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A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03571607
Recruitment Status : Completed
First Posted : June 27, 2018
Results First Posted : December 10, 2019
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Pneumococcal Infections
Intervention Biological: 13-valent pneumococcal conjugate vaccine
Enrollment 206
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 13vPnC: 6 to <18 Years 13vPnC: 18 to <65 Years
Hide Arm/Group Description 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. Participants aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Period Title: Overall Study
Started 53 153
Vaccinated 53 153
Completed 53 153
Not Completed 0 0
Arm/Group Title 13vPnC: 6 to <18 Years 13vPnC: 18 to <65 Years Total
Hide Arm/Group Description Participants aged between 6 to <18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1. Participants aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 53 153 206
Hide Baseline Analysis Population Description
Safety analysis set included all participants who received 1 dose of study vaccine.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 153 participants 206 participants
12.7  (2.66) 49.0  (10.12) 39.6  (18.18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 153 participants 206 participants
Female
22
  41.5%
77
  50.3%
99
  48.1%
Male
31
  58.5%
76
  49.7%
107
  51.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants 153 participants 206 participants
Asian 53 153 206
Non-Hispanic/non-Latino/not of Spanish origin 53 153 206
1.Primary Outcome
Title Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Hide Description 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).
Time Frame Day 1 up to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received 1 dose of study vaccine. Here, "Number analyzed" signifies participants evaluable for each specified category.
Arm/Group Title 13vPnC: 6 to <18 Years
Hide Arm/Group Description:
Participants aged between 6 to <18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Overall Number of Participants Analyzed 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Redness: Any Number Analyzed 47 participants
21.3
(10.7 to 35.7)
Redness: Mild Number Analyzed 47 participants
10.6
(3.5 to 23.1)
Redness: Moderate Number Analyzed 47 participants
10.6
(3.5 to 23.1)
Redness: Severe Number Analyzed 47 participants
0.0
(0.0 to 7.5)
Swelling: Any Number Analyzed 47 participants
34.0
(20.9 to 49.3)
Swelling: Mild Number Analyzed 47 participants
14.9
(6.2 to 28.3)
Swelling: Moderate Number Analyzed 47 participants
17.0
(7.6 to 30.8)
Swelling: Severe Number Analyzed 47 participants
2.1
(0.1 to 11.3)
Pain at the injection site: Any Number Analyzed 52 participants
78.8
(65.3 to 88.9)
Pain at the injection site: Mild Number Analyzed 52 participants
57.7
(43.2 to 71.3)
Pain at the injection site: Moderate Number Analyzed 52 participants
21.2
(11.1 to 34.7)
Pain at the injection site: Severe Number Analyzed 52 participants
0.0
(0.0 to 6.8)
2.Primary Outcome
Title Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Hide Description 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).
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received 1 dose of study vaccine. Here, "Number analyzed" signifies participants evaluable for each specified category.
Arm/Group Title 13vPnC: 18 to <65 Years
Hide Arm/Group Description:
Participants aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Overall Number of Participants Analyzed 153
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Redness: Any Number Analyzed 135 participants
7.4
(3.6 to 13.2)
Redness: Mild Number Analyzed 135 participants
5.2
(2.1 to 10.4)
Redness: Moderate Number Analyzed 135 participants
2.2
(0.5 to 6.4)
Redness: Severe Number Analyzed 135 participants
0.0
(0.0 to 2.7)
Swelling: Any Number Analyzed 136 participants
12.5
(7.5 to 19.3)
Swelling: Mild Number Analyzed 136 participants
5.1
(2.1 to 10.3)
Swelling: Moderate Number Analyzed 136 participants
7.4
(3.6 to 13.1)
Swelling: Severe Number Analyzed 136 participants
0.0
(0.0 to 2.7)
Pain at the injection site: Any Number Analyzed 145 participants
66.2
(57.9 to 73.8)
Pain at the injection site: Mild Number Analyzed 145 participants
53.8
(45.3 to 62.1)
Pain at the injection site: Moderate Number Analyzed 145 participants
11.0
(6.4 to 17.3)
Pain at the injection site: Severe Number Analyzed 145 participants
1.4
(0.2 to 4.9)
3.Primary Outcome
Title 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
Hide Description 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).
Time Frame Day 1 up to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received 1 dose of study vaccine. Here, "Number analyzed" signifies participants evaluable for each specified category.
Arm/Group Title 13vPnC: 6 to <18 Years
Hide Arm/Group Description:
Participants aged between 6 to <18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Overall Number of Participants Analyzed 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Fever: 37.5 degree C to 38.4 degree C Number Analyzed 48 participants
12.5
(4.7 to 25.2)
Fever: 38.5 degree C to 38.9 degree C Number Analyzed 48 participants
2.1
(0.1 to 11.1)
Fever: 39.0 degree C to 40.0 degree C Number Analyzed 48 participants
0.0
(0.0 to 7.4)
Fever: >40.0 degree C Number Analyzed 48 participants
0.0
(0.0 to 7.4)
Fatigue: Any Number Analyzed 48 participants
37.5
(24.0 to 52.6)
Fatigue: Mild Number Analyzed 48 participants
25.0
(13.6 to 39.6)
Fatigue: Moderate Number Analyzed 48 participants
10.4
(3.5 to 22.7)
Fatigue: Severe Number Analyzed 48 participants
2.1
(0.1 to 11.1)
Headache: Any Number Analyzed 49 participants
24.5
(13.3 to 38.9)
Headache: Mild Number Analyzed 49 participants
16.3
(7.3 to 29.7)
Headache: Moderate Number Analyzed 49 participants
6.1
(1.3 to 16.9)
Headache: Severe Number Analyzed 49 participants
2.0
(0.1 to 10.9)
Vomiting: Any Number Analyzed 47 participants
0.0
(0.0 to 7.5)
Vomiting: Mild Number Analyzed 47 participants
0.0
(0.0 to 7.5)
Vomiting: Moderate Number Analyzed 47 participants
0.0
(0.0 to 7.5)
Vomiting: Severe Number Analyzed 47 participants
0.0
(0.0 to 7.5)
Diarrhea: Any Number Analyzed 48 participants
8.3
(2.3 to 20.0)
Diarrhea: Mild Number Analyzed 48 participants
8.3
(2.3 to 20.0)
Diarrhea: Moderate Number Analyzed 48 participants
0.0
(0.0 to 7.4)
Diarrhea: Severe Number Analyzed 48 participants
0.0
(0.0 to 7.4)
Muscle pain: Any Number Analyzed 49 participants
30.6
(18.3 to 45.4)
Muscle pain: Mild Number Analyzed 49 participants
26.5
(14.9 to 41.1)
Muscle pain: Moderate Number Analyzed 49 participants
4.1
(0.5 to 14.0)
Muscle pain: Severe Number Analyzed 49 participants
0.0
(0.0 to 7.3)
Joint pain: Any Number Analyzed 48 participants
6.3
(1.3 to 17.2)
Joint pain: Mild Number Analyzed 48 participants
4.2
(0.5 to 14.3)
Joint pain: Moderate Number Analyzed 48 participants
2.1
(0.1 to 11.1)
Joint pain: Severe Number Analyzed 48 participants
0.0
(0.0 to 7.4)
Use of antipyretic or pain medication Number Analyzed 47 participants
6.4
(1.3 to 17.5)
4.Primary Outcome
Title 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
Hide Description 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).
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received 1 dose of study vaccine. Here, "Number analyzed" signifies participants evaluable for each specified category.
Arm/Group Title 13vPnC: 18 to <65 Years
Hide Arm/Group Description:
Participants aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Overall Number of Participants Analyzed 153
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Fever: 37.5 degree C to 38.4 degree C Number Analyzed 134 participants
6.0
(2.6 to 11.4)
Fever: 38.5 degree C to 38.9 degree C Number Analyzed 134 participants
0.0
(0.0 to 2.7)
Fever: 39.0 degree C to 40.0 degree C Number Analyzed 134 participants
0.0
(0.0 to 2.7)
Fever: >40.0 degree C Number Analyzed 134 participants
0.0
(0.0 to 2.7)
Fatigue: Any Number Analyzed 142 participants
33.1
(25.4 to 41.5)
Fatigue: Mild Number Analyzed 142 participants
25.4
(18.4 to 33.3)
Fatigue: Moderate Number Analyzed 142 participants
7.7
(3.9 to 13.4)
Fatigue: Severe Number Analyzed 142 participants
0.0
(0.0 to 2.6)
Headache: Any Number Analyzed 141 participants
23.4
(16.7 to 31.3)
Headache: Mild Number Analyzed 141 participants
19.1
(13.0 to 26.6)
Headache: Moderate Number Analyzed 141 participants
4.3
(1.6 to 9.0)
Headache: Severe Number Analyzed 141 participants
0.0
(0.0 to 2.6)
Vomiting: Any Number Analyzed 136 participants
1.5
(0.2 to 5.2)
Vomiting: Mild Number Analyzed 136 participants
1.5
(0.2 to 5.2)
Vomiting: Moderate Number Analyzed 136 participants
0.0
(0.0 to 2.7)
Vomiting: Severe Number Analyzed 136 participants
0.0
(0.0 to 2.7)
Diarrhea: Any Number Analyzed 141 participants
18.4
(12.4 to 25.8)
Diarrhea: Mild Number Analyzed 141 participants
15.6
(10.0 to 22.7)
Diarrhea: Moderate Number Analyzed 141 participants
2.1
(0.4 to 6.1)
Diarrhea: Severe Number Analyzed 141 participants
0.7
(0.0 to 3.9)
Muscle pain: Any Number Analyzed 139 participants
27.3
(20.1 to 35.5)
Muscle pain: Mild Number Analyzed 139 participants
20.9
(14.4 to 28.6)
Muscle pain: Moderate Number Analyzed 139 participants
5.8
(2.5 to 11.0)
Muscle pain: Severe Number Analyzed 139 participants
0.7
(0.0 to 3.9)
Joint pain: Any Number Analyzed 138 participants
13.8
(8.5 to 20.7)
Joint pain: Mild Number Analyzed 138 participants
9.4
(5.1 to 15.6)
Joint pain: Moderate Number Analyzed 138 participants
3.6
(1.2 to 8.3)
Joint pain: Severe Number Analyzed 138 participants
0.7
(0.0 to 4.0)
Use of antipyretic or pain medication Number Analyzed 134 participants
8.2
(4.2 to 14.2)
5.Primary Outcome
Title Percentage of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame signing of informed consent form (Day 1) up to Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received 1 dose of study vaccine.
Arm/Group Title 13vPnC: All Participants
Hide Arm/Group Description:
All participants aged between 6 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Overall Number of Participants Analyzed 206
Measure Type: Number
Unit of Measure: percentage of participants
AEs 16
SAEs 0
6.Secondary Outcome
Title Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
Hide Description 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.
Time Frame Pre-vaccination and 1 month after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 13vPnC: All Participants
Hide Arm/Group Description:
All participants aged between 6 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Overall Number of Participants Analyzed 206
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
Pre-vaccination; Serotype 1 Number Analyzed 202 participants
10
(9.2 to 10.2)
1 month after vaccination; Serotype 1 Number Analyzed 201 participants
152
(119.2 to 193.8)
Pre-vaccination; Serotype 3 Number Analyzed 205 participants
11
(9.8 to 13.1)
1 month after vaccination; Serotype 3 Number Analyzed 203 participants
63
(52.6 to 75.8)
Pre-vaccination; Serotype 4 Number Analyzed 195 participants
18
(14.5 to 22.1)
1 month after vaccination; Serotype 4 Number Analyzed 203 participants
1257
(896.0 to 1763.8)
Pre-vaccination; Serotype 5 Number Analyzed 200 participants
16
(15.3 to 17.5)
1 month after vaccination; Serotype 5 Number Analyzed 199 participants
185
(143.9 to 237.5)
Pre-vaccination; Serotype 6A Number Analyzed 171 participants
57
(44.1 to 74.9)
1 month after vaccination; Serotype 6A Number Analyzed 197 participants
2487
(1811.7 to 3415.0)
Pre-vaccination; Serotype 6B Number Analyzed 179 participants
72
(56.3 to 93.0)
1 month after vaccination; Serotype 6B Number Analyzed 198 participants
1845
(1405.9 to 2421.9)
Pre-vaccination; Serotype 7F Number Analyzed 190 participants
167
(137.0 to 203.3)
1 month after vaccination; Serotype 7F Number Analyzed 202 participants
2107
(1752.6 to 2532.5)
Pre-vaccination; Serotype 9V Number Analyzed 192 participants
204
(166.6 to 249.7)
1 month after vaccination; Serotype 9V Number Analyzed 199 participants
1425
(1134.4 to 1789.8)
Pre-vaccination; Serotype 14 Number Analyzed 191 participants
129
(97.9 to 171.1)
1 month after vaccination; Serotype 14 Number Analyzed 200 participants
1919
(1518.8 to 2424.0)
Pre-vaccination; Serotype 18C Number Analyzed 191 participants
61
(46.3 to 81.0)
1 month after vaccination; Serotype 18C Number Analyzed 199 participants
1829
(1390.8 to 2405.1)
Pre-vaccination; Serotype 19A Number Analyzed 202 participants
38
(29.9 to 47.8)
1 month after vaccination; Serotype 19A Number Analyzed 203 participants
955
(745.6 to 1223.2)
Pre-vaccination; Serotype 19F Number Analyzed 198 participants
42
(34.8 to 50.4)
1 month after vaccination; Serotype 19F Number Analyzed 197 participants
1126
(849.5 to 1493.4)
Pre-vaccination; Serotype 23F Number Analyzed 201 participants
14
(11.1 to 17.2)
1 month after vaccination; Serotype 23F Number Analyzed 202 participants
713
(506.7 to 1001.9)
7.Secondary Outcome
Title Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination
Hide Description 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.
Time Frame Pre-vaccination to 1 month after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 13vPnC: All Participants
Hide Arm/Group Description:
All participants aged between 6 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Overall Number of Participants Analyzed 206
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold rise
Serotype 1 Number Analyzed 200 participants
15.6
(12.33 to 19.82)
Serotype 3 Number Analyzed 202 participants
5.5
(4.59 to 6.54)
Serotype 4 Number Analyzed 192 participants
61.7
(42.80 to 88.99)
Serotype 5 Number Analyzed 195 participants
11.2
(8.69 to 14.34)
Serotype 6A Number Analyzed 167 participants
34.7
(24.39 to 49.44)
Serotype 6B Number Analyzed 174 participants
21.9
(15.71 to 30.51)
Serotype 7F Number Analyzed 188 participants
12.1
(9.84 to 14.76)
Serotype 9V Number Analyzed 188 participants
6.8
(5.36 to 8.62)
Serotype 14 Number Analyzed 186 participants
13.2
(9.63 to 18.04)
Serotype 18C Number Analyzed 186 participants
26.7
(19.39 to 36.86)
Serotype 19A Number Analyzed 199 participants
24.9
(19.05 to 32.66)
Serotype 19F Number Analyzed 192 participants
26.6
(19.89 to 35.63)
Serotype 23F Number Analyzed 200 participants
50.4
(35.70 to 71.16)
8.Secondary Outcome
Title Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
Hide Description 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.
Time Frame Pre-vaccination and 1 month after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 13vPnC: All Participants
Hide Arm/Group Description:
All participants aged between 6 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Overall Number of Participants Analyzed 206
Geometric Mean (95% Confidence Interval)
Unit of Measure: microgram per milliliter (mcg/mL)
Pre-vaccination; Serotype 1
0.132
(0.109 to 0.161)
1 month after vaccination; Serotype 1
4.427
(3.423 to 5.726)
Pre-vaccination; Serotype 3
0.115
(0.094 to 0.141)
1 month after vaccination; Serotype 3
0.531
(0.437 to 0.646)
Pre-vaccination; Serotype 4
0.055
(0.045 to 0.068)
1 month after vaccination; Serotype 4
1.826
(1.387 to 2.404)
Pre-vaccination; Serotype 5
0.058
(0.046 to 0.075)
1 month after vaccination; Serotype 5
2.779
(1.972 to 3.915)
Pre-vaccination; Serotype 6A
0.173
(0.133 to 0.224)
1 month after vaccination; Serotype 6A
4.070
(2.915 to 5.684)
Pre-vaccination; Serotype 6B
0.105
(0.080 to 0.138)
1 month after vaccination; Serotype 6B
2.354
(1.631 to 3.396)
Pre-vaccination; Serotype 7F
0.117
(0.092 to 0.150)
1 month after vaccination; Serotype 7F
4.670
(3.629 to 6.010)
Pre-vaccination; Serotype 9V
0.067
(0.054 to 0.082)
1 month after vaccination; Serotype 9V
1.483
(1.131 to 1.944)
Pre-vaccination; Serotype 14
0.335
(0.252 to 0.447)
1 month after vaccination; Serotype 14
7.769
(5.844 to 10.328)
Pre-vaccination; Serotype 18C
0.168
(0.131 to 0.216)
1 month after vaccination; Serotype 18C
5.187
(4.026 to 6.682)
Pre-vaccination; Serotype 19A
0.496
(0.391 to 0.629)
1 month after vaccination; Serotype 19A
7.616
(5.786 to 10.026)
Pre-vaccination; Serotype 19F
0.217
(0.171 to 0.275)
1 month after vaccination; Serotype 19F
4.315
(3.241 to 5.744)
Pre-vaccination; Serotype 23F
0.181
(0.143 to 0.228)
1 month after vaccination; Serotype 23F
6.283
(4.524 to 8.727)
9.Secondary Outcome
Title GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination
Hide Description 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.
Time Frame Pre- vaccination to 1 month after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 13vPnC: All Participants
Hide Arm/Group Description:
All participants aged between 6 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Overall Number of Participants Analyzed 206
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold rise
Serotype 1
33.445
(26.374 to 42.413)
Serotype 3
4.605
(3.839 to 5.524)
Serotype 4
32.960
(25.331 to 42.886)
Serotype 5
47.565
(36.867 to 61.368)
Serotype 6A
23.587
(18.010 to 30.890)
Serotype 6B
22.421
(17.045 to 29.493)
Serotype 7F
39.843
(31.473 to 50.438)
Serotype 9V
22.232
(17.426 to 28.362)
Serotype 14
23.161
(17.179 to 31.227)
Serotype 18C
30.833
(24.008 to 39.597)
Serotype 19A
15.354
(12.116 to 19.459)
Serotype 19F
19.892
(15.552 to 25.443)
Serotype 23F
34.809
(26.436 to 45.833)
Time Frame signing of informed consent form (Day 1) up to Day 43
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 13vPnC: 6 to <18 Years 13vPnC: 18 to <65 Years 13vPnC: All Participants
Hide Arm/Group Description Participants aged between 6 to <18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1. Participants aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1. All participants aged between 6 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
All-Cause Mortality
13vPnC: 6 to <18 Years 13vPnC: 18 to <65 Years 13vPnC: All Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/153 (0.00%)   0/206 (0.00%) 
Hide Serious Adverse Events
13vPnC: 6 to <18 Years 13vPnC: 18 to <65 Years 13vPnC: All Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/153 (0.00%)   0/206 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
13vPnC: 6 to <18 Years 13vPnC: 18 to <65 Years 13vPnC: All Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   49/53 (92.45%)   121/153 (79.08%)   170/206 (82.52%) 
Ear and labyrinth disorders       
Tinnitus * 1  0/53 (0.00%)  1/153 (0.65%)  1/206 (0.49%) 
Gastrointestinal disorders       
Diarrhoea  1 [1]  4/48 (8.33%)  26/141 (18.44%)  30/189 (15.87%) 
Vomiting  1 [1]  0/47 (0.00%)  2/136 (1.47%)  2/183 (1.09%) 
Enteritis * 1  1/53 (1.89%)  0/153 (0.00%)  1/206 (0.49%) 
General disorders       
Fatigue  1 [1]  18/48 (37.50%)  47/142 (33.10%)  65/190 (34.21%) 
Redness  1 [1]  10/47 (21.28%)  10/135 (7.41%)  20/182 (10.99%) 
Injection site erythema * 1  1/53 (1.89%)  0/153 (0.00%)  1/206 (0.49%) 
Pain at the injection site  1 [1]  41/52 (78.85%)  96/145 (66.21%)  137/197 (69.54%) 
Injection site pain * 1  1/53 (1.89%)  2/153 (1.31%)  3/206 (1.46%) 
Injection site swelling  1 [1]  16/47 (34.04%)  17/136 (12.50%)  33/183 (18.03%) 
Pyrexia  1 [1]  7/48 (14.58%)  8/134 (5.97%)  15/182 (8.24%) 
Infections and infestations       
Bronchitis * 1  0/53 (0.00%)  1/153 (0.65%)  1/206 (0.49%) 
Conjunctivitis * 1  0/53 (0.00%)  1/153 (0.65%)  1/206 (0.49%) 
Gastroenteritis * 1  0/53 (0.00%)  1/153 (0.65%)  1/206 (0.49%) 
Herpes zoster * 1  0/53 (0.00%)  1/153 (0.65%)  1/206 (0.49%) 
Nasopharyngitis * 1  1/53 (1.89%)  8/153 (5.23%)  9/206 (4.37%) 
Pharyngitis * 1  3/53 (5.66%)  2/153 (1.31%)  5/206 (2.43%) 
Upper respiratory tract infection * 1  0/53 (0.00%)  1/153 (0.65%)  1/206 (0.49%) 
Injury, poisoning and procedural complications       
Fall * 1  0/53 (0.00%)  1/153 (0.65%)  1/206 (0.49%) 
Wrist fracture * 1  0/53 (0.00%)  1/153 (0.65%)  1/206 (0.49%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  1/53 (1.89%)  0/153 (0.00%)  1/206 (0.49%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1 [1]  3/48 (6.25%)  19/138 (13.77%)  22/186 (11.83%) 
Back pain * 1  0/53 (0.00%)  1/153 (0.65%)  1/206 (0.49%) 
Myalgia  1 [1]  15/49 (30.61%)  38/139 (27.34%)  53/188 (28.19%) 
Pain in extremity * 1  0/53 (0.00%)  1/153 (0.65%)  1/206 (0.49%) 
Nervous system disorders       
Dizziness * 1  0/53 (0.00%)  1/153 (0.65%)  1/206 (0.49%) 
Headache  1 [1]  12/49 (24.49%)  33/141 (23.40%)  45/190 (23.68%) 
Psychiatric disorders       
Middle insomnia * 1  0/53 (0.00%)  1/153 (0.65%)  1/206 (0.49%) 
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  1/53 (1.89%)  0/153 (0.00%)  1/206 (0.49%) 
Hyperventilation * 1  0/53 (0.00%)  1/153 (0.65%)  1/206 (0.49%) 
Skin and subcutaneous tissue disorders       
Pruritus * 1  0/53 (0.00%)  1/153 (0.65%)  1/206 (0.49%) 
Rash papular * 1  1/53 (1.89%)  0/153 (0.00%)  1/206 (0.49%) 
1
Term from vocabulary, MedDRA 21.1
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
[1]
Number of participants at risk = number of participants evaluable for the adverse event.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03571607    
Other Study ID Numbers: B1851172
2018-003054-24 ( EudraCT Number )
First Submitted: June 20, 2018
First Posted: June 27, 2018
Results First Submitted: November 20, 2019
Results First Posted: December 10, 2019
Last Update Posted: February 18, 2020