Trial Outcomes & Findings for A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years. (NCT NCT03571607)
NCT ID: NCT03571607
Last Updated: 2020-02-18
Results Overview
Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.0 centimeter \[cm\]), moderate (greater than \[\>\] 2.0 to 7.0 cm) and severe (\>7.0 cm) for participants aged 6 to \<12 years, and as mild (2.5 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and, severe (\>10.0 cm) for participants aged 12 to \<18 years. Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
206 participants
Primary outcome timeframe
Day 1 up to Day 7
Results posted on
2020-02-18
Participant Flow
Participant milestones
| Measure |
13vPnC: 6 to <18 Years
Participants aged between 6 to less than (\<) 18 years received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly on Day 1.
|
13vPnC: 18 to <65 Years
Participants aged between 18 to \<65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
153
|
|
Overall Study
Vaccinated
|
53
|
153
|
|
Overall Study
COMPLETED
|
53
|
153
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.
Baseline characteristics by cohort
| Measure |
13vPnC: 6 to <18 Years
n=53 Participants
Participants aged between 6 to \<18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
|
13vPnC: 18 to <65 Years
n=153 Participants
Participants aged between 18 to \<65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.7 years
STANDARD_DEVIATION 2.66 • n=5 Participants
|
49.0 years
STANDARD_DEVIATION 10.12 • n=7 Participants
|
39.6 years
STANDARD_DEVIATION 18.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
53 participants
n=5 Participants
|
153 participants
n=7 Participants
|
206 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic/non-Latino/not of Spanish origin
|
53 participants
n=5 Participants
|
153 participants
n=7 Participants
|
206 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 7Population: Safety analysis set included all participants who received 1 dose of study vaccine. Here, "Number analyzed" signifies participants evaluable for each specified category.
Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.0 centimeter \[cm\]), moderate (greater than \[\>\] 2.0 to 7.0 cm) and severe (\>7.0 cm) for participants aged 6 to \<12 years, and as mild (2.5 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and, severe (\>10.0 cm) for participants aged 12 to \<18 years. Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Outcome measures
| Measure |
13vPnC: 6 to <18 Years
n=53 Participants
Participants aged between 6 to \<18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
|
|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Redness: Moderate
|
10.6 percentage of participants
Interval 3.5 to 23.1
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Redness: Severe
|
0.0 percentage of participants
Interval 0.0 to 7.5
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Redness: Any
|
21.3 percentage of participants
Interval 10.7 to 35.7
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Redness: Mild
|
10.6 percentage of participants
Interval 3.5 to 23.1
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Swelling: Any
|
34.0 percentage of participants
Interval 20.9 to 49.3
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Swelling: Mild
|
14.9 percentage of participants
Interval 6.2 to 28.3
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Swelling: Moderate
|
17.0 percentage of participants
Interval 7.6 to 30.8
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Swelling: Severe
|
2.1 percentage of participants
Interval 0.1 to 11.3
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Pain at the injection site: Any
|
78.8 percentage of participants
Interval 65.3 to 88.9
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Pain at the injection site: Mild
|
57.7 percentage of participants
Interval 43.2 to 71.3
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Pain at the injection site: Moderate
|
21.2 percentage of participants
Interval 11.1 to 34.7
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Pain at the injection site: Severe
|
0.0 percentage of participants
Interval 0.0 to 6.8
|
PRIMARY outcome
Timeframe: Day 1 up to Day 14Population: Safety analysis set included all participants who received 1 dose of study vaccine. Here, "Number analyzed" signifies participants evaluable for each specified category.
Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (2.5 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and, severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Outcome measures
| Measure |
13vPnC: 6 to <18 Years
n=153 Participants
Participants aged between 6 to \<18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
|
|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Swelling: Severe
|
0.0 percentage of participants
Interval 0.0 to 2.7
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Redness: Any
|
7.4 percentage of participants
Interval 3.6 to 13.2
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Redness: Mild
|
5.2 percentage of participants
Interval 2.1 to 10.4
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Redness: Moderate
|
2.2 percentage of participants
Interval 0.5 to 6.4
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Redness: Severe
|
0.0 percentage of participants
Interval 0.0 to 2.7
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Swelling: Any
|
12.5 percentage of participants
Interval 7.5 to 19.3
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Swelling: Mild
|
5.1 percentage of participants
Interval 2.1 to 10.3
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Swelling: Moderate
|
7.4 percentage of participants
Interval 3.6 to 13.1
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Pain at the injection site: Any
|
66.2 percentage of participants
Interval 57.9 to 73.8
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Pain at the injection site: Mild
|
53.8 percentage of participants
Interval 45.3 to 62.1
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Pain at the injection site: Moderate
|
11.0 percentage of participants
Interval 6.4 to 17.3
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Pain at the injection site: Severe
|
1.4 percentage of participants
Interval 0.2 to 4.9
|
PRIMARY outcome
Timeframe: Day 1 up to Day 7Population: Safety analysis set included all participants who received 1 dose of study vaccine. Here, "Number analyzed" signifies participants evaluable for each specified category.
Systemic events included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain, and were recorded by using an e-diary. Use of antipyretic or pain medication was also collected by using an e-diary. Fever was graded as 37.5 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \>40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (greater than or equals to \[\>=\] 6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity).
Outcome measures
| Measure |
13vPnC: 6 to <18 Years
n=53 Participants
Participants aged between 6 to \<18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
|
|---|---|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Fever: 39.0 degree C to 40.0 degree C
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Fatigue: Any
|
37.5 percentage of participants
Interval 24.0 to 52.6
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Vomiting: Mild
|
0.0 percentage of participants
Interval 0.0 to 7.5
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Vomiting: Moderate
|
0.0 percentage of participants
Interval 0.0 to 7.5
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Vomiting: Severe
|
0.0 percentage of participants
Interval 0.0 to 7.5
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Diarrhea: Any
|
8.3 percentage of participants
Interval 2.3 to 20.0
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Diarrhea: Mild
|
8.3 percentage of participants
Interval 2.3 to 20.0
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Diarrhea: Moderate
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Diarrhea: Severe
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Muscle pain: Any
|
30.6 percentage of participants
Interval 18.3 to 45.4
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Muscle pain: Mild
|
26.5 percentage of participants
Interval 14.9 to 41.1
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Muscle pain: Severe
|
0.0 percentage of participants
Interval 0.0 to 7.3
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Joint pain: Any
|
6.3 percentage of participants
Interval 1.3 to 17.2
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Joint pain: Mild
|
4.2 percentage of participants
Interval 0.5 to 14.3
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Joint pain: Moderate
|
2.1 percentage of participants
Interval 0.1 to 11.1
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Joint pain: Severe
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Use of antipyretic or pain medication
|
6.4 percentage of participants
Interval 1.3 to 17.5
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Fever: 37.5 degree C to 38.4 degree C
|
12.5 percentage of participants
Interval 4.7 to 25.2
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Fever: 38.5 degree C to 38.9 degree C
|
2.1 percentage of participants
Interval 0.1 to 11.1
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Fever: >40.0 degree C
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Fatigue: Mild
|
25.0 percentage of participants
Interval 13.6 to 39.6
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Fatigue: Moderate
|
10.4 percentage of participants
Interval 3.5 to 22.7
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Fatigue: Severe
|
2.1 percentage of participants
Interval 0.1 to 11.1
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Headache: Any
|
24.5 percentage of participants
Interval 13.3 to 38.9
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Headache: Mild
|
16.3 percentage of participants
Interval 7.3 to 29.7
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Headache: Moderate
|
6.1 percentage of participants
Interval 1.3 to 16.9
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Headache: Severe
|
2.0 percentage of participants
Interval 0.1 to 10.9
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Vomiting: Any
|
0.0 percentage of participants
Interval 0.0 to 7.5
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Muscle pain: Moderate
|
4.1 percentage of participants
Interval 0.5 to 14.0
|
PRIMARY outcome
Timeframe: Day 1 up to Day 14Population: Safety analysis set included all participants who received 1 dose of study vaccine. Here, "Number analyzed" signifies participants evaluable for each specified category.
Systemic events included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain, and were recorded by using an e-diary. Use of antipyretic or pain medication was also collected by using an e-diary. Fever was graded as 37.5 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \>40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity).
Outcome measures
| Measure |
13vPnC: 6 to <18 Years
n=153 Participants
Participants aged between 6 to \<18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
|
|---|---|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Fever: 37.5 degree C to 38.4 degree C
|
6.0 percentage of participants
Interval 2.6 to 11.4
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Fever: 38.5 degree C to 38.9 degree C
|
0.0 percentage of participants
Interval 0.0 to 2.7
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Fever: 39.0 degree C to 40.0 degree C
|
0.0 percentage of participants
Interval 0.0 to 2.7
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Fever: >40.0 degree C
|
0.0 percentage of participants
Interval 0.0 to 2.7
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Fatigue: Moderate
|
7.7 percentage of participants
Interval 3.9 to 13.4
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Fatigue: Severe
|
0.0 percentage of participants
Interval 0.0 to 2.6
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Headache: Any
|
23.4 percentage of participants
Interval 16.7 to 31.3
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Headache: Mild
|
19.1 percentage of participants
Interval 13.0 to 26.6
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Headache: Moderate
|
4.3 percentage of participants
Interval 1.6 to 9.0
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Headache: Severe
|
0.0 percentage of participants
Interval 0.0 to 2.6
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Vomiting: Any
|
1.5 percentage of participants
Interval 0.2 to 5.2
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Vomiting: Mild
|
1.5 percentage of participants
Interval 0.2 to 5.2
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Vomiting: Moderate
|
0.0 percentage of participants
Interval 0.0 to 2.7
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Vomiting: Severe
|
0.0 percentage of participants
Interval 0.0 to 2.7
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Diarrhea: Moderate
|
2.1 percentage of participants
Interval 0.4 to 6.1
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Diarrhea: Severe
|
0.7 percentage of participants
Interval 0.0 to 3.9
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Muscle pain: Any
|
27.3 percentage of participants
Interval 20.1 to 35.5
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Muscle pain: Mild
|
20.9 percentage of participants
Interval 14.4 to 28.6
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Muscle pain: Moderate
|
5.8 percentage of participants
Interval 2.5 to 11.0
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Muscle pain: Severe
|
0.7 percentage of participants
Interval 0.0 to 3.9
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Joint pain: Any
|
13.8 percentage of participants
Interval 8.5 to 20.7
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Joint pain: Mild
|
9.4 percentage of participants
Interval 5.1 to 15.6
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Joint pain: Moderate
|
3.6 percentage of participants
Interval 1.2 to 8.3
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Joint pain: Severe
|
0.7 percentage of participants
Interval 0.0 to 4.0
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Use of antipyretic or pain medication
|
8.2 percentage of participants
Interval 4.2 to 14.2
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Fatigue: Any
|
33.1 percentage of participants
Interval 25.4 to 41.5
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Fatigue: Mild
|
25.4 percentage of participants
Interval 18.4 to 33.3
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Diarrhea: Any
|
18.4 percentage of participants
Interval 12.4 to 25.8
|
|
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Diarrhea: Mild
|
15.6 percentage of participants
Interval 10.0 to 22.7
|
PRIMARY outcome
Timeframe: signing of informed consent form (Day 1) up to Day 43Population: Safety analysis set included all participants who received 1 dose of study vaccine.
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.
Outcome measures
| Measure |
13vPnC: 6 to <18 Years
n=206 Participants
Participants aged between 6 to \<18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
|
|---|---|
|
Percentage of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
16 percentage of participants
|
|
Percentage of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Pre-vaccination and 1 month after vaccinationPopulation: Evaluable immunogenicity population: eligible participants who received the study vaccine and took no prohibited vaccines, had blood drawn within 1 month after vaccination with at least 1 valid and determinate assay and had no major protocol violations. Here, "Number analyzed" signifies participants evaluable for each specified row.
Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). Two (2)-sided 95% CIs were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed based on the Student t distribution. OPA titer was expressed as reciprocal of highest serum dilution.
Outcome measures
| Measure |
13vPnC: 6 to <18 Years
n=206 Participants
Participants aged between 6 to \<18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
|
|---|---|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 1
|
10 titers
Interval 9.2 to 10.2
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 1
|
152 titers
Interval 119.2 to 193.8
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 3
|
11 titers
Interval 9.8 to 13.1
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 3
|
63 titers
Interval 52.6 to 75.8
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 4
|
18 titers
Interval 14.5 to 22.1
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 4
|
1257 titers
Interval 896.0 to 1763.8
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 5
|
16 titers
Interval 15.3 to 17.5
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 5
|
185 titers
Interval 143.9 to 237.5
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 6A
|
57 titers
Interval 44.1 to 74.9
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 6A
|
2487 titers
Interval 1811.7 to 3415.0
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 6B
|
72 titers
Interval 56.3 to 93.0
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 6B
|
1845 titers
Interval 1405.9 to 2421.9
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 7F
|
167 titers
Interval 137.0 to 203.3
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 7F
|
2107 titers
Interval 1752.6 to 2532.5
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 9V
|
204 titers
Interval 166.6 to 249.7
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 9V
|
1425 titers
Interval 1134.4 to 1789.8
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 14
|
129 titers
Interval 97.9 to 171.1
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 14
|
1919 titers
Interval 1518.8 to 2424.0
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 18C
|
61 titers
Interval 46.3 to 81.0
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 18C
|
1829 titers
Interval 1390.8 to 2405.1
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 19A
|
38 titers
Interval 29.9 to 47.8
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 19A
|
955 titers
Interval 745.6 to 1223.2
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 19F
|
42 titers
Interval 34.8 to 50.4
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 19F
|
1126 titers
Interval 849.5 to 1493.4
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 23F
|
14 titers
Interval 11.1 to 17.2
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 23F
|
713 titers
Interval 506.7 to 1001.9
|
SECONDARY outcome
Timeframe: Pre-vaccination to 1 month after vaccinationPopulation: Evaluable immunogenicity set: Eligible participants received study vaccine,took no prohibited vaccine,had blood drawn in specified time frame had atleast 1 valid,determinate OPA titer/IgG concentration result for atleast 1 serotype 1 month after vaccination,no major protocol violation. Number analyzed=participant evaluable for specified row.
OPA GMFRs were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFRs were computed as the fold rise in titer value at 1 month after vaccination compared to baseline (pre-vaccination). The CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean difference of the log-transformed assay results before vaccination and 1 month after vaccination.
Outcome measures
| Measure |
13vPnC: 6 to <18 Years
n=206 Participants
Participants aged between 6 to \<18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
|
|---|---|
|
Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination
Serotype 1
|
15.6 fold rise
Interval 12.33 to 19.82
|
|
Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination
Serotype 3
|
5.5 fold rise
Interval 4.59 to 6.54
|
|
Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination
Serotype 4
|
61.7 fold rise
Interval 42.8 to 88.99
|
|
Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination
Serotype 5
|
11.2 fold rise
Interval 8.69 to 14.34
|
|
Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination
Serotype 6A
|
34.7 fold rise
Interval 24.39 to 49.44
|
|
Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination
Serotype 6B
|
21.9 fold rise
Interval 15.71 to 30.51
|
|
Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination
Serotype 7F
|
12.1 fold rise
Interval 9.84 to 14.76
|
|
Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination
Serotype 23F
|
50.4 fold rise
Interval 35.7 to 71.16
|
|
Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination
Serotype 9V
|
6.8 fold rise
Interval 5.36 to 8.62
|
|
Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination
Serotype 14
|
13.2 fold rise
Interval 9.63 to 18.04
|
|
Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination
Serotype 18C
|
26.7 fold rise
Interval 19.39 to 36.86
|
|
Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination
Serotype 19A
|
24.9 fold rise
Interval 19.05 to 32.66
|
|
Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination
Serotype 19F
|
26.6 fold rise
Interval 19.89 to 35.63
|
SECONDARY outcome
Timeframe: Pre-vaccination and 1 month after vaccinationPopulation: Evaluable immunogenicity set: Eligible participants received study vaccine, took no prohibited vaccine, had blood drawn in specified time frame had atleast 1 valid, determinate OPA titer/IgG concentration result for atleast 1 serotype 1 month after vaccination, no major protocol violation.
Pneumococcal IgG antibody against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using direct binding Luminex assay. Results were expressed as IgG concentrations. IgG concentrations were logarithmically transformed for analysis; geometric means calculated and expressed as GMCs. Two (2)-sided 95% CIs were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed based on the Student t distribution.
Outcome measures
| Measure |
13vPnC: 6 to <18 Years
n=206 Participants
Participants aged between 6 to \<18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
|
|---|---|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 6A
|
4.070 microgram per milliliter (mcg/mL)
Interval 2.915 to 5.684
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 6B
|
0.105 microgram per milliliter (mcg/mL)
Interval 0.08 to 0.138
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 1
|
0.132 microgram per milliliter (mcg/mL)
Interval 0.109 to 0.161
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 1
|
4.427 microgram per milliliter (mcg/mL)
Interval 3.423 to 5.726
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 3
|
0.115 microgram per milliliter (mcg/mL)
Interval 0.094 to 0.141
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 3
|
0.531 microgram per milliliter (mcg/mL)
Interval 0.437 to 0.646
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 4
|
1.826 microgram per milliliter (mcg/mL)
Interval 1.387 to 2.404
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 5
|
0.058 microgram per milliliter (mcg/mL)
Interval 0.046 to 0.075
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 5
|
2.779 microgram per milliliter (mcg/mL)
Interval 1.972 to 3.915
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 6A
|
0.173 microgram per milliliter (mcg/mL)
Interval 0.133 to 0.224
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 6B
|
2.354 microgram per milliliter (mcg/mL)
Interval 1.631 to 3.396
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 7F
|
0.117 microgram per milliliter (mcg/mL)
Interval 0.092 to 0.15
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 7F
|
4.670 microgram per milliliter (mcg/mL)
Interval 3.629 to 6.01
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 9V
|
0.067 microgram per milliliter (mcg/mL)
Interval 0.054 to 0.082
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 9V
|
1.483 microgram per milliliter (mcg/mL)
Interval 1.131 to 1.944
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 14
|
0.335 microgram per milliliter (mcg/mL)
Interval 0.252 to 0.447
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 14
|
7.769 microgram per milliliter (mcg/mL)
Interval 5.844 to 10.328
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 18C
|
0.168 microgram per milliliter (mcg/mL)
Interval 0.131 to 0.216
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 19A
|
0.496 microgram per milliliter (mcg/mL)
Interval 0.391 to 0.629
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 19A
|
7.616 microgram per milliliter (mcg/mL)
Interval 5.786 to 10.026
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 19F
|
0.217 microgram per milliliter (mcg/mL)
Interval 0.171 to 0.275
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 19F
|
4.315 microgram per milliliter (mcg/mL)
Interval 3.241 to 5.744
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 23F
|
0.181 microgram per milliliter (mcg/mL)
Interval 0.143 to 0.228
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 23F
|
6.283 microgram per milliliter (mcg/mL)
Interval 4.524 to 8.727
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
Pre-vaccination; Serotype 4
|
0.055 microgram per milliliter (mcg/mL)
Interval 0.045 to 0.068
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
1 month after vaccination; Serotype 18C
|
5.187 microgram per milliliter (mcg/mL)
Interval 4.026 to 6.682
|
SECONDARY outcome
Timeframe: Pre- vaccination to 1 month after vaccinationPopulation: Evaluable immunogenicity set: Eligible participants received study vaccine, took no prohibited vaccine, had blood drawn in specified time frame had atleast 1 valid, determinate OPA titer/IgG concentration result for atleast 1 serotype 1 month after vaccination, no major protocol violation.
IgG GMFRs were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFRs were computed as the fold rise in concentrations at 1 month after vaccination compared to baseline (pre-vaccination). The CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean difference of the log-transformed assay results before vaccination and 1 month after vaccination.
Outcome measures
| Measure |
13vPnC: 6 to <18 Years
n=206 Participants
Participants aged between 6 to \<18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
|
|---|---|
|
GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination
Serotype 1
|
33.445 fold rise
Interval 26.374 to 42.413
|
|
GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination
Serotype 3
|
4.605 fold rise
Interval 3.839 to 5.524
|
|
GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination
Serotype 4
|
32.960 fold rise
Interval 25.331 to 42.886
|
|
GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination
Serotype 18C
|
30.833 fold rise
Interval 24.008 to 39.597
|
|
GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination
Serotype 23F
|
34.809 fold rise
Interval 26.436 to 45.833
|
|
GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination
Serotype 5
|
47.565 fold rise
Interval 36.867 to 61.368
|
|
GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination
Serotype 6A
|
23.587 fold rise
Interval 18.01 to 30.89
|
|
GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination
Serotype 6B
|
22.421 fold rise
Interval 17.045 to 29.493
|
|
GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination
Serotype 7F
|
39.843 fold rise
Interval 31.473 to 50.438
|
|
GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination
Serotype 9V
|
22.232 fold rise
Interval 17.426 to 28.362
|
|
GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination
Serotype 14
|
23.161 fold rise
Interval 17.179 to 31.227
|
|
GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination
Serotype 19A
|
15.354 fold rise
Interval 12.116 to 19.459
|
|
GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination
Serotype 19F
|
19.892 fold rise
Interval 15.552 to 25.443
|
Adverse Events
13vPnC: 6 to <18 Years
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
13vPnC: 18 to <65 Years
Serious events: 0 serious events
Other events: 121 other events
Deaths: 0 deaths
13vPnC: All Participants
Serious events: 0 serious events
Other events: 170 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
13vPnC: 6 to <18 Years
n=53 participants at risk
Participants aged between 6 to \<18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
|
13vPnC: 18 to <65 Years
n=153 participants at risk
Participants aged between 18 to \<65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
|
13vPnC: All Participants
n=206 participants at risk
All participants aged between 6 to \<65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/53 • signing of informed consent form (Day 1) up to Day 43
|
0.65%
1/153 • signing of informed consent form (Day 1) up to Day 43
|
0.49%
1/206 • signing of informed consent form (Day 1) up to Day 43
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
4/48 • signing of informed consent form (Day 1) up to Day 43
|
18.4%
26/141 • signing of informed consent form (Day 1) up to Day 43
|
15.9%
30/189 • signing of informed consent form (Day 1) up to Day 43
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/47 • signing of informed consent form (Day 1) up to Day 43
|
1.5%
2/136 • signing of informed consent form (Day 1) up to Day 43
|
1.1%
2/183 • signing of informed consent form (Day 1) up to Day 43
|
|
General disorders
Fatigue
|
37.5%
18/48 • signing of informed consent form (Day 1) up to Day 43
|
33.1%
47/142 • signing of informed consent form (Day 1) up to Day 43
|
34.2%
65/190 • signing of informed consent form (Day 1) up to Day 43
|
|
General disorders
Redness
|
21.3%
10/47 • signing of informed consent form (Day 1) up to Day 43
|
7.4%
10/135 • signing of informed consent form (Day 1) up to Day 43
|
11.0%
20/182 • signing of informed consent form (Day 1) up to Day 43
|
|
General disorders
Injection site erythema
|
1.9%
1/53 • signing of informed consent form (Day 1) up to Day 43
|
0.00%
0/153 • signing of informed consent form (Day 1) up to Day 43
|
0.49%
1/206 • signing of informed consent form (Day 1) up to Day 43
|
|
General disorders
Pain at the injection site
|
78.8%
41/52 • signing of informed consent form (Day 1) up to Day 43
|
66.2%
96/145 • signing of informed consent form (Day 1) up to Day 43
|
69.5%
137/197 • signing of informed consent form (Day 1) up to Day 43
|
|
General disorders
Injection site pain
|
1.9%
1/53 • signing of informed consent form (Day 1) up to Day 43
|
1.3%
2/153 • signing of informed consent form (Day 1) up to Day 43
|
1.5%
3/206 • signing of informed consent form (Day 1) up to Day 43
|
|
General disorders
Injection site swelling
|
34.0%
16/47 • signing of informed consent form (Day 1) up to Day 43
|
12.5%
17/136 • signing of informed consent form (Day 1) up to Day 43
|
18.0%
33/183 • signing of informed consent form (Day 1) up to Day 43
|
|
General disorders
Pyrexia
|
14.6%
7/48 • signing of informed consent form (Day 1) up to Day 43
|
6.0%
8/134 • signing of informed consent form (Day 1) up to Day 43
|
8.2%
15/182 • signing of informed consent form (Day 1) up to Day 43
|
|
Infections and infestations
Bronchitis
|
0.00%
0/53 • signing of informed consent form (Day 1) up to Day 43
|
0.65%
1/153 • signing of informed consent form (Day 1) up to Day 43
|
0.49%
1/206 • signing of informed consent form (Day 1) up to Day 43
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/53 • signing of informed consent form (Day 1) up to Day 43
|
0.65%
1/153 • signing of informed consent form (Day 1) up to Day 43
|
0.49%
1/206 • signing of informed consent form (Day 1) up to Day 43
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/53 • signing of informed consent form (Day 1) up to Day 43
|
0.65%
1/153 • signing of informed consent form (Day 1) up to Day 43
|
0.49%
1/206 • signing of informed consent form (Day 1) up to Day 43
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/53 • signing of informed consent form (Day 1) up to Day 43
|
0.65%
1/153 • signing of informed consent form (Day 1) up to Day 43
|
0.49%
1/206 • signing of informed consent form (Day 1) up to Day 43
|
|
Infections and infestations
Nasopharyngitis
|
1.9%
1/53 • signing of informed consent form (Day 1) up to Day 43
|
5.2%
8/153 • signing of informed consent form (Day 1) up to Day 43
|
4.4%
9/206 • signing of informed consent form (Day 1) up to Day 43
|
|
Infections and infestations
Pharyngitis
|
5.7%
3/53 • signing of informed consent form (Day 1) up to Day 43
|
1.3%
2/153 • signing of informed consent form (Day 1) up to Day 43
|
2.4%
5/206 • signing of informed consent form (Day 1) up to Day 43
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/53 • signing of informed consent form (Day 1) up to Day 43
|
0.65%
1/153 • signing of informed consent form (Day 1) up to Day 43
|
0.49%
1/206 • signing of informed consent form (Day 1) up to Day 43
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/53 • signing of informed consent form (Day 1) up to Day 43
|
0.65%
1/153 • signing of informed consent form (Day 1) up to Day 43
|
0.49%
1/206 • signing of informed consent form (Day 1) up to Day 43
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/53 • signing of informed consent form (Day 1) up to Day 43
|
0.65%
1/153 • signing of informed consent form (Day 1) up to Day 43
|
0.49%
1/206 • signing of informed consent form (Day 1) up to Day 43
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.9%
1/53 • signing of informed consent form (Day 1) up to Day 43
|
0.00%
0/153 • signing of informed consent form (Day 1) up to Day 43
|
0.49%
1/206 • signing of informed consent form (Day 1) up to Day 43
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
3/48 • signing of informed consent form (Day 1) up to Day 43
|
13.8%
19/138 • signing of informed consent form (Day 1) up to Day 43
|
11.8%
22/186 • signing of informed consent form (Day 1) up to Day 43
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/53 • signing of informed consent form (Day 1) up to Day 43
|
0.65%
1/153 • signing of informed consent form (Day 1) up to Day 43
|
0.49%
1/206 • signing of informed consent form (Day 1) up to Day 43
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
30.6%
15/49 • signing of informed consent form (Day 1) up to Day 43
|
27.3%
38/139 • signing of informed consent form (Day 1) up to Day 43
|
28.2%
53/188 • signing of informed consent form (Day 1) up to Day 43
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/53 • signing of informed consent form (Day 1) up to Day 43
|
0.65%
1/153 • signing of informed consent form (Day 1) up to Day 43
|
0.49%
1/206 • signing of informed consent form (Day 1) up to Day 43
|
|
Nervous system disorders
Dizziness
|
0.00%
0/53 • signing of informed consent form (Day 1) up to Day 43
|
0.65%
1/153 • signing of informed consent form (Day 1) up to Day 43
|
0.49%
1/206 • signing of informed consent form (Day 1) up to Day 43
|
|
Nervous system disorders
Headache
|
24.5%
12/49 • signing of informed consent form (Day 1) up to Day 43
|
23.4%
33/141 • signing of informed consent form (Day 1) up to Day 43
|
23.7%
45/190 • signing of informed consent form (Day 1) up to Day 43
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/53 • signing of informed consent form (Day 1) up to Day 43
|
0.65%
1/153 • signing of informed consent form (Day 1) up to Day 43
|
0.49%
1/206 • signing of informed consent form (Day 1) up to Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.9%
1/53 • signing of informed consent form (Day 1) up to Day 43
|
0.00%
0/153 • signing of informed consent form (Day 1) up to Day 43
|
0.49%
1/206 • signing of informed consent form (Day 1) up to Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/53 • signing of informed consent form (Day 1) up to Day 43
|
0.65%
1/153 • signing of informed consent form (Day 1) up to Day 43
|
0.49%
1/206 • signing of informed consent form (Day 1) up to Day 43
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/53 • signing of informed consent form (Day 1) up to Day 43
|
0.65%
1/153 • signing of informed consent form (Day 1) up to Day 43
|
0.49%
1/206 • signing of informed consent form (Day 1) up to Day 43
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.9%
1/53 • signing of informed consent form (Day 1) up to Day 43
|
0.00%
0/153 • signing of informed consent form (Day 1) up to Day 43
|
0.49%
1/206 • signing of informed consent form (Day 1) up to Day 43
|
|
Gastrointestinal disorders
Enteritis
|
1.9%
1/53 • signing of informed consent form (Day 1) up to Day 43
|
0.00%
0/153 • signing of informed consent form (Day 1) up to Day 43
|
0.49%
1/206 • signing of informed consent form (Day 1) up to Day 43
|
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