Trial Outcomes & Findings for Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants (NCT NCT03512288)
NCT ID: NCT03512288
Last Updated: 2021-03-02
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 measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (0.5 to 2.0 centimeter \[cm\]), moderate (greater than \[\>\] 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
PHASE2
Target enrollment
460 participants
Primary outcome timeframe
Within 7 days after Vaccination 1
Results posted on
2021-03-02
Participant Flow
Participants were enrolled from 16 April 2018 to 11 February 2020 in the United States.
A total of 460 participants of age greater than or equal to (\>=) 42 to less than or equal to (\<=) 98 days at baseline, were enrolled into the study. Out of these 460 participants, 458 participants received study treatment.
Participant milestones
| Measure |
20vPnC
Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|---|---|---|
|
Overall Study
STARTED
|
232
|
228
|
|
Overall Study
Vaccination 1
|
231
|
227
|
|
Overall Study
Vaccination 2
|
222
|
213
|
|
Overall Study
Vaccination 3
|
210
|
206
|
|
Overall Study
Vaccination 4
|
197
|
194
|
|
Overall Study
COMPLETED
|
191
|
185
|
|
Overall Study
NOT COMPLETED
|
41
|
43
|
Reasons for withdrawal
| Measure |
20vPnC
Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
12
|
15
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Protocol Violation
|
6
|
4
|
|
Overall Study
Medication error without associated adverse event
|
1
|
0
|
|
Overall Study
No longer met eligibility criteria
|
5
|
2
|
|
Overall Study
Withdrawal by parent/guardian
|
14
|
18
|
|
Overall Study
Other
|
1
|
1
|
|
Overall Study
Randomized but not treated
|
1
|
1
|
Baseline Characteristics
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants
Baseline characteristics by cohort
| Measure |
20vPnC
n=232 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
n=228 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
Total
n=460 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.5 days
STANDARD_DEVIATION 8.07 • n=5 Participants
|
64.5 days
STANDARD_DEVIATION 6.68 • n=7 Participants
|
64.5 days
STANDARD_DEVIATION 7.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
191 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
379 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
161 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
332 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
22 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after Vaccination 1Population: Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure.
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (0.5 to 2.0 centimeter \[cm\]), moderate (greater than \[\>\] 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=229 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
n=224 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Any
|
24.9 percentage of participants
Interval 19.4 to 31.0
|
25.4 percentage of participants
Interval 19.9 to 31.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Mild
|
22.3 percentage of participants
Interval 17.1 to 28.2
|
23.7 percentage of participants
Interval 18.3 to 29.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Moderate
|
2.6 percentage of participants
Interval 1.0 to 5.6
|
1.8 percentage of participants
Interval 0.5 to 4.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Severe
|
0 percentage of participants
Interval 0.0 to 1.6
|
0 percentage of participants
Interval 0.0 to 1.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Any
|
12.7 percentage of participants
Interval 8.6 to 17.7
|
14.3 percentage of participants
Interval 10.0 to 19.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Mild
|
10.0 percentage of participants
Interval 6.5 to 14.7
|
12.9 percentage of participants
Interval 8.8 to 18.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Moderate
|
2.2 percentage of participants
Interval 0.7 to 5.0
|
1.3 percentage of participants
Interval 0.3 to 3.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Severe
|
0.4 percentage of participants
Interval 0.0 to 2.4
|
0 percentage of participants
Interval 0.0 to 1.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at the injection site: Any
|
51.1 percentage of participants
Interval 44.4 to 57.7
|
53.6 percentage of participants
Interval 46.8 to 60.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at the injection site: Mild
|
32.3 percentage of participants
Interval 26.3 to 38.8
|
35.7 percentage of participants
Interval 29.4 to 42.4
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at the injection site: Moderate
|
18.3 percentage of participants
Interval 13.5 to 24.0
|
17.9 percentage of participants
Interval 13.1 to 23.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at the injection site: Severe
|
0.4 percentage of participants
Interval 0.0 to 2.4
|
0 percentage of participants
Interval 0.0 to 1.6
|
PRIMARY outcome
Timeframe: Within 7 days after Vaccination 2Population: Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure.
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 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=215 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
n=204 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Any
|
24.7 percentage of participants
Interval 19.0 to 31.0
|
28.4 percentage of participants
Interval 22.4 to 35.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Mild
|
21.9 percentage of participants
Interval 16.5 to 28.0
|
24.0 percentage of participants
Interval 18.3 to 30.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Moderate
|
2.8 percentage of participants
Interval 1.0 to 6.0
|
4.4 percentage of participants
Interval 2.0 to 8.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Severe
|
0 percentage of participants
Interval 0.0 to 1.7
|
0 percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Any
|
16.3 percentage of participants
Interval 11.6 to 21.9
|
18.6 percentage of participants
Interval 13.5 to 24.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Mild
|
12.6 percentage of participants
Interval 8.4 to 17.7
|
13.2 percentage of participants
Interval 8.9 to 18.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Moderate
|
3.7 percentage of participants
Interval 1.6 to 7.2
|
5.4 percentage of participants
Interval 2.7 to 9.4
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Severe
|
0 percentage of participants
Interval 0.0 to 1.7
|
0 percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at the injection site: Any
|
42.8 percentage of participants
Interval 36.1 to 49.7
|
48.5 percentage of participants
Interval 41.5 to 55.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at the injection site: Mild
|
26.0 percentage of participants
Interval 20.3 to 32.5
|
28.9 percentage of participants
Interval 22.8 to 35.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at the injection site: Moderate
|
15.8 percentage of participants
Interval 11.2 to 21.4
|
19.6 percentage of participants
Interval 14.4 to 25.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at the injection site: Severe
|
0.9 percentage of participants
Interval 0.1 to 3.3
|
0 percentage of participants
Interval 0.0 to 1.8
|
PRIMARY outcome
Timeframe: Within 7 days after Vaccination 3Population: Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure.
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 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=201 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
n=204 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Redness: Any
|
26.9 percentage of participants
Interval 20.9 to 33.6
|
26.5 percentage of participants
Interval 20.6 to 33.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Redness: Mild
|
26.4 percentage of participants
Interval 20.4 to 33.0
|
23.0 percentage of participants
Interval 17.4 to 29.4
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Redness: Moderate
|
0.5 percentage of participants
Interval 0.0 to 2.7
|
3.4 percentage of participants
Interval 1.4 to 6.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Redness: Severe
|
0 percentage of participants
Interval 0.0 to 1.8
|
0 percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Swelling: Any
|
17.9 percentage of participants
Interval 12.9 to 23.9
|
19.6 percentage of participants
Interval 14.4 to 25.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Swelling: Mild
|
16.9 percentage of participants
Interval 12.0 to 22.8
|
15.7 percentage of participants
Interval 11.0 to 21.4
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Swelling: Moderate
|
1.0 percentage of participants
Interval 0.1 to 3.5
|
3.4 percentage of participants
Interval 1.4 to 6.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Swelling: Severe
|
0 percentage of participants
Interval 0.0 to 1.8
|
0.5 percentage of participants
Interval 0.0 to 2.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Pain at the injection site: Any
|
44.3 percentage of participants
Interval 37.3 to 51.4
|
40.7 percentage of participants
Interval 33.9 to 47.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Pain at the injection site: Mild
|
28.9 percentage of participants
Interval 22.7 to 35.6
|
27.9 percentage of participants
Interval 21.9 to 34.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Pain at the injection site: Moderate
|
14.9 percentage of participants
Interval 10.3 to 20.6
|
12.7 percentage of participants
Interval 8.5 to 18.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Pain at the injection site: Severe
|
0.5 percentage of participants
Interval 0.0 to 2.7
|
0 percentage of participants
Interval 0.0 to 1.8
|
PRIMARY outcome
Timeframe: Within 7 days after Vaccination 4Population: Dose 4 safety population included participants who received Dose 4 and had safety follow up between Dose 4 and 6 months after Dose 4. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure.
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 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=186 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
n=185 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Redness: Any
|
25.8 percentage of participants
Interval 19.7 to 32.7
|
30.3 percentage of participants
Interval 23.7 to 37.4
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Redness: Mild
|
24.2 percentage of participants
Interval 18.2 to 31.0
|
25.4 percentage of participants
Interval 19.3 to 32.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Redness: Moderate
|
1.6 percentage of participants
Interval 0.3 to 4.6
|
4.9 percentage of participants
Interval 2.2 to 9.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Redness: Severe
|
0 percentage of participants
Interval 0.0 to 2.0
|
0 percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Swelling: Any
|
17.2 percentage of participants
Interval 12.1 to 23.4
|
14.1 percentage of participants
Interval 9.4 to 19.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Swelling: Mild
|
15.1 percentage of participants
Interval 10.2 to 21.0
|
12.4 percentage of participants
Interval 8.0 to 18.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Swelling: Moderate
|
2.2 percentage of participants
Interval 0.6 to 5.4
|
1.6 percentage of participants
Interval 0.3 to 4.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Swelling: Severe
|
0 percentage of participants
Interval 0.0 to 2.0
|
0 percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Pain at the injection site: Any
|
35.5 percentage of participants
Interval 28.6 to 42.8
|
35.7 percentage of participants
Interval 28.8 to 43.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Pain at the injection site: Mild
|
26.9 percentage of participants
Interval 20.7 to 33.9
|
28.6 percentage of participants
Interval 22.3 to 35.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Pain at the injection site: Moderate
|
8.6 percentage of participants
Interval 5.0 to 13.6
|
7.0 percentage of participants
Interval 3.8 to 11.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Pain at the injection site: Severe
|
0 percentage of participants
Interval 0.0 to 2.0
|
0 percentage of participants
Interval 0.0 to 2.0
|
PRIMARY outcome
Timeframe: Within 7 days after Vaccination 1Population: Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure.
Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as greater than or equal to (\>=) 38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, 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).
Outcome measures
| Measure |
20vPnC
n=229 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
n=224 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >=38.0 degree C
|
14.4 percentage of participants
Interval 10.1 to 19.6
|
9.8 percentage of participants
Interval 6.3 to 14.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >=38.0 degree C to 38.4 degree C
|
10.0 percentage of participants
Interval 6.5 to 14.7
|
6.3 percentage of participants
Interval 3.5 to 10.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >38.4 degree C to 38.9 degree C
|
3.9 percentage of participants
Interval 1.8 to 7.3
|
2.2 percentage of participants
Interval 0.7 to 5.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >38.9 degree C to 40.0 degree C
|
0.4 percentage of participants
Interval 0.0 to 2.4
|
1.3 percentage of participants
Interval 0.3 to 3.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >40.0 degree C
|
0 percentage of participants
Interval 0.0 to 1.6
|
0 percentage of participants
Interval 0.0 to 1.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Decreased appetite: Any
|
25.3 percentage of participants
Interval 19.8 to 31.5
|
30.4 percentage of participants
Interval 24.4 to 36.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Decreased appetite: Mild
|
16.2 percentage of participants
Interval 11.6 to 21.6
|
19.2 percentage of participants
Interval 14.3 to 25.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Decreased appetite: Moderate
|
9.2 percentage of participants
Interval 5.8 to 13.7
|
10.7 percentage of participants
Interval 7.0 to 15.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Decreased appetite: Severe
|
0 percentage of participants
Interval 0.0 to 1.6
|
0.4 percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Drowsiness: Any
|
68.1 percentage of participants
Interval 61.7 to 74.1
|
71.0 percentage of participants
Interval 64.6 to 76.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Drowsiness: Mild
|
51.1 percentage of participants
Interval 44.4 to 57.7
|
54.9 percentage of participants
Interval 48.1 to 61.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Drowsiness: Moderate
|
16.6 percentage of participants
Interval 12.0 to 22.1
|
14.3 percentage of participants
Interval 10.0 to 19.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Drowsiness: Severe
|
0.4 percentage of participants
Interval 0.0 to 2.4
|
1.8 percentage of participants
Interval 0.5 to 4.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Irritability: Any
|
79.5 percentage of participants
Interval 73.7 to 84.5
|
77.7 percentage of participants
Interval 71.7 to 83.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Irritability: Mild
|
23.6 percentage of participants
Interval 18.2 to 29.6
|
25.9 percentage of participants
Interval 20.3 to 32.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Irritability: Moderate
|
50.7 percentage of participants
Interval 44.0 to 57.3
|
47.3 percentage of participants
Interval 40.6 to 54.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Irritability: Severe
|
5.2 percentage of participants
Interval 2.7 to 9.0
|
4.5 percentage of participants
Interval 2.2 to 8.1
|
PRIMARY outcome
Timeframe: Within 7 days after Vaccination 2Population: Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure.
Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as \>= 38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, 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).
Outcome measures
| Measure |
20vPnC
n=215 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
n=204 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: >=38.0 degree C
|
17.2 percentage of participants
Interval 12.4 to 22.9
|
23.0 percentage of participants
Interval 17.4 to 29.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: >=38.0 degree C to 38.4 degree C
|
10.2 percentage of participants
Interval 6.5 to 15.1
|
12.7 percentage of participants
Interval 8.5 to 18.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: >38.4 degree C to 38.9 degree C
|
4.2 percentage of participants
Interval 1.9 to 7.8
|
7.8 percentage of participants
Interval 4.5 to 12.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: >38.9 degree C to 40.0 degree C
|
2.8 percentage of participants
Interval 1.0 to 6.0
|
2.5 percentage of participants
Interval 0.8 to 5.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: >40.0 degree C
|
0 percentage of participants
Interval 0.0 to 1.7
|
0 percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Decreased appetite: Any
|
23.3 percentage of participants
Interval 17.8 to 29.5
|
27.0 percentage of participants
Interval 21.0 to 33.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Decreased appetite: Mild
|
14.4 percentage of participants
Interval 10.0 to 19.8
|
14.7 percentage of participants
Interval 10.1 to 20.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Decreased appetite: Moderate
|
7.9 percentage of participants
Interval 4.7 to 12.4
|
11.8 percentage of participants
Interval 7.7 to 17.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Decreased appetite: Severe
|
0.9 percentage of participants
Interval 0.1 to 3.3
|
0.5 percentage of participants
Interval 0.0 to 2.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Drowsiness: Any
|
57.2 percentage of participants
Interval 50.3 to 63.9
|
56.4 percentage of participants
Interval 49.3 to 63.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Drowsiness: Mild
|
37.2 percentage of participants
Interval 30.7 to 44.0
|
37.7 percentage of participants
Interval 31.1 to 44.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Drowsiness: Moderate
|
17.7 percentage of participants
Interval 12.8 to 23.4
|
16.7 percentage of participants
Interval 11.8 to 22.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Drowsiness: Severe
|
2.3 percentage of participants
Interval 0.8 to 5.3
|
2.0 percentage of participants
Interval 0.5 to 4.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Irritability: Any
|
71.2 percentage of participants
Interval 64.6 to 77.1
|
79.9 percentage of participants
Interval 73.7 to 85.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Irritability: Mild
|
20.0 percentage of participants
Interval 14.9 to 26.0
|
22.5 percentage of participants
Interval 17.0 to 28.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Irritability: Moderate
|
48.8 percentage of participants
Interval 42.0 to 55.7
|
52.5 percentage of participants
Interval 45.4 to 59.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Irritability: Severe
|
2.3 percentage of participants
Interval 0.8 to 5.3
|
4.9 percentage of participants
Interval 2.4 to 8.8
|
PRIMARY outcome
Timeframe: Within 7 days after Vaccination 3Population: Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure.
Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as \>= 38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, 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).
Outcome measures
| Measure |
20vPnC
n=201 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
n=204 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fever: >=38.0 degree C
|
17.9 percentage of participants
Interval 12.9 to 23.9
|
18.1 percentage of participants
Interval 13.1 to 24.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fever: >=38.0 degree C to 38.4 degree C
|
10.0 percentage of participants
Interval 6.2 to 14.9
|
9.8 percentage of participants
Interval 6.1 to 14.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fever: >38.4 degree C to 38.9 degree C
|
4.5 percentage of participants
Interval 2.1 to 8.3
|
4.9 percentage of participants
Interval 2.4 to 8.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fever: >38.9 degree C to 40.0 degree C
|
3.5 percentage of participants
Interval 1.4 to 7.0
|
3.4 percentage of participants
Interval 1.4 to 6.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fever: >40.0 degree C
|
0 percentage of participants
Interval 0.0 to 1.8
|
0 percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Decreased appetite: Any
|
30.8 percentage of participants
Interval 24.5 to 37.7
|
33.3 percentage of participants
Interval 26.9 to 40.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Decreased appetite: Mild
|
20.9 percentage of participants
Interval 15.5 to 27.2
|
19.1 percentage of participants
Interval 14.0 to 25.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Decreased appetite: Moderate
|
9.5 percentage of participants
Interval 5.8 to 14.4
|
13.7 percentage of participants
Interval 9.3 to 19.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Decreased appetite: Severe
|
0.5 percentage of participants
Interval 0.0 to 2.7
|
0.5 percentage of participants
Interval 0.0 to 2.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Drowsiness: Any
|
41.3 percentage of participants
Interval 34.4 to 48.4
|
45.6 percentage of participants
Interval 38.6 to 52.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Drowsiness: Mild
|
28.9 percentage of participants
Interval 22.7 to 35.6
|
29.9 percentage of participants
Interval 23.7 to 36.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Drowsiness: Moderate
|
11.4 percentage of participants
Interval 7.4 to 16.7
|
15.7 percentage of participants
Interval 11.0 to 21.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Drowsiness: Severe
|
1.0 percentage of participants
Interval 0.1 to 3.5
|
0 percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Irritability: Any
|
72.6 percentage of participants
Interval 65.9 to 78.7
|
69.6 percentage of participants
Interval 62.8 to 75.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Irritability: Mild
|
28.9 percentage of participants
Interval 22.7 to 35.6
|
27.5 percentage of participants
Interval 21.5 to 34.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Irritability: Moderate
|
40.8 percentage of participants
Interval 33.9 to 47.9
|
37.7 percentage of participants
Interval 31.1 to 44.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Irritability: Severe
|
3.0 percentage of participants
Interval 1.1 to 6.4
|
4.4 percentage of participants
Interval 2.0 to 8.2
|
PRIMARY outcome
Timeframe: Within 7 days after Vaccination 4Population: Dose 4 safety population included participants who received Dose 4 and had safety follow up between Dose 4 and 6 months after Dose 4. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure.
Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as \>= 38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, 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).
Outcome measures
| Measure |
20vPnC
n=186 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
n=185 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Fever: >=38.0 degree C
|
12.4 percentage of participants
Interval 8.0 to 18.0
|
14.6 percentage of participants
Interval 9.8 to 20.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Fever: >=38.0 degree C to 38.4 degree C
|
5.9 percentage of participants
Interval 3.0 to 10.3
|
4.3 percentage of participants
Interval 1.9 to 8.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Fever: >38.4 degree C to 38.9 degree C
|
3.2 percentage of participants
Interval 1.2 to 6.9
|
7.0 percentage of participants
Interval 3.8 to 11.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Fever: >38.9 degree C to 40.0 degree C
|
3.2 percentage of participants
Interval 1.2 to 6.9
|
3.2 percentage of participants
Interval 1.2 to 6.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Fever: >40.0 degree C
|
0 percentage of participants
Interval 0.0 to 2.0
|
0 percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Decreased appetite: Any
|
23.7 percentage of participants
Interval 17.7 to 30.4
|
29.2 percentage of participants
Interval 22.8 to 36.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Decreased appetite: Mild
|
13.4 percentage of participants
Interval 8.9 to 19.2
|
15.7 percentage of participants
Interval 10.8 to 21.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Decreased appetite: Moderate
|
10.2 percentage of participants
Interval 6.3 to 15.5
|
13.5 percentage of participants
Interval 8.9 to 19.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Decreased appetite: Severe
|
0 percentage of participants
Interval 0.0 to 2.0
|
0 percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Drowsiness: Any
|
32.8 percentage of participants
Interval 26.1 to 40.0
|
37.3 percentage of participants
Interval 30.3 to 44.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Drowsiness: Mild
|
26.9 percentage of participants
Interval 20.7 to 33.9
|
25.4 percentage of participants
Interval 19.3 to 32.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Drowsiness: Moderate
|
4.8 percentage of participants
Interval 2.2 to 9.0
|
11.9 percentage of participants
Interval 7.6 to 17.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Drowsiness: Severe
|
1.1 percentage of participants
Interval 0.1 to 3.8
|
0 percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Irritability: Any
|
62.4 percentage of participants
Interval 55.0 to 69.3
|
62.7 percentage of participants
Interval 55.3 to 69.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Irritability: Mild
|
23.7 percentage of participants
Interval 17.7 to 30.4
|
19.5 percentage of participants
Interval 14.0 to 25.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Irritability: Moderate
|
36.0 percentage of participants
Interval 29.1 to 43.4
|
40.0 percentage of participants
Interval 32.9 to 47.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Irritability: Severe
|
2.7 percentage of participants
Interval 0.9 to 6.2
|
3.2 percentage of participants
Interval 1.2 to 6.9
|
PRIMARY outcome
Timeframe: From Vaccination 1 to 1 month after Vaccination 3 (up to 5 months)Population: Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3.
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship.
Outcome measures
| Measure |
20vPnC
n=231 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
n=227 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) From Vaccination 1 to 1 Month After Vaccination 3
|
61.0 percentage of participants
Interval 54.4 to 67.4
|
56.4 percentage of participants
Interval 49.7 to 62.9
|
PRIMARY outcome
Timeframe: From Vaccination 4 to 1 month after Vaccination 4Population: Dose 4 safety population included participants who received Dose 4 and had safety follow up between Dose 4 and 6 months after Dose 4.
An AE was any untoward medical occurrence in study participant who received study vaccine without regard to possibility of causal relationship.
Outcome measures
| Measure |
20vPnC
n=197 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
n=194 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) From Vaccination 4 to 1 Month After Vaccination 4
|
18.3 percentage of participants
Interval 13.1 to 24.4
|
25.3 percentage of participants
Interval 19.3 to 32.0
|
PRIMARY outcome
Timeframe: From Vaccination 1 to 6 months after Vaccination 4 (up to 16 months)Population: Overall safety analysis set included all participants who received at least 1 dose of study vaccine (20vPnC or 13vPnC) and had safety follow up in the study.
An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.
Outcome measures
| Measure |
20vPnC
n=231 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
n=227 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination 1 to 6 Months Following Vaccination 4
|
5.2 percentage of participants
Interval 2.7 to 8.9
|
2.2 percentage of participants
Interval 0.7 to 5.1
|
PRIMARY outcome
Timeframe: From Vaccination 1 to 6 months after Vaccination 4 (duration of 16 months)Population: Overall safety analysis set included all participants who received at least 1 dose of study vaccine (20vPnC or 13vPnC) and had safety follow up in the study.
An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.
Outcome measures
| Measure |
20vPnC
n=231 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
n=227 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|---|---|---|
|
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination 1 to 6 Months Following Vaccination 4
|
5.2 percentage of participants
Interval 2.7 to 8.9
|
3.5 percentage of participants
Interval 1.5 to 6.8
|
SECONDARY outcome
Timeframe: 1 month after Vaccination 3Population: Dose 3 evaluable immunogenicity population: included all eligible participants, who were randomly assigned to receive the vaccine, aged 42-98 days on the day of first vaccination, received 3 doses of assigned vaccine, had valid determinate IgG concentration for at least 1 serotype from 1 month after Dose 3 visit, had blood collection within 27-56 days, inclusive, after Dose 3, had not received prohibited vaccines before blood draw at 1 month after Dose 3, and had no major protocol deviations.
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 milliliter, for serotype 5: \>=0.23 microgram per milliliter, for serotype 6B: \>=0.10 microgram per milliliter and for serotype 19A: \>=0.12 microgram per milliliter.
Outcome measures
| Measure |
20vPnC
n=189 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
n=187 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|---|---|---|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 1
|
87.8 percentage of participants
Interval 82.3 to 92.1
|
87.7 percentage of participants
Interval 82.1 to 92.0
|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 3
|
65.1 percentage of participants
Interval 57.8 to 71.9
|
75.4 percentage of participants
Interval 68.6 to 81.4
|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 4
|
87.8 percentage of participants
Interval 82.3 to 92.1
|
91.4 percentage of participants
Interval 86.5 to 95.0
|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 5
|
87.8 percentage of participants
Interval 82.3 to 92.1
|
89.8 percentage of participants
Interval 84.6 to 93.8
|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 6A
|
93.7 percentage of participants
Interval 89.2 to 96.7
|
92.5 percentage of participants
Interval 87.8 to 95.8
|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 6B
|
86.8 percentage of participants
Interval 81.1 to 91.3
|
90.4 percentage of participants
Interval 85.2 to 94.2
|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 7F
|
98.9 percentage of participants
Interval 96.2 to 99.9
|
97.9 percentage of participants
Interval 94.6 to 99.4
|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 9V
|
89.4 percentage of participants
Interval 84.1 to 93.4
|
89.3 percentage of participants
Interval 84.0 to 93.3
|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 14
|
94.2 percentage of participants
Interval 89.8 to 97.1
|
95.7 percentage of participants
Interval 91.7 to 98.1
|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 18C
|
92.6 percentage of participants
Interval 87.9 to 95.9
|
95.2 percentage of participants
Interval 91.1 to 97.8
|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 19A
|
98.4 percentage of participants
Interval 95.4 to 99.7
|
97.9 percentage of participants
Interval 94.6 to 99.4
|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 19F
|
98.4 percentage of participants
Interval 95.4 to 99.7
|
96.8 percentage of participants
Interval 93.1 to 98.8
|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 23F
|
79.9 percentage of participants
Interval 73.5 to 85.4
|
81.8 percentage of participants
Interval 75.5 to 87.1
|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 8
|
99.5 percentage of participants
Interval 97.1 to 100.0
|
3.7 percentage of participants
Interval 1.5 to 7.6
|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 10A
|
87.8 percentage of participants
Interval 82.3 to 92.1
|
1.1 percentage of participants
Interval 0.1 to 3.8
|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 11A
|
97.4 percentage of participants
Interval 93.9 to 99.1
|
1.6 percentage of participants
Interval 0.3 to 4.6
|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 12F
|
82.5 percentage of participants
Interval 76.4 to 87.7
|
0.5 percentage of participants
Interval 0.0 to 2.9
|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 15B
|
98.9 percentage of participants
Interval 96.2 to 99.9
|
4.3 percentage of participants
Interval 1.9 to 8.3
|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 22F
|
98.9 percentage of participants
Interval 96.2 to 99.9
|
1.1 percentage of participants
Interval 0.1 to 3.8
|
|
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Serotype 33F
|
92.1 percentage of participants
Interval 87.2 to 95.5
|
1.6 percentage of participants
Interval 0.3 to 4.6
|
SECONDARY outcome
Timeframe: 1 month after Vaccination 3Population: Dose 3 evaluable immunogenicity population: included all eligible participants, who were randomly assigned to receive the vaccine, aged 42-98 days on the day of first vaccination, received 3 doses of assigned vaccine, had valid determinate IgG concentration for at least 1 serotype from 1 month after Dose 3 visit, had blood collection within 27-56 days, inclusive, after Dose 3, had not received prohibited vaccines before blood draw at 1 month after Dose 3, and had no major protocol deviations.
IgG GMCs were determined for 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.
Outcome measures
| Measure |
20vPnC
n=189 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
n=187 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|---|---|---|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 1
|
0.92 microgram per milliliter
Interval 0.81 to 1.05
|
1.16 microgram per milliliter
Interval 1.0 to 1.33
|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 3
|
0.43 microgram per milliliter
Interval 0.38 to 0.48
|
0.56 microgram per milliliter
Interval 0.49 to 0.64
|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 4
|
1.36 microgram per milliliter
Interval 1.16 to 1.61
|
1.64 microgram per milliliter
Interval 1.39 to 1.93
|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 5
|
0.93 microgram per milliliter
Interval 0.79 to 1.11
|
1.13 microgram per milliliter
Interval 0.96 to 1.34
|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 6A
|
2.28 microgram per milliliter
Interval 1.94 to 2.67
|
2.57 microgram per milliliter
Interval 2.16 to 3.05
|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 6B
|
0.63 microgram per milliliter
Interval 0.49 to 0.8
|
0.99 microgram per milliliter
Interval 0.77 to 1.27
|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 7F
|
2.15 microgram per milliliter
Interval 1.92 to 2.4
|
2.59 microgram per milliliter
Interval 2.28 to 2.93
|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 9V
|
1.22 microgram per milliliter
Interval 1.05 to 1.42
|
1.45 microgram per milliliter
Interval 1.24 to 1.7
|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 14
|
3.15 microgram per milliliter
Interval 2.69 to 3.7
|
3.60 microgram per milliliter
Interval 3.07 to 4.21
|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 18C
|
1.59 microgram per milliliter
Interval 1.37 to 1.84
|
2.05 microgram per milliliter
Interval 1.76 to 2.38
|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 19A
|
0.85 microgram per milliliter
Interval 0.74 to 0.96
|
1.02 microgram per milliliter
Interval 0.89 to 1.17
|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 19F
|
1.98 microgram per milliliter
Interval 1.76 to 2.22
|
2.28 microgram per milliliter
Interval 1.99 to 2.61
|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 23F
|
0.94 microgram per milliliter
Interval 0.78 to 1.14
|
1.26 microgram per milliliter
Interval 1.03 to 1.55
|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 8
|
2.09 microgram per milliliter
Interval 1.9 to 2.3
|
0.04 microgram per milliliter
Interval 0.03 to 0.04
|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 10A
|
1.67 microgram per milliliter
Interval 1.35 to 2.08
|
0.03 microgram per milliliter
Interval 0.03 to 0.03
|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 11A
|
1.94 microgram per milliliter
Interval 1.7 to 2.21
|
0.01 microgram per milliliter
Interval 0.01 to 0.01
|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 12F
|
0.86 microgram per milliliter
Interval 0.72 to 1.01
|
0.02 microgram per milliliter
Interval 0.02 to 0.02
|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 15B
|
5.86 microgram per milliliter
Interval 5.11 to 6.72
|
0.04 microgram per milliliter
Interval 0.04 to 0.05
|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 22F
|
4.62 microgram per milliliter
Interval 3.99 to 5.35
|
0.01 microgram per milliliter
Interval 0.01 to 0.01
|
|
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Serotype 33F
|
2.21 microgram per milliliter
Interval 1.87 to 2.61
|
0.05 microgram per milliliter
Interval 0.04 to 0.05
|
SECONDARY outcome
Timeframe: 1 Month after Vaccination 4Population: Dose 4 evaluable immunogenicity population: eligible participants, randomly assigned to receive vaccine, aged 42-98 days on day of first vaccination, received all 4 doses of assigned vaccine, with Dose 4 received in defined window (365-386 days of age), had valid determinate IgG concentration for at least 1 serotype 1 month post dose 4,had blood collection within 27-56 days post Dose 4,had not received prohibited vaccines before blood draw at 1 month post Dose 4,had no major protocol deviations.
IgG GMCs were determined for 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.
Outcome measures
| Measure |
20vPnC
n=168 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
n=166 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|---|---|---|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 1
|
2.65 microgram per milliliter
Interval 2.33 to 3.02
|
3.63 microgram per milliliter
Interval 3.2 to 4.11
|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 3
|
1.15 microgram per milliliter
Interval 0.97 to 1.35
|
1.49 microgram per milliliter
Interval 1.28 to 1.74
|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 4
|
7.16 microgram per milliliter
Interval 6.22 to 8.24
|
9.45 microgram per milliliter
Interval 8.16 to 10.95
|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 5
|
3.41 microgram per milliliter
Interval 2.95 to 3.93
|
4.95 microgram per milliliter
Interval 4.29 to 5.71
|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 6A
|
13.77 microgram per milliliter
Interval 12.16 to 15.59
|
18.83 microgram per milliliter
Interval 16.39 to 21.63
|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 6B
|
6.37 microgram per milliliter
Interval 5.42 to 7.5
|
9.73 microgram per milliliter
Interval 8.13 to 11.65
|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 7F
|
6.14 microgram per milliliter
Interval 5.51 to 6.83
|
9.32 microgram per milliliter
Interval 8.26 to 10.52
|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 9V
|
5.52 microgram per milliliter
Interval 4.82 to 6.31
|
7.78 microgram per milliliter
Interval 6.77 to 8.95
|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 14
|
8.61 microgram per milliliter
Interval 7.32 to 10.12
|
11.04 microgram per milliliter
Interval 9.44 to 12.9
|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 18C
|
5.58 microgram per milliliter
Interval 4.89 to 6.36
|
8.46 microgram per milliliter
Interval 7.25 to 9.88
|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 19A
|
5.71 microgram per milliliter
Interval 4.91 to 6.64
|
7.05 microgram per milliliter
Interval 6.04 to 8.24
|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 19F
|
7.79 microgram per milliliter
Interval 6.73 to 9.01
|
9.30 microgram per milliliter
Interval 7.99 to 10.83
|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 23F
|
6.06 microgram per milliliter
Interval 5.16 to 7.12
|
9.81 microgram per milliliter
Interval 8.1 to 11.88
|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 8
|
3.12 microgram per milliliter
Interval 2.78 to 3.49
|
0.05 microgram per milliliter
Interval 0.04 to 0.06
|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 10A
|
9.93 microgram per milliliter
Interval 8.58 to 11.5
|
0.03 microgram per milliliter
Interval 0.03 to 0.04
|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 11A
|
5.70 microgram per milliliter
Interval 4.96 to 6.54
|
0.01 microgram per milliliter
Interval 0.01 to 0.02
|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 12F
|
1.92 microgram per milliliter
Interval 1.68 to 2.2
|
0.02 microgram per milliliter
Interval 0.02 to 0.03
|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 15B
|
18.45 microgram per milliliter
Interval 16.43 to 20.72
|
0.04 microgram per milliliter
Interval 0.04 to 0.05
|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 22F
|
14.68 microgram per milliliter
Interval 12.62 to 17.08
|
0.01 microgram per milliliter
Interval 0.01 to 0.01
|
|
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Serotype 33F
|
4.70 microgram per milliliter
Interval 4.2 to 5.27
|
0.05 microgram per milliliter
Interval 0.04 to 0.05
|
Adverse Events
20vPnC
Serious events: 12 serious events
Other events: 225 other events
Deaths: 0 deaths
13vPnC
Serious events: 5 serious events
Other events: 224 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
20vPnC
n=231 participants at risk
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
n=227 participants at risk
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.43%
1/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.00%
0/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Bronchiolitis
|
0.43%
1/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.00%
0/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Bronchitis viral
|
0.43%
1/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.00%
0/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Croup infectious
|
0.43%
1/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.00%
0/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Gastroenteritis
|
0.43%
1/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.44%
1/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Meningitis viral
|
0.43%
1/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.00%
0/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.44%
1/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.44%
1/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.43%
1/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.00%
0/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.44%
1/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Sepsis
|
0.43%
1/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.00%
0/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Urinary tract infection
|
0.43%
1/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.00%
0/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.43%
1/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.00%
0/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.43%
1/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.00%
0/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.43%
1/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.00%
0/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Nervous system disorders
Seizure like phenomena
|
0.00%
0/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.44%
1/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.43%
1/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.00%
0/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Renal and urinary disorders
Oliguria
|
0.43%
1/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.00%
0/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
Other adverse events
| Measure |
20vPnC
n=231 participants at risk
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
|
13vPnC
n=227 participants at risk
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|---|---|---|
|
Congenital, familial and genetic disorders
Plagiocephaly
|
0.87%
2/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
1.8%
4/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Ear and labyrinth disorders
Ear pain
|
1.3%
3/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.88%
2/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Gastrointestinal disorders
Constipation
|
4.3%
10/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
2.6%
6/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
10/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
4.4%
10/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.6%
6/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
4.4%
10/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
1.3%
3/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Gastrointestinal disorders
Teething
|
4.3%
10/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
7.0%
16/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
8/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
4.0%
9/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
General disorders
Injection site erythema (REDNESS)
|
48.5%
112/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
52.9%
120/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
General disorders
Injection site pain (PAIN)
|
70.6%
163/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
73.6%
167/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
General disorders
Injection site swelling (SWELLING)
|
32.9%
76/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
35.7%
81/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
General disorders
Pyrexia
|
5.2%
12/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
4.4%
10/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Immune system disorders
Food allergy
|
0.00%
0/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
1.3%
3/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Bronchiolitis
|
4.8%
11/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
4.8%
11/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Candida infection
|
1.7%
4/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
2.2%
5/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Candida nappy rash
|
0.00%
0/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
2.2%
5/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Cellulitis
|
1.3%
3/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.44%
1/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Conjunctivitis
|
5.2%
12/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
4.8%
11/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Conjunctivitis bacterial
|
1.3%
3/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.00%
0/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Ear infection
|
0.87%
2/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
1.8%
4/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Gastroenteritis
|
0.87%
2/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
3.5%
8/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Gastroenteritis viral
|
2.6%
6/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.44%
1/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.43%
1/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
1.3%
3/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
15/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
7.0%
16/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Oral candidiasis
|
1.3%
3/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
1.3%
3/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Otitis media
|
10.8%
25/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
9.3%
21/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Otitis media acute
|
3.5%
8/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
6.6%
15/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Pneumonia
|
1.3%
3/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.00%
0/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.87%
2/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
1.3%
3/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Respiratory tract infection viral
|
2.6%
6/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
1.8%
4/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Skin candida
|
0.00%
0/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
2.2%
5/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.3%
40/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
19.4%
44/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Viral infection
|
4.3%
10/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
4.4%
10/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.5%
15/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
4.8%
11/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
6/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.88%
2/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Metabolism and nutrition disorders
Decreased appetite (DECREASED APPETITE)
|
58.0%
134/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
59.9%
136/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.87%
2/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
1.3%
3/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Metabolism and nutrition disorders
Feeding disorder
|
0.87%
2/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
1.3%
3/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Musculoskeletal and connective tissue disorders
Acquired plagiocephaly
|
0.43%
1/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
1.8%
4/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
1.3%
3/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.88%
2/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Nervous system disorders
Agitation neonatal
|
0.87%
2/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
1.8%
4/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Nervous system disorders
Hypersomnia (INCREASED SLEEP)
|
81.4%
188/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
83.3%
189/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Psychiatric disorders
Irritability (IRRITABILITY)
|
92.6%
214/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
90.7%
206/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.9%
9/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
3.5%
8/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.2%
12/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
3.1%
7/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.6%
6/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
2.2%
5/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.3%
3/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
0.00%
0/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
4.8%
11/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
3.5%
8/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.43%
1/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
1.3%
3/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.2%
5/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
1.3%
3/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
0.43%
1/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
1.3%
3/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
5/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
2.2%
5/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
1.8%
4/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
Infections and infestations
Croup infectious
|
1.7%
4/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
1.3%
3/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
|
General disorders
Pyrexia (FEVER)
|
39.0%
90/231 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
39.6%
90/227 • Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
|
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