Diphtheria, Haemophilus Infection, Pertussis, Polio, Tetanus
Conditions
Keywords
Pertussis, Whooping cough, Diphtheria, Tetanus, Haemophilus influenzae, Poliovirus Types 1, 2, and 3.
Brief summary
This study is designed to evaluate in a controlled manner the effect of Prevnar® on the immune responses of Pentacel™ Primary Objective - Stage I: To compare the immune responses elicited by an infant series of Pentacel™ when given at different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®). Primary Objective - Stage II: To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different times from or concurrently with Prevnar®.
Detailed description
This is a 2-staged study. Stage I of this study is designed to compare the immune responses elicited by an infant series (3 doses) of Pentacel™ when given at different times from or concurrently with Prevnar®. Stage II is designed to describe the immune responses elicited by a 4th dose of Pentacel™ (all antigens) when given at different times from or concurrently with Prevnar®.
Interventions
BIOLOGICALPentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®
0.5 mL, Intramuscular
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
42 Days to 89 Days
Healthy volunteers
Yes
Inclusion criteria
: * Healthy infants 2 months (≥ 42 days and ≤ 89 days) of age. * Infants with at least 36 weeks of gestation at delivery. * Must have received 1 dose of Hepatitis B vaccine (with that dose at least 15 days before the administration of study vaccines). * Able to attend the scheduled visits and to comply with the study procedures. * Parent or legal guardian willing to take rectal temperatures during the infant series. * Parent or legal guardian has access to a telephone. * Signed informed consent from parent or legal guardian obtained before the 1st study intervention. * Able to obtain at least 1.5 mL of blood sample prior to Dose 1.
Exclusion criteria
: * Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion). * Known or suspected hypersensitivity to any component of the study vaccine to be administered. * Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth. * Known Human Immunodeficiency Virus (HIV)-positive mother or child. * Personal or immediate family history of congenital immune deficiency. * Developmental delay or neurologic disorder. * Chronic medical, congenital, or developmental disease. * Participation in any other clinical trial. * Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject. * Prior history of having received any Acellular Pertussis- (DTaP) or Whole Cell Pertussis- (DTwP) based combination vaccines, Haemophilus influenzae Type b (Hib)-conjugate, Poliovirus, or Pneumococcal conjugate vaccines.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | 28 to 48 days post-3rd vaccination | Seroconversion was defined as the percentage of subjects with ≥ 4-fold post-dose 3 for anti-pertussis and ≥ 0.15 μg/mL or ≥ 1.0 μg/mL for anti-Polyribosylribitol Phosphate (PRP) responses. |
| Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | 60 Days Post-dose 3 | Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | 0-3 days post- vaccination and entire study period | Solicited local reactions: redness, swelling, and tenderness. Solicited systemic reactions: fever (temperature), irritability post-vaccinal, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash. |
Countries
United States
Participant flow
Recruitment details
Study participants were enrolled from 30 October 2003 to 29 March 2004 in 23 medical clinics in the US.
Pre-assignment details
A total of 1167 subjects that met the inclusion and exclusion criteria were enrolled, 1166 were vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Pentacel™ Concurrently With Prevnar® Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine | 587 |
| Pentacel™ Staggered Schedule With Prevnar® Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule). | 579 |
| Total | 1,166 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not receive vaccine | 0 | 1 |
| Overall Study | Lost to Follow-up | 9 | 6 |
| Overall Study | Protocol Violation | 10 | 12 |
| Overall Study | Withdrawal by Subject | 25 | 22 |
Baseline characteristics
| Characteristic | Pentacel™ Staggered Schedule With Prevnar® | Pentacel™ Concurrently With Prevnar® | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 579 Participants | 587 Participants | 1166 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 2.1 Months STANDARD_DEVIATION 0.28 | 2.2 Months STANDARD_DEVIATION 0.29 | 2.1 Months STANDARD_DEVIATION 0.29 |
| Region of Enrollment United States | 579 participants | 587 participants | 1166 participants |
| Sex: Female, Male Female | 259 Participants | 278 Participants | 537 Participants |
| Sex: Female, Male Male | 320 Participants | 309 Participants | 629 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 475 / 587 | 481 / 579 |
| serious Total, serious adverse events | 32 / 587 | 15 / 579 |
Outcome results
Primary
Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)
Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens.
Time frame: 60 Days Post-dose 3
Population: Geometric mean titer analysis was on the total number of subjects with available serology data from the per-protocol immunogenicity population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Pentacel™ Concurrently With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Pertussis Toxoid (PT) EU/mL | 103.58 All Units |
| Pentacel™ Concurrently With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Filamentous Haemagglutinin (FHA) EU/mL | 82.41 All Units |
| Pentacel™ Concurrently With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Fimbriae Types 2 and 3 (FIM) EU/mL | 272.47 All Units |
| Pentacel™ Concurrently With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Pertactin (PRN) EU/mL | 45.7 All Units |
| Pentacel™ Concurrently With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Poliovirus Polyribosylribitol P Tetanus(PRP) μg/mL | 3.32 All Units |
| Pentacel™ Concurrently With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Diphtheria (IU/mL) | 0.59 All Units |
| Pentacel™ Concurrently With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Tetanus (IU/mL) | 1.27 All Units |
| Pentacel™ Concurrently With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Polio 1 (1/dil) | 543.52 All Units |
| Pentacel™ Concurrently With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Polio 2 (1/dil) | 846.36 All Units |
| Pentacel™ Concurrently With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Polio 3 (1/dil) | 1025.73 All Units |
| Pentacel™ Staggered Schedule With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Polio 1 (1/dil) | 593.09 All Units |
| Pentacel™ Staggered Schedule With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Pertussis Toxoid (PT) EU/mL | 102.78 All Units |
| Pentacel™ Staggered Schedule With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Diphtheria (IU/mL) | 1.32 All Units |
| Pentacel™ Staggered Schedule With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Filamentous Haemagglutinin (FHA) EU/mL | 77.80 All Units |
| Pentacel™ Staggered Schedule With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Polio 3 (1/dil) | 1104.05 All Units |
| Pentacel™ Staggered Schedule With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Fimbriae Types 2 and 3 (FIM) EU/mL | 280.97 All Units |
| Pentacel™ Staggered Schedule With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Tetanus (IU/mL) | 1.30 All Units |
| Pentacel™ Staggered Schedule With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Pertactin (PRN) EU/mL | 44.28 All Units |
| Pentacel™ Staggered Schedule With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Polio 2 (1/dil) | 949.06 All Units |
| Pentacel™ Staggered Schedule With Prevnar® | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Poliovirus Polyribosylribitol P Tetanus(PRP) μg/mL | 3.60 All Units |
Primary
Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)
Seroconversion was defined as the percentage of subjects with ≥ 4-fold post-dose 3 for anti-pertussis and ≥ 0.15 μg/mL or ≥ 1.0 μg/mL for anti-Polyribosylribitol Phosphate (PRP) responses.
Time frame: 28 to 48 days post-3rd vaccination
Population: Analysis was on the total number of subjects with available serology data from the per-protocol immunogenicity population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pentacel™ Concurrently With Prevnar® | Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Pertussis Toxoid (PT) EU/mL | 90 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Filamentous Haemagglutinin (FHA) EU/mL | 82 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Fimbriae Types 2 and 3 (FIM 2&3) EU/mL | 88 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Pertactin (PRN) EU/mL | 74 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Poliovirus Polyribosyl. P Tetanus, PRP ≥0.15 μg/mL | 96 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Poliovirus Polyribosyl. P Tetanus, PRP ≥0.10 μg/mL | 77 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Poliovirus Polyribosyl. P Tetanus, PRP ≥0.15 μg/mL | 95 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Pertussis Toxoid (PT) EU/mL | 90 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Pertactin (PRN) EU/mL | 72 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Filamentous Haemagglutinin (FHA) EU/mL | 82 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Poliovirus Polyribosyl. P Tetanus, PRP ≥0.10 μg/mL | 80 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Fimbriae Types 2 and 3 (FIM 2&3) EU/mL | 88 Percentage of Participants |
Other Pre-specified
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™
Solicited local reactions: redness, swelling, and tenderness. Solicited systemic reactions: fever (temperature), irritability post-vaccinal, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.
Time frame: 0-3 days post- vaccination and entire study period
Population: Analysis was on all enrolled and vaccinated subjects, intend-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Fever Post-dose 2 | 19 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Tenderness Post-dose 1 | 28 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Fever > 39.5°C Post-dose 2 | 1 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Redness All doses | 12 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Lethargy Post-dose 2 | 21 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Swelling, > 50 mm Post-dose 2 | 0 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd3 Lethargy not interested in usual day activity | 1 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Redness, > 50 mm All doses | 0 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Vomiting Post-dose 2 | 9 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Redness Post-dose 1 | 5 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Vomiting, ≥ 3 episodes Post-dose 2 | 1 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Swelling All doses | 7 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Diarrhea Post-dose 2 | 9 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Tenderness Post-dose 2 | 22 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Diarrhea, > 5 stools Post-dose 2 | 0 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Swelling, > 50 mm All doses | 0 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Crying Post-dose 2 | 25 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd 3 Tenderness Cries when limb is moved Post-d 1 | 1 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Crying, > 3 hours Post-dose 2 | 1 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Tenderness All doses | 41 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Irritability Post-dose 2 | 47 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd 3 Tenderness Cries when limb is moved Post-d 2 | 1 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Irritability, > 3 hours Post-dose 2 | 4 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd3 Tenderness Cries when limb is moved All doses | 2 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Appetite Decreased Post-dose 2 | 15 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Swelling Post-Dose 1 | 4 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd 3 Appetite Decreased, Refuses ≥3 feeds Post-D2 | 0 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Solicited Systemic Reaction Post-dose 1 | 69 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Solicited Systemic Reaction, Post-dose 3 | 54 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Solicited Local Reaction, Post-dose 3 | 20 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Fever Post-dose 3 | 20 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Fever Post-dose 1 | 8 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Fever > 39.5°C Post-dose 3 | 0 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Solicited Local Reaction Post-dose 2 | 24 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Lethargy Post-dose 3 | 18 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Fever > 39.5°C Post-dose 1 | 0 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd3 Lethargy not interested in usual day activity | 1 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Redness Post-dose 3 | 6 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Vomiting Post-dose 3 | 4 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Lethargy Post-dose 1 | 33 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Vomiting, ≥ 3 episodes Post-dose 3 | 0 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Solicited Local Reaction Post-dose 1 | 31 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Diarrhea Post-dose 3 | 6 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd3 Lethargy not interested in usual day activity | 1 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Diarrhea, > 5 stools Post-dose 3 | 0 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Redness, > 50 mm Post-dose 3 | 0 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Crying Post-dose 3 | 18 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Vomiting Post-dose 1 | 9 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Crying, > 3 hours Post-dose 3 | 0 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Redness Post-dose 2 | 4 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Irritability Post-dose 3 | 40 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Vomiting, ≥ 3 episodes Post-dose 1 | 0 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Irritability, > 3 hours Post-dose 3 | 2 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Diarrhea Post-dose 1 | 11 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Appetite Decreased Post-dose 3 | 11 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Swelling Post-Dose 3 | 2 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd 3 Appetite Decreased, Refuses ≥3 feeds Post-D3 | 1 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Diarrhea, > 5 stools Post-dose 1 | 1 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Solicited Systemic Reaction, All doses | 87 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Swelling, > 50 mm Post-dose 1 | 0 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Fever All doses | 35 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Crying Post-dose 1 | 31 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Fever > 39.5°C, All doses | 1 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Swelling, > 50 mm Post-dose 3 | 0 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Lethargy All doses | 46 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Crying, > 3 hours Post-dose 1 | 1 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd3 Lethargy not interested in usual day activity | 2 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Redness, > 50 mm Post-dose 2 | 0 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Vomiting All doses | 18 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Irritability Post-dose 1 | 53 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Vomiting, ≥ 3 episodes All doses | 1 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Tenderness Post-dose 3 | 17 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Diarrhea All doses | 21 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Irritability, >3 hours Post-dose 1 | 3 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Diarrhea, > 5 stools All doses | 1 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Redness, > 50 mm Post-dose 1 | 0 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Crying All doses | 48 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Appetite Decreased Post-dose 1 | 18 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Crying, > 3 hours All doses | 1 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd 3 Tenderness Cries when limb is moved Post-d 3 | 1 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Irritability All doses | 74 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd 3 Appetite Decreased, Refuses ≥3 feeds Post-d1 | 1 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Irritability, > 3 hours All doses | 7 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Swelling Post-Dose 2 | 2 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Appetite Decreased All doses | 33 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Solicited Systemic Reaction, Post-dose 2 | 63 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd 3 Appetite Decreased, Refuses ≥ 3 feeds All D | 2 Percentage of Participants |
| Pentacel™ Concurrently With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Solicited Local Reaction All doses | 46 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd 3 Appetite Decreased, Refuses ≥ 3 feeds All D | 1 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Solicited Local Reaction Post-dose 1 | 26 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Redness Post-dose 1 | 3 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Redness, > 50 mm Post-dose 1 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Swelling Post-Dose 1 | 4 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Swelling, > 50 mm Post-dose 1 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Tenderness Post-dose 1 | 24 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd 3 Tenderness Cries when limb is moved Post-d 1 | 1 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Solicited Local Reaction Post-dose 2 | 15 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Redness Post-dose 2 | 4 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Redness, > 50 mm Post-dose 2 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Swelling Post-Dose 2 | 2 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Swelling, > 50 mm Post-dose 2 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Tenderness Post-dose 2 | 12 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd 3 Tenderness Cries when limb is moved Post-d 2 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Solicited Local Reaction, Post-dose 3 | 9 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Redness Post-dose 3 | 3 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Redness, > 50 mm Post-dose 3 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Swelling Post-Dose 3 | 2 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Swelling, > 50 mm Post-dose 3 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Tenderness Post-dose 3 | 7 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd 3 Tenderness Cries when limb is moved Post-d 3 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Solicited Local Reaction All doses | 38 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Redness All doses | 8 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Redness, > 50 mm All doses | 1 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Swelling All doses | 7 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Swelling, > 50 mm All doses | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Tenderness All doses | 33 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd3 Tenderness Cries when limb is moved All doses | 1 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Solicited Systemic Reaction Post-dose 1 | 64 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Fever Post-dose 1 | 11 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Fever > 39.5°C Post-dose 1 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Lethargy Post-dose 1 | 28 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd3 Lethargy not interested in usual day activity | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Vomiting Post-dose 1 | 8 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Diarrhea Post-dose 1 | 9 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Diarrhea, > 5 stools Post-dose 1 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Crying Post-dose 1 | 29 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Crying, > 3 hours Post-dose 1 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Irritability Post-dose 1 | 52 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Irritability, >3 hours Post-dose 1 | 1 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Appetite Decreased Post-dose 1 | 11 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd 3 Appetite Decreased, Refuses ≥3 feeds Post-d1 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Solicited Systemic Reaction, Post-dose 2 | 45 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Fever Post-dose 2 | 16 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Fever > 39.5°C Post-dose 2 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Lethargy Post-dose 2 | 11 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd3 Lethargy not interested in usual day activity | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Vomiting Post-dose 2 | 3 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Vomiting, ≥ 3 episodes Post-dose 2 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Diarrhea Post-dose 2 | 7 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Diarrhea, > 5 stools Post-dose 2 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Crying Post-dose 2 | 14 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Crying, > 3 hours Post-dose 2 | 1 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Irritability Post-dose 2 | 34 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Irritability, > 3 hours Post-dose 2 | 1 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Appetite Decreased Post-dose 2 | 8 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd 3 Appetite Decreased, Refuses ≥3 feeds Post-D2 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Solicited Systemic Reaction, Post-dose 3 | 34 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Fever Post-dose 3 | 16 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Fever > 39.5°C Post-dose 3 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Lethargy Post-dose 3 | 8 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd3 Lethargy not interested in usual day activity | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Vomiting Post-dose 3 | 5 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Vomiting, ≥ 3 episodes Post-dose 3 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Diarrhea Post-dose 3 | 4 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Diarrhea, > 5 stools Post-dose 3 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Crying Post-dose 3 | 9 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Crying, > 3 hours Post-dose 3 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Irritability Post-dose 3 | 26 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Irritability, > 3 hours Post-dose 3 | 2 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Appetite Decreased Post-dose 3 | 7 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd 3 Appetite Decreased, Refuses ≥3 feeds Post-D3 | 0 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Solicited Systemic Reaction, All doses | 78 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Fever All doses | 32 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Fever > 39.5°C, All doses | 1 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Lethargy All doses | 36 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grd3 Lethargy not interested in usual day activity | 1 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Vomiting All doses | 14 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Vomiting, ≥ 3 episodes All doses | 1 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Diarrhea All doses | 18 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Diarrhea, > 5 stools All doses | 1 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Crying All doses | 39 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Crying, > 3 hours All doses | 1 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Irritability All doses | 68 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Irritability, > 3 hours All doses | 4 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Any Appetite Decreased All doses | 21 Percentage of Participants |
| Pentacel™ Staggered Schedule With Prevnar® | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Grade 3 Vomiting, ≥ 3 episodes Post-dose 1 | 1 Percentage of Participants |