Vaccines, Pneumococcal
Conditions
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 vaccines in the United Kingdom.
Interventions
BIOLOGICAL13-valent Pneumococcal Conjugate Vaccine
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age
BIOLOGICAL7vPnC
Single 0.5 mL dose given at 2, 3, 4 and 12 months of age
BIOLOGICALPediacel
concommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age
BIOLOGICALNeisVac-C
concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age
BIOLOGICALMenitorix
concomitant vaccine, both at arm 1 and at arm 2, at 12 months of age
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
42 Days to 98 Days
Healthy volunteers
Yes
Inclusion criteria
1. Aged 2 months (42 to 98 days) at the 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. 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 meningococcal vaccines. 3. A previous anaphylactic reaction to any vaccine or vaccine-related component. 4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, pneumococcal conjugate, or meningococcal conjugate 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, Neisseria meningitidis, 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. This did not include resolving syndromes due to birth trauma such as Erb palsy. 10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®). 11. Participation in another investigational trial. Participation in purely observational studies was acceptable. 12. Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | one month after infant series dose 2 (5 months of age) and before and after toddler dose (12 months of age) | Antibody concentration/geometric mean concentration (GMC) as measured by ELISA for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented with corresponding 2-sided 95% CI. |
| Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | One month after infant series dose 2 (5 months of age) | Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥1:8 and predefined antibody threshold levels with the corresponding 95% CI for concomitant antigens polyribosylribitol phosphate (PRP) in haemophilus influenzae type b \[Hib\](≥0.15 μg/mL or ≥ 1.0 μg/mL), pertussis toxoid \[PT\], filamentous haemagglutinin, pertactin \[FHA\], and pertactin (PRN) (≥5 Elisa Units EU/mL) and fimbrial agglutinogens \[FIM\] (≥2.2 EU/mL) are presented. |
| Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series | one month after infant series dose 2 (5 months of age) | — |
| Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series | one month after infant series dose 2 (5 months of age) | — |
| Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series | one month after infant series dose 2 (5 months of age) | — |
| Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | one month after infant series dose 2 (5 months of age), before and after 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. |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving an SBA Titer ≥1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose. | one month after the toddler dose (13 months of age) |
| Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose. | one month after toddler dose (13 months of age) |
| Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose. | one month after toddler dose (13 months of age) |
| Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | one month after toddler dose (13 months of age) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Pre-Specified Local Reactions | During the 4-day period after each dose | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (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 ≥ 38 degrees Celsius \[C\] but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds) to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary; percentage of participants with each event was evaluated. |
Countries
United Kingdom
Participant flow
Recruitment details
Participants were recruited in the United Kingdom (UK) from October 2006 to June 2007.
Pre-assignment details
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose). | 120 |
| 7vPnC Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose). | 118 |
| Total | 238 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| After Infant Series | Adverse Event | 0 | 1 |
| After Infant Series | Failed to Return | 0 | 2 |
| After Infant Series | Lost to Follow-up | 0 | 1 |
| After Infant Series | Physician Decision | 0 | 1 |
| After Infant Series | Protocol Violation | 2 | 3 |
| After Infant Series | Withdrawal by Subject | 2 | 2 |
| Infant Series | Adverse Event | 1 | 2 |
| Infant Series | Lost to Follow-up | 0 | 1 |
| Infant Series | Not consented | 2 | 6 |
| Infant Series | Protocol Violation | 1 | 2 |
| Infant Series | Withdrawal by Subject | 2 | 2 |
| Toddler Dose | Failed to return | 0 | 1 |
| Toddler Dose | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | 13vPnC | 7vPnC | Total |
|---|---|---|---|
| Age Continuous | 2.1 months STANDARD_DEVIATION 0.3 | 2.1 months STANDARD_DEVIATION 0.2 | 2.1 months STANDARD_DEVIATION 0.3 |
| Sex: Female, Male Female | 55 Participants | 57 Participants | 112 Participants |
| Sex: Female, Male Male | 65 Participants | 61 Participants | 126 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 | 111 / 138 | 105 / 139 | 9 / 138 | 8 / 139 | 72 / 130 | 61 / 122 | 1 / 138 | 1 / 139 |
| serious Total, serious adverse events | 1 / 139 | 3 / 139 | 5 / 139 | 2 / 139 | 1 / 131 | 2 / 122 | 2 / 138 | 0 / 139 |
Outcome results
Primary
Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.
Antibody concentration/geometric mean concentration (GMC) as measured by ELISA for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented with corresponding 2-sided 95% CI.
Time frame: one month after infant series dose 2 (5 months of age) and before and after toddler dose (12 months of age)
Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 18C (n=111,91,91) | 1.37 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Additional Serotypes - Serotype 3 (n=107,85,85) | 0.63 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Additional Serotypes - Serotype 19A (n=110,89,89) | 1.90 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Additional Serotypes - Serotype 5 (n=103,86,86) | 0.95 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Additional Serotypes - Serotype 6A (n=106,83,83) | 0.86 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 4 (n=107,87,87) | 1.37 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Additional Serotypes - Serotype 7F (n=107,87,87) | 2.14 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 14 (n=107,87,87) | 1.83 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 6B (n=107,85,85) | 0.26 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 9V (n=104,88,88) | 0.87 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Additional Serotypes - Serotype 1 (n=107,85,85) | 1.69 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 19F (n=109,90,90) | 2.38 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 23F (n=111,88,88) | 0.53 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 18C (n=111,91,91) | 0.20 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 23F (n=111,88,88) | 0.24 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Additional Serotypes - Serotype 3 (n=107,85,85) | 0.14 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Additional Serotypes - Serotype 1 (n=107,85,85) | 0.39 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 9V (n=104,88,88) | 0.29 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 19F (n=109,90,90) | 0.60 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Additional Serotypes - Serotype 6A (n=106,83,83) | 0.81 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 14 (n=107,87,87) | 1.34 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Additional Serotypes - Serotype 5 (n=103,86,86) | 0.59 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Additional Serotypes - Serotype 7F (n=107,87,87) | 0.56 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 4 (n=107,87,87) | 0.21 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Additional Serotypes - Serotype 19A (n=110,89,89) | 1.01 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 6B (n=107,85,85) | 0.77 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Additional Serotypes - Serotype 19A (n=110,89,89) | 11.33 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 6B (n=107,85,85) | 7.67 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 18C (n=111,91,91) | 2.14 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Additional Serotypes - Serotype 5 (n=103,86,86) | 3.68 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 4 (n=107,87,87) | 3.52 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 9V (n=104,88,88) | 2.46 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 14 (n=107,87,87) | 11.32 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 19F (n=109,90,90) | 7.25 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Common Serotypes - Serotype 23F (n=111,88,88) | 3.13 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Additional Serotypes - Serotype 1 (n=107,85,85) | 5.60 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Additional Serotypes - Serotype 3 (n=107,85,85) | 0.98 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Additional Serotypes - Serotype 6A (n=106,83,83) | 6.31 μg/mL |
| 13vPnC After Toddler Dose | Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. | Additional Serotypes - Serotype 7F (n=107,87,87) | 4.06 μg/mL |
Primary
Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
Time frame: one month after infant series dose 2 (5 months of age)
Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants 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 antibody concentration/titer for the specified concomitant antigen.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 13vPnC | Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series | 3.40 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series | 4.44 μg/mL |
Comparison: For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.54, 1.08]
Primary
Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
Time frame: one month after infant series dose 2 (5 months of age)
Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants 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 antibody concentration/titer for the specified concomitant antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series | Pertussis FHA (n=119,113) | 54.74 EU/mL |
| 13vPnC | Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series | Pertussis PT (n=119,112) | 66.26 EU/mL |
| 13vPnC | Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series | Pertussis PRN (n=119,113) | 61.33 EU/mL |
| 13vPnC | Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series | Pertussis FIM (n=119,113) | 21.72 EU/mL |
| 7vPnC | Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series | Pertussis FIM (n=119,113) | 21.77 EU/mL |
| 7vPnC | Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series | Pertussis FHA (n=119,113) | 55.99 EU/mL |
| 7vPnC | Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series | Pertussis PRN (n=119,113) | 61.07 EU/mL |
| 7vPnC | Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series | Pertussis PT (n=119,112) | 67.05 EU/mL |
Comparison: For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.82, 1.16]
Comparison: For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.83, 1.17]
Comparison: For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.8, 1.26]
Comparison: For Pertussis FIM the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.81, 1.23]
Primary
Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
Time frame: one month after infant series dose 2 (5 months of age)
Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants 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 antibody concentration/titer for the specified concomitant antigen.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 13vPnC | Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series | 306.20 titer |
| 7vPnC | Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series | 345.42 titer |
Comparison: For Meningococcal C the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.68, 1.16]
Primary
Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.
Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥1:8 and predefined antibody threshold levels with the corresponding 95% CI for concomitant antigens polyribosylribitol phosphate (PRP) in haemophilus influenzae type b \[Hib\](≥0.15 μg/mL or ≥ 1.0 μg/mL), pertussis toxoid \[PT\], filamentous haemagglutinin, pertactin \[FHA\], and pertactin (PRN) (≥5 Elisa Units EU/mL) and fimbrial agglutinogens \[FIM\] (≥2.2 EU/mL) are presented.
Time frame: One month after infant series dose 2 (5 months of age)
Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants 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 series antibody concentration to the given concomitant antigen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Hib (PRP) ≥ 1.0 μg/mL (n=114,102) | 85.1 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Pertussis FHA ≥ 20 EU/mL (n=119,113) | 94.1 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Pertussis PT ≥ 17 EU/mL (n=119,112) | 96.6 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Pertussis PRN ≥ 5 EU/mL (n=119,113) | 100.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Hib (PRP) ≥ 0.15 μg/mL (n=114,102) | 96.5 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Pertussis PRN ≥ 15 EU/mL (n=119,113) | 92.4 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Pertussis FHA ≥ 5 EU/mL (n=119,113) | 100.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Pertussis FIM ≥ 2.2 EU/mL (n=119,113) | 100.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Pertussis PT ≥ 5 EU/mL (n=119,112) | 100.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Pertussis FIM ≥ 5 EU/mL (n=119,113) | 97.5 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Pertussis FHA ≥ 7.82 EU/mL (n=119,113) | 100.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Meningococcal C ≥ 1:8 titer (n=120,118) | 99.2 Percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Pertussis FHA ≥ 7.82 EU/mL (n=119,113) | 100.0 Percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Hib (PRP) ≥ 0.15 μg/mL (n=114,102) | 98.0 Percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Hib (PRP) ≥ 1.0 μg/mL (n=114,102) | 89.2 Percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Pertussis PT ≥ 5 EU/mL (n=119,112) | 100.0 Percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Pertussis PT ≥ 17 EU/mL (n=119,112) | 95.5 Percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Pertussis FHA ≥ 5 EU/mL (n=119,113) | 100.0 Percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Meningococcal C ≥ 1:8 titer (n=120,118) | 99.2 Percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Pertussis FHA ≥ 20 EU/mL (n=119,113) | 95.6 Percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Pertussis PRN ≥ 5 EU/mL (n=119,113) | 100.0 Percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Pertussis PRN ≥ 15 EU/mL (n=119,113) | 95.6 Percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Pertussis FIM ≥ 2.2 EU/mL (n=119,113) | 97.3 Percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. | Pertussis FIM ≥ 5 EU/mL (n=119,113) | 96.5 Percentage of participants |
Comparison: For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated95% CI: [-3.8, 3.9]
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: [-7.1, 3.7]
Comparison: For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated95% CI: [-13.4, 5.1]
Comparison: For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated95% CI: [-3.2, 3.3]
Comparison: For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 17 EU/mL threshold was calculated95% CI: [-4.5, 7.1]
Comparison: For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated95% CI: [-3.2, 3.2]
Comparison: For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated95% CI: [-3.2, 3.2]
Comparison: For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 20 EU/mL threshold was calculated95% CI: [-7.9, 4.8]
Comparison: For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated95% CI: [-3.2, 3.2]
Comparison: For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 15 EU/mL threshold was calculated95% CI: [-10, 3.4]
Comparison: For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 2.2 EU/mL threshold was calculated95% CI: [-0.5, 7.6]
Comparison: For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated95% CI: [-4.1, 6.5]
Primary
Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and 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 infant series dose 2 (5 months of age), before and after toddler dose (12 months of age)
Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate igG antibody concentration to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Additional Serotypes - Serotype 3 (n=107,87,102) | 86.0 Percentage of Participants |
| 13vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Additional Serotypes - Serotype 19A (n=110,91,103) | 92.7 Percentage of Participants |
| 13vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 19F (n=109,91,104) | 93.6 Percentage of Participants |
| 13vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Additional Serotypes - Serotype 7F (n=107,91,100) | 94.4 Percentage of Participants |
| 13vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 14 (n=107,88,101) | 92.5 Percentage of Participants |
| 13vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 4 (n=107,89,102) | 95.3 Percentage of Participants |
| 13vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 18C (n=111,91,105) | 92.8 Percentage of Participants |
| 13vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 9V (n=104,91,101) | 85.6 Percentage of Participants |
| 13vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Additional Serotypes - Serotype 6A (n=106,86,99) | 79.2 Percentage of Participants |
| 13vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 6B (n=107,86,102) | 40.2 Percentage of Participants |
| 13vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 23F (n=111,89,104) | 66.7 Percentage of Participants |
| 13vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Additional Serotypes - Serotype 5 (n=103,88,101) | 89.3 Percentage of Participants |
| 13vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Additional Serotypes - Serotype 1 (n=107,88,101) | 97.2 Percentage of Participants |
| 7vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 23F (n=111,89,104) | 37.1 Percentage of Participants |
| 7vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 6B (n=107,86,102) | 74.4 Percentage of Participants |
| 7vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 9V (n=104,91,101) | 44.0 Percentage of Participants |
| 7vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 18C (n=111,91,105) | 13.2 Percentage of Participants |
| 7vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 19F (n=109,91,104) | 67.0 Percentage of Participants |
| 7vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Additional Serotypes - Serotype 3 (n=107,87,102) | 12.6 Percentage of Participants |
| 7vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 4 (n=107,89,102) | 24.7 Percentage of Participants |
| 7vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 14 (n=107,88,101) | 92.0 Percentage of Participants |
| 7vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Additional Serotypes - Serotype 1 (n=107,88,101) | 50.0 Percentage of Participants |
| 7vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Additional Serotypes - Serotype 5 (n=103,88,101) | 78.4 Percentage of Participants |
| 7vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Additional Serotypes - Serotype 6A (n=106,86,99) | 79.1 Percentage of Participants |
| 7vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Additional Serotypes - Serotype 7F (n=107,91,100) | 71.4 Percentage of Participants |
| 7vPnC | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Additional Serotypes - Serotype 19A (n=110,91,103) | 86.8 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Additional Serotypes - Serotype 1 (n=107,88,101) | 100.0 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 23F (n=111,89,104) | 98.1 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 9V (n=104,91,101) | 98.0 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Additional Serotypes - Serotype 5 (n=103,88,101) | 100.0 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 18C (n=111,91,105) | 97.1 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 6B (n=107,86,102) | 98.0 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Additional Serotypes - Serotype 6A (n=106,86,99) | 98.0 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 4 (n=107,89,102) | 99.0 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Additional Serotypes - Serotype 19A (n=110,91,103) | 100.0 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 19F (n=109,91,104) | 98.1 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Common Serotypes - Serotype 14 (n=107,88,101) | 100.0 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Additional Serotypes - Serotype 3 (n=107,87,102) | 88.2 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose | Additional Serotypes - Serotype 7F (n=107,91,100) | 100.0 Percentage of Participants |
Secondary
Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose.
Time frame: one month after toddler dose (13 months of age)
Population: Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N) = number of participants with a determinate antibody concentration/titer to the specific concomitant antigen.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 13vPnC | Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose. | 22.22 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose. | 19.75 μg/mL |
Comparison: For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.83, 1.53]
Secondary
Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Time frame: one month after toddler dose (13 months of age)
Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants 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 antibody concentration/titer for the specified concomitant antigen.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 13vPnC | Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | 656.11 titer |
| 7vPnC | Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | 771.67 titer |
Comparison: For Meningococcal C the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.48, 1.49]
Secondary
Percentage of Participants Achieving an SBA Titer ≥1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose.
Time frame: one month after the toddler dose (13 months of age)
Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate posttoddler dose antibody concentration to the given concomitant antigen.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 13vPnC | Percentage of Participants Achieving an SBA Titer ≥1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose. | 44.1 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving an SBA Titer ≥1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose. | 49.5 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Achieving an SBA Titer ≥1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose. | 91.7 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Achieving an SBA Titer ≥1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose. | 91.8 Percentage of Participants |
Comparison: For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated95% CI: [-19.7, 8.8]
Comparison: For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated95% CI: [-8, 8.1]
Secondary
Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose.
Time frame: one month after toddler dose (13 months of age)
Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N) = number of participants with a determinate posttoddler dose antibody concentration to the given concomitant antigen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose. | Hib (PRP) ≥0.15 μg/mL | 100.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose. | Hib (PRP)≥1.0 μg/mL | 99.0 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose. | Hib (PRP) ≥0.15 μg/mL | 100.0 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose. | Hib (PRP)≥1.0 μg/mL | 100.0 Percentage of Participants |
Comparison: For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated95% CI: [-3.5, 3.8]
Comparison: For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated95% CI: [-5.3, 2.8]
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (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 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Significant (n=116,122,97,89,77,58) | 1.7 Percentage of Participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=120,125,105,93,82,66) | 21.7 Percentage of Participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=122,126,106,99,83,71) | 21.3 Percentage of Participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=121,126,106,93,83,68) | 24.8 Percentage of Participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Moderate (n=116,119,98,88,78,61) | 1.7 Percentage of Participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=115,119,97,88,76,57) | 0.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=122,126,107,99,85,73) | 22.1 Percentage of Participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=123,127,114,96,87,71) | 44.7 Percentage of Participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Moderate (n=118,121,98,88,77,60) | 6.8 Percentage of Participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe (n=115,119,96,88,76,57) | 0.0 Percentage of Participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=123,127,114,96,87,71) | 43.3 Percentage of Participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Moderate (n=118,121,98,88,77,60) | 6.6 Percentage of Participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe (n=115,119,96,88,76,57) | 0.0 Percentage of Participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=122,126,106,99,83,71) | 39.7 Percentage of Participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Significant (n=116,122,97,89,77,58) | 6.6 Percentage of Participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Moderate (n=116,119,98,88,78,61) | 0.0 Percentage of Participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=121,126,106,93,83,68) | 29.4 Percentage of Participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=120,125,105,93,82,66) | 27.2 Percentage of Participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=115,119,97,88,76,57) | 0.0 Percentage of Participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=122,126,107,99,85,73) | 39.7 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=122,126,107,99,85,73) | 39.3 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=115,119,97,88,76,57) | 2.1 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe (n=115,119,96,88,76,57) | 1.0 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Moderate (n=116,119,98,88,78,61) | 4.1 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=123,127,114,96,87,71) | 42.1 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=122,126,106,99,83,71) | 37.7 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Significant (n=116,122,97,89,77,58) | 4.1 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Moderate (n=118,121,98,88,77,60) | 8.2 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=121,126,106,93,83,68) | 30.2 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=120,125,105,93,82,66) | 28.6 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=115,119,97,88,76,57) | 0.0 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=120,125,105,93,82,66) | 29.0 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Moderate (n=118,121,98,88,77,60) | 6.8 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=123,127,114,96,87,71) | 40.6 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Significant (n=116,122,97,89,77,58) | 4.5 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=121,126,106,93,83,68) | 34.4 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe (n=115,119,96,88,76,57) | 0.0 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=122,126,107,99,85,73) | 40.4 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=122,126,106,99,83,71) | 37.4 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Moderate (n=116,119,98,88,78,61) | 3.4 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=122,126,106,99,83,71) | 33.7 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=123,127,114,96,87,71) | 44.8 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=122,126,107,99,85,73) | 38.8 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=120,125,105,93,82,66) | 28.0 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Moderate (n=116,119,98,88,78,61) | 12.8 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Significant (n=116,122,97,89,77,58) | 3.9 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=121,126,106,93,83,68) | 30.1 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=115,119,97,88,76,57) | 0.0 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe (n=115,119,96,88,76,57) | 0.0 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Moderate (n=118,121,98,88,77,60) | 3.9 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe (n=115,119,96,88,76,57) | 0.0 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=121,126,106,93,83,68) | 39.7 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=122,126,106,99,83,71) | 49.3 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=122,126,107,99,85,73) | 53.4 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Significant (n=116,122,97,89,77,58) | 3.4 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=123,127,114,96,87,71) | 50.7 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=115,119,97,88,76,57) | 0.0 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Moderate (n=116,119,98,88,78,61) | 16.4 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Moderate (n=118,121,98,88,77,60) | 11.7 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=120,125,105,93,82,66) | 34.8 Percentage of Participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events
Systemic events (fever ≥ 38 degrees Celsius \[C\] but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds) to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary; percentage of participants with each event was evaluated.
Time frame: During the 4-day period after each dose
Population: 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 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=128,135,117,119,97,80) | 76.6 Percentage of Participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite (n=120,129,104,98,92,68) | 39.2 Percentage of Participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C (n=115,119,96,88,76,57) | 0.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds to prevent symptoms (n=122,124,117,103,92,77) | 49.2 Percentage of Participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds to treat symptoms (n=123,128,108,110,85,72) | 43.9 Percentage of Participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep (n=119,124,98,100,81,67) | 32.8 Percentage of Participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C (n=115,119,95,88,76,58) | 0.9 Percentage of Participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C (n=116,119,96,88,78,61) | 6.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep (n=129,129,114,109,88,71) | 69.8 Percentage of Participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds to prevent symptoms (n=122,124,117,103,92,77) | 40.3 Percentage of Participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C (n=116,119,96,88,78,61) | 3.4 Percentage of Participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C (n=115,119,95,88,76,58) | 0.0 Percentage of Participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C (n=115,119,96,88,76,57) | 0.0 Percentage of Participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite (n=120,129,104,98,92,68) | 34.1 Percentage of Participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep (n=129,129,114,109,88,71) | 66.7 Percentage of Participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep (n=119,124,98,100,81,67) | 33.9 Percentage of Participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=128,135,117,119,97,80) | 74.1 Percentage of Participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds to treat symptoms (n=123,128,108,110,85,72) | 40.6 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds to prevent symptoms (n=122,124,117,103,92,77) | 48.7 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep (n=129,129,114,109,88,71) | 51.8 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite (n=120,129,104,98,92,68) | 35.6 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C (n=115,119,96,88,76,57) | 2.1 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds to treat symptoms (n=123,128,108,110,85,72) | 50.9 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C (n=116,119,96,88,78,61) | 3.1 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C (n=115,119,95,88,76,58) | 0.0 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep (n=119,124,98,100,81,67) | 35.7 Percentage of Participants |
| 13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=128,135,117,119,97,80) | 71.8 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep (n=119,124,98,100,81,67) | 38.0 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite (n=120,129,104,98,92,68) | 37.8 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=128,135,117,119,97,80) | 80.7 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds to prevent symptoms (n=122,124,117,103,92,77) | 50.5 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds to treat symptoms (n=123,128,108,110,85,72) | 54.5 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C (n=115,119,96,88,76,57) | 0.0 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep (n=129,129,114,109,88,71) | 56.9 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C (n=115,119,95,88,76,58) | 0.0 Percentage of Participants |
| 7vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C (n=116,119,96,88,78,61) | 4.5 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C (n=115,119,95,88,76,58) | 0.0 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=128,135,117,119,97,80) | 74.2 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds to treat symptoms (n=123,128,108,110,85,72) | 49.4 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep (n=129,129,114,109,88,71) | 38.6 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep (n=119,124,98,100,81,67) | 32.1 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C (n=116,119,96,88,78,61) | 7.7 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds to prevent symptoms (n=122,124,117,103,92,77) | 52.2 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite (n=120,129,104,98,92,68) | 39.1 Percentage of Participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C (n=115,119,96,88,76,57) | 0.0 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C (n=115,119,96,88,76,57) | 0.0 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds to treat symptoms (n=123,128,108,110,85,72) | 58.3 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C (n=116,119,96,88,78,61) | 16.4 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C (n=115,119,95,88,76,58) | 5.2 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep (n=129,129,114,109,88,71) | 40.8 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=128,135,117,119,97,80) | 76.3 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite (n=120,129,104,98,92,68) | 44.1 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds to prevent symptoms (n=122,124,117,103,92,77) | 67.5 Percentage of Participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep (n=119,124,98,100,81,67) | 44.8 Percentage of Participants |