A Phase 3 interventional study of 13-valent Pneumococcal Conjugate Vaccine and 7-valent pneumococcal conjugate vaccine in Vaccines, Pneumococcal Conjugate Vaccine, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 11 sites in Canada. Open to participants aged 42 Days to 98 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-04-21.
Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer (part of Pfizer) · Phase 3, Interventional, and Prevention
The purpose of this study will be to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric vaccinations in Canada. Immune responses induced by the infant series (NeisVac-C® and Pentacel®)and toddler dose(NeisVac-C®)of routine pediatric vaccines when administered with 13-valent pneumococcal conjugate vaccine will be studied for noninferiority to the immune responses when administered with 7-valent pneumococcal conjugate vaccine. Safety profile and immunogenicity of 13-valent pneumococcal conjugate vaccine will also be evaluated.
Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 484 studies on the registry; none are open to participants now.
First submitted before Wyeth became part of Pfizer.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Biological: 13-valent Pneumococcal Conjugate Vaccine
Biological: 7-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.
7-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.
Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series
Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \> -10%.
Time frame: 1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)
Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series
Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the geometric means for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
Time frame: 1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)
Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Percentage of subjects achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95 % CI for concomitant antigens pertussis (pertussis toxoid \[PT\], filamentous hemagglutinin \[FHA\], and pertactin \[PRN\]) and ≥ 2.2 EU/mL fimbrial agglutinogens (FIM) are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \> -10%.
Time frame: 1 month after the 3-dose infant series (7 months of age)
Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Antibody geometric mean concentration of pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence intervals on the ratio of the GMCs for 13vPnC relative to 7vPnC were constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
Time frame: 1 month after the 3-dose Infant Series (7 months of age)
Percentage of Subjects Achieving Predefined Antibody Level ≥0.15 Micrograms Per mL (μg/mL) for Polyribosylribitol Phosphate (PRP) in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Percentage of subjects achieving predefined antibody threshold ≥0.15 μg/mL along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \> -10%.
Time frame: 1 month after the 3-dose infant series (7 months of age)
Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Antibody geometric mean concentration of PRP in Hib as measured by µg/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMCs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
Time frame: 1 month after the 3-dose infant series (7 months of age)
Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C SBA in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose of NeisVac-C®
Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \> -10%.
Time frame: 1 month after the toddler dose of NeisVac-C® (13 months of age)
Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
Time frame: 1 month after the toddler dose (13 months of age)
Percentage of Subjects Achieving Predefined Antibody Level ≥1.0 μg/mL for PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Percentage of subjects achieving predefined antibody threshold ≥1.0 μg/mL along with the corresponding 95% CI for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \> -10%.
Time frame: 1 month after the 3-dose infant series (7 months of age)
Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the 3-dose Infant Series
Percentage of subjects achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time frame: 1 month after the 3-dose infant series (7 months of age)
Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the 3-dose Infant Series
Antibody geometric mean concentration (GMC) as measured by μg/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% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Time frame: 1 month after the 3-dose infant series (7 months of age)
Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Percentage of subjects achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time frame: 1 month after the toddler dose (13 months of age)
Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the Toddler Dose
Antibody geometric mean concentration (GMC) as measured by μg/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% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Time frame: 1 month after the toddler dose (13 months of age)
Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: 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). Subjects may be represented in more than 1 category.
Time frame: Within 4 days after dose (2 months of age)
Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: 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 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Subjects may be represented in more than 1 category.
Time frame: Within 4 days after dose (4 months of age)
Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: 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 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Subjects may be represented in more than 1 category.
Time frame: Within 4 days after dose (6 months of age)
Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: 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 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Subjects may be represented in more than 1 category.
Time frame: Within 4 days after dose (12 months of age)
Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)
Systemic events (any fever ≥38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.
Time frame: Within 4 days after dose (2 months of age)
Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)
Systemic events (any fever ≥38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.
Time frame: Within 4 days after dose (4 months of age)
Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)
Systemic events (any fever ≥38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.
Time frame: Within 4 days after dose (6 months of age)
Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Toddler Dose (12 Months of Age)
Systemic events (any fever ≥38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.
Time frame: Within 4 days after dose (12 months of age)
Subjects were recruited in Canada from June 2007 through November 2007.
| Milestone | 13vPnC | 7vPnC |
|---|---|---|
| Started | 300 | 303 |
| Vaccinated dose 1 | 300 | 303 |
| Vaccinated dose 2 | 297 | 296 |
| Vaccinated dose 3 | 293 | 294 |
| Completed | 293 | 290 |
| Not completed | 7 | 13 |
| Withdrew: Failed to return | 3 | 4 |
| Withdrew: Parent or legal guardian request | 1 | 5 |
| Withdrew: Protocol violation | 1 | 2 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Adverse event | 0 | 2 |
| Milestone | 13vPnC | 7vPnC |
|---|---|---|
| Started | 293 | 290 |
| Withdrawn after infant series | 6 | 8 |
| Completed | 287 | 282 |
| Not completed | 6 | 8 |
| Withdrew: Adverse event | 0 | 4 |
| Withdrew: Parent or legal guardian request | 2 | 2 |
| Withdrew: Failed to return | 2 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Other | 0 | 1 |
| Milestone | 13vPnC | 7vPnC |
|---|---|---|
| Started | 287 | 282 |
| Completed | 283 | 282 |
| Not completed | 4 | 0 |
| Withdrew: Parent or legal guardian request | 2 | 0 |
| Withdrew: Failed to return | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \> -10%.
| percentage of subjects | 13vPnC | 7vPnC |
|---|---|---|
| Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series | 96.8 (94.1 to 98.5) | 99.3 (97.4 to 99.9) |
Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the geometric means for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
| GMT | 13vPnC | 7vPnC |
|---|---|---|
| Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series | 361.16 (305.46 to 427.00) | 302.55 (263.89 to 346.86) |
Percentage of subjects achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95 % CI for concomitant antigens pertussis (pertussis toxoid \[PT\], filamentous hemagglutinin \[FHA\], and pertactin \[PRN\]) and ≥ 2.2 EU/mL fimbrial agglutinogens (FIM) are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \> -10%.
| percentage of subjects | 13vPnC | 7vPnC |
|---|---|---|
| PT ≥5 EU/mL (n=282, 277) | 99.6 (98.0 to 100.0) | 99.6 (98.0 to 100.0) |
| FHA ≥5 EU/mL (n=283, 278) | 100.0 (98.7 to 100.0) | 100.0 (98.7 to 100.0) |
| PRN ≥5 EU/mL (n=283, 277) | 97.9 (95.4 to 99.2) | 96.8 (93.9 to 98.5) |
| FIM ≥2.2 EU/mL (n=282, 275) | 95.4 (92.2 to 97.5) | 97.5 (94.8 to 99.0) |
Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \> -10%.
| percentage of subjects | 13vPnC | 7vPnC |
|---|---|---|
| Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C SBA in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose of NeisVac-C® | 100.0 (98.6 to 100.0) | 100.0 (98.6 to 100.0) |
Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
| GMT | 13vPnC | 7vPnC |
|---|---|---|
| Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | 1379.75 (1235.06 to 1541.39) | 1083.96 (962.54 to 1220.69) |
Percentage of subjects achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
| percentage of subjects | 13vPnC |
|---|---|
| Common serotypes - serotype 4 (n=277) | 97.1 (94.4 to 98.7) |
| Common serotypes - serotype 6B (n=276) | 93.1 (89.5 to 95.8) |
| Common serotypes - serotype 9V (n=277) | 95.3 (92.1 to 97.5) |
| Common serotypes - serotype 14 (n=275) | 98.2 (95.8 to 99.4) |
| Common serotypes - serotype 18C n=277) | 96.4 (93.5 to 98.3) |
| Common serotypes - serotype 19F (n=273) | 98.5 (96.3 to 99.6) |
| Common serotypes - serotype 23F (n=275) | 90.2 (86.0 to 93.4) |
| Additional serotypes - serotype 1 (n=277) | 95.7 (92.6 to 97.7) |
| Additional serotypes - serotype 3 (n=275) | 79.6 (74.4 to 84.2) |
| Additional serotypes - serotype 5 (n=276) | 87.0 (82.4 to 90.7) |
| Additional serotypes - serotype 6A (n=276) | 96.4 (93.4 to 98.2) |
| Additional serotypes - serotype 7F (n=276) | 98.6 (96.3 to 99.6) |
| Additional serotypes - serotype 19A (n=272) | 97.8 (95.3 to 99.2) |
Antibody geometric mean concentration (GMC) as measured by μg/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% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.
| GMC μg/mL | 13vPnC |
|---|---|
| Common serotypes - serotype 4 (n=277) | 1.46 (1.33 to 1.60) |
| Common serotypes - serotype 6B (n=276) | 2.16 (1.87 to 2.49) |
| Common serotypes - serotype 9V (n=277) | 1.12 (1.03 to 1.22) |
| Common serotypes - serotype 14 (n=275) | 5.43 (4.86 to 6.06) |
| Common serotypes - serotype 18C (n=277) | 1.37 (1.23 to 1.52) |
| Common serotypes - serotype 19F (n=273) | 2.18 (1.99 to 2.39) |
| Common serotypes - serotype 23F (n=275) | 1.15 (1.03 to 1.30) |
| Additional serotypes - serotype 1 (n=277) | 1.82 (1.63 to 2.04) |
| Additional serotypes - serotype 3 (n=275) | 0.63 (0.58 to 0.70) |
| Additional serotypes - serotype 5 (n=276) | 0.90 (0.81 to 0.99) |
| Additional serotypes - serotype 6A (n=276) | 1.92 (1.73 to 2.12) |
| Additional serotypes - serotype 7F (n=276) | 2.26 (2.09 to 2.45) |
| Additional serotypes - serotype 19A (n=272) | 2.00 (1.82 to 2.19) |
Percentage of subjects achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
| percentage of subjects | 13vPnC |
|---|---|
| Common serotypes - serotype 4 (n=264) | 100.0 (98.6 to 100.0) |
| Common serotypes - serotype 6B (n=263) | 100.0 (98.6 to 100.0) |
| Common serotypes - serotype 9V (n=264) | 99.2 (97.3 to 99.9) |
| Common serotypes - serotype 14 (n=264) | 100.0 (98.6 to 100.0) |
| Common serotypes - serotype 18C (n=262) | 98.9 (96.7 to 99.8) |
| Common serotypes - serotype 19F (n=263) | 98.1 (95.6 to 99.4) |
| Common serotypes - serotype 23F (n=263) | 99.6 (97.9 to 100.0) |
| Additional serotypes - serotype 1 (n=264) | 100.0 (98.6 to 100.0) |
| Additional serotypes - serotype 3 (n=264) | 84.8 (79.9 to 88.9) |
| Additional serotypes - serotype 5 (n=264) | 98.5 (96.2 to 99.6) |
| Additional serotypes - serotype 6A (n=264) | 100.0 (98.6 to 100.0) |
| Additional serotypes - serotype 7F (n=264) | 100.0 (98.6 to 100.0) |
| Additional serotypes - serotype 19A (n=263) | 100.0 (98.6 to 100.0) |
Antibody geometric mean concentration (GMC) as measured by μg/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% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.
| GMC μg/mL | 13vPnC |
|---|---|
| Common serotypes - serotype 4 (n=264) | 2.67 (2.43 to 2.92) |
| Common serotypes - serotype 6B (n=263) | 9.83 (8.83 to 10.94) |
| Common serotypes - serotype 9V (n=264) | 2.04 (1.87 to 2.23) |
| Common serotypes - serotype 14 (n=264) | 7.58 (6.86 to 8.37) |
| Common serotypes - serotype 18C (n=262) | 2.00 (1.80 to 2.21) |
| Common serotypes - serotype 19F (n=263) | 5.70 (5.06 to 6.42) |
| Common serotypes - serotype 23F (n=263) | 3.59 (3.21 to 4.01) |
| Additional serotypes - serotype 1 (n=264) | 3.45 (3.11 to 3.82) |
| Additional serotypes - serotype 3 (n=264) | 0.74 (0.67 to 0.81) |
| Additional serotypes - serotype 5 (n=264) | 2.38 (2.15 to 2.62) |
| Additional serotypes - serotype 6A (n=264) | 6.47 (5.87 to 7.12) |
| Additional serotypes - serotype 7F (n=264) | 3.88 (3.59 to 4.21) |
| Additional serotypes - serotype 19A (n=263) | 8.36 (7.61 to 9.19) |
Antibody geometric mean concentration of pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence intervals on the ratio of the GMCs for 13vPnC relative to 7vPnC were constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
| GMC EU/mL | 13vPnC | 7vPnC |
|---|---|---|
| PT (n=282, 277) | 46.06 (42.83 to 49.53) | 40.37 (37.24 to 43.75) |
| FHA (n=283,278) | 78.08 (72.47 to 84.13) | 69.52 (64.39 to 75.05) |
| PRN (n=283, 277) | 42.90 (38.17 to 48.22) | 40.69 (36.16 to 45.79) |
| FIM (n=282, 275) | 11.54 (10.48 to 12.71) | 12.98 (11.81 to 14.27) |
Percentage of subjects achieving predefined antibody threshold ≥0.15 μg/mL along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \> -10%.
| percentage of subjects | 13vPnC | 7vPnC |
|---|---|---|
| Percentage of Subjects Achieving Predefined Antibody Level ≥0.15 Micrograms Per mL (μg/mL) for Polyribosylribitol Phosphate (PRP) in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series | 97.8 (95.3 to 99.2) | 99.6 (97.9 to 100.0) |
Antibody geometric mean concentration of PRP in Hib as measured by µg/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMCs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
| GMC µg/mL | 13vPnC | 7vPnC |
|---|---|---|
| Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series | 2.87 (2.48 to 3.32) | 3.14 (2.74 to 3.60) |
Percentage of subjects achieving predefined antibody threshold ≥1.0 μg/mL along with the corresponding 95% CI for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \> -10%.
| percentage of subjects | 13vPnC | 7vPnC |
|---|---|---|
| Percentage of Subjects Achieving Predefined Antibody Level ≥1.0 μg/mL for PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series | 81.6 (76.5 to 86.0) | 84.6 (79.7 to 88.7) |
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). Subjects may be represented in more than 1 category.
| percentage of subjects | 13vPnC | 7vPnC |
|---|---|---|
| Tenderness: Any (n=281, 283) | 44.5 | 43.8 |
| Tenderness: Significant (n=270, 274) | 4.4 | 4.0 |
| Induration: Any (n=271, 276) | 5.9 | 7.2 |
| Induration: Mild (n=270, 275) | 5.6 | 5.5 |
| Induration: Moderate (n=267, 274) | 0.7 | 2.6 |
| Induration: Severe (n=266, 273) | 0.0 | 0.0 |
| Erythema: Any (n=270, 275) | 11.1 | 14.5 |
| Erythema: Mild (n=270, 275) | 10.7 | 14.2 |
| Erythema: Moderate (n=266, 273) | 0.4 | 0.7 |
| Erythema: Severe (n=266, 273) | 0.0 | 0.0 |
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). Subjects may be represented in more than 1 category.
| percentage of subjects | 13vPnC | 7vPnC |
|---|---|---|
| Tenderness: Any (n=264, 266) | 37.5 | 32.7 |
| Tenderness: Significant (n=248, 252) | 3.6 | 3.6 |
| Induration: Any (n=251, 253) | 10.8 | 11.5 |
| Induration: Mild (n=251, 253) | 10.4 | 11.5 |
| Induration: Moderate (n=245, 252) | 0.8 | 0.4 |
| Induration: Severe (n=245, 252) | 0.0 | 0.0 |
| Erythema: Any (n=258, 257) | 18.2 | 18.3 |
| Erythema: Mild (n=256, 257) | 16.8 | 17.9 |
| Erythema: Moderate (n=247, 252) | 2.0 | 0.8 |
| Erythema: Severe (n=245, 252) | 0.0 | 0.0 |
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). Subjects may be represented in more than 1 category.
| percentage of subjects | 13vPnC | 7vPnC |
|---|---|---|
| Tenderness: Any (n=245, 257) | 27.3 | 28.0 |
| Tenderness: Significant (n=238, 244) | 3.8 | 0.8 |
| Induration: Any (n=243, 250) | 11.5 | 10.0 |
| Induration: Mild (n=243, 250) | 11.1 | 9.6 |
| Induration: Moderate (n=238, 244) | 0.8 | 1.2 |
| Induration: Severe (n=237, 244) | 0.0 | 0.0 |
| Erythema: Any (n=244, 253) | 16.4 | 17.8 |
| Erythema: Mild (n=244, 253) | 16.4 | 17.0 |
| Erythema: Moderate (n=237, 244) | 0.4 | 0.8 |
| Erythema: Severe (n=237, 244) | 0.0 | 0.0 |
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). Subjects may be represented in more than 1 category.
| percentage of subjects | 13vPnC | 7vPnC |
|---|---|---|
| Tenderness: Any (n=216, 223) | 25.0 | 28.7 |
| Tenderness: Significant (n=198, 210) | 2.5 | 1.0 |
| Induration: Any (n=198, 213) | 11.1 | 9.4 |
| Induration: Mild (n=198, 213) | 10.6 | 8.9 |
| Induration: Moderate (n=196, 210) | 1.0 | 2.4 |
| Induration: Severe (n=195, 210) | 0.0 | 0.0 |
| Erythema: Any (n=204, 216) | 19.6 | 16.7 |
| Erythema: Mild (n=202, 216) | 18.8 | 14.8 |
| Erythema: Moderate (n=197, 210) | 2.5 | 2.4 |
| Erythema: Severe (n=195, 210) | 0.0 | 0.0 |
Systemic events (any fever ≥38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.
| percentage of subjects | 13vPnC | 7vPnC |
|---|---|---|
| Fever ≥38 but ≤39 degrees C (n=269, 273) | 8.9 | 9.2 |
| Fever >39 but ≤40 degrees C (n=267, 273) | 0.7 | 0.0 |
| Fever >40 degrees C (n=266, 273) | 0.0 | 0.0 |
| Decreased appetite (n=279, 283) | 42.7 | 36.0 |
| Irritability (n=291, 288) | 80.8 | 83.0 |
| Increased sleep (n=286, 292) | 62.9 | 64.7 |
| Decreased sleep (n=276, 276) | 29.7 | 28.3 |
Systemic events (any fever ≥38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.
| percentage of subjects | 13vPnC | 7vPnC |
|---|---|---|
| Fever ≥38 but ≤39 degrees C (n=249, 255) | 8.0 | 7.5 |
| Fever >39 but ≤40 degrees C (n=245, 253) | 0.4 | 0.4 |
| Fever >40 degrees C (n=245, 252) | 0.0 | 0.0 |
| Decreased appetite (n=254, 262) | 28.7 | 31.3 |
| Irritability (n=283, 281) | 71.0 | 70.1 |
| Increased sleep (n=263, 275) | 54.4 | 52.4 |
| Decreased sleep (n=256, 261) | 25.8 | 31.0 |
Systemic events (any fever ≥38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.
| percentage of subjects | 13vPnC | 7vPnC |
|---|---|---|
| Fever ≥38 but ≤39 degrees C (n=237, 244) | 8.9 | 5.7 |
| Fever >39 but ≤40 degrees C (n=237, 244) | 0.4 | 0.8 |
| Fever >40 degrees C (n=237, 244) | 0.0 | 0.0 |
| Decreased appetite (n=249, 253) | 33.3 | 31.2 |
| Irritability (n=266, 270) | 68.0 | 65.9 |
| Increased sleep (n=255, 258) | 35.7 | 39.9 |
| Decreased sleep (n=251, 254) | 29.9 | 28.3 |
Systemic events (any fever ≥38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.
| percentage of subjects | 13vPnC | 7vPnC |
|---|---|---|
| Fever ≥38 but ≤39 degrees C (n=203, 213) | 13.3 | 12.2 |
| Fever >39 but ≤40 degrees C (n=196, 210) | 2.0 | 1.4 |
| Fever >40 degrees C (n=) 195, 210 | 0.0 | 0.5 |
| Decreased appetite (n=211, 225) | 37.0 | 34.2 |
| Irritability (n=240, 241) | 68.8 | 58.5 |
| Increased sleep (n=212, 226) | 33.5 | 33.2 |
| Decreased sleep (n=212, 227) | 34.0 | 33.9 |
Collected over Baseline through 6 Month Follow-up after last study vaccination (18 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1, 2, and 3 at 2, 4, and 6 months of age, respectively; Toddler Dose at 12 months of age.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 13vPnC Infant Series | — | 5/300 (1.7%) | 273/300 (91%) |
| 7vPnC Infant Series | — | 5/303 (1.7%) | 279/303 (92.1%) |
| 13vPnC After the Infant Series | — | 11/299 (3.7%) | 20/299 (6.7%) |
| 7vPnC After the Infant Series | — | 7/301 (2.3%) | 16/301 (5.3%) |
| 13vPnC Toddler Dose | — | 2/286 (0.7%) | 199/286 (69.6%) |
| 7vPnC Toddler Dose | — | 2/280 (0.7%) | 193/280 (68.9%) |
| 13vPnC Toddler Dose 6-Month Follow-up | — | 7/299 (2.3%) | 6/299 (2%) |
| 7vPnC Toddler Dose 6-Month Follow-up | — | 3/301 (1%) | 4/301 (1.3%) |
| Event | 13vPnC Infant Series | 7vPnC Infant Series | 13vPnC After the Infant Series | 7vPnC After the Infant Series | 13vPnC Toddler Dose | 7vPnC Toddler Dose | 13vPnC Toddler Dose 6-Month Follow-up | 7vPnC Toddler Dose 6-Month Follow-up |
|---|---|---|---|---|---|---|---|---|
| BronchiolitisInfections and infestations | 4/300 | 3/303 | 2/299 | 2/301 | 0/286 | 0/280 | 3/299 | 0/301 |
| PneumoniaInfections and infestations | 0/300 | 0/303 | 0/299 | 0/301 | 0/286 | 0/280 | 2/299 | 3/301 |
| Urinary tract infectionInfections and infestations | 0/300 | 0/303 | 2/299 | 0/301 | 0/286 | 0/280 | 0/299 | 0/301 |
| Meningitis meningococcalInfections and infestations | 0/300 | 0/303 | 0/299 | 0/301 | 0/286 | 1/280 | 0/299 | 0/301 |
| BronchospasmRespiratory, thoracic and mediastinal disorders | 0/300 | 0/303 | 0/299 | 0/301 | 0/286 | 1/280 | 0/299 | 0/301 |
| Developmental delayGeneral disorders | 0/300 | 0/303 | 0/299 | 0/301 | 1/286 | 0/280 | 0/299 | 0/301 |
| PyrexiaGeneral disorders | 1/300 | 0/303 | 0/299 | 0/301 | 1/286 | 0/280 | 0/299 | 0/301 |
| Croup infectiousInfections and infestations | 0/300 | 0/303 | 0/299 | 0/301 | 0/286 | 0/280 | 1/299 | 0/301 |
| GastroenteritisInfections and infestations | 0/300 | 1/303 | 1/299 | 0/301 | 0/286 | 0/280 | 0/299 | 0/301 |
| MastoiditisInfections and infestations | 0/300 | 0/303 | 0/299 | 0/301 | 0/286 | 0/280 | 1/299 | 0/301 |
| Event | 13vPnC Infant Series | 7vPnC Infant Series | 13vPnC After the Infant Series | 7vPnC After the Infant Series | 13vPnC Toddler Dose | 7vPnC Toddler Dose | 13vPnC Toddler Dose 6-Month Follow-up | 7vPnC Toddler Dose 6-Month Follow-up |
|---|---|---|---|---|---|---|---|---|
| IrritabilityGeneral disorders | 235/291 | 239/288 | — | — | 165/240 | 141/241 | — | — |
| IrritabilityGeneral disorders | 201/283 | 197/281 | — | — | — | — | — | — |
| IrritabilityGeneral disorders | 181/266 | 178/270 | — | — | — | — | — | — |
| Increased sleepGeneral disorders | 180/286 | 189/292 | — | — | 71/212 | 75/226 | — | — |
| Increased sleepGeneral disorders | 143/263 | 144/275 | — | — | — | — | — | — |
| Tenderness (any)Skin and subcutaneous tissue disorders | 125/281 | 124/283 | — | — | 54/216 | 64/223 | — | — |
| Decreased appetiteGeneral disorders | 119/279 | 102/283 | — | — | 78/211 | 77/225 | — | — |
| Increased sleepGeneral disorders | 91/255 | 103/258 | — | — | — | — | — | — |
| Tenderness (any)Skin and subcutaneous tissue disorders | 99/264 | 87/266 | — | — | — | — | — | — |
| Decreased sleepGeneral disorders | 82/276 | 78/276 | — | — | 72/212 | 77/227 | — | — |
| Age Continuous(months) | 13vPnC | 7vPnC | Total |
|---|---|---|---|
| Mean | 2.1 ± 0.3 | 2.1 ± 0.3 | 2.1 ± 0.3 |
| Sex: Female, Male(Participants) | 13vPnC | 7vPnC | Total |
|---|---|---|---|
| Female | 143 | 152 | 295 |
| Male | 157 | 151 | 308 |
The record gives a start of Jun 2007, a primary completion of May 2009 and a completion of May 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2010, 1 year 1 month after primary completion.
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