Invasive Pneumococcal Disease
Conditions
Keywords
Immune response, pneumococcal conjugate vaccine, polysaccharide
Brief summary
The primary purpose of this study is to evaluate the immune response to 13-valent pneumococcal conjugate vaccine (13vPnCV) in children who as infants received either a complete series of PnCV versus a combination of PnCV and pneumococcal polysaccharide vaccine (PSV). This study is also intended to evaluate the safety of the 13vPnC.
Detailed description
Follow-up measure for the EMEA supporting a Type II variation for Prevenar (PCV7) label
Interventions
0.5 mL intramuscular injection
PROCEDUREBlood draw
Collection of 10 mL of blood
Sponsors
Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Fully vaccinated children who participated in a previous Wyeth study (Study D139-P506) and received a booster dose of either 23-valent pneumococcal polysaccharide vaccine (PPV23) or pneumococcal conjugate vaccine (PnCV) per the original protocol for that study. * Subjects must be in good health as determined by medical history, physical examination and clinical judgment.
Exclusion criteria
* Known allergy to any component of the 7-valent pneumococcal conjugate vaccine (7vPnC) or 13-valent pneumococcal conjugate vaccine (13vPnC). * History of documented invasive pneumococcal disease (defined as a positive culture of S. pneumoniae from a normally sterile body site). * Any known or suspected disease or dysfunction of the immune system, including: HIV infection, Malignancy, Receipt of immunosuppressive therapy, Sickle cell hemoglobinopathy. * Receipt of immune-globulin within the past 3 months. * Receipt of either PSV or 7vPnCV since the completion of Study D139-P506.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Day 28 | Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. |
| Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Day 28 | Percentage of participants achieving OPA along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Response Measured 1 Month After Vaccination (Avidity Assay) | Day 28 | Avidity assay had measurable range of 0.117 to 7.5. Results expressed as avidity index (AI). Geometric mean avidity presented for 3 common pneumococcal serotypes (serotype 6B, 19F, and 23F) and 2 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1 and 5). |
| Antibody Response Measured 1 Month After Vaccination (OPA) | Day 28 | Antibody response as measured by OPA, 1 month after vaccination. Geometric mean titers (GMTs) calculated using all participants with available data for the specified blood draw. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Day 1 through Day 4 | Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may have been represented in more than 1 category. |
| Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination | Day 1 through Day 4 | Pre-specified systemic events (any fever 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using a diary card. Participants may have been represented in more than 1 category. |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Day 28 | Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. GMCs were calculated using all participants with available data for the specified blood draw. |
Countries
Iceland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PCV/23vPS/13vPnC For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). | 50 |
| PCV/PCV/13vPnC For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV). | 39 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | PCV/PCV/13vPnC | Total | PCV/23vPS/13vPnC |
|---|---|---|---|
| Age, Continuous | 7.6 years STANDARD_DEVIATION 0.2 | 7.6 years STANDARD_DEVIATION 0.2 | 7.6 years STANDARD_DEVIATION 0.2 |
| Sex: Female, Male Female | 20 Participants | 45 Participants | 25 Participants |
| Sex: Female, Male Male | 19 Participants | 44 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 44 / 50 | 30 / 39 |
| serious Total, serious adverse events | 0 / 50 | 0 / 39 |
Outcome results
Primary
Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination
Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Time frame: Day 28
Population: Evaluable Immunogenicity Population: received 1 dose of 13vPnC at Visit 1, blood drawn within specified timeframes, at least 1 valid and determinate assay result at Visits 1 and 3, no major protocol violations, and no prohibited vaccines. N=number of participants with a determinate IgG antibody concentration to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PCV/23vPS/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Common Serotype 9V | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Common Serotype 14 | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Common Serotype18C | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Common Serotype 19F | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Common Serotype 23F | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Additional Serotype 1 | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Additional Serotype 3 | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Additional Serotype 5 | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Additional Serotype 6A | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Additional Serotype 7F | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Additional Serotype 19A | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Common Serotype 4 | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Common Serotype 6B | 100.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Additional Serotype 19A | 100.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Additional Serotype 5 | 100.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Common Serotype 14 | 100.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Common Serotype 6B | 100.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Common Serotype18C | 97.3 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Additional Serotype 6A | 100.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Common Serotype 19F | 100.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Common Serotype 4 | 97.3 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Common Serotype 23F | 100.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Additional Serotype 7F | 100.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Additional Serotype 1 | 97.3 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Common Serotype 9V | 100.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Additional Serotype 3 | 100.0 Percentage of participants |
Comparison: Comparison between treatments for common serotype 495% CI: [-5, 14.2]
Comparison: Comparison between treatments for common serotype 6B95% CI: [-7.3, 9.5]
Comparison: Comparison between treatments for common serotype 9V95% CI: [-7.3, 9.5]
Comparison: Comparison between treatments for common serotype 1495% CI: [-7.8, 9.5]
Comparison: Comparison between treatments for common serotype 18C95% CI: [-5, 14.2]
Comparison: Comparison between treatments for common serotype 19F95% CI: [-7.3, 9.5]
Comparison: Comparison between treatments for common serotype 23F95% CI: [-7.3, 9.5]
Comparison: Comparison between treatments for additional serotype 195% CI: [-5, 14.2]
Comparison: Comparison between treatments for additional serotype 395% CI: [-7.3, 9.5]
Comparison: Comparison between treatments for additional serotype 595% CI: [-7.3, 9.5]
Comparison: Comparison between treatments for additional serotype 6A95% CI: [-7.3, 9.5]
Comparison: Comparison between treatments for additional serotype 7F95% CI: [-7.3, 9.5]
Comparison: Comparison between treatments for additional serotype 19A95% CI: [-7.3, 9.5]
Primary
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
Percentage of participants achieving OPA along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Time frame: Day 28
Population: Evaluable Immunogenicity Population; N=number of participants with a determinate OPA antibody titer to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PCV/23vPS/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Common Serotype 9V | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Additional Serotype 1 | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Common Serotype 18C | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Additional Serotype 3 | 98.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Common Serotype 6B | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Additional Serotype 5 | 98.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Common Serotype 19F | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Additional Serotype 6A | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Common Serotype 14 | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Additional Serotype 7F | 98.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Common Serotype 23F | 98.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Additional Serotype 19A | 100.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Common Serotype 4 | 98.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Additional Serotype 19A | 100.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Common Serotype 4 | 97.2 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Common Serotype 6B | 100.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Common Serotype 9V | 100.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Common Serotype 14 | 100.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Common Serotype 18C | 100.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Common Serotype 19F | 100.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Common Serotype 23F | 100.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Additional Serotype 1 | 97.3 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Additional Serotype 3 | 100.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Additional Serotype 5 | 97.3 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Additional Serotype 6A | 100.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Additional Serotype 7F | 100.0 Percentage of participants |
Comparison: Comparison between treatments for common serotype 495% CI: [-8.6, 12.7]
Comparison: Comparison between treatments for common serotype 6B95% CI: [-7.5, 9.7]
Comparison: Comparison between treatments for common serotype 9V95% CI: [-7.5, 9.7]
Comparison: Comparison between treatments for common serotype 1495% CI: [-7.5, 9.7]
Comparison: Comparison between treatments for common serotype 18C95% CI: [-7.4, 10]
Comparison: Comparison between treatments for common serotype 19F95% CI: [-7.5, 10]
Comparison: Comparison between treatments for common serotype 23F95% CI: [-10.8, 8.1]
Comparison: Comparison between treatments for additional serotype 195% CI: [-5, 14.2]
Comparison: Comparison between treatments for additional serotype 395% CI: [-11.1, 7.9]
Comparison: Comparison between treatments for additional serotype 595% CI: [-8.5, 12.2]
Comparison: Comparison between treatments for additional serotype 6A95% CI: [-7.3, 9.5]
Comparison: Comparison between treatments for additional serotype 7F95% CI: [-11.3, 7.7]
Comparison: Comparison between treatments for additional serotype 19A95% CI: [-7.3, 9.5]
Secondary
Antibody Response Measured 1 Month After Vaccination (Avidity Assay)
Avidity assay had measurable range of 0.117 to 7.5. Results expressed as avidity index (AI). Geometric mean avidity presented for 3 common pneumococcal serotypes (serotype 6B, 19F, and 23F) and 2 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1 and 5).
Time frame: Day 28
Population: Evaluable Immunogenicity Population; In accordance with the recommendation of the lab completing the assays, values above the upper limit were assigned a value of 8.0 and those below the lower limit were assigned a value of 0.10. N=number of participants with a determinate avidity index for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PCV/23vPS/13vPnC | Antibody Response Measured 1 Month After Vaccination (Avidity Assay) | Additional serotype 5 | 1.85 AI |
| PCV/23vPS/13vPnC | Antibody Response Measured 1 Month After Vaccination (Avidity Assay) | Common serotype 19F | 2.17 AI |
| PCV/23vPS/13vPnC | Antibody Response Measured 1 Month After Vaccination (Avidity Assay) | Common serotype 6B | 2.43 AI |
| PCV/23vPS/13vPnC | Antibody Response Measured 1 Month After Vaccination (Avidity Assay) | Common serotype 23F | 3.02 AI |
| PCV/23vPS/13vPnC | Antibody Response Measured 1 Month After Vaccination (Avidity Assay) | Additional serotype 1 | 1.42 AI |
| PCV/PCV/13vPnC | Antibody Response Measured 1 Month After Vaccination (Avidity Assay) | Common serotype 23F | 6.43 AI |
| PCV/PCV/13vPnC | Antibody Response Measured 1 Month After Vaccination (Avidity Assay) | Additional serotype 1 | 4.68 AI |
| PCV/PCV/13vPnC | Antibody Response Measured 1 Month After Vaccination (Avidity Assay) | Additional serotype 5 | 5.85 AI |
| PCV/PCV/13vPnC | Antibody Response Measured 1 Month After Vaccination (Avidity Assay) | Common serotype 6B | 5.48 AI |
| PCV/PCV/13vPnC | Antibody Response Measured 1 Month After Vaccination (Avidity Assay) | Common serotype 19F | 2.46 AI |
Comparison: Serotype 1: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.22, 0.42]
Comparison: Serotype 5: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.23, 0.44]
Comparison: Serotype 6B: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.29, 0.67]
Comparison: Serotype 19F: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.61, 1.27]
Comparison: Serotype 23F: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.34, 0.65]
Secondary
Antibody Response Measured 1 Month After Vaccination (OPA)
Antibody response as measured by OPA, 1 month after vaccination. Geometric mean titers (GMTs) calculated using all participants with available data for the specified blood draw. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time frame: Day 28
Population: Evaluable Immunogenicity Population; N=number of participants with a determinate antibody titre to the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PCV/23vPS/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Additional Serotype 19A | 1256 GMT |
| PCV/23vPS/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Common Serotype 4 | 2374 GMT |
| PCV/23vPS/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Common Serotype 6B | 11156 GMT |
| PCV/23vPS/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Common Serotype 9V | 1651 GMT |
| PCV/23vPS/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Common Serotype 14 | 3041 GMT |
| PCV/23vPS/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Common Serotype 18C | 3230 GMT |
| PCV/23vPS/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Common Serotype 19F | 1266 GMT |
| PCV/23vPS/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Common Serotype 23F | 1678 GMT |
| PCV/23vPS/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Additional Serotype 1 | 217 GMT |
| PCV/23vPS/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Additional Serotype 3 | 153 GMT |
| PCV/23vPS/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Additional Serotype 5 | 264 GMT |
| PCV/23vPS/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Additional Serotype 6A | 7060 GMT |
| PCV/23vPS/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Additional Serotype 7F | 5835 GMT |
| PCV/PCV/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Additional Serotype 5 | 719 GMT |
| PCV/PCV/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Common Serotype 23F | 2714 GMT |
| PCV/PCV/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Common Serotype 4 | 3765 GMT |
| PCV/PCV/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Additional Serotype 7F | 7887 GMT |
| PCV/PCV/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Common Serotype 6B | 11477 GMT |
| PCV/PCV/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Additional Serotype 1 | 1087 GMT |
| PCV/PCV/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Common Serotype 9V | 1713 GMT |
| PCV/PCV/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Additional Serotype 6A | 5034 GMT |
| PCV/PCV/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Common Serotype 14 | 3048 GMT |
| PCV/PCV/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Additional Serotype 3 | 188 GMT |
| PCV/PCV/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Common Serotype 18C | 5684 GMT |
| PCV/PCV/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Additional Serotype 19A | 1556 GMT |
| PCV/PCV/13vPnC | Antibody Response Measured 1 Month After Vaccination (OPA) | Common Serotype 19F | 1198 GMT |
Comparison: Serotype 4: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.35, 1.12]
Comparison: Serotype 6B: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.68, 1.38]
Comparison: Serotype 9V: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.51, 1.81]
Comparison: Serotype 14: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.67, 1.48]
Comparison: Serotype 18C: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.33, 0.98]
Comparison: Serotype 19F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.72, 1.56]
Comparison: Serotype 23F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.39, 0.99]
Comparison: Serotype 1: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.12, 0.32]
Comparison: Serotype 3: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.56, 1.18]
Comparison: Serotype 5: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.21, 0.63]
Comparison: Serotype 6A: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.88, 2.25]
Comparison: Serotype 7F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.48, 1.14]
Comparison: Serotype 19A: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.54, 1.2]
Other Pre-specified
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination
Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. GMCs were calculated using all participants with available data for the specified blood draw.
Time frame: Day 28
Population: Evaluable Immunogenicity Population; N=number of participants with a determinate antibody concentration to the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PCV/23vPS/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Common serotype 9V | 4.31 mcg/mL |
| PCV/23vPS/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Additional serotype 1 | 5.28 mcg/mL |
| PCV/23vPS/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Common serotype 18C | 2.76 mcg/mL |
| PCV/23vPS/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Additional serotype 3 | 3.28 mcg/mL |
| PCV/23vPS/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Common serotype 6B | 29.51 mcg/mL |
| PCV/23vPS/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Additional serotype 5 | 5.75 mcg/mL |
| PCV/23vPS/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Common serotype 19F | 9.78 mcg/mL |
| PCV/23vPS/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Additional serotype 6A | 11.16 mcg/mL |
| PCV/23vPS/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Common serotype 14 | 17.47 mcg/mL |
| PCV/23vPS/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Additional serotype 7F | 7.13 mcg/mL |
| PCV/23vPS/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Common serotype 23F | 7.89 mcg/mL |
| PCV/23vPS/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Additional serotype 19A | 14.62 mcg/mL |
| PCV/23vPS/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Common serotype 4 | 4.18 mcg/mL |
| PCV/PCV/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Additional serotype 19A | 17.07 mcg/mL |
| PCV/PCV/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Common serotype 4 | 11.34 mcg/mL |
| PCV/PCV/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Common serotype 6B | 41.70 mcg/mL |
| PCV/PCV/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Common serotype 9V | 7.39 mcg/mL |
| PCV/PCV/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Common serotype 14 | 22.78 mcg/mL |
| PCV/PCV/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Common serotype 18C | 4.83 mcg/mL |
| PCV/PCV/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Common serotype 19F | 11.60 mcg/mL |
| PCV/PCV/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Common serotype 23F | 12.25 mcg/mL |
| PCV/PCV/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Additional serotype 1 | 19.43 mcg/mL |
| PCV/PCV/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Additional serotype 3 | 2.87 mcg/mL |
| PCV/PCV/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Additional serotype 5 | 15.98 mcg/mL |
| PCV/PCV/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Additional serotype 6A | 14.07 mcg/mL |
| PCV/PCV/13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Additional serotype 7F | 8.05 mcg/mL |
Comparison: Serotype 4: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.25, 0.55]
Comparison: Serotype 6B: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.44, 1.15]
Comparison: Serotype 9V: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.45, 0.75]
Comparison: Serotype 14: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.48, 1.24]
Comparison: Serotype 18C: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.38, 0.85]
Comparison: Serotype 19F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.56, 1.27]
Comparison: Serotype 23F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.44, 0.95]
Comparison: Serotype 1: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.18, 0.4]
Comparison: Serotype 3: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.76, 1.72]
Comparison: Serotype 5: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.25, 0.51]
Comparison: Serotype 6A: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.55, 1.14]
Comparison: Serotype 7F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.61, 1.28]
Comparison: Serotype 19A: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).95% CI: [0.6, 1.23]
Other Pre-specified
Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination
Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may have been represented in more than 1 category.
Time frame: Day 1 through Day 4
Population: Safety Population: all participants who receive at least 1 dose of the study vaccine; N=number of participants reporting yes for at least 1 day or no for all days and number analyzed signifies participants reporting the specific characteristic.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PCV/23vPS/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Tenderness: Any | 88.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Tenderness: Significant | 12.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Redness: Any | 50.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Redness: Mild | 10.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Redness: Moderate | 40.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Redness: Severe | 10.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Swelling: Any | 44.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Swelling: Mild | 16.3 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Swelling: Moderate | 28.6 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Swelling: Severe | 2.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Swelling: Mild | 26.3 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Tenderness: Any | 76.9 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Redness: Severe | 21.1 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Tenderness: Significant | 20.5 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Swelling: Severe | 7.9 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Redness: Any | 66.7 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Swelling: Any | 59.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Redness: Mild | 15.8 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Swelling: Moderate | 44.7 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Redness: Moderate | 52.6 Percentage of participants |
Comparison: Comparison between treatments for any tendernessp-value: 0.253Fisher Exact
Comparison: Comparison between treatments for significant tendernessp-value: 0.38Fisher Exact
Comparison: Comparison between treatments for any rednessp-value: 0.135Fisher Exact
Comparison: Comparison between treatments for mild rednessp-value: 0.52Fisher Exact
Comparison: Comparison between treatments for moderate rednessp-value: 0.283Fisher Exact
Comparison: Comparison between treatments for severe rednessp-value: 0.225Fisher Exact
Comparison: Comparison between treatments for any swellingp-value: 0.202Fisher Exact
Comparison: Comparison between treatments for mild swellingp-value: 0.294Fisher Exact
Comparison: Comparison between treatments for moderate swellingp-value: 0.175Fisher Exact
Comparison: Comparison between treatments for severe swellingp-value: 0.314Fisher Exact
Other Pre-specified
Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination
Pre-specified systemic events (any fever 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using a diary card. Participants may have been represented in more than 1 category.
Time frame: Day 1 through Day 4
Population: Safety; N=number of participants reporting yes for at least 1 day or no for all days and number analyzed signifies participants reporting the specific characteristic.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PCV/23vPS/13vPnC | Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination | Increased sleep | 4.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination | Irritability | 18.4 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination | Decreased appetite | 12.2 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination | Rash | 6.0 Percentage of participants |
| PCV/23vPS/13vPnC | Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination | Fever ≥ 38 degrees C but ≤ 39 degrees C | 2.0 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination | Decreased sleep | 5.1 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination | Rash | 2.6 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination | Fever ≥ 38 degrees C but ≤ 39 degrees C | 2.8 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination | Decreased appetite | 10.3 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination | Irritability | 11.4 Percentage of participants |
| PCV/PCV/13vPnC | Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination | Increased sleep | 12.8 Percentage of participants |
Comparison: Comparison between treatments for fever ≥ 38 degrees C but ≤ 39 degrees Cp-value: >0.99Fisher Exact
Comparison: Comparison between treatments for decreased appetitep-value: >0.99Fisher Exact
Comparison: Comparison between treatments for irritabilityp-value: 0.543Fisher Exact
Comparison: Comparison between treatments for increased sleepp-value: 0.233Fisher Exact
Comparison: Comparison between treatments for decreased sleepp-value: 0.198Fisher Exact
Comparison: Comparison between treatments for rashp-value: 0.628Fisher Exact