Vaccines, Pneumococcal
Conditions
Keywords
Vaccine, Infants
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 Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Italy.
Interventions
BIOLOGICAL13-valent pneumococcal conjugate vaccine
Single 0.5 mL dose of 13vPnC given at 3, 5 and 11 months of age.
BIOLOGICAL7 valent pneumococcal conjugate vaccine
Single 0.5 mL dose of 7vPnC given at 3, 5 and 11 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
75 Days to 105 Days
Healthy volunteers
Yes
Inclusion criteria
1. Aged 3 months (75 to 105 days) at time of enrollment. 2. Available for entire study period and whose parent(s)/legal guardian(s) could be reached by telephone. 3. Healthy infant, as determined by medical history, physical examination, and judgment of the investigator. 4. Born at greater than 32 weeks gestational age and greater than 2000 grams. Regardless of gestational age and birth weight, all subjects must have met inclusion criterion number 3. 5. Parent(s)/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 Hib. 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® \[MedImmune\]). 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 Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | One month after infant series dose 2 (6 months of age) and before the toddler dose (11 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) are presented. |
| Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age) | GMC for Hib polyribosylribitol phosphate as measured by ELISA, expressed in micrograms per milliliter (μg/mL). |
| Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age) | GMC of anti-diphtheria and anti-tetanus toxoids as measured by ELISA (IU/mL). |
| Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age) | GMC of Polio as measured using a polio in vitro plaque neutralization. |
| Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | one month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age) | Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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. |
| Percentage of Participants Reporting Pre-Specified Local Reactions | During the 4-day period after each dose | Local reactions were collected 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 be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events | During the 4-day period after each dose | Systemic events (fever ≥ 37.5 degrees Celsius \[C\], fever ≥ 38 C but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication (meds) to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | One month after the infant series (6 months of age) and after the toddler dose (12 months of age) | Percentage of Participants achieving predefined antibody threshold levels for Pertussis Toxoid (PT) ≥5 ELISA units per milliliter (EU/mL), Filamentous Haemagglutinin (FHA) ≥5 or ≥7.82 EU/mL, and Pertactin (PRN) ≥5 EU/mL, ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B, Haemophilus Influenzae type b (Hib) 0.15 μg/ml, 0.01 or 0.1 IU/mL for Diphtheria, 0.1 IU/mL for Tetanus, and ≥1:8 titer for Polio (Type 1, 2, and 3) with the corresponding 95% CI for antigens are presented. |
| Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age) | GMC of Pertussis (PT, FHA, PRN) were measured using an anti-Bordetella pertussis enzyme-linked immunosorbent assay (ELISA). Results were recorded in ELISA units per milliliter (EU/mL) |
| Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose | One month after the infant series (6 months of age) and the toddler dose (12 months of age) | GMC of anti-hepatitis B surface antigen (HBsAg)using an Food and Drug Administration (FDA) approved in vitro diagnostic kit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | One month after the toddler dose (12 months of age) | Percentages of Participants achieving WHO predefined antibody threshold ≥0.35μg/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 Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | One month after toddler dose (12 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) are presented. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | one month after infant series dose 2 and after the toddler dose | Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay(OPA) for7 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 Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | one month after infant series dose 2 and after the toddler dose | Percentage of subjects 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. (This is not a geometric mean comparison as suggested by the table row heading). |
Countries
Italy
Participant flow
Recruitment details
Participants were recruited in Italy from October 2006 to March 2007.
Pre-assignment details
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period. One subject was prerandomized and counted twice.
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose). | 303 |
| 7vPnC Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose). | 303 |
| Total | 606 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| After Infant Series | Adverse Event | 1 | 2 |
| After Infant Series | Lost to Follow-up | 4 | 3 |
| After Infant Series | Protocol Violation | 1 | 0 |
| After Infant Series | Withdrawal by Subject | 1 | 4 |
| Infant Series | Adverse Event | 0 | 1 |
| Infant Series | Failed to return | 1 | 1 |
| Infant Series | Lost to Follow-up | 0 | 2 |
| Infant Series | Physician Decision | 1 | 0 |
| Infant Series | Protocol Violation | 2 | 1 |
| Infant Series | Randomized but not consented | 1 | 0 |
| Infant Series | Withdrawal by Subject | 4 | 7 |
| Toddler Dose | Protocol Violation | 1 | 0 |
| Toddler Dose | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | 13vPnC | 7vPnC | Total |
|---|---|---|---|
| Age Continuous | 2.9 months STANDARD_DEVIATION 0.3 | 2.9 months STANDARD_DEVIATION 0.3 | 2.9 months STANDARD_DEVIATION 0.3 |
| Gender Female | 138 participants | 133 participants | 271 participants |
| Gender Male | 164 participants | 170 participants | 334 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 | 188 / 303 | 183 / 303 | 96 / 294 | 90 / 291 | 165 / 287 | 170 / 282 | 1 / 290 | 0 / 288 |
| serious Total, serious adverse events | 6 / 303 | 10 / 303 | 8 / 294 | 11 / 291 | 3 / 287 | 1 / 282 | 9 / 290 | 11 / 288 |
Outcome results
Primary
Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose
GMC of anti-hepatitis B surface antigen (HBsAg)using an Food and Drug Administration (FDA) approved in vitro diagnostic kit.
Time frame: One month after the infant series (6 months of age) and the toddler dose (12 months of age)
Population: Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose | 260.46 mIU/mL |
| 7vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose | 272.67 mIU/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose | 1655.30 mIU/mL |
| 7vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose | 2284.95 mIU/mL |
Comparison: For Hepatitis b the geometric mean concentration (GMC) ratio (13vPnC/7vPnC) was calculated95% CI: [0.72, 1.27]
Comparison: For Hepatitis b the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.54, 0.96]
Primary
Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC of anti-diphtheria and anti-tetanus toxoids as measured by ELISA (IU/mL).
Time frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
Population: Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Tetanus (n=155,214,125,96) | 0.53 IU/mL |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Diptheria (n=207,240,164,190) | 0.52 IU/mL |
| 7vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Tetanus (n=155,214,125,96) | 0.63 IU/mL |
| 7vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Diptheria (n=207,240,164,190) | 0.67 IU/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Diptheria (n=207,240,164,190) | 2.77 IU/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Tetanus (n=155,214,125,96) | 2.62 IU/mL |
| 7vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Diptheria (n=207,240,164,190) | 3.71 IU/mL |
| 7vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Tetanus (n=155,214,125,96) | 2.09 IU/mL |
Comparison: For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.65, 0.94]
Comparison: For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.67, 1.08]
Comparison: For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.63, 0.89]
Comparison: For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.88, 1.79]
Primary
Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC for Hib polyribosylribitol phosphate as measured by ELISA, expressed in micrograms per milliliter (μg/mL).
Time frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
Population: Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | 0.99 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | 1.00 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | 9.09 μg/mL |
| 7vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | 8.85 μg/mL |
Comparison: or Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.75, 1.3]
Comparison: For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.81, 1.3]
Primary
Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC of Pertussis (PT, FHA, PRN) were measured using an anti-Bordetella pertussis enzyme-linked immunosorbent assay (ELISA). Results were recorded in ELISA units per milliliter (EU/mL)
Time frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
Population: Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Pertussis PRN | 167.76 EU/mL |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Pertussis PT | 50.01 EU/mL |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Pertussis FHA | 102.87 EU/mL |
| 7vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Pertussis PRN | 166.19 EU/mL |
| 7vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Pertussis PT | 48.44 EU/mL |
| 7vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Pertussis FHA | 105.17 EU/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Pertussis FHA | 463.23 EU/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Pertussis PT | 60.89 EU/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Pertussis PRN | 339.30 EU/mL |
| 7vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Pertussis PRN | 361.70 EU/mL |
| 7vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Pertussis PT | 64.53 EU/mL |
| 7vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Pertussis FHA | 456.55 EU/mL |
Comparison: For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.87, 1.1]
Comparison: For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.92, 1.16]
Comparison: For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.87, 1.17]
Comparison: For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.89, 1.15]
Comparison: For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.83, 1.07]
Comparison: For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.82, 1.07]
Primary
Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC of Polio as measured using a polio in vitro plaque neutralization.
Time frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
Population: Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Polio Type 3 (n=205,262,153,178) | 397.32 Titers |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Polio Type 2 (n=205,262,153,175) | 123.74 Titers |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Polio Type 1 (n=207,262,156,179) | 180.72 Titers |
| 7vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Polio Type 3 (n=205,262,153,178) | 452.14 Titers |
| 7vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Polio Type 1 (n=207,262,156,179) | 207.17 Titers |
| 7vPnC Dose 1 | Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Polio Type 2 (n=205,262,153,175) | 130.39 Titers |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Polio Type 2 (n=205,262,153,175) | 1141.62 Titers |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Polio Type 1 (n=207,262,156,179) | 924.52 Titers |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Polio Type 3 (n=205,262,153,178) | 1567.64 Titers |
| 7vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Polio Type 3 (n=205,262,153,178) | 2421.31 Titers |
| 7vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Polio Type 2 (n=205,262,153,175) | 1340.51 Titers |
| 7vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose | Polio Type 1 (n=207,262,156,179) | 1348.04 Titers |
Comparison: For Polio Type 1 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.7, 1.08]
Comparison: For Polio Type 2 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.74, 1.22]
Comparison: For Polio Type 3 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.68, 1.13]
Comparison: For Polio Type 1 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.55, 0.86]
Comparison: For Polio Type 2 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.68, 1.07]
Comparison: For Polio Type 3 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.51, 0.83]
Primary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before 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) are presented.
Time frame: One month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)
Population: Evaluable pneumococcal immunogenicity (per protocol) had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Common Serotypes - Serotype 19F | 3.42 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Additional Serotypes - Serotype 6A | 1.17 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Common Serotypes - Serotype 4 | 2.38 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Common Serotypes - Serotype 6B | 0.41 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Common Serotypes - Serotype 9V | 1.68 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Common Serotypes - Serotype 14 | 2.84 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Common Serotypes - Serotype 18C | 1.72 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Common Serotypes - Serotype 23F | 0.61 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Additional Serotypes - Serotype 1 | 2.30 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Additional Serotypes - Serotype 3 | 1.15 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Additional Serotypes - Serotype 5 | 1.27 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Additional Serotypes - Serotype 7F | 2.06 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Additional Serotypes - Serotype 19F | 2.87 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Additional Serotypes - Serotype 5 | 0.88 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Common Serotypes - Serotype 23F | 0.26 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Additional Serotypes - Serotype 6A | 0.81 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Common Serotypes - Serotype 4 | 0.53 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Additional Serotypes - Serotype 1 | 0.68 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Common Serotypes - Serotype 6B | 0.61 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Additional Serotypes - Serotype 19F | 1.20 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Common Serotypes - Serotype 9V | 0.48 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Additional Serotypes - Serotype 3 | 0.25 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Common Serotypes - Serotype 14 | 2.03 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Additional Serotypes - Serotype 7F | 0.76 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Common Serotypes - Serotype 18C | 0.35 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose | Common Serotypes - Serotype 19F | 0.94 μg/mL |
Primary
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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 infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)
Population: The evaluable pneumococcal immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Common Serotypes - Serotype 14 | 94.2 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Common Serotypes - Serotype 19F | 95.1 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Additional Serotypes - Serotype 7F | 98.5 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Additional Serotypes - Serotype 19A | 98.5 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Common Serotypes - Serotype 4 | 96.6 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Common Serotypes - Serotype 6B | 58.4 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Common Serotypes - Serotype 9V | 94.7 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Common Serotypes - Serotype 18C | 92.4 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Common Serotypes - Serotype 23F | 68.6 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Additional Serotypes - Serotype 1 | 96.6 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Additional Serotypes - Serotype 3 | 92.8 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Additional Serotypes - Serotype 5 | 91.6 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Additional Serotypes - Serotype 6A | 86.5 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Additional Serotypes - Serotype 5 | 87.3 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Common Serotypes - Serotype 14 | 94.4 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Common Serotypes - Serotype 18C | 53.0 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Common Serotypes - Serotype 19F | 92.4 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Additional Serotypes - Serotype 7F | 90.7 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Additional Serotypes - Serotype 3 | 30.8 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Additional Serotypes - Serotype 19A | 96.2 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Common Serotypes - Serotype 23F | 32.3 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Common Serotypes - Serotype 4 | 66.9 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Additional Serotypes - Serotype 6A | 86.4 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Common Serotypes - Serotype 6B | 76.3 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Additional Serotypes - Serotype 1 | 83.4 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose | Common Serotypes - Serotype 9V | 70.5 percentage of participants |
Primary
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Percentage of Participants achieving predefined antibody threshold levels for Pertussis Toxoid (PT) ≥5 ELISA units per milliliter (EU/mL), Filamentous Haemagglutinin (FHA) ≥5 or ≥7.82 EU/mL, and Pertactin (PRN) ≥5 EU/mL, ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B, Haemophilus Influenzae type b (Hib) 0.15 μg/ml, 0.01 or 0.1 IU/mL for Diphtheria, 0.1 IU/mL for Tetanus, and ≥1:8 titer for Polio (Type 1, 2, and 3) with the corresponding 95% CI for antigens are presented.
Time frame: One month after the infant series (6 months of age) and after the toddler dose (12 months of age)
Population: Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate postinfant antibody concentration/titer for the given concomitant antigen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertactin ≥5 EU/mL (n=248,270,234,217) | 100.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, PT ≥5 EU/mL (n=250,272,235,219) | 99.6 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, FHA ≥5 EU/mL (n=243,272,229,214) | 100.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, FHA ≥7.82 EU/mL (n=243,272,229,214) | 100.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertactin (Infant ≥40; Toddler ≥106) EU/mL | 91.9 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Hepatitis B ≥ 10.0 mIU/mL | 93.8 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Haemophilus Influenzae type b 0.15 μg/ml | 87.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Haemophilus Influenzae type b 1.0 μg/ml | 49.9 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Diptheria 0.01 IU/mL (n=207,240,164,190) | 100.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Diptheria 0.1 IU/mL (n=207,240,164,190) | 92.8 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Tetanus 0.1 IU/mL (n=155,214,125,96) | 94.2 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, FHA (Infant ≥31; Toddler ≥162) EU/mL | 94.7 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Polio, Type 1 ≥1:8 | 99.5 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Polio, Type 2 ≥1:8 | 95.6 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Polio, Type 3 ≥1:8 | 99.5 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, PT (infant ≥16; Toddler ≥21) EU/mL | 95.2 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Hepatitis B ≥ 10.0 mIU/mL | 93.1 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Diptheria 0.01 IU/mL (n=207,240,164,190) | 100.0 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertactin ≥5 EU/mL (n=248,270,234,217) | 100.0 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Polio, Type 3 ≥1:8 | 98.9 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Tetanus 0.1 IU/mL (n=155,214,125,96) | 92.5 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Diptheria 0.1 IU/mL (n=207,240,164,190) | 96.3 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, FHA ≥5 EU/mL (n=243,272,229,214) | 100.0 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, PT (infant ≥16; Toddler ≥21) EU/mL | 95.2 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, PT ≥5 EU/mL (n=250,272,235,219) | 100.0 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Haemophilus Influenzae type b 0.15 μg/ml | 90.3 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, FHA ≥7.82 EU/mL (n=243,272,229,214) | 100.0 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertactin (Infant ≥40; Toddler ≥106) EU/mL | 95.2 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Polio, Type 2 ≥1:8 | 96.6 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Haemophilus Influenzae type b 1.0 μg/ml | 48.7 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Polio, Type 1 ≥1:8 | 99.6 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, FHA (Infant ≥31; Toddler ≥162) EU/mL | 95.6 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Hepatitis B ≥ 10.0 mIU/mL | 98.40 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertactin ≥5 EU/mL (n=248,270,234,217) | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Polio, Type 1 ≥1:8 | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Haemophilus Influenzae type b 0.15 μg/ml | 99.6 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Haemophilus Influenzae type b 1.0 μg/ml | 96.2 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Polio, Type 2 ≥1:8 | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Diptheria 0.01 IU/mL (n=207,240,164,190) | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Diptheria 0.1 IU/mL (n=207,240,164,190) | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Tetanus 0.1 IU/mL (n=155,214,125,96) | 97.6 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, PT (infant ≥16; Toddler ≥21) EU/mL | 92.8 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, FHA (Infant ≥31; Toddler ≥162) EU/mL | 95.2 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertactin (Infant ≥40; Toddler ≥106) EU/mL | 94.9 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, PT ≥5 EU/mL (n=250,272,235,219) | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Polio, Type 3 ≥1:8 | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, FHA ≥5 EU/mL (n=243,272,229,214) | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, FHA ≥7.82 EU/mL (n=243,272,229,214) | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, FHA (Infant ≥31; Toddler ≥162) EU/mL | 95.3 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Haemophilus Influenzae type b 0.15 μg/ml | 98.2 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, FHA ≥5 EU/mL (n=243,272,229,214) | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertactin (Infant ≥40; Toddler ≥106) EU/mL | 95.4 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Tetanus 0.1 IU/mL (n=155,214,125,96) | 93.8 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Polio, Type 3 ≥1:8 | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Polio, Type 1 ≥1:8 | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, PT ≥5 EU/mL (n=250,272,235,219) | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Diptheria 0.1 IU/mL (n=207,240,164,190) | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Polio, Type 2 ≥1:8 | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertactin ≥5 EU/mL (n=248,270,234,217) | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Hepatitis B ≥ 10.0 mIU/mL | 98.80 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, PT (infant ≥16; Toddler ≥21) EU/mL | 95.4 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Diptheria 0.01 IU/mL (n=207,240,164,190) | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Haemophilus Influenzae type b 1.0 μg/ml | 92.2 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose | Pertussis, FHA ≥7.82 EU/mL (n=243,272,229,214) | 100.0 percentage of participants |
Comparison: For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.95% CI: [-2.2, 1]
Comparison: For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥16 EU/mL threshold was calculated.95% CI: [-4, 3.8]
Comparison: For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated95% CI: [-1.6, 1.4]
Comparison: For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥7.82 EU/mL threshold was calculated.95% CI: [-1.6, 1.4]
Comparison: For Pertussis FHA the difference in percentages between the two groups ( 13vPnC - 7vPnC) at ≥31 EU/mL threshold was calculated.95% CI: [-5, 2.9]
Comparison: For Diptheria the difference in percentage between the two groups ( 13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.95% CI: [-8.3, 0.8]
Comparison: For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.95% CI: [-1.5, 1.4]
Comparison: For Pertactin the difference in percentages between the two groups ( 13vPnC - 7vPnC) at ≥40 EU/mL threshold was calculated.95% CI: [-7.8, 1]
Comparison: For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥10.0 mIU/mL threshold was calculated.95% CI: [-3.6, 5]
Comparison: For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 μg/mL threshold was calculated.95% CI: [-9.1, 2.4]
Comparison: For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.95% CI: [-8.2, 9.5]
Comparison: For Diptheria the difference in percentages between the two groups ( 13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated.95% CI: [-1.8, 1.6]
Comparison: For Tetanus the difference in percentage between the two groups ( 13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.95% CI: [-3.9, 7.1]
Comparison: For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.95% CI: [-2.3, 1.7]
Comparison: For Polio Type 2 the difference in percentage between the two groups ( 13vPnC - 7vPnC) at ≥1:8 threshold was calculated.95% CI: [-5, 2.8]
Comparison: For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.95% CI: [-1.6, 2.9]
Comparison: For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated95% CI: [-1.6, 1.7]
Comparison: For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥21 EU/mL threshold was calculated.95% CI: [-7.3, 1.8]
Comparison: For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated95% CI: [-1.6, 1.7]
Comparison: For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥7.82 EU/mL threshold was calculated95% CI: [-1.6, 1.7]
Comparison: For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥162 EU/mL threshold was calculated95% CI: [-4.3, 4.1]
Comparison: For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.95% CI: [-1.6, 1.7]
Comparison: For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥106 EU/mL threshold was calculated.95% CI: [-4.7, 3.7]
Comparison: For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥10.0 mIU/mL threshold was calculated.95% CI: [-3, 2]
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: [-0.8, 4.2]
Comparison: For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.95% CI: [-0.4, 8.7]
Comparison: For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated.95% CI: [-2.3, 2]
Comparison: For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated95% CI: [-2.3, 2]
Comparison: For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.95% CI: [-1.7, 10.9]
Comparison: For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.95% CI: [-2.4, 2.1]
Comparison: For Polio Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.95% CI: [-2.4, 2.1]
Comparison: For Polio Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.95% CI: [-2.4, 2.1]
Primary
Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were collected 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 be represented in more than 1 category.
Time frame: During the 4-day period after each dose
Population: The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Any (n=234,243,214,215,199,188) | 32.1 Percentage of Participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Severe (n=222,229,197,194,159,152) | 0.0 Percentage of Participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Moderate (n=223,229,198,195,160,157) | 3.6 Percentage of Participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Severe (n=243,255,197,194,159,152) | 0.0 Percentage of Participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Significant (n=224,231,199,199,164,153) | 2.7 Percentage of Participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Moderate (n=222,231,200,195,160,156) | 2.7 Percentage of Participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Any (n=232,240,207,209,175,165) | 19.0 Percentage of Participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Mild (n=233,244,211,211,178,172) | 24.0 Percentage of Participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Any (n=233,245,213,212,178,174) | 25.8 Percentage of Participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Mild (n=232,240,207,208,174,161) | 17.7 Percentage of Participants |
| 7vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Any (n=233,245,213,212,178,174) | 26.5 Percentage of Participants |
| 7vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Mild (n=233,244,211,211,178,172) | 24.6 Percentage of Participants |
| 7vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Moderate (n=223,229,198,195,160,157) | 3.1 Percentage of Participants |
| 7vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Mild (n=232,240,207,208,174,161) | 18.3 Percentage of Participants |
| 7vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Severe (n=243,255,197,194,159,152) | 0.0 Percentage of Participants |
| 7vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Any (n=232,240,207,209,175,165) | 19.6 Percentage of Participants |
| 7vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Severe (n=222,229,197,194,159,152) | 0.0 Percentage of Participants |
| 7vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Significant (n=224,231,199,199,164,153) | 3.5 Percentage of Participants |
| 7vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Any (n=234,243,214,215,199,188) | 30.0 Percentage of Participants |
| 7vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Moderate (n=222,231,200,195,160,156) | 3.0 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Any (n=232,240,207,209,175,165) | 24.6 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Any (n=234,243,214,215,199,188) | 30.4 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Significant (n=224,231,199,199,164,153) | 4.5 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Mild (n=232,240,207,208,174,161) | 21.7 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Moderate (n=223,229,198,195,160,157) | 5.6 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Severe (n=222,229,197,194,159,152) | 0.0 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Any (n=233,245,213,212,178,174) | 31.5 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Mild (n=233,244,211,211,178,172) | 28.4 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Moderate (n=222,231,200,195,160,156) | 5.5 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Severe (n=243,255,197,194,159,152) | 0.0 Percentage of Participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Mild (n=232,240,207,208,174,161) | 26.4 Percentage of Participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Any (n=234,243,214,215,199,188) | 36.7 Percentage of Participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Severe (n=222,229,197,194,159,152) | 0.0 Percentage of Participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Any (n=232,240,207,209,175,165) | 28.7 Percentage of Participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Any (n=233,245,213,212,178,174) | 34.4 Percentage of Participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Severe (n=243,255,197,194,159,152) | 0.0 Percentage of Participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Mild (n=233,244,211,211,178,172) | 32.2 Percentage of Participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Significant (n=224,231,199,199,164,153) | 5.0 Percentage of Participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Moderate (n=222,231,200,195,160,156) | 3.6 Percentage of Participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Moderate (n=223,229,198,195,160,157) | 5.1 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Any (n=233,245,213,212,178,174) | 36.5 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Any (n=234,243,214,215,199,188) | 47.2 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Mild (n=232,240,207,208,174,161) | 26.4 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Mild (n=233,244,211,211,178,172) | 32.6 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Significant (n=224,231,199,199,164,153) | 8.5 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Severe (n=243,255,197,194,159,152) | 0.0 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Moderate (n=223,229,198,195,160,157) | 7.5 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Moderate (n=222,231,200,195,160,156) | 7.5 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Severe (n=222,229,197,194,159,152) | 0.0 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Any (n=232,240,207,209,175,165) | 28.6 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Severe (n=222,229,197,194,159,152) | 0.0 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Any (n=233,245,213,212,178,174) | 36.2 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Any (n=232,240,207,209,175,165) | 27.3 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Significant (n=224,231,199,199,164,153) | 5.9 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Mild (n=232,240,207,208,174,161) | 21.7 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Any (n=234,243,214,215,199,188) | 44.1 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Moderate (n=222,231,200,195,160,156) | 10.9 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Mild (n=233,244,211,211,178,172) | 30.8 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Severe (n=243,255,197,194,159,152) | 0.0 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Moderate (n=223,229,198,195,160,157) | 10.2 Percentage of Participants |
Primary
Percentage of Participants Reporting Pre-Specified Systemic Events
Systemic events (fever ≥ 37.5 degrees Celsius \[C\], fever ≥ 38 C but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication (meds) to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: During the 4-day period after each dose
Population: The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat symptoms (n=244,245,219,109,192,190) | 34.8 Percentage of Participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent symptoms (n=230,238,208,208,172,169) | 12.6 Percentage of Participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C (n=222,230,198,195,160,152) | 0.0 Percentage of Participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep (n=269,276,226,232,195,196) | 65.8 Percentage of Participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep (n=244,242,222,213,180,171) | 39.3 Percentage of Participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=258,259,245,243,221,227) | 72.9 Percentage of Participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C (n=224,233,204,201,167,160) | 3.6 Percentage of Participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C (n=247,246,227,226,204,197) | 41.7 Percentage of Participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite (n=246,248,220,218,198,197) | 35.4 Percentage of Participants |
| 7vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent symptoms (n=230,238,208,208,172,169) | 18.1 Percentage of Participants |
| 7vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep (n=269,276,226,232,195,196) | 64.5 Percentage of Participants |
| 7vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C (n=224,233,204,201,167,160) | 4.7 Percentage of Participants |
| 7vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C (n=222,230,198,195,160,152) | 0.0 Percentage of Participants |
| 7vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C (n=247,246,227,226,204,197) | 38.6 Percentage of Participants |
| 7vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat symptoms (n=244,245,219,109,192,190) | 30.6 Percentage of Participants |
| 7vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite (n=246,248,220,218,198,197) | 34.3 Percentage of Participants |
| 7vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep (n=244,242,222,213,180,171) | 36.4 Percentage of Participants |
| 7vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=258,259,245,243,221,227) | 63.7 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C (n=224,233,204,201,167,160) | 6.9 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep (n=269,276,226,232,195,196) | 57.1 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite (n=246,248,220,218,198,197) | 47.3 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat symptoms (n=244,245,219,109,192,190) | 43.4 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent symptoms (n=230,238,208,208,172,169) | 20.2 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C (n=222,230,198,195,160,152) | 0.0 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep (n=244,242,222,213,180,171) | 40.1 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=258,259,245,243,221,227) | 75.5 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C (n=247,246,227,226,204,197) | 55.5 Percentage of Participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep (n=269,276,226,232,195,196) | 56.5 Percentage of Participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C (n=247,246,227,226,204,197) | 60.6 Percentage of Participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C (n=224,233,204,201,167,160) | 7.0 Percentage of Participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C (n=222,230,198,195,160,152) | 0.0 Percentage of Participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite (n=246,248,220,218,198,197) | 45.4 Percentage of Participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=258,259,245,243,221,227) | 75.3 Percentage of Participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep (n=244,242,222,213,180,171) | 41.8 Percentage of Participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat symptoms (n=244,245,219,109,192,190) | 47.8 Percentage of Participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent symptoms (n=230,238,208,208,172,169) | 24.5 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=258,259,245,243,221,227) | 74.7 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite (n=246,248,220,218,198,197) | 52.0 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep (n=244,242,222,213,180,171) | 35.6 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C (n=222,230,198,195,160,152) | 0.0 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent symptoms (n=230,238,208,208,172,169) | 27.9 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat symptoms (n=244,245,219,109,192,190) | 53.1 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C (n=224,233,204,201,167,160) | 9.6 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C (n=247,246,227,226,204,197) | 63.7 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep (n=269,276,226,232,195,196) | 53.8 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C (n=247,246,227,226,204,197) | 52.3 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite (n=246,248,220,218,198,197) | 57.4 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep (n=269,276,226,232,195,196) | 54.6 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent symptoms (n=230,238,208,208,172,169) | 24.3 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat symptoms (n=244,245,219,109,192,190) | 43.7 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep (n=244,242,222,213,180,171) | 35.7 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C (n=222,230,198,195,160,152) | 0.7 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=258,259,245,243,221,227) | 74.9 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C (n=224,233,204,201,167,160) | 12.5 Percentage of Participants |
Secondary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After 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) are presented.
Time frame: One month after toddler dose (12 months of age)
Population: Evaluable pneumococcal immunogenicity (per protocol) 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 serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 9V (n=235,248) | 3.02 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 1 (n=244,240) | 5.76 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 4 (n=244,245) | 4.77 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 3 (n=245,240) | 1.22 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 14 (n=237,240) | 10.30 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 5 (n=245,218) | 3.59 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 23F (n=244,245) | 3.43 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 6A (n=243,243) | 6.78 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 18C (n=245,247) | 2.83 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 7F (n=242,243) | 4.31 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 6B (n=243,243) | 10.00 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 19F (n=241,241) | 9.81 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 19F (n=243,245) | 9.01 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 19F (n=241,241) | 4.24 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 23F (n=244,245) | 4.87 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 4 (n=244,245) | 7.08 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 9V (n=235,248) | 4.10 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 14 (n=237,240) | 11.99 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 18C (n=245,247) | 4.26 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 19F (n=243,245) | 8.06 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 1 (n=244,240) | 0.03 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 3 (n=245,240) | 0.07 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 5 (n=245,218) | 0.56 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 6A (n=243,243) | 1.42 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 7F (n=242,243) | 0.04 μg/mL |
| 7vPnC Dose 1 | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 6B (n=243,243) | 10.39 μg/mL |
Secondary
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
Percentages of Participants achieving WHO predefined antibody threshold ≥0.35μg/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 the toddler dose (12 months of age)
Population: Evaluable pneumococcal immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 6B (n=243,243) | 100.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 23F (n=240,243) | 99.2 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 1 (n=244,240) | 99.6 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 14 (n=237,240) | 99.6 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 3 (n=245,218) | 93.9 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 4 (n=244,245) | 100.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 5 (n=245,243) | 100.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 18C (n=245,245) | 99.2 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 6A (n=243,243) | 99.6 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 7F (n=242,243) | 99.6 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 9V (n=235,248) | 100.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 19A (n=241,241) | 100.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 19F (n=243,245) | 98.8 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 19A (n=241,241) | 99.6 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 6A (n=243,243) | 86.4 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 4 (n=244,245) | 100.0 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 6B (n=243,243) | 100.0 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 9V (n=235,248) | 100.0 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 14 (n=237,240) | 99.6 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 18C (n=245,245) | 99.6 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 19F (n=243,245) | 98.4 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 1 (n=244,240) | 3.3 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 3 (n=245,218) | 6.7 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 5 (n=245,243) | 70.2 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 7F (n=242,243) | 4.9 percentage of participants |
| 7vPnC Dose 1 | Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 23F (n=240,243) | 98.8 percentage of participants |
Other Pre-specified
Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay(OPA) for7 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 infant series dose 2 and after the toddler dose
Population: OPAS were done in a subset of approximately 100 subjects (range 90-100 per serotype) in the 13vPnC group
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 9V | 3585.80 Titers |
| 13vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 1 | 62.63 Titers |
| 13vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 18C | 294.48 Titers |
| 13vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 3 | 176.07 Titers |
| 13vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 6B | 191.34 Titers |
| 13vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 5 | 127.11 Titers |
| 13vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 19F | 222.86 Titers |
| 13vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 6A | 541.81 Titers |
| 13vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 14 | 1882.96 Titers |
| 13vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 7F | 5914.33 Titers |
| 13vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 23F | 487.51 Titers |
| 13vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 19F | 157.59 Titers |
| 13vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 4 | 526.69 Titers |
| 7vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 19F | 1415.08 Titers |
| 7vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 4 | 1276.21 Titers |
| 7vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 6B | 2383.31 Titers |
| 7vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 9V | 16384.00 Titers |
| 7vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 14 | 1903.89 Titers |
| 7vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 18C | 1324.41 Titers |
| 7vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 19F | 391.97 Titers |
| 7vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 23F | 3679.67 Titers |
| 7vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 1 | 294.07 Titers |
| 7vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 3 | 504.66 Titers |
| 7vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 5 | 333.24 Titers |
| 7vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 6A | 2217.29 Titers |
| 7vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 7F | 14886.35 Titers |
Other Pre-specified
Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Percentage of subjects 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. (This is not a geometric mean comparison as suggested by the table row heading).
Time frame: one month after infant series dose 2 and after the toddler dose
Population: OPAs were done in a subset of approximately 100 subjects (range 90-100 per serotype) in the 13vPnC group
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 14 | 100.0 % Achieving OPA Titer ≥1:8 |
| 13vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 1 | 94.8 % Achieving OPA Titer ≥1:8 |
| 13vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 6B | 90.0 % Achieving OPA Titer ≥1:8 |
| 13vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 3 | 99.0 % Achieving OPA Titer ≥1:8 |
| 13vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 18C | 97.0 % Achieving OPA Titer ≥1:8 |
| 13vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 5 | 96.0 % Achieving OPA Titer ≥1:8 |
| 13vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 9V | 100.0 % Achieving OPA Titer ≥1:8 |
| 13vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 6A | 95.9 % Achieving OPA Titer ≥1:8 |
| 13vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 19F | 96.0 % Achieving OPA Titer ≥1:8 |
| 13vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 7F | 100.0 % Achieving OPA Titer ≥1:8 |
| 13vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 4 | 100.0 % Achieving OPA Titer ≥1:8 |
| 13vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 19A | 95.6 % Achieving OPA Titer ≥1:8 |
| 13vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 23F | 97.0 % Achieving OPA Titer ≥1:8 |
| 7vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 19A | 100.0 % Achieving OPA Titer ≥1:8 |
| 7vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 4 | 100.0 % Achieving OPA Titer ≥1:8 |
| 7vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 9V | 100.0 % Achieving OPA Titer ≥1:8 |
| 7vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 14 | 100.0 % Achieving OPA Titer ≥1:8 |
| 7vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 18C | 100.0 % Achieving OPA Titer ≥1:8 |
| 7vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 19F | 97.9 % Achieving OPA Titer ≥1:8 |
| 7vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 23F | 100.0 % Achieving OPA Titer ≥1:8 |
| 7vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 1 | 100.0 % Achieving OPA Titer ≥1:8 |
| 7vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 3 | 100.0 % Achieving OPA Titer ≥1:8 |
| 7vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 5 | 100.0 % Achieving OPA Titer ≥1:8 |
| 7vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 6A | 100.0 % Achieving OPA Titer ≥1:8 |
| 7vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Additional Serotypes - Serotype 7F | 100.0 % Achieving OPA Titer ≥1:8 |
| 7vPnC Dose 1 | Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose | Common Serotypes - Serotype 6B | 99.0 % Achieving OPA Titer ≥1:8 |