Vaccines, Pneumococcal
Conditions
Keywords
safety, Vaccine
Brief summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to 7-valent pneumococcal conjugate (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months (infant series) and at 11-12 months of age (toddler dose) in Germany.
Interventions
BIOLOGICAL13-valent pneumococcal conjugate vaccine
Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age
BIOLOGICAL7-valent pneumococcal conjugate vaccine
Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
56 Days to 112 Days
Healthy volunteers
Yes
Inclusion criteria
1. Aged 2 months (56 to 112 days) at time of enrollment. 2. Available for entire study period and whose parent(s) or legal guardian(s) could be reached by telephone. 3. Healthy infant, as determined by medical history, physical examination, and judgment of the investigator. 4. Parent(s) or legal guardian(s) had to be able to complete all relevant study procedures during study participation.
Exclusion criteria
1. Previous vaccination with licensed or investigational pneumococcal vaccine. 2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines. 3. A previous anaphylactic reaction to any vaccine or vaccine-related component. 4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B, or pneumococcal vaccines. 5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 6. Known or suspected immune deficiency or suppression. 7. History of culture-proven invasive disease caused by S pneumoniae or H influenzae type b. 8. Major known congenital malformation or serious chronic disorder. 9. Significant neurological disorder or history of seizure, including febrile seizure, or significant stable or evolving disorders, such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Did not include resolving syndromes due to birth trauma such as Erb palsy. 10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®). 11. Participation in another investigational trial. Participation in purely observational studies was acceptable. 12. Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age) | — |
| Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | One month after 3-dose infant series (5 months of age) | Percentage of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/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. |
| Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | One month after 3-dose infant series (5 months of age) | Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) 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 ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated. |
| Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | One month after 3-dose infant series (5 months of age) | Percentage of Participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (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. |
| Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | One month after 3-dose infant series (5 months of age) | Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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. |
| Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age) | Predefined Antibody Levels for Haemophilus Influenzae Type b (0.15 µg/mL or 1.0 µg/mL), for Diphtheria Toxoid (0.01 or 0.1 International units \[IU\]/mL) and for Hepatitis B (≥ 10.0 mIU/mL). |
| Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age) | — |
| Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age) | Antibody geometric mean concentration (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. |
| Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Immediately before (12 months of age) and one month after the toddler dose (13 months of age) | Antibody concentration/geometric mean concentration as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose 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. |
| Percentage of Participants Reporting Pre-Specified Local Reactions | Day 1 through 4 after each dose | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (Mod)(2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Day 1 through 4 after each dose | Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Day 1 through 4 after each dose | Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category. |
Countries
Germany
Participant flow
Recruitment details
Participants were recruited in Germany from October 2006 to April 2007.
Pre-assignment details
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). | 301 |
| 7vPnC Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose) | 303 |
| Total | 604 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| After the Infant Series | Adverse Event | 0 | 1 |
| After the Infant Series | Failed to return | 0 | 1 |
| After the Infant Series | Lost to Follow-up | 0 | 1 |
| After the Infant Series | Parent/legal guardian request | 1 | 1 |
| After the Infant Series | Protocol Violation | 2 | 2 |
| Infant Series | Adverse Event | 0 | 2 |
| Infant Series | Failure to return | 1 | 0 |
| Infant Series | Lost to Follow-up | 1 | 1 |
| Infant Series | Protocol Violation | 3 | 4 |
| Infant Series | Withdrawal by Subject | 3 | 3 |
| Toddler Dose | Failed to return | 1 | 0 |
| Toddler Dose | Parent/legal guardian request | 0 | 1 |
Baseline characteristics
| Characteristic | 13vPnC | 7vPnC | Total |
|---|---|---|---|
| Age Continuous | 2.5 months STANDARD_DEVIATION 0.6 | 2.5 months STANDARD_DEVIATION 0.6 | 2.5 months STANDARD_DEVIATION 0.6 |
| Sex: Female, Male Female | 151 Participants | 127 Participants | 278 Participants |
| Sex: Female, Male Male | 150 Participants | 176 Participants | 326 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 220 / 299 | 225 / 300 | 13 / 299 | 25 / 300 | 152 / 289 | 143 / 284 | 11 / 287 | 8 / 287 |
| serious Total, serious adverse events | 12 / 300 | 10 / 303 | 21 / 300 | 23 / 303 | 3 / 300 | 4 / 303 | 11 / 300 | 14 / 303 |
Outcome results
Primary
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) 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 ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.
Time frame: One month after 3-dose infant series (5 months of age)
Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 9V | 1.65 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 1 | 1.83 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 18C | 1.94 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 3 | 1.55 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 6B | 0.98 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 5 | 1.31 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 19F | 1.73 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 6A | 1.33 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 14 | 4.14 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 7F | 2.59 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 23F | 1.26 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 19A | 3.26 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 4 | 2.18 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 19A | 0.64 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 4 | 2.99 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 6B | 1.49 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 9V | 1.96 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 14 | 4.61 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 18C | 2.25 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 19F | 2.86 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 23F | 1.44 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 1 | 0.03 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 3 | 0.05 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 5 | 0.20 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 6A | 0.23 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 7F | 0.04 μg/mL |
Comparison: For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.63, 0.84]
Comparison: For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.52, 0.82]
Comparison: For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.74, 0.96]
Comparison: For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.76, 1.07]
Comparison: For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [2.04, 2.49]
Comparison: For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.51, 0.71]
Comparison: For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.73, 1.06]
Primary
Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Time frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Population: Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant antigen.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 13vPnC | Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | 0.36 IU/mL |
| 7vPnC | Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | 0.53 IU/mL |
| 13vPnC After Toddler Dose | Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | 2.67 IU/mL |
| 7vPnC After Toddler Dose | Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | 3.08 IU/mL |
Comparison: For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.57, 0.8]
Comparison: For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.75, 1.01]
Primary
Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Time frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Population: Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant antigen.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 13vPnC | Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | 1.23 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | 1.00 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | 11.79 μg/mL |
| 7vPnC After Toddler Dose | Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | 10.24 μg/mL |
Comparison: For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.96, 1.58]
Comparison: For Haemophilus influenzae type b µg/mL the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.95, 1.39]
Primary
Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Antibody geometric mean concentration (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.
Time frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Population: Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant antigen.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 13vPnC | Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | 145.19 mIU/mL |
| 7vPnC | Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | 165.25 mIU/mL |
| 13vPnC After Toddler Dose | Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | 1118.05 mIU/mL |
| 7vPnC After Toddler Dose | Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | 1195.82 mIU/mL |
Comparison: For hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated.95% CI: [0.69, 1.11]
Comparison: For hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.71, 1.22]
Primary
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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.
Time frame: One month after 3-dose infant series (5 months of age)
Population: Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate antibody titer for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 14 (n=95,89) | 2139.65 titer |
| 13vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 1 (n=100,92) | 50.21 titer |
| 13vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 6B (n=100,94) | 744.43 titer |
| 13vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 3 (n=100,94) | 250.73 titer |
| 13vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 18C (n=100,94) | 1509.65 titer |
| 13vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 5 (n=100,94) | 162.02 titer |
| 13vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 9V (n=89,89) | 4937.84 titer |
| 13vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 6A (n=99,93) | 1228.45 titer |
| 13vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 19F (n=100,94) | 150.12 titer |
| 13vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 7F (n=99,94) | 11544.75 titer |
| 13vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes -Serotype 4 (n=92,94) | 1573.29 titer |
| 13vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 19A (n=95,94) | 442.48 titer |
| 13vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 23F (n=100,93) | 1089.92 titer |
| 7vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 19A (n=95,94) | 6.70 titer |
| 7vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes -Serotype 4 (n=92,94) | 1860.79 titer |
| 7vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 9V (n=89,89) | 5379.51 titer |
| 7vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 14 (n=95,89) | 3345.19 titer |
| 7vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 18C (n=100,94) | 1780.26 titer |
| 7vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 19F (n=100,94) | 165.69 titer |
| 7vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 23F (n=100,93) | 1070.83 titer |
| 7vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 1 (n=100,92) | 4.15 titer |
| 7vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 3 (n=100,94) | 6.13 titer |
| 7vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 5 (n=100,94) | 4.64 titer |
| 7vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 6A (n=99,93) | 122.40 titer |
| 7vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 7F (n=99,94) | 115.45 titer |
| 7vPnC | Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 6B (n=100,94) | 1160.76 titer |
Primary
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Antibody concentration/geometric mean concentration as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose 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.
Time frame: Immediately before (12 months of age) and one month after the toddler dose (13 months of age)
Population: Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate antibody concentration for the specified concomitant antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes -Serotype 4 (n=277,264,276,263) | 0.46 μg/mL |
| 13vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes - Serotype 6B (n=275,261,273,251) | 0.97 μg/mL |
| 13vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes - Serotype 9V (n=277,265,277,262) | 0.46 μg/mL |
| 13vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes - Serotype 14 (n=273,263,276,260) | 2.20 μg/mL |
| 13vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 18C (n=277,265,276,263) | 0.33 μg/mL |
| 13vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 19F (n=276,264,276,263) | 0.68 μg/mL |
| 13vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 23F (n=275,264,277,264) | 0.33 μg/mL |
| 13vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 1 (n=277,264,278,257) | 0.52 μg/mL |
| 13vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 3 (n=275,264,278,255) | 0.25 μg/mL |
| 13vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 5 (n=275,264,276,220) | 0.74 μg/mL |
| 13vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 6A (n=276,264,274,255) | 0.76 μg/mL |
| 13vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 7F (n=277,264,278,263) | 0.99 μg/mL |
| 13vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 19A (n=277,264,271,260) | 1.28 μg/mL |
| 7vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes - Serotype 14 (n=273,263,276,260) | 2.65 μg/mL |
| 7vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 19A (n=277,264,271,260) | 0.72 μg/mL |
| 7vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 6A (n=276,264,274,255) | 0.33 μg/mL |
| 7vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 1 (n=277,264,278,257) | 0.03 μg/mL |
| 7vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes - Serotype 9V (n=277,265,277,262) | 0.52 μg/mL |
| 7vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes -Serotype 4 (n=277,264,276,263) | 0.58 μg/mL |
| 7vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 5 (n=275,264,276,220) | 0.34 μg/mL |
| 7vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 3 (n=275,264,278,255) | 0.05 μg/mL |
| 7vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 19F (n=276,264,276,263) | 0.58 μg/mL |
| 7vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 18C (n=277,265,276,263) | 0.39 μg/mL |
| 7vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes - Serotype 6B (n=275,261,273,251) | 1.06 μg/mL |
| 7vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 7F (n=277,264,278,263) | 0.04 μg/mL |
| 7vPnC | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 23F (n=275,264,277,264) | 0.39 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 6A (n=276,264,274,255) | 5.88 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes - Serotype 14 (n=273,263,276,260) | 8.34 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 18C (n=277,265,276,263) | 2.79 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 19A (n=277,264,271,260) | 9.58 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 19F (n=276,264,276,263) | 5.99 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 23F (n=275,264,277,264) | 3.36 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 7F (n=277,264,278,263) | 4.79 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 1 (n=277,264,278,257) | 4.25 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 3 (n=275,264,278,255) | 1.02 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 5 (n=275,264,276,220) | 3.56 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes -Serotype 4 (n=277,264,276,263) | 4.16 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes - Serotype 6B (n=275,261,273,251) | 9.14 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes - Serotype 9V (n=277,265,277,262) | 2.75 μg/mL |
| 7vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 5 (n=275,264,276,220) | 0.51 μg/mL |
| 7vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 1 (n=277,264,278,257) | 0.03 μg/mL |
| 7vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes - Serotype 14 (n=273,263,276,260) | 11.01 μg/mL |
| 7vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes -Serotype 4 (n=277,264,276,263) | 5.07 μg/mL |
| 7vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 23F (n=275,264,277,264) | 4.33 μg/mL |
| 7vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 19F (n=276,264,276,263) | 4.72 μg/mL |
| 7vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes - Serotype 9V (n=277,265,277,262) | 3.36 μg/mL |
| 7vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes - Serotype 6B (n=275,261,273,251) | 9.85 μg/mL |
| 7vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 18C (n=277,265,276,263) | 3.44 μg/mL |
| 7vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 3 (n=275,264,278,255) | 0.07 μg/mL |
| 7vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 19A (n=277,264,271,260) | 3.79 μg/mL |
| 7vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 7F (n=277,264,278,263) | 0.05 μg/mL |
| 7vPnC After Toddler Dose | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional - Serotype 6A (n=276,264,274,255) | 1.74 μg/mL |
Primary
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Percentage of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/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.
Time frame: One month after 3-dose infant series (5 months of age)
Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes-Serotype 9V | 98.6 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 1 | 96.1 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes-Serotype 18C | 97.2 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 3 | 98.2 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes-Serotype 6B | 77.5 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 5 | 93.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes-Serotype 19F | 95.8 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 6A | 91.9 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes-Serotype 14 | 98.9 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 7F | 98.6 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes-Serotype 23F | 88.7 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 19A | 99.3 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes-Serotype 4 | 98.2 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 19A | 79.2 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes-Serotype 4 | 98.2 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes-Serotype 6B | 87.1 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes-Serotype 9V | 96.4 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes-Serotype 14 | 97.5 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes-Serotype 18C | 98.6 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes-Serotype 19F | 96.0 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes-Serotype 23F | 89.5 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 1 | 1.4 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 3 | 6.3 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 5 | 31.6 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 6A | 31.6 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 7F | 4.0 Percentage of Participants |
Comparison: For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-2.5, 2.6]
Comparison: For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-16, -3.3]
Comparison: For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-0.4, 5.2]
Comparison: For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-0.9, 4.1]
Comparison: For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-4.2, 1.2]
Comparison: For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-3.8, 3.3]
Comparison: For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-6, 4.5]
Primary
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
Percentage of Participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (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.
Time frame: One month after 3-dose infant series (5 months of age)
Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)=number of participants with a determinate postinfant series OPA antibody titer to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Common Serotypes - Serotype 9V (n=89,89) | 100.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Additional Serotypes - Serotype 1 (n=100,92) | 93.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Common Serotypes - Serotype 18C (n=100,94) | 100.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Additional Serotypes - Serotype 3 (n=100,94) | 99.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Common Serotypes - Serotype 6B (n=100,94) | 96.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Additional Serotypes - Serotype 5 (n=100,94) | 99.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Common Serotypes - Serotype 19F (n=100,94) | 96.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Additional Serotypes - Serotype 6A (n=99,93) | 96.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Common Serotypes - Serotype 14 (n=95,89) | 100.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Additional Serotypes - Serotype 7F (n=99,94) | 100.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Common Serotypes - Serotype 23F (n=100,93) | 96.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Additional Serotypes - Serotype 19A (n=95,94) | 100.00 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Common Serotypes - Serotype 4 (n=92,94) | 100.0 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Additional Serotypes - Serotype 19A (n=95,94) | 17.0 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Common Serotypes - Serotype 4 (n=92,94) | 100.0 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Common Serotypes - Serotype 6B (n=100,94) | 98.9 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Common Serotypes - Serotype 9V (n=89,89) | 100.0 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Common Serotypes - Serotype 14 (n=95,89) | 100.0 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Common Serotypes - Serotype 18C (n=100,94) | 98.9 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Common Serotypes - Serotype 19F (n=100,94) | 93.6 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Common Serotypes - Serotype 23F (n=100,93) | 95.7 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Additional Serotypes - Serotype 1 (n=100,92) | 4.3 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Additional Serotypes - Serotype 3 (n=100,94) | 24.5 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Additional Serotypes - Serotype 5 (n=100,94) | 4.3 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Additional Serotypes - Serotype 6A (n=99,93) | 72.0 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. | Additional Serotypes - Serotype 7F (n=99,94) | 78.7 Percentage of Participants |
Primary
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Predefined Antibody Levels for Haemophilus Influenzae Type b (0.15 µg/mL or 1.0 µg/mL), for Diphtheria Toxoid (0.01 or 0.1 International units \[IU\]/mL) and for Hepatitis B (≥ 10.0 mIU/mL).
Time frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Population: Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a antibody concentration ≥ the prespecified level for the given concomitant antigen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Diphtheria toxoid at 0.1 IU/mL threshold | 89.7 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Haemophilus influenzae type b 1.0 µg/mL threshold | 58.4 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Hepatitis B at ≥ 10.0 mIU/mL | 94.9 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Diphtheria toxoid at 0.01 IU/mL threshold | 100.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Haemophilus influenzae type b 0.15 µg/mL threshold | 89.5 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Diphtheria toxoid at 0.01 IU/mL threshold | 100.0 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Diphtheria toxoid at 0.1 IU/mL threshold | 94.2 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Hepatitis B at ≥ 10.0 mIU/mL | 96.3 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Haemophilus influenzae type b 1.0 µg/mL threshold | 54.0 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Haemophilus influenzae type b 0.15 µg/mL threshold | 86.9 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Diphtheria toxoid at 0.01 IU/mL threshold | 100.0 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Haemophilus influenzae type b 0.15 µg/mL threshold | 100.0 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Haemophilus influenzae type b 1.0 µg/mL threshold | 99.6 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Diphtheria toxoid at 0.1 IU/mL threshold | 100.0 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Hepatitis B at ≥ 10.0 mIU/mL | 99.3 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Diphtheria toxoid at 0.1 IU/mL threshold | 100.0 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Haemophilus influenzae type b 1.0 µg/mL threshold | 97.9 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Haemophilus influenzae type b 0.15 µg/mL threshold | 100.0 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Diphtheria toxoid at 0.01 IU/mL threshold | 100.0 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose | Hepatitis B at ≥ 10.0 mIU/mL | 98.5 Percentage of Participants |
Comparison: For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated95% CI: [-0.4, 4.4]
Comparison: For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated95% CI: [-1.4, 1.4]
Comparison: For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated95% CI: [-3, 8.3]
Comparison: For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated95% CI: [-4.1, 13]
Comparison: For diphtheria toxoid the difference in percentages between the two groups(13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated95% CI: [-1.4, 1.5]
Comparison: For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated95% CI: [-9.3, 0.3]
Comparison: For Haemophilus Influenzae Type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated95% CI: [-1.5, 1.5]
Comparison: For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/mL threshold was calculated95% CI: [-5, 2.3]
Comparison: For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated95% CI: [-1.4, 1.4]
Comparison: For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/mL threshold was calculated95% CI: [-1.3, 3.3]
Primary
Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (Mod)(2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category.
Time frame: Day 1 through 4 after each dose
Population: Safety population, included participants who received given dose; (n) = number of participants reporting the specific characteristic.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=261,256,235,227,217,211,174,158) | 7.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=265,263,243,239,226,223,186,172) | 24.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=259,255,232,222,214,208,166,153) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=260,256,232,224,217,210,173,158) | 1.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=260,258,236,226,215,209,176,158) | 7.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=267,267,250,241,229,221,206,96) | 33.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=265,271,247,250,237,229,191,180) | 27.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=266,272,247,252,238,231,196,184) | 28.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=259,255,232,223,214,208,166,152) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=266,263,244,242,226,224,190,176) | 28.2 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=267,267,250,241,229,221,206,96) | 32.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=265,263,243,239,226,223,186,172) | 19.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=261,256,235,227,217,211,174,158) | 5.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=259,255,232,222,214,208,166,153) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=266,272,247,252,238,231,196,184) | 36.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=260,256,232,224,217,210,173,158) | 1.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=266,263,244,242,226,224,190,176) | 20.5 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=265,271,247,250,237,229,191,180) | 36.2 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=259,255,232,223,214,208,166,152) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=260,258,236,226,215,209,176,158) | 7.0 percentage of participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=260,258,236,226,215,209,176,158) | 4.7 percentage of participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=267,267,250,241,229,221,206,96) | 29.2 percentage of participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=266,263,244,242,226,224,190,176) | 26.6 percentage of participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=265,263,243,239,226,223,186,172) | 24.3 percentage of participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=261,256,235,227,217,211,174,158) | 7.7 percentage of participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=259,255,232,223,214,208,166,152) | 0.0 percentage of participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=266,272,247,252,238,231,196,184) | 34.4 percentage of participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=265,271,247,250,237,229,191,180) | 33.6 percentage of participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=260,256,232,224,217,210,173,158) | 1.7 percentage of participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=259,255,232,222,214,208,166,153) | 0.0 percentage of participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=261,256,235,227,217,211,174,158) | 6.6 percentage of participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=260,256,232,224,217,210,173,158) | 3.6 percentage of participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=259,255,232,222,214,208,166,153) | 0.0 percentage of participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=259,255,232,223,214,208,166,152) | 0.0 percentage of participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=266,272,247,252,238,231,196,184) | 46.8 percentage of participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=265,263,243,239,226,223,186,172) | 33.5 percentage of participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=267,267,250,241,229,221,206,96) | 31.5 percentage of participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=265,271,247,250,237,229,191,180) | 45.6 percentage of participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=266,263,244,242,226,224,190,176) | 35.1 percentage of participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=260,258,236,226,215,209,176,158) | 7.5 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=260,258,236,226,215,209,176,158) | 4.2 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=266,272,247,252,238,231,196,184) | 34.9 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=261,256,235,227,217,211,174,158) | 6.9 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=265,263,243,239,226,223,186,172) | 24.8 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=267,267,250,241,229,221,206,96) | 27.1 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=260,256,232,224,217,210,173,158) | 4.6 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=259,255,232,223,214,208,166,152) | 0.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=266,263,244,242,226,224,190,176) | 26.1 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=265,271,247,250,237,229,191,180) | 34.2 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=259,255,232,222,214,208,166,153) | 0.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=265,263,243,239,226,223,186,172) | 27.8 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=261,256,235,227,217,211,174,158) | 5.2 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=259,255,232,223,214,208,166,152) | 0.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=260,258,236,226,215,209,176,158) | 2.9 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=266,272,247,252,238,231,196,184) | 39.8 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=259,255,232,222,214,208,166,153) | 0.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=265,271,247,250,237,229,191,180) | 38.9 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=267,267,250,241,229,221,206,96) | 21.3 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=260,256,232,224,217,210,173,158) | 2.4 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=266,263,244,242,226,224,190,176) | 28.6 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=259,255,232,223,214,208,166,152) | 0.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=261,256,235,227,217,211,174,158) | 12.1 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=265,271,247,250,237,229,191,180) | 44.5 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=267,267,250,241,229,221,206,96) | 53.4 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=259,255,232,222,214,208,166,153) | 0.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=260,258,236,226,215,209,176,158) | 10.8 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=260,256,232,224,217,210,173,158) | 11.6 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=266,263,244,242,226,224,190,176) | 36.8 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=266,272,247,252,238,231,196,184) | 47.4 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=265,263,243,239,226,223,186,172) | 33.3 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=259,255,232,223,214,208,166,152) | 0.0 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=260,256,232,224,217,210,173,158) | 15.2 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=261,256,235,227,217,211,174,158) | 12.7 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=265,271,247,250,237,229,191,180) | 52.8 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=266,263,244,242,226,224,190,176) | 43.8 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=259,255,232,222,214,208,166,153) | 0.7 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=267,267,250,241,229,221,206,96) | 51.9 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=266,272,247,252,238,231,196,184) | 56.0 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=260,258,236,226,215,209,176,158) | 12.7 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=265,263,243,239,226,223,186,172) | 40.7 percentage of participants |
Primary
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Day 1 through 4 after each dose
Population: Safety population, participants who received given dose; (n)= number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to Prevent Sx (n=261,262,237,234,220,220) | 8.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to Treat Sx (n=263,266,244,235,226,225) | 20.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >40°C (n=259,256,233,223,216,209) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Increased Sleep (n=284,272,258,256,240,241) | 61.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased Sleep (n=266,264,240,234,230,221) | 25.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Irritability (n=275,266,254,252,238,235) | 42.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >39°C but ≤40°C (n=260,256,238,225,216,210) | 4.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever ≥38°C but ≤ 39°C (n=269,266,248,250,242,232) | 43.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased Appetite (n=269,267,249,245,236,225) | 33.1 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to Treat Sx (n=263,266,244,235,226,225) | 21.1 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Increased Sleep (n=284,272,258,256,240,241) | 58.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >39°C but ≤40°C (n=260,256,238,225,216,210) | 1.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >40°C (n=259,256,233,223,216,209) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever ≥38°C but ≤ 39°C (n=269,266,248,250,242,232) | 38.7 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to Prevent Sx (n=261,262,237,234,220,220) | 9.5 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased Appetite (n=269,267,249,245,236,225) | 30.3 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased Sleep (n=266,264,240,234,230,221) | 26.1 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Irritability (n=275,266,254,252,238,235) | 45.1 percentage of participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >39°C but ≤40°C (n=260,256,238,225,216,210) | 8.8 percentage of participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Increased Sleep (n=284,272,258,256,240,241) | 53.9 percentage of participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased Appetite (n=269,267,249,245,236,225) | 33.7 percentage of participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to Prevent Sx (n=261,262,237,234,220,220) | 10.1 percentage of participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to Treat Sx (n=263,266,244,235,226,225) | 28.3 percentage of participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >40°C (n=259,256,233,223,216,209) | 0.0 percentage of participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased Sleep (n=266,264,240,234,230,221) | 23.8 percentage of participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Irritability (n=275,266,254,252,238,235) | 47.2 percentage of participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever ≥38°C but ≤ 39°C (n=269,266,248,250,242,232) | 46.8 percentage of participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Increased Sleep (n=284,272,258,256,240,241) | 66.8 percentage of participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever ≥38°C but ≤ 39°C (n=269,266,248,250,242,232) | 48.4 percentage of participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >39°C but ≤40°C (n=260,256,238,225,216,210) | 4.4 percentage of participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >40°C (n=259,256,233,223,216,209) | 0.0 percentage of participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased Appetite (n=269,267,249,245,236,225) | 34.3 percentage of participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Irritability (n=275,266,254,252,238,235) | 55.2 percentage of participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased Sleep (n=266,264,240,234,230,221) | 23.1 percentage of participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to Prevent Sx (n=261,262,237,234,220,220) | 15.4 percentage of participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to Treat Sx (n=263,266,244,235,226,225) | 27.2 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Irritability (n=275,266,254,252,238,235) | 45.4 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased Appetite (n=269,267,249,245,236,225) | 33.1 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased Sleep (n=266,264,240,234,230,221) | 20.9 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >40°C (n=259,256,233,223,216,209) | 0.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to Treat Sx (n=263,266,244,235,226,225) | 20.8 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to Prevent Sx (n=261,262,237,234,220,220) | 10.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >39°C but ≤40°C (n=260,256,238,225,216,210) | 3.7 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever ≥38°C but ≤ 39°C (n=269,266,248,250,242,232) | 46.3 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Increased Sleep (n=284,272,258,256,240,241) | 49.6 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever ≥38°C but ≤ 39°C (n=269,266,248,250,242,232) | 36.6 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased Appetite (n=269,267,249,245,236,225) | 30.2 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Increased Sleep (n=284,272,258,256,240,241) | 49.4 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to Treat Sx (n=263,266,244,235,226,225) | 19.1 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to Prevent Sx (n=261,262,237,234,220,220) | 15.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased Sleep (n=266,264,240,234,230,221) | 24.4 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >40°C (n=259,256,233,223,216,209) | 0.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Irritability (n=275,266,254,252,238,235) | 48.9 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >39°C but ≤40°C (n=260,256,238,225,216,210) | 1.4 percentage of participants |
Primary
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Day 1 through 4 after each dose
Population: Safety population, participants who received given dose; (n)= number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Fever >39°C but ≤40°C (n=174,157) | 12.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Increased Sleep (n=202,197) | 56.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Decreased Appetite (n=204,192) | 43.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Decreased Sleep (n=195,170) | 31.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Fever >40°C (n=166,152) | 0.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Medication to Prevent Symptoms (n=184,182) | 32.1 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Irritability (n=213,200) | 55.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Medication to Treat Symptoms (n=178,167) | 18.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Fever ≥38°C but ≤ 39°C (n=206,200) | 58.7 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Medication to Treat Symptoms (n=178,167) | 18.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Fever ≥38°C but ≤ 39°C (n=206,200) | 62.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Fever >39°C but ≤40°C (n=174,157) | 8.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Fever >40°C (n=166,152) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Decreased Appetite (n=204,192) | 46.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Irritability (n=213,200) | 61.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Increased Sleep (n=202,197) | 54.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Decreased Sleep (n=195,170) | 28.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Medication to Prevent Symptoms (n=184,182) | 33.0 percentage of participants |