after Dose 4Population: Dose 4 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received all 4 doses, have at least 1 valid immunogenicity result within 27 to 56 days after Dose 4, and had no other major protocol deviations as determined by the clinician. "Number of Participants Analyzed"=number of participants in Dose 4 evaluable immunogenicity population with valid antibody concentrations for the specified antigen reported at 1 month after Dose 4.
Antibody concentrations to concomitant vaccine antigen (measles) were determined on sera collected 1 month after Dose 4 from a randomly selected subset of participants with sufficient sera volumes. GMs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution and were reported from Dose 4 evaluable immunogenicity participants.
Outcome measures
| Measure |
20vPnC
n=234 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=232 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Geometric Mean Ratios (GMRs) of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Measles) 1 Month After Dose 4
|
277.74 AU/mL
Interval 243.88 to 316.3
|
215.41 AU/mL
Interval 184.61 to 251.35
|
SECONDARY outcome
Timeframe: 1 month after Dose 4Population: Dose 4 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received all 4 doses, have at least 1 valid immunogenicity result within 27 to 56 days after Dose 4, and had no other major protocol deviations as determined by the clinician. "Number of Participants Analyzed"=number of participants in Dose 4 evaluable immunogenicity population with valid antibody concentrations for the specified antigen reported at 1 month after Dose 4.
Antibody concentrations to concomitant vaccine antigen (mumps) were determined on sera collected 1 month after Dose 4 from a randomly selected subset of participants with sufficient sera volumes. GMs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution and were reported from Dose 4 evaluable immunogenicity participants.
Outcome measures
| Measure |
20vPnC
n=234 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=232 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Mumps) 1 Month After Dose 4
|
36.96 AU/mL
Interval 30.82 to 44.33
|
34.19 AU/mL
Interval 28.94 to 40.39
|
SECONDARY outcome
Timeframe: 1 month after Dose 4Population: Dose 4 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received all 4 doses, had at least 1 valid immunogenicity result within 27 to 56 days after Dose 4, and had no other major protocol deviations as determined by the clinician. "Number of Participants Analyzed"= number of participants in Dose 4 evaluable immunogenicity population with valid antibody concentrations for the specified antigen reported at 1 month after Dose 4
Antibody concentrations to concomitant vaccine antigen (rubella) were determined on sera collected 1 month after Dose 4 from a randomly selected subset of participants with sufficient sera volumes. GMs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution and were reported from Dose 4 evaluable immunogenicity participants.
Outcome measures
| Measure |
20vPnC
n=234 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=232 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens (Rubella) 1 Month After Dose 4
|
49.63 IU/mL
Interval 43.88 to 56.13
|
40.44 IU/mL
Interval 35.19 to 46.48
|
SECONDARY outcome
Timeframe: 1 month after Dose 4Population: Dose 4 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received all 4 doses, had at least 1 valid immunogenicity result within 27 to 56 days after Dose 4, and had no other major protocol deviations as determined by the clinician. "Number of Participants Analyzed"= number of participants in Dose 4 evaluable immunogenicity population with valid antibody concentrations for the specified antigen reported at 1 month after Dose 4.
Antibody concentrations to concomitant vaccine antigen (varicella) were determined on sera collected 1 month after Dose 4 from a randomly selected subset of participants with sufficient sera volumes. GMs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution and were reported from Dose 4 evaluable immunogenicity participants.
Outcome measures
| Measure |
20vPnC
n=231 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=229 Participants
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Varicella) 1 Month After Dose 4
|
233.05 mIU/mL
Interval 207.25 to 262.06
|
234.78 mIU/mL
Interval 208.84 to 263.94
|
Adverse Events
20vPnC
Serious events: 45 serious events
Other events: 966 other events
Deaths: 0 deaths
13vPnC
Serious events: 31 serious events
Other events: 939 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
20vPnC
n=1001 participants at risk
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=987 participants at risk
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/1001 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.10%
1/987 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
General disorders
Systemic inflammatory response syndrome
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/1001 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.10%
1/987 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Gastrointestinal disorders
Vomiting
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Adenovirus infection
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Bronchiolitis
|
0.40%
4/1001 • Number of events 6 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.41%
4/987 • Number of events 4 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Bullous impetigo
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
COVID-19
|
0.00%
0/1001 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.10%
1/987 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Cellulitis
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Coronavirus infection
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Croup infectious
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Dengue fever
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/1001 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.20%
2/987 • Number of events 2 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1001 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.51%
5/987 • Number of events 5 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Groin abscess
|
0.10%
1/1001 • Number of events 2 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.10%
1/987 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Metapneumovirus bronchiolitis
|
0.00%
0/1001 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.10%
1/987 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Otitis media acute
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/1001 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.10%
1/987 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Pneumonia
|
0.20%
2/1001 • Number of events 2 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.10%
1/987 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Pyelonephritis acute
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.70%
7/1001 • Number of events 7 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.30%
3/987 • Number of events 3 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.50%
5/1001 • Number of events 5 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.20%
2/987 • Number of events 2 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/1001 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.10%
1/987 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/1001 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.10%
1/987 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Urinary tract infection
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Viral infection
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.10%
1/987 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Injury, poisoning and procedural complications
Accidental poisoning
|
0.00%
0/1001 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.10%
1/987 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Injury, poisoning and procedural complications
Fall
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/1001 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.10%
1/987 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Metabolism and nutrition disorders
Dehydration
|
0.20%
2/1001 • Number of events 2 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.10%
1/987 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.20%
2/1001 • Number of events 2 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.10%
1/987 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Nervous system disorders
Febrile convulsion
|
0.20%
2/1001 • Number of events 2 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.20%
2/987 • Number of events 2 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.00%
0/1001 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.10%
1/987 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/1001 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.10%
1/987 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/1001 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.10%
1/987 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/1001 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.10%
1/987 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/1001 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.10%
1/987 • Number of events 2 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Vascular disorders
Kawasaki's disease
|
0.10%
1/1001 • Number of events 1 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
0.00%
0/987 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
Other adverse events
| Measure |
20vPnC
n=1001 participants at risk
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
13vPnC
n=987 participants at risk
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
|
|---|---|---|
|
General disorders
Injection site erythema (REDNESS)
|
49.8%
498/1001 • Number of events 944 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
49.8%
492/987 • Number of events 986 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
General disorders
Injection site pain (PAIN)
|
68.8%
689/1001 • Number of events 1634 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
67.2%
663/987 • Number of events 1543 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
General disorders
Injection site swelling (SWELLING)
|
35.3%
353/1001 • Number of events 635 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
36.4%
359/987 • Number of events 707 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
General disorders
Pyrexia (FEVER)
|
32.2%
322/1001 • Number of events 550 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
31.8%
314/987 • Number of events 504 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Otitis media
|
5.6%
56/1001 • Number of events 73 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
5.1%
50/987 • Number of events 65 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Infections and infestations
Upper respiratory tract infection
|
11.4%
114/1001 • Number of events 137 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
11.3%
112/987 • Number of events 137 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Metabolism and nutrition disorders
Decreased appetite (DECREASED APPETITE)
|
52.0%
521/1001 • Number of events 1041 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
49.8%
492/987 • Number of events 1028 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Nervous system disorders
Hypersomnia (INCREASED SLEEP)
|
82.2%
823/1001 • Number of events 2309 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
80.9%
798/987 • Number of events 2268 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
|
Psychiatric disorders
Irritability (IRRITABILITY)
|
89.3%
894/1001 • Number of events 3380 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
87.4%
863/987 • Number of events 3301 • Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
|
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