Trial Outcomes & Findings for Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India (NCT NCT03548337)
NCT ID: NCT03548337
Last Updated: 2020-09-30
Results Overview
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 centimeters \[cm\]), moderate (2.5 to 7.0 cm) and, severe (greater than \[\>\] 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
301 participants
Primary outcome timeframe
Within 7 days after Vaccination 1
Results posted on
2020-09-30
Participant Flow
Participant milestones
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
Infant series: participants were randomized to receive a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with preservative 2-phenoxyethanol (2-PE) from a multi-dose vial (MDV), intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) diphtheria, tetanus, and pertussis; Haemophilus influenzae type b; and hepatitis B virus (DTP-Hib-HBV) vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose prefilled syringe (PFS), intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Infant Series
STARTED
|
151
|
150
|
|
Infant Series
Vaccination 1
|
150
|
150
|
|
Infant Series
Vaccination 2
|
144
|
144
|
|
Infant Series
Vaccination 3
|
144
|
141
|
|
Infant Series
COMPLETED
|
139
|
139
|
|
Infant Series
NOT COMPLETED
|
12
|
11
|
|
Toddler Dose
STARTED
|
139
|
139
|
|
Toddler Dose
Vaccination 4
|
139
|
139
|
|
Toddler Dose
COMPLETED
|
138
|
138
|
|
Toddler Dose
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
Infant series: participants were randomized to receive a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with preservative 2-phenoxyethanol (2-PE) from a multi-dose vial (MDV), intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) diphtheria, tetanus, and pertussis; Haemophilus influenzae type b; and hepatitis B virus (DTP-Hib-HBV) vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose prefilled syringe (PFS), intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Infant Series
Withdrawal by Parent/Guardian
|
8
|
8
|
|
Infant Series
No Longer Met Eligibility Criteria
|
1
|
0
|
|
Infant Series
Lost to Follow-up
|
2
|
1
|
|
Infant Series
Adverse Event
|
0
|
2
|
|
Infant Series
Randomized but Not Vaccinated
|
1
|
0
|
|
Toddler Dose
Withdrawal by parent/guardian
|
1
|
1
|
Baseline Characteristics
Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India
Baseline characteristics by cohort
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=150 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=150 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.9 Weeks
STANDARD_DEVIATION 0.95 • n=5 Participants
|
6.9 Weeks
STANDARD_DEVIATION 0.99 • n=7 Participants
|
6.9 Weeks
STANDARD_DEVIATION 0.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
150 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
300 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
150 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after Vaccination 1Population: Safety population of infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, "Overall Number of Participants analyzed" signifies participants who were evaluable for this outcome measure.
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 centimeters \[cm\]), moderate (2.5 to 7.0 cm) and, severe (greater than \[\>\] 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=147 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=148 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Any
|
19.7 percentage of participants
Interval 13.6 to 27.1
|
16.9 percentage of participants
Interval 11.2 to 23.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Mild
|
17.7 percentage of participants
Interval 11.9 to 24.8
|
12.8 percentage of participants
Interval 7.9 to 19.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Moderate
|
2.0 percentage of participants
Interval 0.4 to 5.8
|
4.1 percentage of participants
Interval 1.5 to 8.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Severe
|
0 percentage of participants
Interval 0.0 to 2.5
|
0 percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Any
|
27.9 percentage of participants
Interval 20.8 to 35.9
|
33.8 percentage of participants
Interval 26.2 to 42.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Mild
|
21.8 percentage of participants
Interval 15.4 to 29.3
|
23.6 percentage of participants
Interval 17.1 to 31.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Moderate
|
6.1 percentage of participants
Interval 2.8 to 11.3
|
10.1 percentage of participants
Interval 5.8 to 16.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Severe
|
0 percentage of participants
Interval 0.0 to 2.5
|
0 percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at injection site: Any
|
61.9 percentage of participants
Interval 53.5 to 69.8
|
67.6 percentage of participants
Interval 59.4 to 75.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at injection site: Mild
|
28.6 percentage of participants
Interval 21.4 to 36.6
|
33.1 percentage of participants
Interval 25.6 to 41.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at injection site: Moderate
|
30.6 percentage of participants
Interval 23.3 to 38.7
|
29.1 percentage of participants
Interval 21.9 to 37.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at injection site: Severe
|
2.7 percentage of participants
Interval 0.7 to 6.8
|
5.4 percentage of participants
Interval 2.4 to 10.4
|
PRIMARY outcome
Timeframe: Within 7 days after Vaccination 1Population: Safety population for infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability,were recorded daily using an electronic diary. Fever graded as:1)less than (\<)38.0 degrees Celsius \[C\], 2)greater than or equal to(\>=)38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as:mild(increased or prolonged sleeping bouts), moderate(slightly subdued; interfering with daily activity), and severe(disabling; not interested in usual daily activity). Irritability graded as: mild(easily consolable), moderate(required increased attention), and severe(inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here,"Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=147 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=148 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: <38.0 degree C
|
15.0 percentage of participants
Interval 9.6 to 21.8
|
10.8 percentage of participants
Interval 6.3 to 17.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >=38.0 degree C to 38.4 degree C
|
10.9 percentage of participants
Interval 6.4 to 17.1
|
8.1 percentage of participants
Interval 4.3 to 13.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: 38.5 degree C to 38.9 degree C
|
1.4 percentage of participants
Interval 0.2 to 4.8
|
2.7 percentage of participants
Interval 0.7 to 6.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: 39.0 degree C to 40.0 degree C
|
1.4 percentage of participants
Interval 0.2 to 4.8
|
0 percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >40.0 degree C
|
1.4 percentage of participants
Interval 0.2 to 4.8
|
0 percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Decreased appetite: Any
|
42.2 percentage of participants
Interval 34.1 to 50.6
|
53.4 percentage of participants
Interval 45.0 to 61.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Decreased appetite: Mild
|
23.8 percentage of participants
Interval 17.2 to 31.5
|
30.4 percentage of participants
Interval 23.1 to 38.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Decreased appetite: Moderate
|
17.7 percentage of participants
Interval 11.9 to 24.8
|
21.6 percentage of participants
Interval 15.3 to 29.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Decreased appetite: Severe
|
0.7 percentage of participants
Interval 0.0 to 3.7
|
1.4 percentage of participants
Interval 0.2 to 4.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Drowsiness: Any
|
55.1 percentage of participants
Interval 46.7 to 63.3
|
66.2 percentage of participants
Interval 58.0 to 73.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Drowsiness: Mild
|
29.3 percentage of participants
Interval 22.0 to 37.3
|
33.1 percentage of participants
Interval 25.6 to 41.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Drowsiness: Moderate
|
25.2 percentage of participants
Interval 18.4 to 33.0
|
31.1 percentage of participants
Interval 23.7 to 39.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Drowsiness: Severe
|
0.7 percentage of participants
Interval 0.0 to 3.7
|
2.0 percentage of participants
Interval 0.4 to 5.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Irritability: Any
|
64.6 percentage of participants
Interval 56.3 to 72.3
|
65.5 percentage of participants
Interval 57.3 to 73.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Irritability: Mild
|
37.4 percentage of participants
Interval 29.6 to 45.8
|
32.4 percentage of participants
Interval 25.0 to 40.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Irritability: Moderate
|
21.8 percentage of participants
Interval 15.4 to 29.3
|
26.4 percentage of participants
Interval 19.5 to 34.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Irritability: Severe
|
5.4 percentage of participants
Interval 2.4 to 10.4
|
6.8 percentage of participants
Interval 3.3 to 12.1
|
PRIMARY outcome
Timeframe: Within 7 days after Vaccination 2Population: Safety population for infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (\> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=141 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=140 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at injection site: Mild
|
32.6 percentage of participants
Interval 25.0 to 41.0
|
29.3 percentage of participants
Interval 21.9 to 37.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Any
|
17.0 percentage of participants
Interval 11.2 to 24.3
|
19.3 percentage of participants
Interval 13.1 to 26.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Mild
|
16.3 percentage of participants
Interval 10.6 to 23.5
|
17.9 percentage of participants
Interval 11.9 to 25.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Moderate
|
0.7 percentage of participants
Interval 0.0 to 3.9
|
1.4 percentage of participants
Interval 0.2 to 5.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Severe
|
0 percentage of participants
Interval 0.0 to 2.6
|
0 percentage of participants
Interval 0.0 to 2.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Any
|
24.8 percentage of participants
Interval 17.9 to 32.8
|
27.9 percentage of participants
Interval 20.6 to 36.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Mild
|
21.3 percentage of participants
Interval 14.8 to 29.0
|
22.9 percentage of participants
Interval 16.2 to 30.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Moderate
|
3.5 percentage of participants
Interval 1.2 to 8.1
|
5.0 percentage of participants
Interval 2.0 to 10.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Severe
|
0 percentage of participants
Interval 0.0 to 2.6
|
0 percentage of participants
Interval 0.0 to 2.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at injection site: Any
|
59.6 percentage of participants
Interval 51.0 to 67.7
|
62.1 percentage of participants
Interval 53.6 to 70.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at injection site: Moderate
|
20.6 percentage of participants
Interval 14.2 to 28.2
|
26.4 percentage of participants
Interval 19.3 to 34.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at injection site: Severe
|
6.4 percentage of participants
Interval 3.0 to 11.8
|
6.4 percentage of participants
Interval 3.0 to 11.9
|
PRIMARY outcome
Timeframe: Within 7 days after Vaccination 2Population: Safety population for infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) \< 38.0 degrees C, 2) \>= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here, "Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=141 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=140 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: <38.0 degree C
|
8.5 percentage of participants
Interval 4.5 to 14.4
|
8.6 percentage of participants
Interval 4.5 to 14.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: >=38.0 degree C to 38.4 degree C
|
6.4 percentage of participants
Interval 3.0 to 11.8
|
5.7 percentage of participants
Interval 2.5 to 10.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: 38.5 degree C to 38.9 degree C
|
2.1 percentage of participants
Interval 0.4 to 6.1
|
2.1 percentage of participants
Interval 0.4 to 6.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: 39.0 degree C to 40.0 degree C
|
0 percentage of participants
Interval 0.0 to 2.6
|
0 percentage of participants
Interval 0.0 to 2.6
|
|
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 2.6
|
0.7 percentage of participants
Interval 0.0 to 3.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Decreased appetite: Any
|
40.4 percentage of participants
Interval 32.3 to 49.0
|
38.6 percentage of participants
Interval 30.5 to 47.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Decreased appetite: Mild
|
27.0 percentage of participants
Interval 19.8 to 35.1
|
25.0 percentage of participants
Interval 18.1 to 33.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Decreased appetite: Moderate
|
12.1 percentage of participants
Interval 7.2 to 18.6
|
12.1 percentage of participants
Interval 7.2 to 18.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Decreased appetite: Severe
|
1.4 percentage of participants
Interval 0.2 to 5.0
|
1.4 percentage of participants
Interval 0.2 to 5.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Drowsiness: Any
|
50.4 percentage of participants
Interval 41.8 to 58.9
|
52.1 percentage of participants
Interval 43.5 to 60.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Drowsiness: Mild
|
23.4 percentage of participants
Interval 16.7 to 31.3
|
22.1 percentage of participants
Interval 15.6 to 29.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Drowsiness: Moderate
|
25.5 percentage of participants
Interval 18.6 to 33.6
|
26.4 percentage of participants
Interval 19.3 to 34.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Drowsiness: Severe
|
1.4 percentage of participants
Interval 0.2 to 5.0
|
3.6 percentage of participants
Interval 1.2 to 8.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Irritability: Any
|
56.7 percentage of participants
Interval 48.1 to 65.0
|
60.0 percentage of participants
Interval 51.4 to 68.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Irritability: Mild
|
29.1 percentage of participants
Interval 21.7 to 37.3
|
37.9 percentage of participants
Interval 29.8 to 46.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Irritability: Moderate
|
24.8 percentage of participants
Interval 17.9 to 32.8
|
17.9 percentage of participants
Interval 11.9 to 25.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Irritability: Severe
|
2.8 percentage of participants
Interval 0.8 to 7.1
|
4.3 percentage of participants
Interval 1.6 to 9.1
|
PRIMARY outcome
Timeframe: Within 7 days after Vaccination 3Population: Safety population for infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (\> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=139 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=140 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Pain at injection site: Mild
|
30.2 percentage of participants
Interval 22.7 to 38.6
|
27.9 percentage of participants
Interval 20.6 to 36.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Redness: Any
|
20.1 percentage of participants
Interval 13.8 to 27.8
|
22.9 percentage of participants
Interval 16.2 to 30.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Redness: Mild
|
20.1 percentage of participants
Interval 13.8 to 27.8
|
20.0 percentage of participants
Interval 13.7 to 27.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Redness: Moderate
|
0 percentage of participants
Interval 0.0 to 2.6
|
2.9 percentage of participants
Interval 0.8 to 7.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Redness: Severe
|
0 percentage of participants
Interval 0.0 to 2.6
|
0 percentage of participants
Interval 0.0 to 2.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Swelling: Any
|
23.0 percentage of participants
Interval 16.3 to 30.9
|
27.1 percentage of participants
Interval 20.0 to 35.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Swelling: Mild
|
20.9 percentage of participants
Interval 14.4 to 28.6
|
23.6 percentage of participants
Interval 16.8 to 31.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Swelling: Moderate
|
2.2 percentage of participants
Interval 0.4 to 6.2
|
2.9 percentage of participants
Interval 0.8 to 7.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Swelling: Severe
|
0 percentage of participants
Interval 0.0 to 2.6
|
0.7 percentage of participants
Interval 0.0 to 3.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Pain at injection site: Any
|
55.4 percentage of participants
Interval 46.7 to 63.8
|
54.3 percentage of participants
Interval 45.7 to 62.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Pain at injection site: Moderate
|
23.0 percentage of participants
Interval 16.3 to 30.9
|
21.4 percentage of participants
Interval 14.9 to 29.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Pain at injection site: Severe
|
2.2 percentage of participants
Interval 0.4 to 6.2
|
5.0 percentage of participants
Interval 2.0 to 10.0
|
PRIMARY outcome
Timeframe: Within 7 days after Vaccination 3Population: Safety population for infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) \< 38.0 degrees C, 2) \>= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here, "Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=139 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=140 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Irritability: Any
|
54.7 percentage of participants
Interval 46.0 to 63.1
|
60.0 percentage of participants
Interval 51.4 to 68.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Irritability: Mild
|
31.7 percentage of participants
Interval 24.0 to 40.1
|
37.9 percentage of participants
Interval 29.8 to 46.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Irritability: Moderate
|
19.4 percentage of participants
Interval 13.2 to 27.0
|
15.7 percentage of participants
Interval 10.1 to 22.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Irritability: Severe
|
3.6 percentage of participants
Interval 1.2 to 8.2
|
6.4 percentage of participants
Interval 3.0 to 11.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fever: <38.0 degree C
|
7.2 percentage of participants
Interval 3.5 to 12.8
|
9.3 percentage of participants
Interval 5.0 to 15.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fever: >=38.0 degree C to 38.4 degree C
|
4.3 percentage of participants
Interval 1.6 to 9.2
|
6.4 percentage of participants
Interval 3.0 to 11.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fever: 38.5 degree C to 38.9 degree C
|
2.2 percentage of participants
Interval 0.4 to 6.2
|
1.4 percentage of participants
Interval 0.2 to 5.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fever: 39.0 degree C to 40.0 degree C
|
0 percentage of participants
Interval 0.0 to 2.6
|
1.4 percentage of participants
Interval 0.2 to 5.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fever: >40.0 degree C
|
0.7 percentage of participants
Interval 0.0 to 3.9
|
0 percentage of participants
Interval 0.0 to 2.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Decreased appetite: Any
|
34.5 percentage of participants
Interval 26.7 to 43.1
|
36.4 percentage of participants
Interval 28.5 to 45.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Decreased appetite: Mild
|
20.1 percentage of participants
Interval 13.8 to 27.8
|
23.6 percentage of participants
Interval 16.8 to 31.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Decreased appetite: Moderate
|
11.5 percentage of participants
Interval 6.7 to 18.0
|
10.0 percentage of participants
Interval 5.6 to 16.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Decreased appetite: Severe
|
2.9 percentage of participants
Interval 0.8 to 7.2
|
2.9 percentage of participants
Interval 0.8 to 7.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Drowsiness: Any
|
36.0 percentage of participants
Interval 28.0 to 44.5
|
39.3 percentage of participants
Interval 31.1 to 47.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Drowsiness: Mild
|
20.9 percentage of participants
Interval 14.4 to 28.6
|
19.3 percentage of participants
Interval 13.1 to 26.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Drowsiness: Moderate
|
13.7 percentage of participants
Interval 8.4 to 20.5
|
17.9 percentage of participants
Interval 11.9 to 25.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Drowsiness: Severe
|
1.4 percentage of participants
Interval 0.2 to 5.1
|
2.1 percentage of participants
Interval 0.4 to 6.1
|
PRIMARY outcome
Timeframe: Within 7 days after Vaccination 4Population: Safety population for toddler dose included all participants who received at least 1 dose of study vaccine during toddler dosing. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (\> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=132 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=132 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Redness: Any
|
8.3 percentage of participants
Interval 4.2 to 14.4
|
11.4 percentage of participants
Interval 6.5 to 18.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Redness: MIld
|
8.3 percentage of participants
Interval 4.2 to 14.4
|
10.6 percentage of participants
Interval 5.9 to 17.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Redness: Moderate
|
0 percentage of participants
Interval 0.0 to 2.8
|
0.8 percentage of participants
Interval 0.0 to 4.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Redness: Severe
|
0 percentage of participants
Interval 0.0 to 2.8
|
0 percentage of participants
Interval 0.0 to 2.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Swelling: Any
|
9.1 percentage of participants
Interval 4.8 to 15.3
|
12.1 percentage of participants
Interval 7.1 to 18.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Swelling: Mild
|
6.8 percentage of participants
Interval 3.2 to 12.5
|
11.4 percentage of participants
Interval 6.5 to 18.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Swelling: Moderate
|
2.3 percentage of participants
Interval 0.5 to 6.5
|
0.8 percentage of participants
Interval 0.0 to 4.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Swelling: Severe
|
0 percentage of participants
Interval 0.0 to 2.8
|
0 percentage of participants
Interval 0.0 to 2.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Pain at injection site: Any
|
25.0 percentage of participants
Interval 17.9 to 33.3
|
19.7 percentage of participants
Interval 13.3 to 27.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Pain at injection site: Mild
|
18.9 percentage of participants
Interval 12.6 to 26.7
|
13.6 percentage of participants
Interval 8.3 to 20.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Pain at injection site: Moderate
|
6.1 percentage of participants
Interval 2.7 to 11.6
|
5.3 percentage of participants
Interval 2.2 to 10.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Pain at injection site: Severe
|
0 percentage of participants
Interval 0.0 to 2.8
|
0.8 percentage of participants
Interval 0.0 to 4.1
|
PRIMARY outcome
Timeframe: Within 7 days after Vaccination 4Population: Safety population for toddler dose included all participants who received at least 1 dose of study vaccine during toddler dosing. Here, "Overall Number of Participants Analyzed, N" signifies participants who were evaluable for this outcome measure.
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) \< 38.0 degrees C, 2) \>= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here, "Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=132 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=132 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Fever: <38.0 degree C
|
3.0 percentage of participants
Interval 0.8 to 7.6
|
4.5 percentage of participants
Interval 1.7 to 9.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Fever: >=38.0 degree C to 38.4 degree C
|
1.5 percentage of participants
Interval 0.2 to 5.4
|
3.8 percentage of participants
Interval 1.2 to 8.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Fever: 38.5 degree C to 38.9 degree C
|
0 percentage of participants
Interval 0.0 to 2.8
|
0 percentage of participants
Interval 0.0 to 2.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Fever: 39.0 degree C to 40.0 degree C
|
0 percentage of participants
Interval 0.0 to 2.8
|
0.8 percentage of participants
Interval 0.0 to 4.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Fever: >40.0 degree C
|
1.5 percentage of participants
Interval 0.2 to 5.4
|
0 percentage of participants
Interval 0.0 to 2.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Decreased appetite: Any
|
15.2 percentage of participants
Interval 9.5 to 22.4
|
16.7 percentage of participants
Interval 10.7 to 24.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Decreased appetite: Mild
|
10.6 percentage of participants
Interval 5.9 to 17.2
|
6.8 percentage of participants
Interval 3.2 to 12.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Decreased appetite: Moderate
|
4.5 percentage of participants
Interval 1.7 to 9.6
|
9.8 percentage of participants
Interval 5.3 to 16.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Decreased appetite: Severe
|
0 percentage of participants
Interval 0.0 to 2.8
|
0 percentage of participants
Interval 0.0 to 2.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Drowsiness: Any
|
7.6 percentage of participants
Interval 3.7 to 13.5
|
18.9 percentage of participants
Interval 12.6 to 26.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Drowsiness: Mild
|
3.8 percentage of participants
Interval 1.2 to 8.6
|
12.9 percentage of participants
Interval 7.7 to 19.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Drowsiness: Moderate
|
3.8 percentage of participants
Interval 1.2 to 8.6
|
6.1 percentage of participants
Interval 2.7 to 11.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Drowsiness: Severe
|
0 percentage of participants
Interval 0.0 to 2.8
|
0 percentage of participants
Interval 0.0 to 2.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Irritability: Any
|
24.2 percentage of participants
Interval 17.2 to 32.5
|
23.5 percentage of participants
Interval 16.5 to 31.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Irritability: Mild
|
15.9 percentage of participants
Interval 10.1 to 23.3
|
16.7 percentage of participants
Interval 10.7 to 24.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Irritability: Moderate
|
7.6 percentage of participants
Interval 3.7 to 13.5
|
5.3 percentage of participants
Interval 2.2 to 10.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Irritability: Severe
|
0.8 percentage of participants
Interval 0.0 to 4.1
|
1.5 percentage of participants
Interval 0.2 to 5.4
|
PRIMARY outcome
Timeframe: From Vaccination 1 up to 1 Month after Vaccination 3 (for a maximum study duration of 3 months)Population: Safety population for infant series included all participants who received at least 1 dose of study vaccine during infant series.
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=150 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=150 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) After Vaccination 1 up to 1 Month After Vaccination 3
|
47.3 percentage of participants
Interval 39.1 to 55.6
|
49.3 percentage of participants
Interval 41.1 to 57.6
|
PRIMARY outcome
Timeframe: From Vaccination 4 up to 1 month after Vaccination 4 (for a maximum study duration of 1 month)Population: Safety population for toddler dose included all participants who received at least 1 dose of study vaccine during toddler dosing.
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=139 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=139 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) From Vaccination 4 up to 1 Month After Vaccination 4
|
7.9 percentage of participants
Interval 4.0 to 13.7
|
8.6 percentage of participants
Interval 4.5 to 14.6
|
PRIMARY outcome
Timeframe: From Vaccination 1 up to 1 month after Vaccination 4 (for a maximum study duration of 11.5 months)Population: Safety population included all participants who received at least 1 dose of study vaccine in study.
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=150 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=150 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) After Vaccination 1 up to 1 Month After Vaccination 4
|
8.0 percentage of participants
Interval 4.2 to 13.6
|
4.7 percentage of participants
Interval 1.9 to 9.4
|
PRIMARY outcome
Timeframe: From 1 month after Vaccination 3 up to Vaccination 4 (for a maximum study duration of 7.5 months)Population: Safety population for study included all participants who received at least 1 dose of study vaccine in study.
A newly diagnosed chronic medical condition was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=150 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=150 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Number of Participants With New Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Vaccination 3 up to Vaccination 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 month after Vaccination 3Population: Evaluable immunogenicity population(EIP) for infant series: all eligible participants aged 6 weeks at time of Dose 1, who received 3 doses of infant series vaccine, had blood drawn post Dose 3 within 27 to 56 days(inclusive) post Dose 3, had at least 1 valid and determinate assay result post Dose 3, and had no major protocol violations.
Percentage of participants achieving predefined antibody threshold: \>=0.35 microgram per milliliter (mcg/mL) for the 10 pneumococcal serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F and 23F; threshold \>= 0.23 mcg/mL for serotype 5, threshold \>= 0.10 mcg/mL for serotype 6B, threshold \>= 0.12 mcg/mL for serotype 19A, along with the corresponding 95 percent (%) confidence interval (CI) are reported.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=136 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=133 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 1
|
91.2 percentage of participants
Interval 85.1 to 95.4
|
85.0 percentage of participants
Interval 77.7 to 90.6
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 3
|
91.9 percentage of participants
Interval 86.0 to 95.9
|
85.7 percentage of participants
Interval 78.6 to 91.2
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 4
|
91.2 percentage of participants
Interval 85.1 to 95.4
|
91.0 percentage of participants
Interval 84.8 to 95.3
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 5
|
84.6 percentage of participants
Interval 77.4 to 90.2
|
82.0 percentage of participants
Interval 74.4 to 88.1
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 6A
|
83.8 percentage of participants
Interval 76.5 to 89.6
|
71.4 percentage of participants
Interval 63.0 to 78.9
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 6B
|
77.2 percentage of participants
Interval 69.2 to 84.0
|
75.2 percentage of participants
Interval 67.0 to 82.3
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 7F
|
96.3 percentage of participants
Interval 91.6 to 98.8
|
93.2 percentage of participants
Interval 87.5 to 96.9
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 9V
|
85.3 percentage of participants
Interval 78.2 to 90.8
|
83.5 percentage of participants
Interval 76.0 to 89.3
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 14
|
88.2 percentage of participants
Interval 81.6 to 93.1
|
82.7 percentage of participants
Interval 75.2 to 88.7
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 18C
|
92.6 percentage of participants
Interval 86.9 to 96.4
|
84.2 percentage of participants
Interval 76.9 to 90.0
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 19A
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
98.5 percentage of participants
Interval 94.7 to 99.8
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 19F
|
97.8 percentage of participants
Interval 93.7 to 99.5
|
95.5 percentage of participants
Interval 90.4 to 98.3
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 23F
|
84.6 percentage of participants
Interval 77.4 to 90.2
|
76.7 percentage of participants
Interval 68.6 to 83.6
|
SECONDARY outcome
Timeframe: 1 month after Vaccination 4Population: EIP for toddler dose: all eligible participants who received 3 doses in infant series and 1 toddler dose of vaccine, had blood drawn post Dose 4 within 27 to 56 days (inclusive) post Dose 4, had at least 1 valid and determinate assay result post Dose 4, and had no major protocol violations. "N": signifies participants evaluable for this measure.
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL for the 10 pneumococcal serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F and 23F, threshold \>= 0.23 mcg/mL for serotype 5, threshold \>= 0.10 mcg/mL for serotype 6B, threshold \>= 0.12 mcg/mL for serotype 19A, along with the corresponding 95% CI are reported.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=132 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=129 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 1
|
99.2 percentage of participants
Interval 95.9 to 100.0
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 3
|
97.0 percentage of participants
Interval 92.4 to 99.2
|
98.4 percentage of participants
Interval 94.5 to 99.8
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 4
|
99.2 percentage of participants
Interval 95.9 to 100.0
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 5
|
99.2 percentage of participants
Interval 95.9 to 100.0
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 6A
|
96.2 percentage of participants
Interval 91.4 to 98.8
|
96.9 percentage of participants
Interval 92.3 to 99.1
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 6B
|
98.5 percentage of participants
Interval 94.6 to 99.8
|
96.9 percentage of participants
Interval 92.3 to 99.1
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 7F
|
99.2 percentage of participants
Interval 95.9 to 100.0
|
99.2 percentage of participants
Interval 95.8 to 100.0
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 9V
|
98.5 percentage of participants
Interval 94.6 to 99.8
|
99.2 percentage of participants
Interval 95.8 to 100.0
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 14
|
97.7 percentage of participants
Interval 93.5 to 99.5
|
96.1 percentage of participants
Interval 91.2 to 98.7
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 18C
|
97.0 percentage of participants
Interval 92.4 to 99.2
|
99.2 percentage of participants
Interval 95.8 to 100.0
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 19A
|
99.2 percentage of participants
Interval 95.9 to 100.0
|
99.2 percentage of participants
Interval 95.8 to 100.0
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 19F
|
98.5 percentage of participants
Interval 94.6 to 99.8
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
|
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 23F
|
99.2 percentage of participants
Interval 95.9 to 100.0
|
96.9 percentage of participants
Interval 92.3 to 99.1
|
SECONDARY outcome
Timeframe: 1 month after Vaccination 3Population: Evaluable immunogenicity population for infant series: all eligible participants aged 6 weeks at time of Dose 1, who received 3 doses of infant series vaccine, had blood drawn post-Dose 3 within 27 to 56 days (inclusive) post Dose 3, had at least 1 valid and determinate assay result post Dose 3, and had no major protocol violations.
Antibody (IgG) GMCs for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) and corresponding 2-sided 95% CI are reported.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=136 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=133 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 1
|
1.36 mcg/mL
Interval 1.15 to 1.6
|
1.13 mcg/mL
Interval 0.94 to 1.36
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 3
|
1.01 mcg/mL
Interval 0.88 to 1.16
|
0.93 mcg/mL
Interval 0.8 to 1.07
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 4
|
1.67 mcg/mL
Interval 1.4 to 1.98
|
1.75 mcg/mL
Interval 1.45 to 2.11
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 5
|
0.83 mcg/mL
Interval 0.67 to 1.02
|
0.86 mcg/mL
Interval 0.67 to 1.11
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 6A
|
1.45 mcg/mL
Interval 1.13 to 1.87
|
0.86 mcg/mL
Interval 0.66 to 1.12
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 6B
|
0.41 mcg/mL
Interval 0.31 to 0.55
|
0.33 mcg/mL
Interval 0.24 to 0.46
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 7F
|
2.01 mcg/mL
Interval 1.74 to 2.33
|
1.85 mcg/mL
Interval 1.52 to 2.26
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 9V
|
1.42 mcg/mL
Interval 1.17 to 1.73
|
1.28 mcg/mL
Interval 1.02 to 1.62
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 14
|
1.66 mcg/mL
Interval 1.33 to 2.06
|
1.39 mcg/mL
Interval 1.09 to 1.76
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 18C
|
1.81 mcg/mL
Interval 1.5 to 2.18
|
1.37 mcg/mL
Interval 1.1 to 1.71
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 19A
|
2.33 mcg/mL
Interval 1.96 to 2.78
|
1.86 mcg/mL
Interval 1.51 to 2.28
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 19F
|
2.89 mcg/mL
Interval 2.52 to 3.31
|
2.43 mcg/mL
Interval 2.04 to 2.89
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 23F
|
1.48 mcg/mL
Interval 1.2 to 1.81
|
0.94 mcg/mL
Interval 0.73 to 1.21
|
SECONDARY outcome
Timeframe: 1 month after Vaccination 4Population: Evaluable immunogenicity population for toddler dose: all eligible participants who received 3 doses in infant series and 1 toddler dose of vaccine, had blood drawn post Dose 4 within 27 to 56 days (inclusive) post Dose 4, had at least 1 valid and determinate assay result post Dose 4, and had no major protocol violations.
Antibody (IgG) GMCs for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) and corresponding 2-sided 95% CI are reported.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=132 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=130 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 1
|
4.35 mcg/mL
Interval 3.71 to 5.1
|
4.27 mcg/mL
Interval 3.65 to 4.99
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 3
|
1.58 mcg/mL
Interval 1.36 to 1.83
|
1.63 mcg/mL
Interval 1.43 to 1.86
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 4
|
10.58 mcg/mL
Interval 8.89 to 12.6
|
11.91 mcg/mL
Interval 10.19 to 13.93
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 5
|
5.16 mcg/mL
Interval 4.37 to 6.1
|
5.68 mcg/mL
Interval 4.81 to 6.7
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 6A
|
18.55 mcg/mL
Interval 14.32 to 24.02
|
20.51 mcg/mL
Interval 16.32 to 25.78
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 6B
|
11.76 mcg/mL
Interval 9.24 to 14.98
|
10.87 mcg/mL
Interval 8.14 to 14.53
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 7F
|
7.92 mcg/mL
Interval 6.88 to 9.13
|
8.29 mcg/mL
Interval 7.17 to 9.57
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 9V
|
8.78 mcg/mL
Interval 7.19 to 10.73
|
9.57 mcg/mL
Interval 8.0 to 11.44
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 14
|
13.20 mcg/mL
Interval 10.69 to 16.3
|
11.78 mcg/mL
Interval 9.31 to 14.9
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 18C
|
6.21 mcg/mL
Interval 5.19 to 7.44
|
6.27 mcg/mL
Interval 5.25 to 7.48
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 19A
|
12.26 mcg/mL
Interval 10.26 to 14.65
|
12.02 mcg/mL
Interval 9.75 to 14.82
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 19F
|
13.65 mcg/mL
Interval 11.16 to 16.69
|
14.09 mcg/mL
Interval 11.71 to 16.96
|
|
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 23F
|
10.89 mcg/mL
Interval 8.78 to 13.5
|
9.90 mcg/mL
Interval 7.75 to 12.66
|
SECONDARY outcome
Timeframe: 1 month after Vaccination 3Population: Evaluable immunogenicity population for infant series: all eligible participants aged 6 weeks at time of Dose 1, who received 3 doses of infant series vaccine, had blood drawn post Dose 3 within 27 to 56 days (inclusive) post Dose 3, had at least 1 valid and determinate assay result post Dose 3, and had no major protocol violations.
Antibody-mediated serum OPA against the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a pneumococcal OPA assay. Initial results were measured as OPA titers, which were then logarithmically transformed for analysis; geometric means calculated and expressed as GMTs.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=136 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=133 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 1
|
21.8 titer (1/dilution)
Interval 18.1 to 26.2
|
22.5 titer (1/dilution)
Interval 18.1 to 27.9
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 3
|
79.7 titer (1/dilution)
Interval 68.8 to 92.3
|
72.8 titer (1/dilution)
Interval 62.7 to 84.6
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 4
|
1158.8 titer (1/dilution)
Interval 938.3 to 1431.1
|
1159.2 titer (1/dilution)
Interval 948.3 to 1417.0
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 5
|
37.0 titer (1/dilution)
Interval 31.4 to 43.5
|
40.9 titer (1/dilution)
Interval 34.0 to 49.3
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 6A
|
1211.7 titer (1/dilution)
Interval 896.4 to 1638.0
|
1321.9 titer (1/dilution)
Interval 1026.7 to 1701.9
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 6B
|
1145.8 titer (1/dilution)
Interval 870.4 to 1508.3
|
957.6 titer (1/dilution)
Interval 708.2 to 1294.8
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 7F
|
1743.3 titer (1/dilution)
Interval 1436.6 to 2115.5
|
1178.8 titer (1/dilution)
Interval 952.6 to 1458.6
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 9V
|
643.9 titer (1/dilution)
Interval 498.6 to 831.7
|
683.3 titer (1/dilution)
Interval 522.6 to 893.3
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 14
|
496.9 titer (1/dilution)
Interval 344.2 to 717.3
|
341.8 titer (1/dilution)
Interval 236.0 to 495.0
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 18C
|
3055.8 titer (1/dilution)
Interval 2378.5 to 3926.0
|
2183.9 titer (1/dilution)
Interval 1686.9 to 2827.3
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 19A
|
219.3 titer (1/dilution)
Interval 169.4 to 283.9
|
275.7 titer (1/dilution)
Interval 212.0 to 358.6
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 19F
|
236.1 titer (1/dilution)
Interval 191.6 to 291.1
|
272.7 titer (1/dilution)
Interval 219.1 to 339.4
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 23F
|
1036.4 titer (1/dilution)
Interval 746.9 to 1438.0
|
926.8 titer (1/dilution)
Interval 673.9 to 1274.7
|
SECONDARY outcome
Timeframe: 1 month after Vaccination 4Population: Evaluable immunogenicity population for toddler dose: all eligible participants who received 3 doses in infant series and 1 toddler dose of vaccine, had blood drawn post Dose 4 within 27 to 56 days (inclusive) post Dose 4, had at least 1 valid and determinate assay result post Dose 4, and had no major protocol violations.
Antibody-mediated serum OPA against the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a pneumococcal OPA assay. Initial results were measured as OPA titers, which were then logarithmically transformed for analysis; geometric means calculated and expressed as GMTs.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=132 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=130 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 19F
|
808.0 titer (1/dilution)
Interval 633.0 to 1033.5
|
766.0 titer (1/dilution)
Interval 609.2 to 963.2
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 1
|
204.2 titer (1/dilution)
Interval 164.7 to 253.3
|
217.0 titer (1/dilution)
Interval 176.4 to 266.9
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 3
|
121.0 titer (1/dilution)
Interval 104.4 to 140.3
|
129.8 titer (1/dilution)
Interval 111.7 to 150.8
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 4
|
2991.4 titer (1/dilution)
Interval 2437.5 to 3671.3
|
2519.0 titer (1/dilution)
Interval 2098.7 to 3023.6
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 5
|
157.6 titer (1/dilution)
Interval 131.9 to 188.3
|
153.4 titer (1/dilution)
Interval 126.6 to 185.8
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 6A
|
2945.7 titer (1/dilution)
Interval 2376.0 to 3652.1
|
3092.5 titer (1/dilution)
Interval 2493.5 to 3835.4
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 6B
|
1948.9 titer (1/dilution)
Interval 1521.4 to 2496.7
|
1750.1 titer (1/dilution)
Interval 1360.9 to 2250.8
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 7F
|
4161.5 titer (1/dilution)
Interval 3498.0 to 4950.9
|
4353.8 titer (1/dilution)
Interval 3706.5 to 5114.0
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 9V
|
6927.5 titer (1/dilution)
Interval 5765.9 to 8323.2
|
6460.4 titer (1/dilution)
Interval 5277.3 to 7908.7
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 14
|
1505.8 titer (1/dilution)
Interval 1246.5 to 1819.0
|
1302.2 titer (1/dilution)
Interval 1106.1 to 1533.2
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 18C
|
8028.3 titer (1/dilution)
Interval 6233.7 to 10339.7
|
7830.0 titer (1/dilution)
Interval 5998.5 to 10220.7
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 19A
|
1848.9 titer (1/dilution)
Interval 1472.0 to 2322.2
|
1832.5 titer (1/dilution)
Interval 1454.9 to 2308.1
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 23F
|
3125.0 titer (1/dilution)
Interval 2450.8 to 3984.7
|
3348.8 titer (1/dilution)
Interval 2639.5 to 4248.5
|
SECONDARY outcome
Timeframe: 1 month after Vaccination 3Population: Evaluable immunogenicity population for infant series was analyzed. "Overall Number of Participants Analyzed": signifies participants evaluable for this outcome measure. "Number Analyzed": signifies participants evaluable for specific serotype.
Percentage of participants achieving OPA titer \>=LLOQ along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of participants was presented. LLOQ (measured in mcg/mL) for each serotype is as follows: Serotype 1=18; Serotype 3=12; Serotype 4=21; Serotype 5=29; Serotype 6A=37; Serotype 6B=43; Serotype 7F=113; Serotype 9V=141; Serotype 14=35; Serotype 18C=31; Serotype 19A=18; Serotype 19F=48; Serotype 23F=13.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=114 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=108 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 1
|
51.4 percentage of participants
Interval 41.7 to 61.0
|
46.2 percentage of participants
Interval 36.5 to 56.2
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 3
|
98.2 percentage of participants
Interval 93.5 to 99.8
|
98.1 percentage of participants
Interval 93.4 to 99.8
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 4
|
98.1 percentage of participants
Interval 93.3 to 99.8
|
99.0 percentage of participants
Interval 94.6 to 100.0
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 5
|
62.3 percentage of participants
Interval 52.7 to 71.2
|
62.6 percentage of participants
Interval 52.7 to 71.8
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 6A
|
91.2 percentage of participants
Interval 84.3 to 95.7
|
94.4 percentage of participants
Interval 88.2 to 97.9
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 6B
|
94.5 percentage of participants
Interval 88.4 to 98.0
|
92.3 percentage of participants
Interval 85.4 to 96.6
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 7F
|
99.0 percentage of participants
Interval 94.3 to 100.0
|
96.8 percentage of participants
Interval 90.9 to 99.3
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 9V
|
88.3 percentage of participants
Interval 80.5 to 93.8
|
88.0 percentage of participants
Interval 80.0 to 93.6
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 14
|
82.9 percentage of participants
Interval 74.6 to 89.4
|
76.9 percentage of participants
Interval 67.8 to 84.4
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 18C
|
98.1 percentage of participants
Interval 93.2 to 99.8
|
98.0 percentage of participants
Interval 92.9 to 99.8
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 19A
|
92.1 percentage of participants
Interval 85.0 to 96.5
|
95.7 percentage of participants
Interval 89.2 to 98.8
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 19F
|
89.7 percentage of participants
Interval 82.3 to 94.8
|
91.4 percentage of participants
Interval 84.4 to 96.0
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Serotype: 23F
|
94.9 percentage of participants
Interval 88.6 to 98.3
|
94.9 percentage of participants
Interval 88.5 to 98.3
|
SECONDARY outcome
Timeframe: 1 month after Vaccination 4Population: Evaluable immunogenicity population for toddler dose was analyzed. "Overall Number of Participants Analyzed": signifies participants evaluable for this outcome measure. "Number Analyzed": signifies participants evaluable for specific serotype.
Percentage of participants achieving OPA titer \>=LLOQ along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of participants was presented. LLOQ (measured in mcg/mL) for each serotype is as follows: Serotype 1=18; Serotype 3=12; Serotype 4=21; Serotype 5=29; Serotype 6A=37; Serotype 6B=43; Serotype 7F=113; Serotype 9V=141; Serotype 14=35; Serotype 18C=31; Serotype 19A=18; Serotype 19F=48; Serotype 23F=13.
Outcome measures
| Measure |
13vPnC: Multi-dose Vial (With Preservative)
n=106 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC: Single-dose Prefilled Syringe (Without Preservative)
n=102 Participants
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 1
|
97.1 percentage of participants
Interval 91.9 to 99.4
|
97.1 percentage of participants
Interval 91.6 to 99.4
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 3
|
98.1 percentage of participants
Interval 93.4 to 99.8
|
100.0 percentage of participants
Interval 96.4 to 100.0
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 4
|
100.0 percentage of participants
Interval 96.4 to 100.0
|
100.0 percentage of participants
Interval 96.3 to 100.0
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 5
|
95.2 percentage of participants
Interval 89.2 to 98.4
|
97.1 percentage of participants
Interval 91.6 to 99.4
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 6A
|
100.0 percentage of participants
Interval 96.5 to 100.0
|
99.0 percentage of participants
Interval 94.6 to 100.0
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 6B
|
97.0 percentage of participants
Interval 91.6 to 99.4
|
95.0 percentage of participants
Interval 88.8 to 98.4
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 7F
|
100.0 percentage of participants
Interval 96.3 to 100.0
|
100.0 percentage of participants
Interval 96.0 to 100.0
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 9V
|
100.0 percentage of participants
Interval 96.4 to 100.0
|
99.0 percentage of participants
Interval 94.4 to 100.0
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 14
|
100.0 percentage of participants
Interval 96.6 to 100.0
|
100.0 percentage of participants
Interval 96.4 to 100.0
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 18C
|
99.0 percentage of participants
Interval 94.6 to 100.0
|
99.0 percentage of participants
Interval 94.6 to 100.0
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 19A
|
100.0 percentage of participants
Interval 96.3 to 100.0
|
99.0 percentage of participants
Interval 94.3 to 100.0
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 19F
|
96.1 percentage of participants
Interval 90.3 to 98.9
|
97.0 percentage of participants
Interval 91.4 to 99.4
|
|
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Serotype: 23F
|
99.0 percentage of participants
Interval 94.7 to 100.0
|
99.0 percentage of participants
Interval 94.3 to 100.0
|
Adverse Events
13vPnC, MDV With Preservative: Infant Series
Serious events: 5 serious events
Other events: 145 other events
Deaths: 0 deaths
13vPnC, PFS Without Preservative: Infant Series
Serious events: 4 serious events
Other events: 141 other events
Deaths: 0 deaths
13vPnC, MDV: Between Infant Series and Toddler Dose
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
13vPnC, PFS: Between Infant Series and Toddler Dose
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
13vPnC, MDV With Preservative: Toddler Dose
Serious events: 1 serious events
Other events: 58 other events
Deaths: 0 deaths
13vPnC, PFS Without Preservative: Toddler Dose
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC, MDV With Preservative: Infant Series
n=150 participants at risk
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) respectively along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC, PFS Without Preservative: Infant Series
n=150 participants at risk
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) respectively along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC, MDV: Between Infant Series and Toddler Dose
n=150 participants at risk
This arm is created to report the safety data of participants for the duration "from 1 month after infant series until the time of toddler dose vaccination (pre-vaccination)". It included participants who received any dose of 13vPnC vaccine with preservative 2-PE from a MDV, intramuscularly during infant series and followed up to vaccination in toddler dose.
|
13vPnC, PFS: Between Infant Series and Toddler Dose
n=150 participants at risk
This arm is created to report the safety data of participants for the duration "from 1 month after infant series until the time of toddler dose vaccination (pre-vaccination)". It included participants who received any dose of 13vPnC vaccine without preservative 2-PE from a single dose PFS, intramuscularly during infant series and followed up to vaccination in toddler dose.
|
13vPnC, MDV With Preservative: Toddler Dose
n=139 participants at risk
Toddler dose followed infant series. Toddler dose: participants were administered a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from a MDV intramuscularly, at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC, PFS Without Preservative: Toddler Dose
n=139 participants at risk
Toddler dose followed infant series. Toddler dose: participants were administered a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from a single- dose PFS, at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.67%
1/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
Infections and infestations
Bronchiolitis
|
2.7%
4/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
1.3%
2/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.67%
1/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.67%
1/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.67%
1/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.67%
1/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.67%
1/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
Nervous system disorders
Seizure
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
1.3%
2/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.67%
1/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.72%
1/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.67%
1/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.72%
1/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.67%
1/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
Infections and infestations
Viral infection
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.67%
1/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.67%
1/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.67%
1/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.67%
1/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
Other adverse events
| Measure |
13vPnC, MDV With Preservative: Infant Series
n=150 participants at risk
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) respectively along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC, PFS Without Preservative: Infant Series
n=150 participants at risk
Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) respectively along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC, MDV: Between Infant Series and Toddler Dose
n=150 participants at risk
This arm is created to report the safety data of participants for the duration "from 1 month after infant series until the time of toddler dose vaccination (pre-vaccination)". It included participants who received any dose of 13vPnC vaccine with preservative 2-PE from a MDV, intramuscularly during infant series and followed up to vaccination in toddler dose.
|
13vPnC, PFS: Between Infant Series and Toddler Dose
n=150 participants at risk
This arm is created to report the safety data of participants for the duration "from 1 month after infant series until the time of toddler dose vaccination (pre-vaccination)". It included participants who received any dose of 13vPnC vaccine without preservative 2-PE from a single dose PFS, intramuscularly during infant series and followed up to vaccination in toddler dose.
|
13vPnC, MDV With Preservative: Toddler Dose
n=139 participants at risk
Toddler dose followed infant series. Toddler dose: participants were administered a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from a MDV intramuscularly, at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
13vPnC, PFS Without Preservative: Toddler Dose
n=139 participants at risk
Toddler dose followed infant series. Toddler dose: participants were administered a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from a single- dose PFS, at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
|
|---|---|---|---|---|---|---|
|
General disorders
Injection site pain-1
|
29.3%
44/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
30.7%
46/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
General disorders
Injection site pain-2
|
78.0%
117/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
83.3%
125/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
23.7%
33/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
18.7%
26/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
General disorders
Injection site swelling
|
11.3%
17/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
10.7%
16/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
General disorders
Pyrexia-1
|
8.0%
12/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
4.7%
7/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
General disorders
Pyrexia-2
|
24.7%
37/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
21.3%
32/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
General disorders
Swelling
|
42.7%
64/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
46.7%
70/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
8.6%
12/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
11.5%
16/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.7%
16/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
6.7%
10/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
0.00%
0/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
61.3%
92/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
71.3%
107/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
14.4%
20/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
15.8%
22/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
Nervous system disorders
Hypersomnia (Increased sleep)
|
70.0%
105/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
77.3%
116/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
7.2%
10/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
18.0%
25/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
Psychiatric disorders
Irritability
|
76.0%
114/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
78.0%
117/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
23.0%
32/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
22.3%
31/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
|
Skin and subcutaneous tissue disorders
Erythema (Redness)
|
34.7%
52/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
32.7%
49/150 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
—
0/0 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
|
7.9%
11/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
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10.8%
15/139 • Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment)
AE term can be both SAE and non-SAE, but are distinct events. Participant may have an event both as SAE and non-SAE. Safety population evaluated. Participants in infant series were followed up from Vaccination 1 till pre-vaccination 4 (toddler dose) irrespective of dose received in infant series, so counted in arms: "13vPnC, MDV: Between Infant Series And Toddler Dose" and "13vPnC, PFS: Between Infant Series and Toddler Dose". Toddler dose series included 139 participants who had Vaccination 4.
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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