Vaccines, Pneumococcal
Conditions
Keywords
Vaccine, Infants, Pneumococcal Conjugate Vaccines, Vaccines, Pneumococcal
Brief summary
The purpose of this study will be to evaluate safety, tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied for consistency of the immune response, as well as for non-inferiority and safety as compared to 7-valent Pneumococcal Conjugate Vaccine.
Interventions
BIOLOGICAL13-valent Pneumococcal Conjugate Vaccine
0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
BIOLOGICAL7vPnC
0.5 mL of study vaccine administered IM at 2, 4, 6, and 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
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
42 Days to 98 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy 2 month old infants * Available for the duration of the study and reachable by telephone * Able to complete two blood drawing procedures during the study
Exclusion criteria
* Previous vaccination, contraindication or history of allergic reaction to vaccines or vaccine components * Bleeding disorder, immune deficiency or significant chronic or congenital disease * Previous receipt of blood products or immune globulin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | 1 Month after the infant series (7 Months of age) | Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. |
| Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | 1 month after the infant series (7 months of age) | Percentage of participants achieving predefined antibody threshold ≥10.0 mIU/ mL along with the corresponding 95% CI for concomitant antigen hepatitis B are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot. |
| Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | 1 month after the infant series (7 months of age) | Percentage of participants achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen poliovirus type 1, type 2, and type 3 (Sabin strains 1, 2, 3) are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot. |
| Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | 1 month after the infant series (7 months of age) | Percentage of participants achieving predefined antibody threshold ≥0.1 IU/ mL along with the corresponding 95% CI for concomitant antigen tetanus toxoid are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | 1 month after the infant series (7 months of age) | Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. |
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | 1 month after the toddler dose (13 months of age) | Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. |
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series | 1 month after the infant series (7 months of age) | Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. |
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | 1 month after the toddler dose (13 months of age) | Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | 1 month after the toddler dose (13 months of age) | Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Within 7 days after dose (2 months of age) | Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Within 7 days after dose (12 months of age) | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 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 Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Within 7 days after dose (6 months of age) | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 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 Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Within 7 days after dose (4 months of age) | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 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 Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Within 7 days after dose (4 months of age) | Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Within 7 days after dose (6 months of age) | Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Within 7 days after dose (12 months of age) | Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Within 7 days after dose (2 months of age) | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC (Pilot Lot 1) Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age. | 489 |
| 13vPnC (Pilot Lot 2) Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age. | 488 |
| 13vPnC (Manufacturing Lot) Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age. | 489 |
| 7vPnC Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age. | 246 |
| Total | 1,712 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| After Infant Series | Adverse Event | 2 | 2 | 0 | 0 |
| After Infant Series | Failed to return | 7 | 6 | 5 | 1 |
| After Infant Series | Investigator request | 0 | 0 | 0 | 1 |
| After Infant Series | Lost to Follow-up | 5 | 5 | 5 | 2 |
| After Infant Series | Other | 0 | 1 | 1 | 1 |
| After Infant Series | Parent or legal guardian request | 4 | 11 | 6 | 3 |
| After Infant Series | Protocol Violation | 2 | 4 | 2 | 2 |
| Infant Series | Adverse Event | 1 | 2 | 2 | 0 |
| Infant Series | Death | 0 | 1 | 1 | 1 |
| Infant Series | Failed to return | 5 | 4 | 4 | 2 |
| Infant Series | Investigator request | 4 | 3 | 3 | 2 |
| Infant Series | Lost to Follow-up | 10 | 11 | 7 | 6 |
| Infant Series | Other | 0 | 1 | 0 | 0 |
| Infant Series | Parent or legal guardian request | 18 | 29 | 34 | 14 |
| Infant Series | Protocol Violation | 16 | 8 | 6 | 3 |
| Toddler Dose | Failed to return | 2 | 2 | 1 | 3 |
| Toddler Dose | Lost to Follow-up | 4 | 1 | 1 | 3 |
| Toddler Dose | Parent or legal guardian request | 0 | 3 | 2 | 1 |
| Toddler Dose | Protocol Violation | 1 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | 13vPnC (Pilot Lot 1) | 13vPnC (Pilot Lot 2) | 13vPnC (Manufacturing Lot) | 7vPnC | Total |
|---|---|---|---|---|---|
| Age Continuous | 2.2 months STANDARD_DEVIATION 0.3 | 2.2 months STANDARD_DEVIATION 0.3 | 2.2 months STANDARD_DEVIATION 0.3 | 2.2 months STANDARD_DEVIATION 0.3 | 2.2 months STANDARD_DEVIATION 0.3 |
| Sex/Gender, Customized Female | 230 participants | 226 participants | 213 participants | 115 participants | 784 participants |
| Sex/Gender, Customized Male | 259 participants | 260 participants | 275 participants | 131 participants | 925 participants |
| Sex/Gender, Customized Unknown | 0 participants | 2 participants | 1 participants | 0 participants | 3 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 | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 407 / 486 | 394 / 483 | 402 / 483 | 207 / 244 | 88 / 1,445 | 11 / 244 | 771 / 1,210 | 128 / 208 | 37 / 1,443 | 9 / 244 |
| serious Total, serious adverse events | 13 / 486 | 23 / 483 | 17 / 483 | 15 / 244 | 25 / 1,445 | 3 / 244 | 9 / 1,210 | 1 / 208 | 21 / 1,443 | 7 / 244 |
Outcome results
Primary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series
Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Time frame: 1 Month after the infant series (7 Months of age)
Population: Evaluable immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations; (n)=number of participants with IgG antibody concentration to given serotype for the three 13vPnC lots, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 7F (n=412,401,397) | 2.54 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 3 (n=406, 391,393) | 0.52 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 19F (n=408, 399, 398) | 1.85 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 9V (n=411, 403, 396) | 1.05 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 1 (n=411, 403,395) | 1.62 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 23F (n=411, 402, 399) | 1.24 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 4 (n=411, 404, 398) | 1.33 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 6B (n=409, 401, 396) | 2.89 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 6A (n=413,402,398) | 2.40 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 14 (n=398. 387, 387) | 4.97 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotype - serotype 19A (n=411,403,397) | 1.85 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 5 (n=412, 402,393) | 1.35 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 18C (n=413, 401, 398) | 1.30 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 23F (n=411, 402, 399) | 1.27 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 4 (n=411, 404, 398) | 1.34 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 6B (n=409, 401, 396) | 2.15 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 9V (n=411, 403, 396) | 1.11 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 14 (n=398. 387, 387) | 5.13 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 18C (n=413, 401, 398) | 1.34 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 19F (n=408, 399, 398) | 2.07 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 1 (n=411, 403,395) | 1.81 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 3 (n=406, 391,393) | 0.56 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 5 (n=412, 402,393) | 1.05 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 6A (n=413,402,398) | 2.10 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 7F (n=412,401,397) | 2.52 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotype - serotype 19A (n=411,403,397) | 2.00 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 3 (n=406, 391,393) | 0.61 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 14 (n=398. 387, 387) | 5.18 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 7F (n=412,401,397) | 2.67 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 5 (n=412, 402,393) | 1.35 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 9V (n=411, 403, 396) | 1.11 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 4 (n=411, 404, 398) | 1.75 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 6A (n=413,402,398) | 2.12 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 23F (n=411, 402, 399) | 1.03 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 19F (n=408, 399, 398) | 2.59 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 6B (n=409, 401, 396) | 2.54 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 1 (n=411, 403,395) | 1.91 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 18C (n=413, 401, 398) | 1.48 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotype - serotype 19A (n=411,403,397) | 1.88 GMC mcg/mL |
Comparison: Common serotypes - serotype 495% CI: [-0.11, 0.09]
Comparison: Common serotypes - serotype 495% CI: [-0.38, -0.17]
Comparison: Common serotypes - serotype 495% CI: [-0.37, -0.16]
Comparison: Common serotypes - serotype 6B95% CI: [0.13, 0.46]
Comparison: Common serotypes - serotype 6B95% CI: [-0.04, 0.29]
Comparison: Common serotypes - serotype 6B95% CI: [-0.33, -0.01]
Comparison: Common serotypes - serotype 9V95% CI: [-0.16, 0.04]
Comparison: Common serotypes - serotype 9V95% CI: [-0.16, 0.04]
Comparison: Common serotypes - serotype 9V95% CI: [-0.1, 0.1]
Comparison: Common serotypes - serotype 1495% CI: [-0.15, 0.09]
Comparison: Common serotypes - serotype 1495% CI: [-0.16, 0.08]
Comparison: Common serotypes - serotype 1495% CI: [-0.13, 0.11]
Comparison: Common serotypes - serotype 18C95% CI: [-0.13, 0.07]
Comparison: Common serotypes - serotype 18C95% CI: [-0.23, -0.03]
Comparison: Common serotypes - serotype 18C95% CI: [-0.2, 0]
Comparison: Common serotypes - serotype 23F95% CI: [-0.16, 0.11]
Comparison: Common serotypes - serotype 23F95% CI: [0.04, 0.31]
Comparison: Common serotypes - serotype 23F95% CI: [0.07, 0.34]
Comparison: Additional serotypes - serotype 195% CI: [-0.23, 0.01]
Comparison: Additional serotypes - serotype 195% CI: [-0.28, -0.04]
Comparison: Common serotypes - serotype 19F95% CI: [-0.22, -0.01]
Comparison: Common serotypes - serotype 19F95% CI: [-0.44, -0.23]
Comparison: Common serotypes - serotype 19F95% CI: [-0.33, -0.11]
Comparison: Additional serotypes - serotype 195% CI: [-0.17, 0.06]
Comparison: Additional serotypes - serotype 395% CI: [-0.19, 0.02]
Comparison: Additional serotypes - serotype 395% CI: [-0.28, -0.07]
Comparison: Additional serotypes - serotype 395% CI: [-0.19, 0.02]
Comparison: Additional serotypes - serotype 595% CI: [0.13, 0.37]
Comparison: Additional serotypes - serotype 595% CI: [-0.12, 0.12]
Comparison: Additional serotypes - serotype 595% CI: [-0.37, -0.13]
Comparison: Additional serotypes - serotype 6A95% CI: [0.02, 0.25]
Comparison: Additional serotypes - serotype 6A95% CI: [0.01, 0.24]
Comparison: Additional serotypes - serotype 6A95% CI: [-0.13, 0.11]
Comparison: Additional serotypes - serotype 7F95% CI: [-0.09, 0.1]
Comparison: Additional serotypes - serotype 7F95% CI: [-0.14, 0.04]
Comparison: Additional serotypes - serotype 7F95% CI: [-0.15, 0.04]
Comparison: Additional serotypes - serotype 19A95% CI: [-0.19, 0.03]
Comparison: Additional serotypes - serotype 19A95% CI: [-0.12, 0.09]
Comparison: Additional serotypes - serotype 19A95% CI: [-0.05, 0.17]
Primary
Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold ≥0.1 IU/ mL along with the corresponding 95% CI for concomitant antigen tetanus toxoid are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.
Time frame: 1 month after the infant series (7 months of age)
Population: Evaluable immunogenicity population. Combined 13vPnC group includes participants who received pilot lot 1, pilot lot 2, or manufacturing lot; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | 98.4 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | 98.5 observed percentage of participants |
Comparison: Tetanus toxoid: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.95% CI: [-3.3, 3]
Primary
Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold ≥10.0 mIU/ mL along with the corresponding 95% CI for concomitant antigen hepatitis B are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.
Time frame: 1 month after the infant series (7 months of age)
Population: Evaluable immunogenicity population; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | 100.0 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | 100.0 observed percentage of participants |
Comparison: Hepatitis B: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.95% CI: [-2.4, 2.2]
Primary
Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen poliovirus type 1, type 2, and type 3 (Sabin strains 1, 2, 3) are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.
Time frame: 1 month after the infant series (7 months of age)
Population: Evaluable immunogenicity population; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component; n)=number of participants with an antibody titer ≥ prespecified level for given concomitant vaccine antigen for combined 13vPnC and 7vPnC, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Poliovirus type 1 (n=183, 187) | 100.0 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Poliovirus type 2 (n=181, 186) | 98.9 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Poliovirus type 3 (n=182, 186) | 100.0 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Poliovirus type 1 (n=183, 187) | 100.0 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Poliovirus type 2 (n=181, 186) | 99.5 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Poliovirus type 3 (n=182, 186) | 99.5 observed percentage of participants |
Comparison: Poliovirus type 1: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.95% CI: [-2.1, 2]
Comparison: Poliovirus type 2: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.95% CI: [-3.4, 2]
Comparison: Poliovirus type 3: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.95% CI: [-1.5, 3]
Secondary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose
Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Time frame: 1 month after the toddler dose (13 months of age)
Population: Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 7F (n=366,343,358) | 4.35 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 3 (n=366,343,356) | 0.75 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 19F (n=362,342,353) | 4.51 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 9V (n=368,342,357) | 1.91 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 1 (n=367,344,357) | 2.75 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 23F (n=362,340,353) | 3.35 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 4 (n=364,342,355) | 2.29 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 6B (n=368,341,357) | 11.14 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 6A (n=366,342,355) | 7.52 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 14 (n=366,344,358) | 6.61 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotype - serotype 19A (n=362,341,353) | 8.41 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 5 (n=368,343,357) | 3.11 GMC mcg/mL |
| 13vPnC (Pilot Lot 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 18C (n=362,341,354) | 1.95 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 23F (n=362,340,353) | 3.46 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 4 (n=364,342,355) | 2.25 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 6B (n=368,341,357) | 9.33 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 9V (n=368,342,357) | 1.95 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 14 (n=366,344,358) | 7.05 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 18C (n=362,341,354) | 2.20 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 19F (n=362,342,353) | 4.67 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 1 (n=367,344,357) | 2.95 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 3 (n=366,343,356) | 0.71 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 5 (n=368,343,357) | 2.63 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 6A (n=366,342,355) | 6.97 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 7F (n=366,343,358) | 4.24 GMC mcg/mL |
| 13vPnC (Pilot Lot 2) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotype - serotype 19A (n=362,341,353) | 8.32 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 3 (n=366,343,356) | 0.80 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 14 (n=366,344,358) | 6.91 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 7F (n=366,343,358) | 4.58 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 5 (n=368,343,357) | 2.80 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 9V (n=368,342,357) | 1.99 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 4 (n=364,342,355) | 3.06 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 6A (n=366,342,355) | 6.83 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 23F (n=362,340,353) | 3.10 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 19F (n=362,342,353) | 6.51 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 6B (n=368,341,357) | 9.92 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 1 (n=367,344,357) | 3.01 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 18C (n=362,341,354) | 2.48 GMC mcg/mL |
| 13vPnC (Manufacturing Lot) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotype - serotype 19A (n=362,341,353) | 8.60 GMC mcg/mL |
Comparison: Common serotypes - serotype 495% CI: [-0.1, 0.13]
Comparison: Common serotypes - serotype 495% CI: [-0.41, -0.17]
Comparison: Common serotypes - serotype 495% CI: [-0.43, -0.19]
Comparison: Common serotypes - serotype 6B95% CI: [0.06, 0.3]
Comparison: Common serotypes - serotype 6B95% CI: [0, 0.23]
Comparison: Common serotypes - serotype 6B95% CI: [-0.18, 0.06]
Comparison: Common serotypes - serotype 9V95% CI: [-0.13, 0.09]
Comparison: Common serotypes - serotype 9V95% CI: [-0.15, 0.07]
Comparison: Common serotypes - serotype 9V95% CI: [-0.13, 0.09]
Comparison: Common serotypes - serotype 1495% CI: [-0.19, 0.06]
Comparison: Common serotypes - serotype 1495% CI: [-0.17, 0.08]
Comparison: Common serotypes - serotype 1495% CI: [-0.11, 0.15]
Comparison: Common serotypes - serotype 18C95% CI: [-0.25, 0]
Comparison: Common serotypes - serotype 18C95% CI: [-0.37, -0.12]
Comparison: Common serotypes - serotype 18C95% CI: [-0.25, 0.01]
Comparison: Common serotypes - serotype 19F95% CI: [-0.18, 0.11]
Comparison: Common serotypes - serotype 19F95% CI: [-0.51, -0.22]
Comparison: Common serotypes - serotype 19F95% CI: [-0.47, -0.2]
Comparison: Common serotypes - serotype 23F95% CI: [-0.17, 0.11]
Comparison: Common serotypes - serotype 23F95% CI: [-0.07, 0.22]
Comparison: Common serotypes - serotype 23F95% CI: [-0.03, 0.25]
Comparison: Additional serotypes - serotype 195% CI: [-0.2, 0.06]
Comparison: Additional serotypes - serotype 195% CI: [-0.21, 0.03]
Comparison: Additional serotypes - serotype 195% CI: [-0.15, 0.11]
Comparison: Additional serotypes - serotype 395% CI: [-0.06, 0.18]
Comparison: Additional serotypes - serotype 395% CI: [-0.18, 0.04]
Comparison: Additional serotypes - serotype 395% CI: [-0.25, -0.01]
Comparison: Additional serotypes - serotype 595% CI: [0.05, 0.28]
Comparison: Additional serotypes - serotype 595% CI: [0, 0.21]
Comparison: Additional serotypes - serotype 595% CI: [-0.17, 0.05]
Comparison: Additional serotypes - serotype 6A95% CI: [-0.04, 0.19]
Comparison: Additional serotypes - serotype 6A95% CI: [-0.02, 0.21]
Comparison: Additional serotypes - serotype 6A95% CI: [-0.1, 0.14]
Comparison: Additional serotypes - serotype 7F95% CI: [-0.1, 0.15]
Comparison: Additional serotypes - serotype 7F95% CI: [-0.17, 0.07]
Comparison: Additional serotypes - serotype 7F95% CI: [-0.2, 0.05]
Comparison: Additional serotypes - serotype 19A95% CI: [-0.11, 0.13]
Comparison: Additional serotypes - serotype 19A95% CI: [-0.14, 0.1]
Comparison: Additional serotypes - serotype 19A95% CI: [-0.15, 0.08]
Secondary
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Time frame: 1 month after the infant series (7 months of age)
Population: Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 7F (n=412,401,397) | 99.8 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 3 (n=406, 391,393) | 68.5 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 19F (n=408, 399, 398) | 97.8 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 9V (n=411, 403, 396) | 95.4 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 1 (n=411, 403,395) | 97.8 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 23F (n=411, 402, 399) | 91.2 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 4 (n=411, 404, 398) | 97.6 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 6B (n=409, 401, 396) | 94.9 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 6A (n=413,402,398) | 98.1 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 14 (n=398, 387, 387) | 99.2 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotype - serotype 19A (n=411,403,397) | 98.1 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 5 (n=412, 402,393) | 94.2 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 18C (n=413, 401, 398) | 97.8 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 23F (n=411, 402, 399) | 88.1 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 4 (n=411, 404, 398) | 95.5 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 6B (n=409, 401, 396) | 89.5 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 9V (n=411, 403, 396) | 95.5 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 14 (n=398, 387, 387) | 99.0 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 18C (n=413, 401, 398) | 95.8 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 19F (n=408, 399, 398) | 97.5 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 1 (n=411, 403,395) | 97.0 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 3 (n=406, 391,393) | 72.4 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 5 (n=412, 402,393) | 90.3 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 6A (n=413,402,398) | 95.5 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 7F (n=412,401,397) | 99.0 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotype - serotype 19A (n=411,403,397) | 99.0 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 3 (n=406, 391,393) | 79.1 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 14 (n=398, 387, 387) | 98.2 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 7F (n=412,401,397) | 99.7 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 5 (n=412, 402,393) | 94.4 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 9V (n=411, 403, 396) | 96.5 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 4 (n=411, 404, 398) | 98.5 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 6A (n=413,402,398) | 98.2 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 23F (n=411, 402, 399) | 87.2 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 19F (n=408, 399, 398) | 99.2 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 6B (n=409, 401, 396) | 94.4 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotypes - serotype 1 (n=411, 403,395) | 98.5 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Common serotypes - serotype 18C (n=413, 401, 398) | 98.0 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series | Additional serotype - serotype 19A (n=411,403,397) | 98.7 observed percentage of participants |
Comparison: Common serotypes - serotype 495% CI: [-0.51, 4.75]
Comparison: Common serotypes - serotype 495% CI: [-3.09, 1.1]
Comparison: Common serotypes - serotype 495% CI: [-5.58, -0.58]
Comparison: Common serotypes - serotype 6B95% CI: [1.55, 9.19]
Comparison: Common serotypes - serotype 6B95% CI: [-2.77, 3.66]
Comparison: Common serotypes - serotype 6B95% CI: [-8.82, -1.1]
Comparison: Common serotypes - serotype 9V95% CI: [-3.13, 2.83]
Comparison: Additional serotypes - serotype 195% CI: [-2.78, 1.34]
Comparison: Common serotypes - serotype 9V95% CI: [-3.97, 1.73]
Comparison: Common serotypes - serotype 9V95% CI: [-3.81, 1.88]
Comparison: Common serotypes - serotype 1495% CI: [-1.27, 1.95]
Comparison: Common serotypes - serotype 1495% CI: [-0.6, 3.01]
Comparison: Common serotypes - serotype 1495% CI: [-1.04, 2.76]
Comparison: Common serotypes - serotype 18C95% CI: [-0.38, 4.74]
Comparison: Common serotypes - serotype 18C95% CI: [-2.33, 1.99]
Comparison: Common serotypes - serotype 18C95% CI: [-4.89, 0.23]
Comparison: Common serotypes - serotype 19F95% CI: [-1.93, 2.6]
Comparison: Common serotypes - serotype 19F95% CI: [-3.46, 0.28]
Comparison: Common serotypes - serotype 19F95% CI: [-3.87, 0.02]
Comparison: Common serotypes - serotype 23F95% CI: [-1.03, 7.46]
Comparison: Common serotypes - serotype 23F95% CI: [-0.27, 8.39]
Comparison: Common serotypes - serotype 23F95% CI: [-3.75, 5.46]
Comparison: Additional serotypes - serotype 195% CI: [-1.48, 3.18]
Comparison: Additional serotypes - serotype 195% CI: [-3.77, 0.67]
Comparison: Additional serotypes - serotype 395% CI: [-10.27, 2.45]
Comparison: Additional serotypes - serotype 395% CI: [-16.8, -4.57]
Comparison: Additional serotypes - serotype 395% CI: [-12.76, -0.74]
Comparison: Additional serotypes - serotype 595% CI: [0.15, 7.69]
Comparison: Additional serotypes - serotype 595% CI: [-3.52, 3.09]
Comparison: Additional serotypes - serotype 595% CI: [-7.92, -0.36]
Comparison: Additional serotypes - serotype 6A95% CI: [0.12, 5.23]
Comparison: Additional serotypes - serotype 6A95% CI: [-2.22, 1.86]
Comparison: Additional serotypes - serotype 6A95% CI: [-5.39, -0.27]
Comparison: Additional serotypes - serotype 7F95% CI: [-0.47, 2.3]
Comparison: Additional serotypes - serotype 7F95% CI: [-1.12, 1.18]
Comparison: Additional serotypes - serotype 7F95% CI: [-2.3, 0.52]
Comparison: Additional serotypes - serotype 19A95% CI: [-2.91, 0.8]
Comparison: Additional serotypes - serotype 19A95% CI: [-2.69, 1.19]
Comparison: Additional serotypes - serotype 19A95% CI: [-1.4, 2.04]
Secondary
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Time frame: 1 month after the toddler dose (13 months of age)
Population: Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 7F (n=366,343,358) | 100.0 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 3 (n=366,343,356) | 83.6 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 19F (n=362,342,353) | 98.3 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 9V (n=368,342,357) | 99.7 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 1 (n=367,344,357) | 100.0 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 23F (n=362,340,353) | 99.4 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 4 (n=364, 342, 355) | 99.2 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 6B (n=368,341,357) | 100.0 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 6A (n=366,342,355) | 100.0 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 14 (n=366,344,358) | 100.0 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotype - serotype 19A (n=362,341,353) | 100.0 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 5 (n=368,343,357) | 99.7 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 18C (n=362,341,354) | 98.9 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 23F (n=362,340,353) | 99.1 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 4 (n=364, 342, 355) | 99.1 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 6B (n=368,341,357) | 100.0 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 9V (n=368,342,357) | 99.7 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 14 (n=366,344,358) | 99.7 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 18C (n=362,341,354) | 98.5 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 19F (n=362,342,353) | 98.8 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 1 (n=367,344,357) | 99.1 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 3 (n=366,343,356) | 80.8 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 5 (n=368,343,357) | 99.4 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 6A (n=366,342,355) | 100.0 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 7F (n=366,343,358) | 99.4 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotype - serotype 19A (n=362,341,353) | 100.0 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 3 (n=366,343,356) | 88.5 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 14 (n=366,344,358) | 100.0 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 7F (n=366,343,358) | 99.4 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 5 (n=368,343,357) | 99.7 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 9V (n=368,342,357) | 99.2 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 4 (n=364, 342, 355) | 100.0 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 6A (n=366,342,355) | 99.7 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 23F (n=362,340,353) | 98.3 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 19F (n=362,342,353) | 99.4 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 6B (n=368,341,357) | 100.0 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 1 (n=367,344,357) | 99.2 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 18C (n=362,341,354) | 99.4 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotype - serotype 19A (n=362,341,353) | 100.0 observed percentage of participants |
Comparison: Common serotypes - serotype 18C95% CI: [-1.52, 2.39]
Comparison: Common serotypes - serotype 18C95% CI: [-2.3, 1.04]
Comparison: Common serotypes - serotype 23F95% CI: [-1.21, 2.05]
Comparison: Common serotypes - serotype 495% CI: [-1.61, 1.81]
Comparison: Common serotypes - serotype 495% CI: [-2.39, 0.23]
Comparison: Common serotypes - serotype 495% CI: [-2.54, 0.2]
Comparison: Common serotypes - serotype 6B95% CI: [-1.02, 1.11]
Comparison: Common serotypes - serotype 6B95% CI: [-1.03, 1.04]
Comparison: Common serotypes - serotype 6B95% CI: [-1.13, 1.06]
Comparison: Common serotypes - serotype 9V95% CI: [-1.25, 1.37]
Comparison: Common serotypes - serotype 9V95% CI: [-0.76, 2.18]
Comparison: Common serotypes - serotype 9V95% CI: [-0.87, 2.18]
Comparison: Common serotypes - serotype 1495% CI: [-0.74, 1.62]
Comparison: Common serotypes - serotype 1495% CI: [-1.03, 1.04]
Comparison: Common serotypes - serotype 1495% CI: [-1.61, 0.76]
Comparison: Common serotypes - serotype 18C95% CI: [-2.87, 0.74]
Comparison: Common serotypes - serotype 19F95% CI: [-2.55, 1.5]
Comparison: Common serotypes - serotype 19F95% CI: [-3.06, 0.57]
Comparison: Common serotypes - serotype 19F95% CI: [-2.44, 1]
Comparison: Common serotypes - serotype 23F95% CI: [-0.52, 3.16]
Comparison: Common serotypes - serotype 23F95% CI: [-1.05, 2.87]
Comparison: Additional serotypes - serotype 195% CI: [-0.17, 2.53]
Comparison: Additional serotypes - serotype 195% CI: [-0.2, 2.44]
Comparison: Additional serotypes - serotype 195% CI: [-1.79, 1.66]
Comparison: Additional serotypes - serotype 395% CI: [-2.85, 8.55]
Comparison: Additional serotypes - serotype 395% CI: [-9.99, 0.21]
Comparison: Additional serotypes - serotype 395% CI: [-13.14, -2.37]
Comparison: Additional serotypes - serotype 595% CI: [-1, 1.84]
Comparison: Additional serotypes - serotype 595% CI: [-1.27, 1.3]
Comparison: Additional serotypes - serotype 595% CI: [-1.84, 1.02]
Comparison: Additional serotypes - serotype 6A95% CI: [-1.04, 1.08]
Comparison: Additional serotypes - serotype 6A95% CI: [-0.76, 1.56]
Comparison: Additional serotypes - serotype 6A95% CI: [-0.83, 1.56]
Comparison: Additional serotypes - serotype 7F95% CI: [-0.47, 2.09]
Comparison: Additional serotypes - serotype 7F95% CI: [-0.48, 2]
Comparison: Additional serotypes - serotype 7F95% CI: [-1.59, 1.49]
Comparison: Additional serotypes - serotype 19A95% CI: [-1.04, 1.09]
Comparison: Additional serotypes - serotype 19A95% CI: [-1.05, 1.04]
Comparison: Additional serotypes - serotype 19A95% CI: [-1.09, 1.07]
Secondary
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Time frame: 1 month after the infant series (7 months of age)
Population: Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the combined 13vPnC lot.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 4 (n=1213) | 70.7 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 6B (n=1206) | 78.9 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 9V (n=1210) | 55.7 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 14 (n=1172) | 95.2 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 18C (n=1212) | 68.7 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 19F (n=1205) | 85.4 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 23F (n=1212) | 60.1 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series | Additional serotypes - serotype 1 (n=1209) | 75.2 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series | Additional serotypes - serotype 3 (n=1190) | 21.3 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series | Additional serotypes - serotype 5 (n=1207) | 60.3 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series | Additional serotypes - serotype 6A (n=1213) | 85.1 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series | Additional serotypes - serotype 7F (n=1210) | 92.8 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series | Additional serotypes - serotype 19A (n=1211) | 80.8 observed percentage of participants |
Secondary
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Time frame: 1 month after the toddler dose (13 months of age)
Population: Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 18C (n=362,341,354) | 79.6 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 4 (n=364,342,355) | 86.0 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 3 (n=366,343,356) | 32.0 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 19F (n=362,342,353) | 94.5 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 7F (n=366,343,358) | 98.1 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 1 (n=367,344,357) | 91.8 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 23F (n=362,340,353) | 91.7 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 9V (n=368,342,357) | 80.7 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotype - serotype 19A (n=362,341,353) | 100.0 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 6A (n=366,342,355) | 99.2 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 14 (n=366,344,358) | 98.6 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 6B (n=368,341,357) | 99.5 observed percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 5 (n=368,343,357) | 94.0 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotype - serotype 19A (n=362,341,353) | 99.4 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 4 (n=364,342,355) | 87.4 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 6B (n=368,341,357) | 99.1 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 9V (n=368,342,357) | 84.5 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 14 (n=366,344,358) | 98.8 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 18C (n=362,341,354) | 85.0 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 19F (n=362,342,353) | 95.3 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 23F (n=362,340,353) | 91.2 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 1 (n=367,344,357) | 91.0 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 3 (n=366,343,356) | 30.3 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 5 (n=368,343,357) | 91.0 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 6A (n=366,342,355) | 98.2 observed percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 7F (n=366,343,358) | 96.2 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotype - serotype 19A (n=362,341,353) | 99.7 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 3 (n=366,343,356) | 36.8 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 14 (n=366,344,358) | 98.3 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 7F (n=366,343,358) | 98.6 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 5 (n=368,343,357) | 93.6 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 9V (n=368,342,357) | 85.4 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 4 (n=364,342,355) | 92.7 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 6A (n=366,342,355) | 99.2 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 23F (n=362,340,353) | 89.8 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 19F (n=362,342,353) | 97.7 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 6B (n=368,341,357) | 99.7 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Additional serotypes - serotype 1 (n=367,344,357) | 94.4 observed percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose | Common serotypes - serotype 18C (n=362,341,354) | 89.5 observed percentage of participants |
Comparison: Additional serotypes - serotype 595% CI: [-3.14, 4.11]
Comparison: Additional serotypes - serotype 595% CI: [-6.72, 1.4]
Comparison: Common serotypes - serotype 495% CI: [-6.52, 3.63]
Comparison: Common serotypes - serotype 495% CI: [-11.3, -2.15]
Comparison: Common serotypes - serotype 495% CI: [-9.85, -0.79]
Comparison: Common serotypes - serotype 6B95% CI: [-1.19, 2.07]
Comparison: Common serotypes - serotype 6B95% CI: [-1.69, 1.06]
Comparison: Common serotypes - serotype 6B95% CI: [-2.27, 0.75]
Comparison: Common serotypes - serotype 9V95% CI: [-9.46, 1.82]
Comparison: Common serotypes - serotype 9V95% CI: [-10.24, 0.76]
Comparison: Common serotypes - serotype 9V95% CI: [-6.3, 4.41]
Comparison: Common serotypes - serotype 1495% CI: [-2.14, 1.73]
Comparison: Common serotypes - serotype 1495% CI: [-1.69, 2.39]
Comparison: Common serotypes - serotype 1495% CI: [-1.46, 2.59]
Comparison: Common serotypes - serotype 18C95% CI: [-11.17, 0.2]
Comparison: Common serotypes - serotype 18C95% CI: [-15.31, -4.7]
Comparison: Common serotypes - serotype 18C95% CI: [-9.55, 0.46]
Comparison: Common serotypes - serotype 19F95% CI: [-4.23, 2.52]
Comparison: Common serotypes - serotype 19F95% CI: [-6.35, -0.4]
Comparison: Common serotypes - serotype 19F95% CI: [-5.44, 0.33]
Comparison: Common serotypes - serotype 23F95% CI: [-3.67, 4.8]
Comparison: Common serotypes - serotype 23F95% CI: [-2.38, 6.28]
Comparison: Common serotypes - serotype 23F95% CI: [-3.06, 5.82]
Comparison: Additional serotypes - serotype 195% CI: [-3.34, 5.08]
Comparison: Additional serotypes - serotype 195% CI: [-6.39, 1.18]
Comparison: Additional serotypes - serotype 195% CI: [-7.45, 0.46]
Comparison: Additional serotypes - serotype 395% CI: [-5.2, 8.55]
Comparison: Additional serotypes - serotype 395% CI: [-11.79, 2.16]
Comparison: Additional serotypes - serotype 395% CI: [-13.51, 0.54]
Comparison: Additional serotypes - serotype 595% CI: [-0.84, 7.13]
Comparison: Additional serotypes - serotype 6A95% CI: [-0.87, 3.02]
Comparison: Additional serotypes - serotype 6A95% CI: [-1.62, 1.71]
Comparison: Additional serotypes - serotype 6A95% CI: [-3, 0.92]
Comparison: Additional serotypes - serotype 7F95% CI: [-0.62, 4.67]
Comparison: Additional serotypes - serotype 7F95% CI: [-2.67, 1.55]
Comparison: Additional serotypes - serotype 7F95% CI: [-5.11, -0.01]
Comparison: Additional serotypes - serotype 19A95% CI: [-0.45, 2.1]
Comparison: Additional serotypes - serotype 19A95% CI: [-0.75, 1.58]
Comparison: Additional serotypes - serotype 19A95% CI: [-1.86, 1.05]
Other Pre-specified
Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 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: Within 7 days after dose (12 months of age)
Population: Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the combined 13vPnC group and 7vPnC, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Erythema: Severe (n=603, 93) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Tenderness: Any (n=826, 131) | 57.3 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Tenderness: Significant (n=630, 97) | 6.7 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Induration: Any (n=698, 110) | 31.5 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Induration: Mild (n=689, 107) | 28.9 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Induration: Moderate (n=627, 101) | 8.5 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Induration: Severe (n=603, 93) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Erythema: Any (n=749, 121) | 42.6 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Erythema: Mild (n=735, 116) | 39.2 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Erythema: Moderate (n=631, 104) | 10.6 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Erythema: Any (n=749, 121) | 52.9 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Erythema: Severe (n=603, 93) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Induration: Moderate (n=627, 101) | 17.8 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Tenderness: Any (n=826, 131) | 63.4 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Erythema: Moderate (n=631, 104) | 21.2 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Tenderness: Significant (n=630, 97) | 4.1 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Induration: Severe (n=603, 93) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Induration: Any (n=698, 110) | 43.6 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Erythema: Mild (n=735, 116) | 50.0 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Induration: Mild (n=689, 107) | 41.1 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). 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: Within 7 days after dose (2 months of age)
Population: Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Tenderness: Any (n=420, 409, 400, 212) | 62.4 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Tenderness: Significant (n=348, 337, 345, 170) | 9.2 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Induration: Any (n=356, 347, 352, 176) | 16.6 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Induration: Mild (n=353, 344, 348, 173) | 14.7 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Induration: Moderate (n=338, 328, 340, 167) | 3.6 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Induration: Severe (n=333, 325, 335, 164) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Erythema: Any (n=355, 352, 360, 180) | 19.4 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Erythema: Mild (n=354, 352, 358, 180) | 18.1 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Erythema: Moderate (n=334, 326, 337, 164) | 2.1 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Erythema: Severe (n=333, 325, 335, 164) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Induration: Any (n=356, 347, 352, 176) | 19.6 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Erythema: Moderate (n=334, 326, 337, 164) | 0.6 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Induration: Mild (n=353, 344, 348, 173) | 16.9 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Induration: Moderate (n=338, 328, 340, 167) | 5.8 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Induration: Severe (n=333, 325, 335, 164) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Erythema: Any (n=355, 352, 360, 180) | 25.0 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Erythema: Severe (n=333, 325, 335, 164) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Erythema: Mild (n=354, 352, 358, 180) | 24.7 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Tenderness: Any (n=420, 409, 400, 212) | 64.1 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Tenderness: Significant (n=348, 337, 345, 170) | 10.4 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Erythema: Mild (n=354, 352, 358, 180) | 21.2 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Erythema: Any (n=355, 352, 360, 180) | 23.1 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Erythema: Severe (n=333, 325, 335, 164) | 0.0 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Tenderness: Any (n=420, 409, 400, 212) | 62.5 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Induration: Mild (n=353, 344, 348, 173) | 15.5 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Induration: Severe (n=333, 325, 335, 164) | 0.0 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Erythema: Moderate (n=334, 326, 337, 164) | 2.4 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Tenderness: Significant (n=348, 337, 345, 170) | 10.4 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Induration: Moderate (n=338, 328, 340, 167) | 5.0 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Induration: Any (n=356, 347, 352, 176) | 19.3 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Induration: Moderate (n=338, 328, 340, 167) | 3.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Erythema: Mild (n=354, 352, 358, 180) | 21.7 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Induration: Severe (n=333, 325, 335, 164) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Erythema: Severe (n=333, 325, 335, 164) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Erythema: Any (n=355, 352, 360, 180) | 22.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Tenderness: Significant (n=348, 337, 345, 170) | 12.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Induration: Any (n=356, 347, 352, 176) | 18.2 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Induration: Mild (n=353, 344, 348, 173) | 16.2 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Tenderness: Any (n=420, 409, 400, 212) | 67.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Erythema: Moderate (n=334, 326, 337, 164) | 1.2 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 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: Within 7 days after dose (4 months of age)
Population: Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Induration: Severe (n=263, 221, 250, 127) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Erythema: Severe (n=263, 221, 249, 127) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Erythema: Moderate (n=268, 223, 252, 128) | 3.4 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Induration: Mild (n=288, 246, 276, 141) | 22.6 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Tenderness: Significant (n=269, 231, 262, 132) | 9.7 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Tenderness: Any (n=354, 330, 337, 176) | 66.4 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Erythema: Any (n=292, 265, 281, 153) | 30.1 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Induration: Moderate (n=270, 224, 255, 128) | 4.1 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Induration: Any (n=291, 248, 279, 141) | 24.4 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Erythema: Mild (n=289, 263, 279, 153) | 28.4 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Tenderness: Any (n=354, 330, 337, 176) | 67.3 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Induration: Severe (n=263, 221, 250, 127) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Erythema: Severe (n=263, 221, 249, 127) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Erythema: Any (n=292, 265, 281, 153) | 35.8 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Erythema: Moderate (n=268, 223, 252, 128) | 1.8 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Tenderness: Significant (n=269, 231, 262, 132) | 7.4 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Induration: Any (n=291, 248, 279, 141) | 22.6 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Induration: Mild (n=288, 246, 276, 141) | 22.0 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Erythema: Mild (n=289, 263, 279, 153) | 34.6 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Induration: Moderate (n=270, 224, 255, 128) | 1.3 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Tenderness: Significant (n=269, 231, 262, 132) | 12.2 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Tenderness: Any (n=354, 330, 337, 176) | 65.0 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Induration: Any (n=291, 248, 279, 141) | 28.7 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Induration: Mild (n=288, 246, 276, 141) | 26.8 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Induration: Moderate (n=270, 224, 255, 128) | 4.7 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Induration: Severe (n=263, 221, 250, 127) | 0.4 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Erythema: Any (n=292, 265, 281, 153) | 34.5 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Erythema: Mild (n=289, 263, 279, 153) | 33.3 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Erythema: Moderate (n=268, 223, 252, 128) | 3.2 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Erythema: Severe (n=263, 221, 249, 127) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Induration: Mild (n=288, 246, 276, 141) | 17.7 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Erythema: Severe (n=263, 221, 249, 127) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Erythema: Mild (n=289, 263, 279, 153) | 28.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Induration: Any (n=291, 248, 279, 141) | 17.7 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Tenderness: Any (n=354, 330, 337, 176) | 64.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Tenderness: Significant (n=269, 231, 262, 132) | 11.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Induration: Severe (n=263, 221, 250, 127) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Erythema: Moderate (n=268, 223, 252, 128) | 3.1 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Erythema: Any (n=292, 265, 281, 153) | 30.1 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Induration: Moderate (n=270, 224, 255, 128) | 3.9 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 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: Within 7 days after dose (6 months of age)
Population: Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Tenderness: Any (n=317, 304, 300, 156) | 62.5 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Tenderness: Significant (n=248, 226, 237, 118) | 8.9 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Induration: Any (n=263, 250, 262, 128) | 27.0 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Induration: Mild (n=260, 249, 260, 127) | 24.6 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Induration: Moderate (n=242, 221, 229, 114) | 4.1 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Induration: Severe (n=237, 217, 227, 111) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Erythema: Any (n=278, 262, 274, 137) | 39.6 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Erythema: Mild (n=275, 260, 272, 135) | 37.1 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Erythema: Moderate (n=243, 219, 231, 116) | 5.3 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Erythema: Severe (n=237, 217, 227, 111) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Induration: Any (n=263, 250, 262, 128) | 23.6 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Erythema: Moderate (n=243, 219, 231, 116) | 4.1 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Induration: Mild (n=260, 249, 260, 127) | 22.5 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Induration: Moderate (n=242, 221, 229, 114) | 4.1 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Induration: Severe (n=237, 217, 227, 111) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Erythema: Any (n=278, 262, 274, 137) | 35.9 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Erythema: Severe (n=237, 217, 227, 111) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Erythema: Mild (n=275, 260, 272, 135) | 33.8 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Tenderness: Any (n=317, 304, 300, 156) | 60.9 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Tenderness: Significant (n=248, 226, 237, 118) | 7.5 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Erythema: Mild (n=275, 260, 272, 135) | 36.4 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Erythema: Any (n=278, 262, 274, 137) | 37.6 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Erythema: Severe (n=237, 217, 227, 111) | 0.0 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Tenderness: Any (n=317, 304, 300, 156) | 55.0 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Induration: Mild (n=260, 249, 260, 127) | 27.3 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Induration: Severe (n=237, 217, 227, 111) | 0.0 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Erythema: Moderate (n=243, 219, 231, 116) | 5.6 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Tenderness: Significant (n=248, 226, 237, 118) | 10.1 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Induration: Moderate (n=242, 221, 229, 114) | 3.9 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Induration: Any (n=263, 250, 262, 128) | 28.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Induration: Moderate (n=242, 221, 229, 114) | 7.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Erythema: Mild (n=275, 260, 272, 135) | 38.5 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Induration: Severe (n=237, 217, 227, 111) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Erythema: Severe (n=237, 217, 227, 111) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Erythema: Any (n=278, 262, 274, 137) | 39.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Tenderness: Significant (n=248, 226, 237, 118) | 11.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Induration: Any (n=263, 250, 262, 128) | 30.5 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Induration: Mild (n=260, 249, 260, 127) | 29.1 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Tenderness: Any (n=317, 304, 300, 156) | 64.7 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Erythema: Moderate (n=243, 219, 231, 116) | 7.8 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)
Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 7 days after dose (12 months of age)
Population: Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the combined 13vPnC group and 7vPnC, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Fever ≥38 but ≤39 degrees C (n=667, 107) | 28.8 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Fever >39 but ≤40 degrees C (n=592, 95) | 4.4 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Fever >40 degrees C (n=586, 93) | 1.0 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Decreased appetite (n=790, 115) | 51.9 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Irritability (n=943, 160) | 81.8 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Increased sleep (n=779, 126) | 47.8 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Decreased sleep (n=770, 117) | 46.9 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Hives [urticaria] (n=607, 96) | 2.1 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Hives [urticaria] (n=607, 96) | 5.2 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Fever ≥38 but ≤39 degrees C (n=667, 107) | 29.9 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Irritability (n=943, 160) | 80.0 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Fever >39 but ≤40 degrees C (n=592, 95) | 5.3 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Decreased sleep (n=770, 117) | 42.7 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Fever >40 degrees C (n=586, 93) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Increased sleep (n=779, 126) | 47.6 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) | Decreased appetite (n=790, 115) | 50.4 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)
Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 7 days after dose (2 months of age)
Population: Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Increased sleep (n=425, 417, 402, 212) | 71.5 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Hives [urticaria] (n=333, 328, 335, 164) | 0.6 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Fever ≥38 but ≤39 degrees C (n=353, 337, 353, 173) | 24.6 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Decreased sleep (n=379, 377, 377, 194) | 44.1 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Fever >40 degrees C (n=328, 319, 331, 160) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Irritability (n=435, 432, 433, 226) | 85.7 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Decreased appetite (n=393, 385, 386, 200) | 50.6 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Fever >39 but ≤40 degrees C (n=328, 319, 333, 161) | 0.6 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Decreased appetite (n=393, 385, 386, 200) | 46.0 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Increased sleep (n=425, 417, 402, 212) | 72.7 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Irritability (n=435, 432, 433, 226) | 84.3 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Fever ≥38 but ≤39 degrees C (n=353, 337, 353, 173) | 23.4 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Hives [urticaria] (n=333, 328, 335, 164) | 0.9 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Decreased sleep (n=379, 377, 377, 194) | 46.9 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Fever >39 but ≤40 degrees C (n=328, 319, 333, 161) | 0.3 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Fever >40 degrees C (n=328, 319, 331, 160) | 0.0 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Decreased appetite (n=393, 385, 386, 200) | 50.0 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Fever >40 degrees C (n=328, 319, 331, 160) | 0.3 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Irritability (n=435, 432, 433, 226) | 89.1 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Fever ≥38 but ≤39 degrees C (n=353, 337, 353, 173) | 24.6 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Fever >39 but ≤40 degrees C (n=328, 319, 333, 161) | 0.9 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Increased sleep (n=425, 417, 402, 212) | 69.4 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Decreased sleep (n=379, 377, 377, 194) | 42.2 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Hives [urticaria] (n=333, 328, 335, 164) | 0.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Fever >39 but ≤40 degrees C (n=328, 319, 333, 161) | 1.2 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Fever ≥38 but ≤39 degrees C (n=353, 337, 353, 173) | 26.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Hives [urticaria] (n=333, 328, 335, 164) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Decreased sleep (n=379, 377, 377, 194) | 46.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Irritability (n=435, 432, 433, 226) | 87.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Decreased appetite (n=393, 385, 386, 200) | 49.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Fever >40 degrees C (n=328, 319, 331, 160) | 0.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) | Increased sleep (n=425, 417, 402, 212) | 72.6 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)
Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 7 days after dose (4 months of age)
Population: Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Decreased sleep (n=324, 291, 305, 159) | 49.1 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Decreased appetite (n=322, 293, 325, 164) | 48.4 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Fever >40 degrees C (n=259, 214, 245, 124) | 0.4 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Fever ≥38 but ≤39 degrees C (n=290, 250, 290, 143) | 33.4 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Hives [urticaria] (n=263, 225, 253, 127) | 0.4 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Increased sleep (n=332, 318, 343, 177) | 64.8 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Irritability (n=377, 370, 376, 201) | 86.5 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Fever >39 but ≤40 degrees C (n=263, 216, 248, 124) | 3.4 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Hives [urticaria] (n=263, 225, 253, 127) | 2.2 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Fever ≥38 but ≤39 degrees C (n=290, 250, 290, 143) | 36.4 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Fever >39 but ≤40 degrees C (n=263, 216, 248, 124) | 3.2 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Fever >40 degrees C (n=259, 214, 245, 124) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Decreased appetite (n=322, 293, 325, 164) | 49.1 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Increased sleep (n=332, 318, 343, 177) | 68.2 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Decreased sleep (n=324, 291, 305, 159) | 48.8 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Irritability (n=377, 370, 376, 201) | 86.5 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Fever >39 but ≤40 degrees C (n=263, 216, 248, 124) | 3.6 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Decreased appetite (n=322, 293, 325, 164) | 48.0 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Irritability (n=377, 370, 376, 201) | 84.6 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Fever ≥38 but ≤39 degrees C (n=290, 250, 290, 143) | 35.5 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Increased sleep (n=332, 318, 343, 177) | 67.3 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Hives [urticaria] (n=263, 225, 253, 127) | 1.6 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Fever >40 degrees C (n=259, 214, 245, 124) | 0.0 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Decreased sleep (n=324, 291, 305, 159) | 44.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Fever >40 degrees C (n=259, 214, 245, 124) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Increased sleep (n=332, 318, 343, 177) | 63.3 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Decreased appetite (n=322, 293, 325, 164) | 49.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Fever ≥38 but ≤39 degrees C (n=290, 250, 290, 143) | 28.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Hives [urticaria] (n=263, 225, 253, 127) | 0.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Irritability (n=377, 370, 376, 201) | 81.1 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Fever >39 but ≤40 degrees C (n=263, 216, 248, 124) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) | Decreased sleep (n=324, 291, 305, 159) | 48.4 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)
Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 7 days after dose (6 months of age)
Population: Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Irritability (n=352, 339, 347, 186) | 79.5 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Decreased sleep (n=282, 272, 289, 147) | 42.6 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Fever ≥38 but ≤39 degrees C (n=266, 246, 252, 132) | 26.3 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Fever >40 degrees C (n=234, 216, 224, 111) | 0.0 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Hives [urticaria] (n=239, 218, 229, 112) | 1.7 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Increased sleep (n=289, 289, 286, 138) | 55.4 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Decreased appetite (n=286, 273, 286, 144) | 45.8 percentage of participants |
| 13vPnC (Pilot Lot 1) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Fever >39 but ≤40 degrees C (n=237, 219, 231, 113) | 2.5 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Fever >40 degrees C (n=234, 216, 224, 111) | 0.5 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Decreased sleep (n=282, 272, 289, 147) | 50.4 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Hives [urticaria] (n=239, 218, 229, 112) | 0.9 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Fever >39 but ≤40 degrees C (n=237, 219, 231, 113) | 3.7 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Decreased appetite (n=286, 273, 286, 144) | 48.0 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Irritability (n=352, 339, 347, 186) | 80.5 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Fever ≥38 but ≤39 degrees C (n=266, 246, 252, 132) | 27.6 percentage of participants |
| 13vPnC (Pilot Lot 2) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Increased sleep (n=289, 289, 286, 138) | 58.8 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Decreased appetite (n=286, 273, 286, 144) | 50.7 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Fever ≥38 but ≤39 degrees C (n=266, 246, 252, 132) | 31.7 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Irritability (n=352, 339, 347, 186) | 82.7 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Increased sleep (n=289, 289, 286, 138) | 59.8 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Fever >39 but ≤40 degrees C (n=237, 219, 231, 113) | 5.6 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Fever >40 degrees C (n=234, 216, 224, 111) | 0.0 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Hives [urticaria] (n=239, 218, 229, 112) | 1.7 percentage of participants |
| 13vPnC (Manufacturing Lot) | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Decreased sleep (n=282, 272, 289, 147) | 48.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Hives [urticaria] (n=239, 218, 229, 112) | 1.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Decreased appetite (n=286, 273, 286, 144) | 50.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Fever ≥38 but ≤39 degrees C (n=266, 246, 252, 132) | 32.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Fever >39 but ≤40 degrees C (n=237, 219, 231, 113) | 6.2 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Irritability (n=352, 339, 347, 186) | 84.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Increased sleep (n=289, 289, 286, 138) | 51.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Decreased sleep (n=282, 272, 289, 147) | 56.5 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) | Fever >40 degrees C (n=234, 216, 224, 111) | 0.9 percentage of participants |