Diphtheria, Pertussis, Tetanus
Conditions
Keywords
DAPTACEL®, Pentacel™, Diphtheria, Tetanus, Pertussis, Whooping cough, Acellular Pertussis Vaccine Adsorbed
Brief summary
Primary Objectives: 1. To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. 2. To present the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. Observational Objectives: 1. To compare under equivalence criteria the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. 2. To present the pre-vaccination anti-poliovirus GMTs and seroprotection rates. 3. To present the post-vaccination anti-poliovirus GMTs and seroprotection rates among subjects receiving a 4th dose of IPV concurrently with the 5th dose of DAPTACEL and a 2nd dose of MMR.
Interventions
BIOLOGICALDAPTACEL®: DTaP
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged ≥ 4 and \< 7 years from date of birth at the time of study vaccination * Signed and dated Investigational Review Board (IRB)-approved informed consent from a parent or legally authorized representative. Signed and dated IRB-approved assent from subject if required by IRB * 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 the 4th dose of DAPTACEL® or Pentacel™ in Study P3T06 (i.e., 4 previous administrations of DAPTACEL® or Pentacel™).
Exclusion criteria
* Received a 5th dose of DTaP-containing vaccine * a. For subjects in the DAPTACEL® arm: Received a 4th dose of Inactivated Poliovirus Vaccine (IPV) vaccine and/or a 2nd dose of Measles, Mumps, and Rubella (MMR) vaccine scheduled at 4 to 6 years of age. b. For subjects in the Pentacel™ arm: Received a 2nd dose of MMR vaccine scheduled at 4 to 6 years of age * Severe hypersensitivity to any component of the vaccine such as an anaphylactic reaction observed following a previous vaccination * Serious underlying chronic disease, including, but not limited to:·Diabetes mellitus; malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder·Unstable or evolving neurologic disorders that may predispose the subject to seizures or neurologic deterioration. These may include progressive neurologic disorders (e.g., infantile spasms, uncontrolled progressive encephalopathy) and encephalopathy within 7 days following previous vaccination * Known or suspected primary or acquired disease of the immune system * Administration of immune globulin, other blood products within the last 3 months, injected or oral corticosteroids or other immunomodulator therapy within 6 weeks prior to study vaccination. 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 4 weeks prior to study vaccination * Receipt of any other vaccine within 30 days prior to study vaccination, or planning to receive another vaccine within 30 days before the Visit 2 blood draw (if applicable) * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | 0 to 7 days Post-Dose 5 | — |
| Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination | 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-Dose 5 of DAPTACEL® Vaccination | 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 Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Day 0 and between Days 28-48 Post-dose 5 | — |
| Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Day 0 and between Days 28-48 post-dose 5 | — |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 30 March 2005 to 02 March 2006 at 22 US sites.
Pre-assignment details
A total of 649 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| DAPTACEL®-Primed Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study. | 487 |
| Pentacel®-Primed Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study. | 162 |
| Total | 649 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Protocol Violation | 6 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Pentacel®-Primed | DAPTACEL®-Primed | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 162 Participants | 487 Participants | 649 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 | 4.1 Years STANDARD_DEVIATION 0.16 | 4.1 Years STANDARD_DEVIATION 0.14 | 4.1 Years STANDARD_DEVIATION 0.14 |
| Region of Enrollment United States | 162 participants | 487 participants | 649 participants |
| Sex: Female, Male Female | 83 Participants | 244 Participants | 327 Participants |
| Sex: Female, Male Male | 79 Participants | 243 Participants | 322 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 62 / 487 | 55 / 162 |
| serious Total, serious adverse events | 5 / 487 | 3 / 162 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination
Time frame: Day 0 and between Days 28-48 post-dose 5
Population: GMTs were assessed for each of the antigens in DAPTACEL vaccine in the per-protocol immunogenicity population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DAPTACEL®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Pertussis (EU/mL) Pre-Dose | 7.67 All units |
| DAPTACEL®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Pertussis (EU/mL) Post-Dose | 154.32 All units |
| DAPTACEL®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Filamentous Haemagglutinin (EU/mL) Pre-Dose | 5.03 All units |
| DAPTACEL®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Filamentous Haemagglutinin (EU/mL) Post-Dose | 82.11 All units |
| DAPTACEL®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Fimbriae Types 2 and 3 (EU/mL) Pre-dose | 24.45 All units |
| DAPTACEL®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Fimbriae Types 2 and 3 (EU/mL) Post-dose | 450.56 All units |
| DAPTACEL®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Pertactin (EU/mL) Pre-dose | 15.62 All units |
| DAPTACEL®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Pertactin (EU/mL) Post-dose | 229.59 All units |
| DAPTACEL®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Diphtheria (IU/mL) Pre-dose | 0.11 All units |
| DAPTACEL®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Diphtheria (IU/mL) Post-dose | 19.59 All units |
| DAPTACEL®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Tetanus (IU/mL) Pre-dose | 0.38 All units |
| DAPTACEL®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Tetanus (IU/mL) Post-dose | 6.21 All units |
| Pentacel®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Tetanus (IU/mL) Pre-dose | 0.27 All units |
| Pentacel®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Pertussis (EU/mL) Pre-Dose | 9.80 All units |
| Pentacel®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Pertactin (EU/mL) Pre-dose | 9.16 All units |
| Pentacel®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Pertussis (EU/mL) Post-Dose | 180.77 All units |
| Pentacel®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Diphtheria (IU/mL) Post-dose | 22.56 All units |
| Pentacel®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Filamentous Haemagglutinin (EU/mL) Pre-Dose | 7.52 All units |
| Pentacel®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Pertactin (EU/mL) Post-dose | 148.80 All units |
| Pentacel®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Filamentous Haemagglutinin (EU/mL) Post-Dose | 120.03 All units |
| Pentacel®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Tetanus (IU/mL) Post-dose | 4.47 All units |
| Pentacel®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Fimbriae Types 2 and 3 (EU/mL) Pre-dose | 34.50 All units |
| Pentacel®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Diphtheria (IU/mL) Pre-dose | 0.11 All units |
| Pentacel®-Primed | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Anti-Fimbriae Types 2 and 3 (EU/mL) Post-dose | 649.86 All units |
Primary
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination
Time frame: 0 to 7 days Post-Dose 5
Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Fever (> 39.5 ºC) | 0 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Swelling (> 5 mm) | 24 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Irritability | 36 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Change in Limb Circumference (> 5 mm) | 39 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Irritability (Incapacitating) | 0 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Solicited Local Reaction - Dose 5 | 75 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Crying | 15 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Change in Limb Circumference (> 40 mm) | 2 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Crying (Incapacitating) | 0 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Swelling (> 50 mm) | 8 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Lethargy | 22 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Functional Impairment | 20 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Lethargy (Incapacitating) | 1 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Redness (> 50 mm) | 16 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Anorexia | 16 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Functional Impairment (Incapacitating) | 0 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Anorexia (skipped 2 meals) | 1 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Tenderness | 62 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Vomiting (per 24 hours) | 4 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Solicited Systemic Reaction - Dose 5 | 55 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Redness (> 5 mm) | 36 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Diarrhea (per 24 hours) | 8 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Fever (≥ 38.0 ºC) | 8 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Diarrhea (> 5 diarrhea stools) | 0 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Tenderness (Incapacitating) | 2 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Rash | 10 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Vomiting (≥ 3 episodes) | 1 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Rash | 5 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Solicited Local Reaction - Dose 5 | 70 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Redness (> 5 mm) | 24 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Redness (> 50 mm) | 9 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Swelling (> 5 mm) | 14 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Swelling (> 50 mm) | 1 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Tenderness | 55 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Tenderness (Incapacitating) | 0 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Change in Limb Circumference (> 5 mm) | 32 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Change in Limb Circumference (> 40 mm) | 0 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Functional Impairment | 12 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Functional Impairment (Incapacitating) | 0 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Solicited Systemic Reaction - Dose 5 | 45 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Fever (≥ 38.0 ºC) | 6 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Fever (> 39.5 ºC) | 1 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Irritability | 28 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Irritability (Incapacitating) | 0 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Crying | 11 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Crying (Incapacitating) | 0 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Lethargy | 17 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Lethargy (Incapacitating) | 1 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Anorexia | 14 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Anorexia (skipped 2 meals) | 1 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Vomiting (per 24 hours) | 4 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Vomiting (≥ 3 episodes) | 0 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Any Diarrhea (per 24 hours) | 6 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Grade 3 Diarrhea (> 5 diarrhea stools) | 0 Percentage of Participants |
Primary
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination.
Time frame: Day 0 and between Days 28-48 Post-dose 5
Population: Antibody responses were assessed for each of the antigens in DAPTACEL vaccine in the per-protocol immunogenicity population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DAPTACEL®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Diphtheria (IU/mL) ≥ 0.01 Pre-dose 5 | 99 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Diphtheria (IU/mL) ≥ 0.1 Pre-dose 5 | 47 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Diptheria (IU/mL) ≥ 1.0 Pre-dose 5 | 1 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Diphtheria (IU/mL) ≥ 0.1 Post-dose 5 | 100 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Diphtheria (IU/mL) ≥ 1.0 Post-dose 5 | 100 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Tetanus (IU/mL) ≥ 0.01 Pre-dose 5 | 100 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Tetanus (IU/mL) ≥ 0.1 Pre-dose 5 | 85 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Tetanus (IU/mL) ≥ 1.0 Pre-dose 5 | 20 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Tetanus (IU/mL) ≥ 0.1 Post-dose 5 | 100 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Tetanus (IU/mL) ≥ 1.0 Post-dose 5 | 99 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Tetanus (IU/mL) ≥ 1.0 Pre-dose 5 | 12 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Diphtheria (IU/mL) ≥ 0.01 Pre-dose 5 | 99 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Tetanus (IU/mL) ≥ 0.01 Pre-dose 5 | 99 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Diphtheria (IU/mL) ≥ 0.1 Pre-dose 5 | 50 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Tetanus (IU/mL) ≥ 1.0 Post-dose 5 | 98 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Diptheria (IU/mL) ≥ 1.0 Pre-dose 5 | 1 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Tetanus (IU/mL) ≥ 0.1 Pre-dose 5 | 82 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Diphtheria (IU/mL) ≥ 0.1 Post-dose 5 | 100 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Tetanus (IU/mL) ≥ 0.1 Post-dose 5 | 100 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Anti-Diphtheria (IU/mL) ≥ 1.0 Post-dose 5 | 100 Percentage of Participants |
Primary
Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination
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 anti-Pertussis 4-fold rises were evaluated in the per-protocol immunology population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DAPTACEL®-Primed | Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination | Anti-Pertussis (EU/mL) | 92 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination | Anti-Filamentous Haemagglutinin (EU/mL) | 89 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination | Anti-Fimbriae Types 2 and 3 (EU/mL) | 90 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination | Anti-Pertactin (EU/mL) | 94 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination | Anti-Pertactin (EU/mL) | 95 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination | Anti-Pertussis (EU/mL) | 98 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination | Anti-Fimbriae Types 2 and 3 (EU/mL) | 96 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination | Anti-Filamentous Haemagglutinin (EU/mL) | 89 Percentage of Participants |
Primary
Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination
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 assessed in the per-protocol immunogenicity population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DAPTACEL®-Primed | Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination | Anti-Pertussis (EU/mL) | 96 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination | Anti-Fillamentous Haemagglutinin (EU/mL) | 93 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination | Anti-Fimbriae Types 2 and 3 (EU/mL) | 96 Percentage of Participants |
| DAPTACEL®-Primed | Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination | Anti-Pertactin (EU/mL) | 97 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination | Anti-Pertactin (EU/mL) | 96 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination | Anti-Pertussis (EU/mL) | 99 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination | Anti-Fimbriae Types 2 and 3 (EU/mL) | 99 Percentage of Participants |
| Pentacel®-Primed | Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination | Anti-Fillamentous Haemagglutinin (EU/mL) | 96 Percentage of Participants |