Pneumococcal Vaccines, Pneumococcal Conjugate Vaccine
Conditions
Keywords
13VPNC, 23VPS
Brief summary
The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of 23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.
Interventions
BIOLOGICAL13-valent pneumococcal conjugate vaccine
A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Japanese male and female adults aged 65 years old and older at time of enrollment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of the study vaccine, are eligible. 2. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study or for at least 28 days after the last dose of the study vaccine whichever is longer.
Exclusion criteria
1. History of severe adverse reaction including hypersensitivity such as anaphylaxis associated with a vaccine or vaccine component. 2. Previous vaccination with any licensed or experimental pneumococcal vaccine. 3. Documented Streptococcus pneumoniae infection within the past 5 years. 4. Residence in a nursing home, long-term care facility, or other institution or requirement of semiskilled nursing care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | One month after vaccination | Antibody-mediated serum OPA against each of the 12 pneumococcal serotypes (1, 3, 4, 5, 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). |
| Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination | One month after vaccination | For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | One month after vaccination | 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 microcolonoy 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Within 14 days after vaccination | Local reactions reported using an electronic diary. Redness and swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \[cm\]; Moderate (5.1 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder). |
| Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Within 14 days after vaccination | Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (\>=) 37.5 degrees Celsius \[C\], fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, aggravated muscle pain, new joint pain, aggravated joint pain, use of medication to treat fever and use of medication to treat pain. All reports of fever \>=39 degrees C in 13vPnC and 23vPS were confirmed as data entry errors. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1. | 382 |
| 23vPS 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1. | 382 |
| Total | 764 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | 13vPnC | 23vPS | Total |
|---|---|---|---|
| Age Continuous | 70.0 years STANDARD_DEVIATION 4.08 | 69.7 years STANDARD_DEVIATION 3.66 | 69.9 years STANDARD_DEVIATION 3.87 |
| Sex: Female, Male Female | 198 Participants | 187 Participants | 385 Participants |
| Sex: Female, Male Male | 184 Participants | 195 Participants | 379 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 211 / 382 | 166 / 382 |
| serious Total, serious adverse events | 1 / 382 | 0 / 382 |
Outcome results
Primary
Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination
For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
Time frame: One month after vaccination
Population: Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with determinate fold rise of OPA antibody titer to serotype 6A.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 13vPnC | Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination | 74.0 percentage of participants |
| 23vPS | Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination | 47.2 percentage of participants |
Comparison: Difference in proportions (13vPnC - 23vPS) expressed as a percentage presented along with exact, 2-sided 95%CI. Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.95% CI: [19.3, 34]
Primary
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination
Antibody-mediated serum OPA against each of the 12 pneumococcal serotypes (1, 3, 4, 5, 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).
Time frame: One month after vaccination
Population: Evaluable immunogenicity population:eligible participants, received study vaccine to which randomized, received no prohibited vaccines, had at least 1 valid and determinate assay result, had blood drawn within prescribed time frame and had no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 9V (n=365,358) | 858 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 3 (n=365, 367) | 44 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 4 (n=360, 362) | 1016 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 5 (n=350, 361) | 347 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 6B (n=360, 359) | 1995 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 7F (n=365, 364) | 1901 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 14 (n=363, 359) | 1028 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 18C (n=366, 362) | 2015 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 19A (n=365, 362) | 985 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 19F (n=352, 357) | 773 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 23F (n=366, 363) | 456 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 1 (n=366, 366) | 103 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 23F (n=366, 363) | 180 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 1 (n=366, 366) | 78 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 14 (n=363, 359) | 1059 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 3 (n=365, 367) | 61 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 19F (n=352, 357) | 388 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 4 (n=360, 362) | 392 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 18C (n=366, 362) | 938 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 5 (n=350, 361) | 118 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 7F (n=365, 364) | 1361 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 6B (n=360, 359) | 1440 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 19A (n=365, 362) | 429 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | 9V (n=365,358) | 379 titer |
Comparison: Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [0.99, 1.75]
Comparison: Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [0.59, 0.89]
Comparison: Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [1.96, 3.44]
Comparison: Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [2.22, 3.86]
Comparison: Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [1.1, 1.75]
Comparison: Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [1.12, 1.74]
Comparison: Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [1.59, 3.24]
Comparison: Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [0.77, 1.23]
Comparison: Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [1.61, 2.86]
Comparison: Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [1.81, 2.92]
Comparison: Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [1.42, 2.79]
Comparison: Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [1.84, 3.49]
Secondary
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination
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 microcolonoy 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).
Time frame: One month after vaccination
Population: Evaluable immunogenicity population:eligible participants, received study vaccine to which randomized, received no prohibited vaccines, had at least 1 valid and determinate assay result, had blood drawn within prescribed time frame and had no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 4 (n=360, 362) | 1016 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 14 (n=363, 359) | 1028 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 6B (n=360, 359) | 1995 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 18C (n=366, 362) | 2015 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 3 (n=365, 367) | 44 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 19A (n=365, 362) | 985 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 7F (n=365, 364) | 1901 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 19F (n=352, 357) | 773 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 5 (n=350, 361) | 347 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 23F (n=366, 363) | 456 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 9V (n=365,358) | 858 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 6A (n=360, 349) | 2122 titer |
| 13vPnC | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 1 (n=366, 366) | 103 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 6A (n=360, 349) | 676 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 1 (n=366, 366) | 78 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 3 (n=365, 367) | 61 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 4 (n=360, 362) | 392 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 5 (n=350, 361) | 118 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 6B (n=360, 359) | 1440 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 7F (n=365, 364) | 1361 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 9V (n=365,358) | 379 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 14 (n=363, 359) | 1059 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 18C (n=366, 362) | 938 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 19A (n=365, 362) | 429 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 19F (n=352, 357) | 388 titer |
| 23vPS | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | 23F (n=366, 363) | 180 titer |
Comparison: Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.95% CI: [0.99, 1.75]
Comparison: Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.95% CI: [0.59, 0.89]
Comparison: Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.95% CI: [1.96, 3.44]
Comparison: Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.95% CI: [2.22, 3.86]
Comparison: Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.95% CI: [1.1, 1.75]
Comparison: Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.95% CI: [1.12, 1.74]
Comparison: Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.95% CI: [1.59, 3.24]
Comparison: Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.95% CI: [0.77, 1.23]
Comparison: Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.95% CI: [1.61, 2.86]
Comparison: Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.95% CI: [1.81, 2.92]
Comparison: Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.95% CI: [1.42, 2.79]
Comparison: Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.95% CI: [1.84, 3.49]
Comparison: Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 2.0.95% CI: [2.38, 4.14]
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination
Local reactions reported using an electronic diary. Redness and swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \[cm\]; Moderate (5.1 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Time frame: Within 14 days after vaccination
Population: Safety population included all participants who received the study vaccine. 'N' (number of participants analyzed)=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Swelling: Severe (n=349, 359) | 1.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Swelling: Moderate (n=351, 359) | 9.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Swelling: Any (n=353, 360) | 21.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Pain: Mild (n=362, 368) | 45.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Redness: Moderate (n=353, 360) | 17.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Pain: Moderate (n=349, 361) | 2.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Pain: Any (n=362, 368) | 45.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Pain: Severe (n=348, 359) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Redness: Severe (n=349, 359) | 3.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Limitation of arm movement: Any (n=355, 362) | 16.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Redness: Mild (n=352, 362) | 22.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Limitation of arm movement: Mild (n=355, 361) | 15.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Limitation of arm movement: Moderate(n=348, 360) | 1.1 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Swelling: Mild (n=351, 360) | 16.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Limitation of arm movement: Severe (n=348, 359) | 0.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Redness: Any (n=355, 363) | 28.7 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Limitation of arm movement: Severe (n=348, 359) | 1.7 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Redness: Mild (n=352, 362) | 7.7 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Swelling: Any (n=353, 360) | 6.7 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Swelling: Severe (n=349, 359) | 0.3 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Pain: Any (n=362, 368) | 38.3 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Limitation of arm movement: Mild (n=355, 361) | 15.8 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Redness: Any (n=355, 363) | 10.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Redness: Moderate (n=353, 360) | 3.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Redness: Severe (n=349, 359) | 0.3 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Swelling: Mild (n=351, 360) | 5.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Swelling: Moderate (n=351, 359) | 2.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Pain: Mild (n=362, 368) | 37.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Pain: Moderate (n=349, 361) | 5.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Pain: Severe (n=348, 359) | 1.4 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Limitation of arm movement: Any (n=355, 362) | 16.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Limitation of arm movement: Moderate(n=348, 360) | 3.6 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination
Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (\>=) 37.5 degrees Celsius \[C\], fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, aggravated muscle pain, new joint pain, aggravated joint pain, use of medication to treat fever and use of medication to treat pain. All reports of fever \>=39 degrees C in 13vPnC and 23vPS were confirmed as data entry errors.
Time frame: Within 14 days after vaccination
Population: Safety population included all participants who received the study vaccine. 'N' (number of participants analyzed)=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Fever >=38.5 to <39 degrees C (n=348, 359) | 0.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Fever >=39 to <=40 degrees C (n=348, 359) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Fatigue (n=352, 362) | 17.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Rash (n=350, 359) | 8.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | New muscle pain (n=354, 362) | 18.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Aggravated muscle pain (n=350, 359) | 4.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | New joint pain (n=350, 359) | 7.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Use of medication to treat fever (n=348, 360) | 0.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Use of medication to treat pain (n=348, 360) | 1.1 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Fever >=37.5 to <38.5 degrees C (n=348, 359) | 2.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Fever >40 degrees C (n=348, 359) | 0.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Headache (n=351, 361) | 9.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Chills (n=348, 359) | 2.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Vomiting (n=348, 359) | 1.1 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Decreased appetite (n=348, 360) | 3.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Aggravated joint pain (n=349, 359) | 2.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Vomiting (n=348, 359) | 0.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Fever >=38.5 to <39 degrees C (n=348, 359) | 0.3 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Use of medication to treat fever (n=348, 360) | 2.2 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Fever >=39 to <=40 degrees C (n=348, 359) | 0.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Fever >40 degrees C (n=348, 359) | 0.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Headache (n=351, 361) | 11.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Chills (n=348, 359) | 1.1 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Use of medication to treat pain (n=348, 360) | 2.8 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Rash (n=350, 359) | 3.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Decreased appetite (n=348, 360) | 5.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Fever >=37.5 to <38.5 degrees C (n=348, 359) | 2.8 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | New muscle pain (n=354, 362) | 17.4 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | New joint pain (n=350, 359) | 7.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Aggravated muscle pain (n=350, 359) | 3.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Fatigue (n=352, 362) | 16.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Aggravated joint pain (n=349, 359) | 3.1 percentage of participants |