Diphtheria, Pertussis, Polio
Conditions
Keywords
Pertussis, Whooping cough, Filamentous Haemagglutinin, Fimbriae Types 2 and 3;, Pertactin, Diphtheria, Tetanus, Poliovirus Types 1, 2, and 3.
Brief summary
The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.
Interventions
BIOLOGICALDAPTACEL®. (DTaP), IPOL®., and ActHIB®.
0.5 mL, Intramuscular
BIOLOGICALPentacel®: DTaP-IPV/Hib combined
0.5 mL, Intramuscular
BIOLOGICALDTaP-IPV and ActHIB®
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
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
* Aged ≥ 42 days and ≤ 89 days on the day of inclusion * Born at full term of pregnancy (≥ 36 weeks) * Informed consent form signed by the parent(s) or other legally authorized representative(s) before the 1st study related procedure * Vaccination with a hepatitis B vaccine at least 30 days before inclusion * Able to attend all scheduled visits and to comply with all trial procedures(i.e., access to a phone) * Provide blood sample prior to Dose 1 * Parent or legal representative willing to take rectal temperatures after each vaccination.
Exclusion criteria
* Participation in another clinical trial in the 4 weeks preceding the (first)trial vaccination * Planned participation in another clinical trial during the present trial period * Personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy * Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s) * Chronic illness that could interfere with trial conduct or completion * Received blood or blood-derived products since birth * Any vaccination in the 2 weeks preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination. Flu vaccine could be administered only 2 weeks after any trial vaccination * Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis- (DTwP) based combination vaccines, Haemophilus influenzae type b (Hib)-conjugate, poliovirus, or pneumococcal conjugate vaccines * Coagulation disorder contraindicating intramuscular (IM) vaccination * Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion) * Developmental delay or neurological disorder * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | 30 Days post-dose 3 vaccination | Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer \> LLOQ; or a pre-dose 1 titer \> LLOQ and post-dose 3 titer ≥ pre-dose 1 titer. |
| Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) | 30 Days post-dose 3 vaccination | — |
| Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | 30 Days post-dose 3 vaccination. | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | 7 days post-vaccination 3 | Solicited injection site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (body temperature), Vomiting, Abnormal crying, Lethargy, Appetite decreased, Irritability, and Rash. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 10 November 2005 through 21 September 2006 in 38 Clinics in the Untied States.
Pre-assignment details
A total of 2167 participants that met the inclusion and exclusion criteria were enrolled and vaccinated. Data on Stage I, up to the 3rd dose are presented.
Participants by arm
| Arm | Count |
|---|---|
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively. | 538 |
| Study Group 2: Pentacel® Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively. | 535 |
| Study Group 3: DTaP-IPV and ActHIB® Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively. | 546 |
| Study Group 4: Pentacel® Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively. | 548 |
| Total | 2,167 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 | 2 | 1 |
| Overall Study | Lost to Follow-up | 9 | 8 | 5 | 6 |
| Overall Study | Protocol Violation | 13 | 13 | 16 | 20 |
| Overall Study | Serious Adverse Events | 2 | 1 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 24 | 23 | 25 | 18 |
Baseline characteristics
| Characteristic | Study Group 2: Pentacel® | Study Group 3: DTaP-IPV and ActHIB® | Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Study Group 4: Pentacel® | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 535 Participants | 546 Participants | 538 Participants | 548 Participants | 2167 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 2.1 Months STANDARD_DEVIATION 0.27 | 2.2 Months STANDARD_DEVIATION 0.27 | 2.2 Months STANDARD_DEVIATION 0.27 | 2.1 Months STANDARD_DEVIATION 0.28 | 2.1 Months STANDARD_DEVIATION 0.27 |
| Region of Enrollment United States | 535 participants | 546 participants | 538 participants | 548 participants | 2167 participants |
| Sex: Female, Male Female | 242 Participants | 249 Participants | 251 Participants | 274 Participants | 1016 Participants |
| Sex: Female, Male Male | 293 Participants | 297 Participants | 287 Participants | 274 Participants | 1151 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 399 / 538 | 394 / 535 | 421 / 546 | 414 / 548 |
| serious Total, serious adverse events | 18 / 538 | 18 / 535 | 21 / 546 | 11 / 548 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.
Time frame: 30 Days post-dose 3 vaccination.
Population: Geometric mean titers were evaluated in the per-protocol immunogenicity population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Diphtheria (IU/mL) | 0.32 Titers |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Poliovirus Types 2 (≥ 1:8 dil) | 734.50 Titers |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Pertactin (EU/mL) | 33.63 Titers |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Fimbriae Types 2 and 3 (EU/mL) | 181.66 Titers |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Poliovirus Types 1 (≥ 1:8 dil) | 719.83 Titers |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Poliovirus Types 3 (≥ 1:8 dil) | 916.90 Titers |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Pertussis Toxoid (EU/mL) | 66.48 Titers |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Polyribosylribitol Phosphate-Tetanus Toxoid; μg/mL | 2.38 Titers |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Tetanus toxoid (IU/mL, ≥ 0.01) | 0.97 Titers |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Filamentous Haemagglutinin (EU/mL) | 22.51 Titers |
| Study Group 2: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Poliovirus Types 3 (≥ 1:8 dil) | 666.6 Titers |
| Study Group 2: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Diphtheria (IU/mL) | 0.3 Titers |
| Study Group 2: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Poliovirus Types 2 (≥ 1:8 dil) | 699.5 Titers |
| Study Group 2: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Filamentous Haemagglutinin (EU/mL) | 53.0 Titers |
| Study Group 2: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Tetanus toxoid (IU/mL, ≥ 0.01) | 0.8 Titers |
| Study Group 2: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Poliovirus Types 1 (≥ 1:8 dil) | 397.7 Titers |
| Study Group 2: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Pertactin (EU/mL) | 32.5 Titers |
| Study Group 2: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Pertussis Toxoid (EU/mL) | 96.8 Titers |
| Study Group 2: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Fimbriae Types 2 and 3 (EU/mL) | 188.5 Titers |
| Study Group 2: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Polyribosylribitol Phosphate-Tetanus Toxoid; μg/mL | 2.5 Titers |
| Study Group 3: DTaP-IPV and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Fimbriae Types 2 and 3 (EU/mL) | 273.10 Titers |
| Study Group 3: DTaP-IPV and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Filamentous Haemagglutinin (EU/mL) | 56.88 Titers |
| Study Group 3: DTaP-IPV and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Poliovirus Types 2 (≥ 1:8 dil) | 1203.20 Titers |
| Study Group 3: DTaP-IPV and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Poliovirus Types 3 (≥ 1:8 dil) | 1115.00 Titers |
| Study Group 3: DTaP-IPV and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Pertactin (EU/mL) | 44.70 Titers |
| Study Group 3: DTaP-IPV and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Pertussis Toxoid (EU/mL) | 116.86 Titers |
| Study Group 3: DTaP-IPV and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Poliovirus Types 1 (≥ 1:8 dil) | 776.44 Titers |
| Study Group 3: DTaP-IPV and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Polyribosylribitol Phosphate-Tetanus Toxoid; μg/mL | 3.76 Titers |
| Study Group 3: DTaP-IPV and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Diphtheria (IU/mL) | 0.37 Titers |
| Study Group 3: DTaP-IPV and ActHIB® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Tetanus toxoid (IU/mL, ≥ 0.01) | 1.09 Titers |
| Study Group 4: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Poliovirus Types 3 (≥ 1:8 dil) | 819.9 Titers |
| Study Group 4: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Pertussis Toxoid (EU/mL) | 97.8 Titers |
| Study Group 4: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Filamentous Haemagglutinin (EU/mL) | 54.1 Titers |
| Study Group 4: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Pertactin (EU/mL) | 32.5 Titers |
| Study Group 4: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Fimbriae Types 2 and 3 (EU/mL) | 199.0 Titers |
| Study Group 4: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Polyribosylribitol Phosphate-Tetanus Toxoid; μg/mL | 2.5 Titers |
| Study Group 4: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Diphtheria (IU/mL) | 0.3 Titers |
| Study Group 4: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Poliovirus Types 1 (≥ 1:8 dil) | 468.3 Titers |
| Study Group 4: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Poliovirus Types 2 (≥ 1:8 dil) | 812.5 Titers |
| Study Group 4: Pentacel® | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Tetanus toxoid (IU/mL, ≥ 0.01) | 0.8 Titers |
Primary
Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.
Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer \> LLOQ; or a pre-dose 1 titer \> LLOQ and post-dose 3 titer ≥ pre-dose 1 titer.
Time frame: 30 Days post-dose 3 vaccination
Population: The vaccine response to pertussis antigens were determined in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | Pertussis Toxoid (PT) | 98 Percentage of Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | Filamentous Haemagglutinin (FHA) | 86 Percentage of Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | Pertactin (PRN) | 94 Percentage of Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | Fimbriae Types 2 and 3 (FIM) | 97 Percentage of Participants |
| Study Group 2: Pentacel® | Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | Filamentous Haemagglutinin (FHA) | 96 Percentage of Participants |
| Study Group 2: Pentacel® | Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | Pertactin (PRN) | 92 Percentage of Participants |
| Study Group 2: Pentacel® | Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | Fimbriae Types 2 and 3 (FIM) | 96 Percentage of Participants |
| Study Group 2: Pentacel® | Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | Pertussis Toxoid (PT) | 99 Percentage of Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | Pertactin (PRN) | 94 Percentage of Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | Filamentous Haemagglutinin (FHA) | 95 Percentage of Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | Fimbriae Types 2 and 3 (FIM) | 99 Percentage of Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | Pertussis Toxoid (PT) | 99 Percentage of Participants |
| Study Group 4: Pentacel® | Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | Fimbriae Types 2 and 3 (FIM) | 97 Percentage of Participants |
| Study Group 4: Pentacel® | Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | Filamentous Haemagglutinin (FHA) | 96 Percentage of Participants |
| Study Group 4: Pentacel® | Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | Pertussis Toxoid (PT) | 99 Percentage of Participants |
| Study Group 4: Pentacel® | Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | Pertactin (PRN) | 92 Percentage of Participants |
Primary
Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion)
Time frame: 30 Days post-dose 3 vaccination
Population: Four-fold rise titers (seroconversion) were evaluated in the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) | Pertussis Toxoid (PT) | 89 Percentage of participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) | Filamentous Haemagglutinin (FHA) | 54 Percentage of participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) | Pertactin (PRN) | 71 Percentage of participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) | Fimbriae Types 2 and 3 (FIM) | 86 Percentage of participants |
| Study Group 2: Pentacel® | Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) | Filamentous Haemagglutinin (FHA) | 75 Percentage of participants |
| Study Group 2: Pentacel® | Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) | Pertactin (PRN) | 67 Percentage of participants |
| Study Group 2: Pentacel® | Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) | Fimbriae Types 2 and 3 (FIM) | 85 Percentage of participants |
| Study Group 2: Pentacel® | Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) | Pertussis Toxoid (PT) | 92 Percentage of participants |
| Study Group 3: DTaP-IPV and ActHIB® | Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) | Pertactin (PRN) | 76 Percentage of participants |
| Study Group 3: DTaP-IPV and ActHIB® | Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) | Filamentous Haemagglutinin (FHA) | 77 Percentage of participants |
| Study Group 3: DTaP-IPV and ActHIB® | Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) | Fimbriae Types 2 and 3 (FIM) | 94 Percentage of participants |
| Study Group 3: DTaP-IPV and ActHIB® | Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) | Pertussis Toxoid (PT) | 92 Percentage of participants |
| Study Group 4: Pentacel® | Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) | Fimbriae Types 2 and 3 (FIM) | 90 Percentage of participants |
| Study Group 4: Pentacel® | Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) | Filamentous Haemagglutinin (FHA) | 77 Percentage of participants |
| Study Group 4: Pentacel® | Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) | Pertussis Toxoid (PT) | 92 Percentage of participants |
| Study Group 4: Pentacel® | Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) | Pertactin (PRN) | 68 Percentage of participants |
Other Pre-specified
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Solicited injection site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (body temperature), Vomiting, Abnormal crying, Lethargy, Appetite decreased, Irritability, and Rash.
Time frame: 7 days post-vaccination 3
Population: Solicited injection site and systemic reactions were evaluated in the intend-to-treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Lethargy (disabling) | 4 Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Vomitting (≥3 episodes) | 9 Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Swelling | 12 Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Lethargy | 114 Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Anormal crying | 144 Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Solicited Injection Site Reaction | 203 Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Abnormal crying (Inconsolable > 3 hrs) | 3 Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Erythema | 34 Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Irritability | 242 Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Swelling Any dose (>50 mm) | 0 Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Tenderness | 186 Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Appetite decreased (skips ≥ 2 meals) | 4 Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grd 3 Tenderness (cries when inj. limb is moved) | 11 Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Irritability (continuously for >3 hours) | 5 Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Solicited Systemic Reaction | 311 Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Erythema Any dose (>50 mm) | 0 Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Appetite decreased | 84 Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Fever | 102 Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Fever (> 39.5 C) | 3 Participants |
| Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Vomitting | 49 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Lethargy (disabling) | 0 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Vomitting | 40 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Irritability | 239 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Lethargy | 97 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Tenderness | 152 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Vomitting (≥3 episodes) | 3 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Solicited Injection Site Reaction | 160 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Irritability (continuously for >3 hours) | 12 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Fever (> 39.5 C) | 4 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Anormal crying | 114 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grd 3 Tenderness (cries when inj. limb is moved) | 4 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Abnormal crying (Inconsolable > 3 hrs) | 1 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Fever | 102 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Swelling | 18 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Appetite decreased | 72 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Erythema Any dose (>50 mm) | 1 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Solicited Systemic Reaction | 303 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Swelling Any dose (>50 mm) | 1 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Erythema | 28 Participants |
| Study Group 2: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Appetite decreased (skips ≥ 2 meals) | 0 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Anormal crying | 125 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Solicited Injection Site Reaction | 164 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Erythema | 21 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Erythema Any dose (>50 mm) | 0 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Swelling | 10 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Swelling Any dose (>50 mm) | 0 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Tenderness | 150 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grd 3 Tenderness (cries when inj. limb is moved) | 6 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Solicited Systemic Reaction | 328 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Fever | 124 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Fever (> 39.5 C) | 7 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Vomitting | 41 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Vomitting (≥3 episodes) | 3 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Abnormal crying (Inconsolable > 3 hrs) | 2 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Lethargy | 100 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Lethargy (disabling) | 4 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Appetite decreased | 85 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Appetite decreased (skips ≥ 2 meals) | 3 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Irritability | 254 Participants |
| Study Group 3: DTaP-IPV and ActHIB® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Irritability (continuously for >3 hours) | 11 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Fever (> 39.5 C) | 1 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Fever | 94 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Irritability | 242 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Lethargy (disabling) | 0 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Solicited Systemic Reaction | 309 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grd 3 Tenderness (cries when inj. limb is moved) | 4 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Erythema | 18 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Appetite decreased | 65 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Tenderness | 148 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Swelling Any dose (>50 mm) | 0 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Solicited Injection Site Reaction | 160 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Appetite decreased (skips ≥ 2 meals) | 1 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Swelling | 14 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Anormal crying | 133 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Erythema Any dose (>50 mm) | 0 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Abnormal crying (Inconsolable > 3 hrs) | 4 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Vomitting (≥3 episodes) | 7 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Vomitting | 42 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Grade 3 Irritability (continuously for >3 hours) | 11 Participants |
| Study Group 4: Pentacel® | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Any Lethargy | 91 Participants |