Pneumococcal Vaccines
Conditions
Keywords
Healthy Subjects, Vaccines, Pneumococcal
Brief summary
The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.
Interventions
BIOLOGICAL13vPnC
13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
140 Days to 392 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy children previously immunized with 1 or 2 doses of Prevenar. * Group 1: Male or female subjects between the age of \>=140 and \<=196 days of age at time of enrollment. * Group 2: Male or female subjects between the age of \>=336 and \<=392 days of age at time of enrollment * Available for entire study period.
Exclusion criteria
* Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component. * Previous vaccination with licensed or investigational pneumococcal vaccine other than Prevenar.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | 1 month after the toddler dose (13 months of age) | Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (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) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose | 1 Month after the infant series (6 months of age) | Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL 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. |
| GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose | 1 Month after the infant series (6 months of age) | Antibody GMC 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) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all participants with available data for the specified blood draw. |
| GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | 12 months of age (prior to toddler dose) | Antibody GMC 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) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all participants with available data for the specified blood draw. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) | Day 1 through Day 7 after vaccination | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness 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 Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Day 1 through Day 7 after vaccination | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness 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 Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) | Day 1 through 7 after vaccination | Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category. |
| Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) | Day 1 through 7 after vaccination | Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category. |
Countries
Sweden
Participant flow
Pre-assignment details
Group 1 participants received 1 dose of Prevenar at least 42 days prior to study enrollment. Group 2 participants received 2 doses of Prevenar with the last dose at least 140 days prior to study enrollment.
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC/13vPnC Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study. | 118 |
| 13vPnC Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study. | 116 |
| Total | 234 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Toddler Dose (12 Months of Age) | Adverse Event | 1 | 0 |
| Toddler Dose (12 Months of Age) | Parent/legal guardian request | 1 | 0 |
Baseline characteristics
| Characteristic | 13vPnC/13vPnC | 13vPnC | Total |
|---|---|---|---|
| Age Continuous | 5.1 months STANDARD_DEVIATION 0.37 | 11.9 months STANDARD_DEVIATION 0.52 | 8.5 months STANDARD_DEVIATION 3.42 |
| Sex/Gender, Customized Female | 50 participants | 60 participants | 110 participants |
| Sex/Gender, Customized Male | 68 participants | 56 participants | 124 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 92 / 118 | 4 / 118 | 91 / 116 | 86 / 116 |
| serious Total, serious adverse events | 1 / 118 | 4 / 118 | 1 / 116 | 0 / 116 |
Outcome results
Primary
Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose
Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (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) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.
Time frame: 1 month after the toddler dose (13 months of age)
Population: Evaluable Toddler Immunogenicity Population: eligible participants who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC/13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Common Serotype 9V | 3.50 mcg/mL |
| 13vPnC/13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Additional Serotype 1 | 14.65 mcg/mL |
| 13vPnC/13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Common Serotype 18C | 2.93 mcg/mL |
| 13vPnC/13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Additional Serotype 3 | 1.85 mcg/mL |
| 13vPnC/13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Common Serotype 6B | 9.63 mcg/mL |
| 13vPnC/13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Additional Serotype 5 | 7.02 mcg/mL |
| 13vPnC/13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Common Serotype 19F | 7.70 mcg/mL |
| 13vPnC/13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Additional Serotype 6A | 6.14 mcg/mL |
| 13vPnC/13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Common Serotype 14 | 9.22 mcg/mL |
| 13vPnC/13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Additional Serotype 7F | 5.86 mcg/mL |
| 13vPnC/13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Common Serotype 23F | 3.27 mcg/mL |
| 13vPnC/13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Additional Serotype 19A | 7.25 mcg/mL |
| 13vPnC/13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Common Serotype 4 | 5.27 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Additional Serotype 19A | 13.16 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Common Serotype 4 | 5.06 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Common Serotype 6B | 8.75 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Common Serotype 9V | 3.33 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Common Serotype 14 | 9.30 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Common Serotype 18C | 3.87 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Common Serotype 19F | 8.31 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Common Serotype 23F | 4.40 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Additional Serotype 1 | 1.58 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Additional Serotype 3 | 1.34 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Additional Serotype 5 | 1.44 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Additional Serotype 6A | 2.48 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Additional Serotype 7F | 3.55 mcg/mL |
Secondary
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose
Antibody GMC 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) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all participants with available data for the specified blood draw.
Time frame: 1 Month after the infant series (6 months of age)
Population: Evaluable Infant Immunogenicity Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose | Additional Serotype 7F | 1.78 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose | Common Serotype 4 | 2.90 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose | Common Serotype 6B | 0.40 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose | Common Serotype 9V | 1.73 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose | Common Serotype 14 | 4.70 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose | Common Serotype 18C | 1.56 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose | Common Serotype 19F | 3.01 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose | Common Serotype 23F | 0.57 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose | Additional Serotype 1 | 0.89 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose | Additional Serotype 3 | 1.88 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose | Additional Serotype 5 | 0.72 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose | Additional Serotype 6A | 0.28 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose | Additional Serotype 19A | 0.85 mcg/mL |
Secondary
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose
Antibody GMC 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) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all participants with available data for the specified blood draw.
Time frame: 12 months of age (prior to toddler dose)
Population: Evaluable Toddler Immunogenicity Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Common Serotype 9V | 0.74 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Additional Serotype 1 | 0.46 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Common Serotype 18C | 0.35 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Additional Serotype 3 | 0.40 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Common Serotype 6B | 0.83 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Additional Serotype 5 | 1.18 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Common Serotype 19F | 0.85 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Additional Serotype 6A | 0.71 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Common Serotype 14 | 1.99 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Additional Serotype 7F | 1.08 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Common Serotype 23F | 0.33 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Additional Serotype 19A | 1.06 mcg/mL |
| 13vPnC/13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Common Serotype 4 | 0.66 mcg/mL |
| 13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Additional Serotype 19A | 1.55 mcg/mL |
| 13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Common Serotype 4 | 0.62 mcg/mL |
| 13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Common Serotype 6B | 0.65 mcg/mL |
| 13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Common Serotype 9V | 0.70 mcg/mL |
| 13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Common Serotype 14 | 2.23 mcg/mL |
| 13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Common Serotype 18C | 0.44 mcg/mL |
| 13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Common Serotype 19F | 0.81 mcg/mL |
| 13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Common Serotype 23F | 0.41 mcg/mL |
| 13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Additional Serotype 1 | 0.01 mcg/mL |
| 13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Additional Serotype 3 | 0.05 mcg/mL |
| 13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Additional Serotype 5 | 0.33 mcg/mL |
| 13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Additional Serotype 6A | 0.24 mcg/mL |
| 13vPnC | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Additional Serotype 7F | 0.02 mcg/mL |
Secondary
Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose
Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL 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: 1 Month after the infant series (6 months of age)
Population: Evaluable Infant Immunogenicity Population: eligible participants who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC/13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose | Common Serotype 4 | 99.1 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose | Common Serotype 6B | 53.0 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose | Common Serotype 9V | 99.1 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose | Common Serotype 14 | 96.5 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose | Common Serotype 18C | 95.7 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose | Common Serotype 19F | 92.2 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose | Common Serotype 23F | 62.6 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose | Additional Serotype 1 | 80.9 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose | Additional Serotype 3 | 100.0 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose | Additional Serotype 5 | 83.5 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose | Additional Serotype 6A | 36.8 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose | Additional Serotype 7F | 93.0 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose | Additional Serotype 19A | 87.8 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness 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 7 after vaccination
Population: Safety Population: all participants who received at least 1 dose of the study vaccine; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) | Tenderness: Any (n=108) | 36.1 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) | Tenderness: Significant (n=99) | 3.0 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) | Swelling: Any (n=104) | 33.7 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) | Swelling: Mild (n=104) | 31.7 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) | Swelling: Moderate (n=101) | 9.9 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) | Swelling: Severe (n=99) | 0.0 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) | Redness: Any (n=107) | 40.2 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) | Redness: Mild (n=107) | 36.4 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) | Redness: Moderate (n=99) | 4.0 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) | Redness: Severe (n=99) | 0.0 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness 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 7 after vaccination
Population: Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Tenderness: Any (n=104,110) | 59.6 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Tenderness: Significant (n=96,103) | 5.2 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Swelling: Any (n=104,110) | 53.8 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Swelling: Mild (n=104,109) | 50.0 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Swelling: Moderate (n=100,105) | 24.0 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Swelling: Severe (n=95,101) | 0.0 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Redness: Any (n=104,113) | 62.5 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Redness: Mild (n=103,113) | 52.4 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Redness: Moderate (n=98,106) | 20.4 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Redness: Severe (n=95,101) | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Redness: Mild (n=103,113) | 51.3 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Tenderness: Any (n=104,110) | 52.7 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Swelling: Severe (n=95,101) | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Tenderness: Significant (n=96,103) | 7.8 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Redness: Severe (n=95,101) | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Swelling: Any (n=104,110) | 54.5 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Redness: Any (n=104,113) | 59.3 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Swelling: Mild (n=104,109) | 52.3 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Redness: Moderate (n=98,106) | 26.4 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Swelling: Moderate (n=100,105) | 29.5 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age)
Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.
Time frame: Day 1 through 7 after vaccination
Population: Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) | Increased sleep (n=106) | 50.9 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) | Fever ≥38 degrees C but ≤39 degrees C (n=103) | 26.2 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) | Fever >39 degrees C but ≤40 degrees C (n=99) | 2.0 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) | Fever >40 degrees C (n=99) | 0.0 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) | Decreased appetite (n=107) | 36.4 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) | Irritability (n=114) | 80.7 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) | Decreased sleep (n=112) | 39.3 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age)
Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.
Time frame: Day 1 through 7 after vaccination
Population: Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) | Fever >40 degrees C (n=95,101) | 0.0 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) | Irritability (n=111,113) | 82.0 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) | Fever >39 degrees C but ≤40 degrees C (n=96,102) | 5.2 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) | Increased sleep (n=101,108) | 49.5 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) | Decreased appetite (n=103,109) | 46.6 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) | Decreased sleep (n=105,106) | 36.2 Percentage of participants |
| 13vPnC/13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) | Fever ≥38 degrees C but ≤39 degrees C (n=99,105) | 31.3 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) | Decreased sleep (n=105,106) | 33.0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) | Fever ≥38 degrees C but ≤39 degrees C (n=99,105) | 32.4 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) | Fever >39 degrees C but ≤40 degrees C (n=96,102) | 3.9 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) | Fever >40 degrees C (n=95,101) | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) | Decreased appetite (n=103,109) | 44.0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) | Irritability (n=111,113) | 76.1 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) | Increased sleep (n=101,108) | 38.9 Percentage of participants |