Diphtheria, Haemophilus Infection, Pertussis, Polio, Tetanus
Conditions
Keywords
DAPTACEL®, PENTACEL™, Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b
Brief summary
Objectives: * To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine. * To present immunogenicity before and after a single dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.
Detailed description
This study is designed to assess the safety and immunogenicity of DAPTACEL® vaccine administered at 4 to 6 years of age according to the US standard of care. The study population consists of PENTACEL™-primed subjects from Aventis Pasteur's pivotal studies 494-01 and 494-03. These children will receive DAPTACEL® vaccine as a 5th dose immunization between 4 to 6 years of age.
Interventions
BIOLOGICALDiphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
: * Aged ≥ 4 years and 6 years. * Signed and dated Investigational Review Board-approved informed consent from a parent or legally authorized representative. * Judged to be in good health on the basis of reported medical history and physical examination. * Able and willing to attend the scheduled visits and to comply with the study procedures. * Has documented complete infant series and 4th dose in Study 494-01 or Study 494-03, consisting of four previous administrations of PENTACEL™.
Exclusion criteria
: * Received a 5th dose of DTaP-containing vaccine scheduled at 4 to 6 years of age. * Serious underlying chronic disease, including, but not limited to: * Diabetes mellitus; malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder; or * Unstable or evolving neurologic disorders that may predispose the subject to seizures or neurologic deterioration. * Known or suspected primary or acquired disease of the immune system. * Administration of immune globulin or other blood products within the last 3 months, or injected or oral corticosteroids or other immunomodulatory therapy within 6 weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \<7 days may be included in the trial as long as they have not received more than 1 course within the last 2 weeks prior to enrollment. * Had allergy shots started or had changes in regimen or dosing of allergy shots within the last 4 weeks. * Receipt of any other vaccine within the past 30 days, or planning to receive another vaccine within 30 days before the Visit 2 blood draw, with the exclusion of M-M-R®II and IPV. * Any other condition which, in the opinion of the Investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine. * Enrolled in another vaccine trial. * Personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the past 30 months. * Known or suspected allergy to any of the vaccines or vaccine components intended for use in this study. Temporary contraindications: * A subject who meets either of the following criteria at the time of planned vaccination will have enrollment deferred until complete resolution of symptoms: Oral temperature ≥ 100.4°F (≥ 38.0ºC) (Note: A tympanic thermometer should not be used). * Any moderate or severe acute illness with or without fever.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | 0 to 3 days post-dose 5 vaccination | Solicited local reactions: Redness, swelling, tenderness at injection site, change in limb circumference, and limb function. Systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose. | Day 28 to 48 Post-dose 5 | Anti-pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin). Fold-rise is calculated as Post-Dose 5/Pre-Dose 5 titer. |
| Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose | Day 28 to 48 Post-dose 5 | Booster response calculation: If Pre-Dose 5 titer \< 4x limit of quantitation (LOQ), a 4-fold rise of Post-dose 5/Pre-dose 5; If Pre-dose 5 titer ≥ 4x LOQ, a 2-fold rise of Post-dose 5/Pre-dose 5. |
| Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Day 28 to 48 Post-dose 5 | Seroprotection is defined as a titer of ≥ 0.01 IU/mL for both Diphtheria and Tetanus before the fifth dose booster vaccination |
| Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Pre-dose 5 and Day 28 to 48 Post-dose 5 | — |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 05 February through 30 November 2004 at 19 US sites.
Pre-assignment details
A total of 989 participants were enrolled and vaccinated with DAPTACEL as the fifth dose after receiving 4 doses of Pentacel vaccine in previous studies.
Participants by arm
| Arm | Count |
|---|---|
| DAPTACEL® Vaccine Group Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03. | 989 |
| Total | 989 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | DAPTACEL® Vaccine Group |
|---|---|
| Age, Categorical <=18 years | 989 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 4.2 Years STANDARD_DEVIATION 0.15 |
| Region of Enrollment United States | 989 participants |
| Sex: Female, Male Female | 514 Participants |
| Sex: Female, Male Male | 475 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 49 / 989 |
| serious Total, serious adverse events | 10 / 989 |
Outcome results
Primary
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel®
Solicited local reactions: Redness, swelling, tenderness at injection site, change in limb circumference, and limb function. Systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.
Time frame: 0 to 3 days post-dose 5 vaccination
Population: Safety analysis was on all enrolled and vaccinated participants intend-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Any Tenderness | 50 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Any Irritability | 23 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Rash Present | 5 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Any Solicited Systemic Reaction Post-dose 5 | 62 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Any Redness (> 5 mm) | 20 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Grade 3 Redness (> 50 mm) | 7 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Any Swelling (> 5 mm) | 12 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Grade 3 Swelling (> 50 mm) | 3 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Grade 3 Tenderness (Incapacitating) | 0 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Any Change in Limb Circumference (> 5 mm) | 29 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Grade 3 Change in Limb Circumference (> 40 mm) | 1 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Any Functional Impairment | 9 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Grade 3 Functional Impairment (Incapacitating) | 0 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Any Solicited Systemic Reaction Post-dose 5 | 37 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Any Fever (≥ 38 ºC) | 5 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Grade 3 Fever (> 39.5 ºC) | 0 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Grade 3 Irritability (Incapacitating) | 1 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Any Crying | 7 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Grade 3 Crying (Incapacitating) | 0 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Any Lethargy | 13 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Grade 3 Lethargy (Incapacitating) | 0 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Any Anorexia | 11 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Grade 3 Anorexia (Skips 2 meals) | 1 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Any Vomiting | 3 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Grade 3 Vomiting (≥ 3 episodes) | 1 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Any Diarrhea | 4 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Grade 3 Diarrhea (> 5 diarrhea stools) | 0 Percentage of Participants |
Other Pre-specified
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose
Time frame: Pre-dose 5 and Day 28 to 48 Post-dose 5
Population: The GMTs of anti-Pertussis, anti-Diphtheria, and anti-Tetanus Toxoids Responses were evaluated in a subset of the per-protocol population for immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DAPTACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Pertussis (EU/mL) - Pre-dose 5 | 12.73 Titers |
| DAPTACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Pertussis (EU/mL) - Post-dose 5 | 309.64 Titers |
| DAPTACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Filamentous Haemagglutinin (EU/mL) Pre-dose 5 | 9.90 Titers |
| DAPTACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Filamentous Haemagglutinin (EU/mL) Post-dose5 | 158.27 Titers |
| DAPTACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Fimbriae Types 2 and 3 (EU/mL) Pre-dose 5 | 40.62 Titers |
| DAPTACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Fimbriae Types 2 and 3 (EU/mL) Post-dose 5 | 659.28 Titers |
| DAPTACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Pertactin (EU/mL) Pre-dose 5 | 10.36 Titers |
| DAPTACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Pertactin (EU/mL) Post-dose 5 | 140.86 Titers |
| DAPTACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Diphtheria (IU/mL) Pre-dose 5 | 0.25 Titers |
| DAPTACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Diphtheria (IU/mL) Post-dose 5 | 18.98 Titers |
| DAPTACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Tetanus (IU/mL) Pre-dose 5 | 0.38 Titers |
| DAPTACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Tetanus (IU/mL) Post-dose 5 | 4.30 Titers |
Other Pre-specified
Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose.
Anti-pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin). Fold-rise is calculated as Post-Dose 5/Pre-Dose 5 titer.
Time frame: Day 28 to 48 Post-dose 5
Population: The vaccine antibody responses were evaluated in a subset of the per-protocol population for immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DAPTACEL® Vaccine Group | Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose. | Anti-Pertussis (EU/mL) ≥ 4-Fold Rise | 94 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose. | Anti-Filamentous Haemagglutinin ≥ 4-Fold Rise | 91 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose. | Anti-Fimbriae Types 2 and 3 ≥ 4-Fold Rise | 91 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose. | Anti-Pertactin (EU/mL) ≥ 4-Fold Rise | 90 Percentage of Participants |
Other Pre-specified
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose
Seroprotection is defined as a titer of ≥ 0.01 IU/mL for both Diphtheria and Tetanus before the fifth dose booster vaccination
Time frame: Day 28 to 48 Post-dose 5
Population: The anti-Diphtheria and anti-Tetanus Toxoids Responses were evaluated in a subset of the per-protocol population for immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DAPTACEL® Vaccine Group | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Diphtheria (IU/mL) ≥0.01 Pre-dose 5 | 100 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Diphtheria (IU/mL) ≥0.1 Pre-dose 5 | 77 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Diphtheria (IU/mL) ≥1.0 Pre-dose 5 | 9 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Diphtheria (IU/mL) ≥0.1 Post-dose 5 | 100 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Diphtheria (IU/mL) ≥1.0 Post-dose 5 | 100 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Tetanus (IU/mL) ≥0.01 Pre-dose 5 | 100 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Tetanus (IU/mL) ≥0.1 Pre-dose 5 | 92 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Tetanus (IU/mL) ≥1.0 Pre-dose 5 | 13 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Tetanus (IU/mL) ≥0.1 Post-dose 5 | 100 Percentage of Participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Tetanus (IU/mL) ≥1.0 Post-dose 5 | 96 Percentage of Participants |
Other Pre-specified
Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose
Booster response calculation: If Pre-Dose 5 titer \< 4x limit of quantitation (LOQ), a 4-fold rise of Post-dose 5/Pre-dose 5; If Pre-dose 5 titer ≥ 4x LOQ, a 2-fold rise of Post-dose 5/Pre-dose 5.
Time frame: Day 28 to 48 Post-dose 5
Population: The anti-Pertussis Booster response was evaluated in a subset of the per-protocol population for immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DAPTACEL® Vaccine Group | Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Pertactin (EU/mL) | 95 Percentage of participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Pertussis (EU/mL) | 98 Percentage of participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Filamentous Haemagglutinin | 97 Percentage of participants |
| DAPTACEL® Vaccine Group | Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose | Anti-Fimbriae Types 2 and 3 | 96 Percentage of participants |