A Phase 3 interventional study of 13-valent Pneumococcal Conjugate Vaccine and 7 valent pneumococcal conjugate vaccine in Pneumococcal Infections, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 12 sites in India. Open to participants aged 42 Days to 72 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer (part of Pfizer) · Phase 3, Interventional, and Prevention
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in India.
298 studies on the registry are indexed under Pneumococcal Infections; 26 are open to participants now.
This study's enrollment of 708 is above the median of 373 across 253 interventional studies indexed under Pneumococcal Infections.
Browse Pneumococcal Infections studies →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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: 13-valent Pneumococcal Conjugate Vaccine
Biological: 7 valent pneumococcal conjugate vaccine
1 dose at 6, 10, 14 weeks and 12 months of age
1 dose at 6, 10, 14 weeks and 12 months of age
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series.
Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% confidence interval (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 19 A) are presented.
Time frame: 1 month after the infant series (18 weeks of age)
Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series.
Percentage of participants achieving a predefined antibody level (measured in enzyme-linked immunosorbent assay \[ELISA\] units per mL \[EU/mL\]) along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% CI for concomitant antigens pertussis (PT, FHA and PRN) are presented.
Time frame: 1 month after the infant series (18 weeks of age)
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose.
Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact, 2-sided 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 19 A) are presented.
Time frame: 1 month after the toddler dose (13 months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series
Antibody GMC as measured in 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 O'Brien-Fleming-adjusted, 2-sided 95% CIs were calculated.
Time frame: 1 month after the 3-dose infant series (18 weeks of age)
GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose
Antibody GMC as measured in 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% CIs were presented.
Time frame: 1 month after toddler dose (13 months of age)
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks 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 4 days after the dose 1 of the infant series (6 weeks of age)
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks 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 4 days after the dose 2 of the infant series (10 weeks of age)
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)
Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and 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 4 days after the dose 3 of the infant series (14 weeks of age)
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and 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 4 days after the toddler dose (12 months of age)
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age)
Systemic events (any fever \>=38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 4 days after the dose 1 of the infant series (6 weeks of age)
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age)
Systemic events (any fever \>=38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 4 days after the dose 2 of the infant series (10 weeks of age)
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age)
Systemic events (any fever \>=38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 4 days after the dose 3 of the infant series (14 weeks of age)
Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
Systemic events (any fever \>=38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 4 days after the toddler dose(12 months of age)
| Milestone | 13vPnC | 7vPnC |
|---|---|---|
| Started | 354 | 355 |
| Vaccinated dose 1 | 353 | 353 |
| Vaccinated dose 2 | 300 | 300 |
| Vaccinated dose 3 | 221 | 218 |
| Completed | 219 | 214 |
| Not completed | 135 | 141 |
| Withdrew: Clinical hold - consent withdrawn | 118 | 123 |
| Withdrew: Parent/legal guardian request | 8 | 6 |
| Withdrew: Failed to return | 4 | 1 |
| Withdrew: Protocol violation | 1 | 3 |
| Withdrew: Lost to follow-up | 2 | 2 |
| Withdrew: Adverse event | 1 | 2 |
| Withdrew: Other reasons | 1 | 2 |
| Withdrew: Investigator request | 0 | 1 |
| Withdrew: Death | 0 | 1 |
| Milestone | 13vPnC | 7vPnC |
|---|---|---|
| Started | 219 | 214 |
| Completed | 198 | 200 |
| Not completed | 21 | 14 |
| Withdrew: Investigator request | 10 | 10 |
| Withdrew: Adverse event | 4 | 1 |
| Withdrew: Parent/legal guardian request | 1 | 3 |
| Withdrew: Lost to follow-up | 4 | 0 |
| Withdrew: Failed to return | 1 | 0 |
| Withdrew: Other reasons | 1 | 0 |
| Milestone | 13vPnC | 7vPnC |
|---|---|---|
| Started | 198 | 200 |
| Completed | 198 | 198 |
| Not completed | 0 | 2 |
| Withdrew: Failed to return | 0 | 1 |
| Withdrew: Parent/legal guardian request | 0 | 1 |
Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% confidence interval (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 19 A) are presented.
| Percentage of participants | 13vPnC | 7vPnC |
|---|---|---|
| Common serotypes - serotype 4 (n= 203, 192) | 97.0 (93.6 to 98.9) | 97.9 (94.7 to 99.4) |
| Common serotypes - serotype 6B (n= 196,194) | 84.7 (78.8 to 89.5) | 87.1 (81.5 to 91.5) |
| Common serotypes - serotype 9V (n= 204,195) | 92.6 (88.1 to 95.8) | 94.4 (90.1 to 97.2) |
| Common serotypes - serotype 14 (n= 185,186) | 91.4 (86.3 to 95.0) | 93.5 (89.0 to 96.6) |
| Common serotypes - serotype 18C (n= 204,188) | 95.1 (91.1 to 97.6) | 93.1 (88.4 to 96.3) |
| Common serotypes - serotype 19F (n= 200,188) | 95.0 (91.0 to 97.6) | 94.7 (90.4 to 97.4) |
| Common serotypes - serotype 23F (n= 202,186) | 90.1 (85.1 to 93.9) | 89.2 (83.8 to 93.3) |
| Additional serotypes - serotype 1 (n= 206,195) | 96.6 (93.1 to 98.6) | 0.5 (0.0 to 2.8) |
| Additional serotypes - serotype 3 (n= 201,187) | 87.6 (82.1 to 91.8) | 2.1 (0.6 to 5.4) |
| Additional serotypes - serotype 5 (n= 201,185) | 85.1 (79.3 to 89.7) | 24.3 (18.3 to 31.2) |
| Additional serotypes - serotype 6A (n= 200,191) | 90.0 (84.9 to 93.8) | 36.1 (29.3 to 43.4) |
| Additional serotypes - serotype 7F (n= 203,192) | 98.0 (95.0 to 99.5) | 2.6 (0.8 to 6.0) |
| Additional serotypes - serotype 19 A (n= 204,190) | 99.5 (97.3 to 100.0) | 84.7 (78.8 to 89.6) |
Antibody GMC as measured in 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 O'Brien-Fleming-adjusted, 2-sided 95% CIs were calculated.
| mcg/mL | 13vPnC | 7vPnC |
|---|---|---|
| Common serotypes - serotype 4 (n= 203,192) | 2.19 (1.95 to 2.46) | 2.58 (2.26 to 2.95) |
| Common serotypes - serotype 6B (n= 196,194) | 1.45 (1.20 to 1.75) | 1.56 (1.28 to 1.89) |
| Common serotypes - serotype 9V (n= 204,195) | 1.34 (1.19 to 1.50) | 1.46 (1.28 to 1.65) |
| Common serotypes - serotype 14 (n= 185,186) | 2.84 (2.35 to 3.43) | 2.39 (1.98 to 2.90) |
| Common serotypes - serotype 18C (n= 204,188) | 1.61 (1.42 to 1.82) | 1.70 (1.47 to 1.96) |
| Common serotypes - serotype 19F (n= 200,188) | 2.25 (1.97 to 2.56) | 2.47 (2.11 to 2.89) |
| Common serotypes - serotype 23F (n= 202,186) | 1.38 (1.18 to 1.60) | 1.46 (1.25 to 1.70) |
| Additional serotypes - serotype 1 (n= 206,195) | 1.95 (1.72 to 2.22) | 0.03 (0.03 to 0.04) |
| Additional serotypes - serotype 3 (n= 201,195) | 0.80 (0.72 to 0.90) | 0.05 (0.05 to 0.06) |
| Additional serotypes - serotype 5 (n= 201,195) | 0.93 (0.82 to 1.06) | 0.20 (0.18 to 0.23) |
| Additional serotypes - serotype 6A (n= 200,195) | 1.44 (1.25 to 1.66) | 0.28 (0.25 to 0.31) |
| Additional serotypes - serotype 7F (n= 203,195) | 2.27 (2.05 to 2.33) | 0.06 (0.05 to 0.06) |
| Additional serotypes - serotype 19A (n= 204,195) | 2.76 (2.46 to 3.10) | 0.74 (0.66 to 0.82) |
Percentage of participants achieving a predefined antibody level (measured in enzyme-linked immunosorbent assay \[ELISA\] units per mL \[EU/mL\]) along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% CI for concomitant antigens pertussis (PT, FHA and PRN) are presented.
| Percentage of participants | 13vPnC | 7vPnC |
|---|---|---|
| PT >=0.975 EU/mL | 100.0 (98.2 to 100.0) | 100.0 (98.1 to 100.0) |
| FHA >=3.91 EU/mL | 100.0 (98.2 to 100.0) | 100.0 (98.1 to 100.0) |
| PRN >=6 EU/mL | 92.7 (88.2 to 95.9) | 95.9 (92.1 to 98.2) |
Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact, 2-sided 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 19 A) are presented.
| Percentage of participants | 13vPnC | 7vPnC |
|---|---|---|
| Common serotypes - serotype 4 (n= 193, 196) | 100.0 (98.1 to 100.0) | 100.0 (98.1 to 100.0) |
| Common serotypes - serotype 6B (n= 192,195) | 100.0 (98.1 to 100.0) | 99.5 (97.2 to 100.0) |
| Common serotypes - serotype 9V (n= 193,196) | 99.5 (97.1 to 100.0) | 99.5 (97.2 to 100.0) |
| Common serotypes - serotype 14 (n= 193,196) | 99.5 (97.1 to 100.0) | 99.5 (97.2 to 100.0) |
| Common serotypes - serotype 18C (n= 193,196) | 99.5 (97.1 to 100.0) | 99.0 (96.4 to 99.9) |
| Common serotypes - serotype 19F (n= 193,196) | 97.9 (94.8 to 99.4) | 98.0 (94.9 to 99.4) |
| Common serotypes - serotype 23F (n= 193,196) | 98.4 (95.5 to 99.7) | 99.5 (97.2 to 100.0) |
| Additional serotypes - serotype 1 (n= 193,196) | 98.4 (95.5 to 99.7) | 3.1 (1.1 to 6.6) |
| Additional serotypes - serotype 3 (n= 193,196) | 90.2 (85.1 to 94.0) | 12.9 (8.5 to 18.4) |
| Additional serotypes - serotype 5 (n= 192,196) | 100.0 (98.1 to 100.0) | 74.3 (67.4 to 80.5) |
| Additional serotypes - serotype 6A (n= 193,196) | 100.0 (98.1 to 100.0) | 92.8 (88.2 to 96.0) |
| Additional serotypes - serotype 7F (n= 193,196) | 99.0 (96.3 to 99.9) | 9.8 (6.0 to 14.9) |
| Additional serotypes - serotype 19 A (n= 193,196) | 100.0 (98.1 to 100.0) | 98.5 (95.5 to 99.7) |
Antibody GMC as measured in 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% CIs were presented.
| mcg/mL | 13vPnC | 7vPnC |
|---|---|---|
| Common serotypes - serotype 4 (n= 193, 196) | 5.33 (4.69 to 6.04) | 5.85 (5.13 to 6.68) |
| Common serotypes - serotype 6B (n= 192, 195) | 12.24 (10.60 to 14.13) | 11.60 (9.95 to 13.53) |
| Common serotypes - serotype 9V (n= 193,196) | 3.01 (2.68 to 3.37) | 3.33 (2.96 to 3.75) |
| Common serotypes - serotype 14 (n= 193,196) | 10.59 (9.21 to 12.18) | 10.95 (9.41 to 12.74) |
| Common serotypes - serotype 18C (n= 193,196) | 2.63 (2.33 to 2.97) | 2.98 (2.65 to 3.34) |
| Common serotypes - serotype 19F (n= 193,196) | 8.38 (7.11 to 9.87) | 5.65 (4.84 to 6.58) |
| Common serotypes - serotype 23F (n= 193,196) | 4.27 (3.66 to 4.98) | 5.31 (4.66 to 6.04) |
| Additional serotypes - serotype 1 (n= 193,196) | 5.10 (4.39 to 5.92) | 0.04 (0.04 to 0.05) |
| Additional serotypes - serotype 3 (n= 193,196) | 0.91 (0.81 to 1.03) | 0.09 (0.08 to 0.11) |
| Additional serotypes - serotype 5 (n= 192,196) | 3.58 (3.20 to 4.00) | 0.64 (0.55 to 0.75) |
| Additional serotypes - serotype 6A (n= 193,196) | 8.13 (7.11 to 9.28) | 1.87 (1.62 to 2.17) |
| Additional serotypes - serotype 7F (n= 193,196) | 4.81 (4.27 to 5.42) | 0.06 (0.05 to 0.08) |
| Additional serotypes - serotype 19A (n= 193,196) | 14.12 (12.45 to 16.01) | 3.56 (3.14 to 4.05) |
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 | 13vPnC | 7vPnC |
|---|---|---|
| Tenderness: Any (n= 347,347) | 62.5 | 59.7 |
| Tenderness: Significant (n= 341,343) | 42.2 | 40.5 |
| Induration: Any (n= 339,342) | 21.5 | 22.5 |
| Induration: Mild (n= 338,340) | 19.2 | 19.1 |
| Induration: Moderate (n= 331,338) | 4.8 | 5.6 |
| Induration: Severe (n= 329,336) | 0.0 | 0.0 |
| Erythema: Any (n= 333,339) | 12.6 | 13.3 |
| Erythema: Mild (n= 333,338) | 11.4 | 11.8 |
| Erythema: Moderate (n= 330,337) | 1.5 | 1.8 |
| Erythema: Severe (n= 329,336) | 0.0 | 0.0 |
| Any of the above (n= 349,348) | 66.8 | 65.2 |
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 | 13vPnC | 7vPnC |
|---|---|---|
| Tenderness: Any (n= 284,282) | 44.4 | 44.0 |
| Tenderness: Significant (n= 278,279) | 26.6 | 28.0 |
| Induration: Any (n= 281,278) | 20.6 | 18.7 |
| Induration: Mild (n= 281,277) | 16.7 | 16.2 |
| Induration: Moderate (n= 273,272) | 5.1 | 4.0 |
| Induration: Severe (n= 273,271) | 0.0 | 0.0 |
| Erythema: Any (n= 275,280) | 13.8 | 17.9 |
| Erythema: Mild (n= 275,279) | 13.1 | 15.8 |
| Erythema: Moderate (n= 273,273) | 1.5 | 2.9 |
| Erythema: Severe (n= 273,271) | 0.0 | 0.0 |
| Any of the above (n= 285,286) | 51.6 | 53.1 |
Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and 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 | 13vPnC | 7vPnC |
|---|---|---|
| Tenderness: Any (n= 204,200) | 37.3 | 38.0 |
| Tenderness: Significant (n= 199,196) | 24.1 | 23.5 |
| Induration: Any (n= 198,195) | 17.2 | 13.8 |
| Induration: Mild (n= 196,195) | 15.8 | 11.8 |
| Induration: Moderate (n= 193,193) | 2.6 | 3.6 |
| Induration: Severe (n= 191,193) | 0.0 | 0.0 |
| Erythema: Any (n= 192,195) | 10.4 | 9.7 |
| Erythema: Mild (n= 192,195) | 10.4 | 9.2 |
| Erythema: Moderate (n= 191,193) | 0.0 | 0.5 |
| Erythema: Severe (n= 191,193) | 0.0 | 0.0 |
| Any of the above (n= 206,202) | 43.2 | 42.1 |
Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and 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 | 13vPnC | 7vPnC |
|---|---|---|
| Tenderness: Any (n= 174,176) | 29.9 | 30.7 |
| Tenderness: Significant (n= 171,170) | 15.8 | 17.1 |
| Induration: Any (n= 173,176) | 19.7 | 17.6 |
| Induration: Mild (n= 170,175) | 15.9 | 14.9 |
| Induration: Moderate (n= 170,171) | 5.3 | 7.6 |
| Induration: Severe (n= 167,169) | 0.0 | 0.0 |
| Erythema: Any (n= 174,176) | 14.9 | 14.2 |
| Erythema: Mild (n= 172,175) | 12.2 | 10.9 |
| Erythema: Moderate (n= 169,170) | 3.6 | 4.1 |
| Erythema: Severe (n= 167,169) | 0.0 | 0.0 |
| Any of the above (n= 177,178) | 36.7 | 41.0 |
Systemic events (any fever \>=38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
| Percentage of participants | 13vPnC | 7vPnC |
|---|---|---|
| Fever >=38 but <=39 degrees C (n= 313,324) | 19.8 | 21.6 |
| Fever >39 but <=40 degrees C (n= 309,322) | 2.3 | 1.2 |
| Fever >40 degrees C (n= 309,322) | 0.3 | 0.9 |
| Decreased appetite (n= 343,347) | 55.7 | 55.9 |
| Irritability (n= 345,347) | 83.2 | 79.8 |
| Increased sleep (n= 338,342) | 40.8 | 36.8 |
| Decreased sleep (n= 336,343) | 55.7 | 56.0 |
| Any systemic event (n= 350,348) | 94.3 | 90.8 |
Systemic events (any fever \>=38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
| Percentage of participants | 13vPnC | 7vPnC |
|---|---|---|
| Fever >=38 but <=39 degrees C (n= 263,249) | 10.3 | 15.3 |
| Fever >39 but <=40 degrees C (n= 259,247) | 0.8 | 0.4 |
| Fever >40 degrees C (n= 259,247) | 0.0 | 0.4 |
| Decreased appetite (n= 281,282) | 48.0 | 46.5 |
| Irritability (n= 290,291) | 70.7 | 69.8 |
| Increased sleep (n= 285,275) | 33.7 | 26.9 |
| Decreased sleep (n= 282,286) | 37.9 | 46.9 |
| Any systemic event (n= 294,297) | 80.6 | 80.5 |
Systemic events (any fever \>=38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
| Percentage of participants | 13vPnC | 7vPnC |
|---|---|---|
| Fever >=38 but <=39 degrees C (n= 181,172) | 7.7 | 14.0 |
| Fever >39 but <=40 degrees C (n= 179,170) | 0.0 | 0.0 |
| Fever >40 degrees C (n= 179,171) | 0.0 | 0.6 |
| Decreased appetite (n= 202,200) | 42.1 | 41.0 |
| Irritability (n= 208,208) | 64.4 | 67.3 |
| Increased sleep (n= 199,195) | 20.1 | 20.5 |
| Decreased sleep (n= 205,201) | 42.4 | 36.8 |
| Any systemic event (n= 213,209) | 75.1 | 78.5 |
Systemic events (any fever \>=38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
| Percentage of participants | 13vPnC | 7vPnC |
|---|---|---|
| Fever >=38 but <=39 degrees C (n= 161,154) | 5.6 | 6.5 |
| Fever >39 but <=40 degrees (n= 160,152) | 0.6 | 0.0 |
| Fever >40 degrees C (n= 160,152) | 0.0 | 0.0 |
| Decreased appetite (n= 174,179) | 28.7 | 24.6 |
| Irritability (n= 174,183) | 38.5 | 35.0 |
| Increased sleep (n= 171,170) | 12.3 | 9.4 |
| Decreased sleep (n= 172,178) | 22.7 | 27.0 |
| Any systemic event (n= 179,186) | 54.7 | 52.7 |
Collected over Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Infant Series 13vPnC | — | 8/353 (2.3%) | 330/353 (93.5%) |
| Infant Series 7vPnC | — | 6/353 (1.7%) | 316/353 (89.5%) |
| After the Infant Series 13vPnC | — | 8/353 (2.3%) | 5/353 (1.4%) |
| After the Infant Series 7vPnC | — | 11/353 (3.1%) | 9/353 (2.5%) |
| Toddler Dose 13vPnC | — | 4/198 (2%) | 98/198 (49.5%) |
| Toddler Dose 7vPnC | — | 1/200 (0.5%) | 98/200 (49%) |
| Event | Infant Series 13vPnC | Infant Series 7vPnC | After the Infant Series 13vPnC | After the Infant Series 7vPnC | Toddler Dose 13vPnC | Toddler Dose 7vPnC |
|---|---|---|---|---|---|---|
| BronchiolitisInfections and infestations | 2/353 | 4/353 | 0/353 | 0/353 | 0/198 | 0/200 |
| GastroenteritisInfections and infestations | 0/353 | 0/353 | 1/353 | 4/353 | 2/198 | 0/200 |
| BronchopneumoniaInfections and infestations | 3/353 | 0/353 | 1/353 | 1/353 | 1/198 | 0/200 |
| Lower respiratory tract infectionInfections and infestations | 0/353 | 0/353 | 2/353 | 1/353 | 0/198 | 0/200 |
| Lower respiratory tract infection viralInfections and infestations | 0/353 | 0/353 | 2/353 | 1/353 | 0/198 | 0/200 |
| Gastroenteritis viralInfections and infestations | 0/353 | 0/353 | 2/353 | 0/353 | 0/198 | 0/200 |
| DehydrationMetabolism and nutrition disorders | 0/353 | 0/353 | 2/353 | 1/353 | 0/198 | 0/200 |
| Bronchial hyperreactivityRespiratory, thoracic and mediastinal disorders | 0/353 | 0/353 | 0/353 | 0/353 | 1/198 | 0/200 |
| Breath holdingPsychiatric disorders | 0/353 | 0/353 | 0/353 | 0/353 | 0/198 | 1/200 |
| Cardiac failure congestiveCardiac disorders | 1/353 | 0/353 | 0/353 | 1/353 | 0/198 | 0/200 |
| Event | Infant Series 13vPnC | Infant Series 7vPnC | After the Infant Series 13vPnC | After the Infant Series 7vPnC | Toddler Dose 13vPnC | Toddler Dose 7vPnC |
|---|---|---|---|---|---|---|
| IrritabilityGeneral disorders | 287/345 | 277/347 | — | — | 67/174 | 64/183 |
| IrritabilityGeneral disorders | 205/290 | 203/291 | — | — | — | — |
| IrritabilityGeneral disorders | 134/208 | 140/208 | — | — | — | — |
| Tenderness (any)Skin and subcutaneous tissue disorders | 217/347 | 207/347 | — | — | 52/174 | 54/176 |
| Decreased sleepGeneral disorders | 187/336 | 192/343 | — | — | 39/172 | 48/178 |
| Decreased appetiteGeneral disorders | 191/343 | 194/347 | — | — | 50/174 | 44/179 |
| Decreased appetiteGeneral disorders | 135/281 | 131/282 | — | — | — | — |
| Decreased sleepGeneral disorders | 107/282 | 134/286 | — | — | — | — |
| Tenderness (any)Skin and subcutaneous tissue disorders | 126/284 | 124/282 | — | — | — | — |
| Decreased sleepGeneral disorders | 87/205 | 74/201 | — | — | — | — |
| Age, Continuous(months) | 13vPnC | 7vPnC | Total |
|---|---|---|---|
| Mean | 1.6 ± 0.3 | 1.6 ± 0.2 | 1.6 ± 0.3 |
| Age, Continuous(weeks) | 13vPnC | 7vPnC | Total |
|---|---|---|---|
| Mean | 7.1 ± 1.1 | 7.2 ± 1.1 | 7.1 ± 1.1 |
| Sex/Gender, Customized(participants) | 13vPnC | 7vPnC | Total |
|---|---|---|---|
| Male | 184 | 186 | 370 |
| Female | 169 | 169 | 338 |
| Unknown | 1 | 0 | 1 |
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