Diphtheria, Measles, Pertussis, Polio, Tetanus
Conditions
Keywords
Tetanus, Diphtheria, Pertussis, DTap-IPV, DAPTACEL®, VARIVAX®
Brief summary
The study was designed to compare the safety and immunogenicity of DTap-IPV with DAPTACEL® + IPOL® as the 5th dose booster in children ≥ 4 to \< 7 years of age in the US and Puerto Rico who were previously vaccinated with DAPTACEL® and/or Pentacel® vaccines only. Primary Objectives: * To compare the pertussis \[Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN), and Fimbriae Types 2 and 3 (FIM)\] booster responses and geometric mean concentrations (GMCs) (as measured by enzyme-linked immunosorbent assay \[ELISA\]) following DTap-IPV vaccination to those elicited following DAPTACEL® + IPOL® vaccination when administered as a 5th dose. * To compare the diphtheria and tetanus booster responses and GMCs (as measured by ELISA) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations when administered as a 5th dose . * To compare the Inactivated Poliovirus Vaccine booster responses (as measured by neutralizing assay) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations. Observational Objectives: * To compare the polio (types 1, 2, and 3) geometric mean titers (GMTs) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations. * To assess the safety of DTap-IPV vaccine or DAPTACEL® + IPOL® vaccine when administered as the fifth dose booster vaccine in participants previously vaccinated with DAPTACEL and/or Pentacel vaccines.
Detailed description
All participants will be randomized to receive either one dose each of DTap-IPV + Measles, Mumps, and Rubella Virus Vaccine Live (M-M-R®II) + VARIVAX® or one dose each of DAPTACEL® + IPOL® + M-M-R®II + VARIVAX® on Day 0.
Interventions
BIOLOGICALDiphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus
0.5 mL, Intramuscular (DTap-IPV); Subcutaneous (M-M-R®II and VARIVAX®)
BIOLOGICALDiphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
0.5 mL, Intramuscular (IM) DAPTACEL®; Subcutaneous (SC) MMR®II and VARIVAX®; IM or SC IPOL®
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
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 to \< 7 years on the day of inclusion * Informed consent form has been signed and dated by the parent/guardian before the first study-related procedure * Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures * Subject has documented completion of primary infant series and booster with DAPTACEL® and/or Pentacel® vaccine(s) only.
Exclusion criteria
* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination * Planned participation in another clinical trial during the present trial period * Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for any influenza vaccine, which may be received at least 2 weeks before study vaccines * Planned receipt of any vaccine in the 4 weeks following the trial vaccination except for any influenza vaccine, which may be received at least 2 weeks after study vaccines * Receipt of blood or blood-derived products in the past 3 months * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C * History of diphtheria, tetanus, or pertussis infection, confirmed either clinically, serologically, or microbiologically * Known systemic hypersensitivity to any of the vaccines' components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances * Laboratory-confirmed thrombocytopenia, contraindicating intramuscular vaccination * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion * Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | Geometric mean concentrations to anti-polio were measured by enzyme-linked immunosorbent assay (ELISA). |
| Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | Booster responses to pertussis antigens \[pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM)\] were measured by enzyme-linked immunosorbent assay (ELISA). Booster responses were defined as participants with either a pre-vaccination antibody concentration less than lower limit of quantitation (\<LLOQ), achieving a post-vaccination level ≥4X LLOQ, or pre-vaccination antibody concentrations ≥LLOQ but \<4X LLOQ, achieving a 4-fold rise rate of post-vaccination, or a pre-vaccination antibody concentration ≥4X LLOQ, achieving a 2-fold response. |
| Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | Geometric mean concentrations to pertussis antigens (pertussis toxoid \[PT\], filamentous hemagglutinin \[FHA\], pertactin \[PRN\], and fimbriae types 2 and 3 \[FIM\]) were measured by enzyme-linked immunosorbent assay (ELISA). |
| Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Anti-Diphtheria antibodies were measured by a toxin neutralization test. Booster responses were defined as participants with a pre-vaccination antibody concentration \<0.1 IU/ml, achieving a post-vaccination level ≥0.4 IU/ml, or a pre-vaccination antibody concentration ≥0.1 IU/ml but \<2.0 IU/ml, achieving a 4-fold rise rate post-vaccination, or a pre-vaccination antibody concentration ≥2.0 IU/ml, achieving a 2-fold response. |
| Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | Geometric mean concentrations to anti-tetanus and anti-diphtheria were measured by enzyme-linked immunosorbent assay (ELISA). |
| Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | Anti-poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Booster responses were defined as participants with a pre-vaccination antibody concentration \<1:8 dil, achieving a post-vaccination level ≥1:8 dil, or a pre-vaccination antibody concentration ≥1:8 dil, achieving a 4-fold response. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Seroprotection for anti-polio types was defined as antibody titers ≥1:8 dilution. |
| Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose | Day 0 (pre-vaccination) and Day 28 post-vaccination | Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Four-fold rise in booster responses between groups was defined as post/pre-vaccination ≥4. |
| Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination | Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. |
| Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Day 0 up to Day 28 post-final vaccination | Solicited injection-site: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb, Change in Limb Circumference. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection-site: Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, ≥50 mm; Change in limb circumference \>50 mm increase over pre-vaccination measurement; Extensive limb swelling (ELS) was considered severe. Grade 3 systemic reactions: Fever ≥39.0˚C; Headache, Malaise, and Myalgia Significant, prevents daily activity. |
| Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | Anti-Tetanus antibodies were measured by ELISA. Anti diphtheria antibodies were measured by a toxin neutralization test. Seroprotection for anti-tetanus and anti-diphtheria was defined as antibody concentrations ≥0.1 IU/ml and ≥1.0 IU/ml. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
The study participants were enrolled from 28 April to 16 November 2012 at 70 clinic sites in the United States and Puerto Rico.
Pre-assignment details
A total of 3372 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.
Participants by arm
| Arm | Count |
|---|---|
| DTaP-IPV Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly | 2,743 |
| DAPTACEL®+IPOL® Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL® | 629 |
| Total | 3,372 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 21 | 8 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Protocol Violation | 30 | 9 |
| Overall Study | Withdrawal by Subject | 15 | 4 |
Baseline characteristics
| Characteristic | DTaP-IPV | DAPTACEL®+IPOL® | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2743 Participants | 629 Participants | 3372 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 | 4.4 Years STANDARD_DEVIATION 0.5 | 4.4 Years STANDARD_DEVIATION 0.5 | 4.4 Years STANDARD_DEVIATION 0.5 |
| Region of Enrollment United States | 2743 Participants | 629 Participants | 3372 Participants |
| Sex: Female, Male Female | 1330 Participants | 306 Participants | 1636 Participants |
| Sex: Female, Male Male | 1413 Participants | 323 Participants | 1736 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2,081 / 2,733 | 461 / 621 |
| serious Total, serious adverse events | 21 / 2,733 | 3 / 621 |
Outcome results
Primary
Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Geometric mean concentrations to anti-polio were measured by enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Geometric mean concentrations of poliovirus antibodies were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTaP-IPV | Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 1 post-vaccination (N=258, 253) | 3477 Titers |
| DTaP-IPV | Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 3 post-vaccination (N=258, 252) | 4591 Titers |
| DTaP-IPV | Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 1 pre-vaccination (N=254, 248) | 135 Titers |
| DTaP-IPV | Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 2 pre-vaccination (N=254, 248) | 214 Titers |
| DTaP-IPV | Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 2 post-vaccination (N=258, 253) | 3491 Titers |
| DTaP-IPV | Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 3 pre-vaccination (N=252, 248) | 102 Titers |
| DAPTACEL®+IPOL® | Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 2 post-vaccination (N=258, 253) | 3894 Titers |
| DAPTACEL®+IPOL® | Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 3 pre-vaccination (N=252, 248) | 90.9 Titers |
| DAPTACEL®+IPOL® | Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 2 pre-vaccination (N=254, 248) | 188 Titers |
| DAPTACEL®+IPOL® | Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 3 post-vaccination (N=258, 252) | 3419 Titers |
| DAPTACEL®+IPOL® | Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 1 pre-vaccination (N=254, 248) | 129 Titers |
| DAPTACEL®+IPOL® | Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 1 post-vaccination (N=258, 253) | 2731 Titers |
Primary
Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Geometric mean concentrations to pertussis antigens (pertussis toxoid \[PT\], filamentous hemagglutinin \[FHA\], pertactin \[PRN\], and fimbriae types 2 and 3 \[FIM\]) were measured by enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Geometric mean concentrations were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTaP-IPV | Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-FIM post-vaccination (N=260, 253) | 506 Titers |
| DTaP-IPV | Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-PT pre-vaccination (N=254, 248) | 5.16 Titers |
| DTaP-IPV | Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-PT post-vaccination (N=261, 252) | 121 Titers |
| DTaP-IPV | Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-FHA pre-vaccination (N=255, 248) | 7.93 Titers |
| DTaP-IPV | Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-FHA post-vaccination (N=263, 253) | 123 Titers |
| DTaP-IPV | Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-PRN pre-vaccination (N=255, 249) | 18.6 Titers |
| DTaP-IPV | Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-PRN post-vaccination (N=262, 252) | 283 Titers |
| DTaP-IPV | Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-FIM pre-vaccination (N=253, 249) | 31.9 Titers |
| DAPTACEL®+IPOL® | Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-FIM pre-vaccination (N=253, 249) | 33.3 Titers |
| DAPTACEL®+IPOL® | Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-FIM post-vaccination (N=260, 253) | 379 Titers |
| DAPTACEL®+IPOL® | Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-FHA post-vaccination (N=263, 253) | 79.0 Titers |
| DAPTACEL®+IPOL® | Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-PT pre-vaccination (N=254, 248) | 4.74 Titers |
| DAPTACEL®+IPOL® | Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-PRN post-vaccination (N=262, 252) | 187 Titers |
| DAPTACEL®+IPOL® | Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-PT post-vaccination (N=261, 252) | 61.3 Titers |
| DAPTACEL®+IPOL® | Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-PRN pre-vaccination (N=255, 249) | 16.7 Titers |
| DAPTACEL®+IPOL® | Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-FHA pre-vaccination (N=255, 248) | 9.42 Titers |
Comparison: Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each Pertussis antigen and their 2-sided 95% Confidence Intervals.95% CI: [1.68, 2.31]
Comparison: Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.95% CI: [1.3, 1.88]
Comparison: Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.95% CI: [1.27, 1.79]
Comparison: Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.95% CI: [1.12, 1.6]
Primary
Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Geometric mean concentrations to anti-tetanus and anti-diphtheria were measured by enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Geometric mean concentrations of tetanus and diptheria antibodies were assessed in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTaP-IPV | Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Tetanus pre-vaccination (N=254, 248) | 0.644 Titers |
| DTaP-IPV | Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Tetanus post-vaccination (N=262, 253) | 6.42 Titers |
| DTaP-IPV | Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Diphtheria pre-vaccination (N=257, 249) | 0.510 Titers |
| DTaP-IPV | Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Diphtheria post-vaccination (N=262, 253) | 18.6 Titers |
| DAPTACEL®+IPOL® | Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Diphtheria post-vaccination (N=262, 253) | 15.5 Titers |
| DAPTACEL®+IPOL® | Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Tetanus pre-vaccination (N=254, 248) | 0.608 Titers |
| DAPTACEL®+IPOL® | Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Diphtheria pre-vaccination (N=257, 249) | 0.426 Titers |
| DAPTACEL®+IPOL® | Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Tetanus post-vaccination (N=262, 253) | 5.48 Titers |
Primary
Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Booster responses were defined as participants with a pre-vaccination antibody concentration \<1:8 dil, achieving a post-vaccination level ≥1:8 dil, or a pre-vaccination antibody concentration ≥1:8 dil, achieving a 4-fold response.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Anti-polio booster responses were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV | Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 2 (N=249, 248) | 195 Participants |
| DTaP-IPV | Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 1 (N=249, 248) | 214 Participants |
| DTaP-IPV | Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 3 (N=247, 248) | 210 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 1 (N=249, 248) | 204 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 2 (N=249, 248) | 196 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 3 (N=247, 248) | 210 Participants |
Primary
Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Anti-Diphtheria antibodies were measured by a toxin neutralization test. Booster responses were defined as participants with a pre-vaccination antibody concentration \<0.1 IU/ml, achieving a post-vaccination level ≥0.4 IU/ml, or a pre-vaccination antibody concentration ≥0.1 IU/ml but \<2.0 IU/ml, achieving a 4-fold rise rate post-vaccination, or a pre-vaccination antibody concentration ≥2.0 IU/ml, achieving a 2-fold response.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Anti-Tetanus and anti-diphtheria booster responses were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV | Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Tetanus (N=253, 248) | 213 Participants |
| DTaP-IPV | Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Diphtheria (N=256, 249) | 249 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Tetanus (N=253, 248) | 209 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Diphtheria (N=256, 249) | 247 Participants |
Primary
Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Booster responses to pertussis antigens \[pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM)\] were measured by enzyme-linked immunosorbent assay (ELISA). Booster responses were defined as participants with either a pre-vaccination antibody concentration less than lower limit of quantitation (\<LLOQ), achieving a post-vaccination level ≥4X LLOQ, or pre-vaccination antibody concentrations ≥LLOQ but \<4X LLOQ, achieving a 4-fold rise rate of post-vaccination, or a pre-vaccination antibody concentration ≥4X LLOQ, achieving a 2-fold response.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Anti-pertussis booster responses were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV | Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Pertussis toxoid (N=252, 247) | 240 Participants |
| DTaP-IPV | Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Filamentous hemagglutinin (N=255, 248) | 242 Participants |
| DTaP-IPV | Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Pertactin (N=254, 248) | 246 Participants |
| DTaP-IPV | Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Fimbriae types 2 and 3 (N=250, 249) | 243 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Fimbriae types 2 and 3 (N=250, 249) | 230 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Pertussis toxoid (N=252, 247) | 222 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Pertactin (N=254, 248) | 231 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Filamentous hemagglutinin (N=255, 248) | 217 Participants |
Comparison: Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.95% CI: [0.7, 10.2]
Comparison: Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.95% CI: [2.5, 21.5]
Comparison: Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.3.7% CI: [-0.2, 7.9]
Comparison: Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.95% CI: [0.9, 9.1]
Other Pre-specified
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Solicited injection-site: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb, Change in Limb Circumference. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection-site: Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, ≥50 mm; Change in limb circumference \>50 mm increase over pre-vaccination measurement; Extensive limb swelling (ELS) was considered severe. Grade 3 systemic reactions: Fever ≥39.0˚C; Headache, Malaise, and Myalgia Significant, prevents daily activity.
Time frame: Day 0 up to Day 28 post-final vaccination
Population: Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Grade 3 Injection-site Pain (N=2689, 603) | 53 Participants |
| DTaP-IPV | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Grade 3 Change in limb circumference (N=2500, 464) | 4 Participants |
| DTaP-IPV | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Injection-site Swelling (N=2678, 602) | 1076 Participants |
| DTaP-IPV | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Fever (N=2668, 598) | 161 Participants |
| DTaP-IPV | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Injection-site Pain (N=2689, 603) | 2081 Participants |
| DTaP-IPV | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Grade 3 Fever (N=2668, 598) | 35 Participants |
| DTaP-IPV | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Grade 3 Injection-site Swelling (N=2678, 602) | 229 Participants |
| DTaP-IPV | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Headache (N=2688, 603) | 419 Participants |
| DTaP-IPV | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Injection-site Erythema (N=2687, 603) | 1587 Participants |
| DTaP-IPV | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Grade 3 Headache (N=2688, 603) | 15 Participants |
| DTaP-IPV | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Grade 3 Malaise (N=2687, 603) | 71 Participants |
| DTaP-IPV | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Malaise (N=2687, 603) | 940 Participants |
| DTaP-IPV | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Grade 3 Extensive limb swelling (N=2666, 598) | 39 Participants |
| DTaP-IPV | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Grade 3 Injection-site Erythema (N=2687, 603) | 484 Participants |
| DTaP-IPV | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Myalgia (N=2688, 603) | 1445 Participants |
| DTaP-IPV | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Change in limb circumference (N=2500, 464) | 1703 Participants |
| DTaP-IPV | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Grade 3 Myalgia (N=2688, 603) | 52 Participants |
| DTaP-IPV | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Extensive limb swelling (N=2666, 598) | 39 Participants |
| DAPTACEL®+IPOL® | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Grade 3 Myalgia (N=2688, 603) | 17 Participants |
| DAPTACEL®+IPOL® | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Injection-site Pain (N=2689, 603) | 461 Participants |
| DAPTACEL®+IPOL® | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Grade 3 Injection-site Pain (N=2689, 603) | 18 Participants |
| DAPTACEL®+IPOL® | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Injection-site Erythema (N=2687, 603) | 322 Participants |
| DAPTACEL®+IPOL® | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Grade 3 Injection-site Erythema (N=2687, 603) | 72 Participants |
| DAPTACEL®+IPOL® | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Injection-site Swelling (N=2678, 602) | 219 Participants |
| DAPTACEL®+IPOL® | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Grade 3 Injection-site Swelling (N=2678, 602) | 43 Participants |
| DAPTACEL®+IPOL® | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Extensive limb swelling (N=2666, 598) | 8 Participants |
| DAPTACEL®+IPOL® | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Grade 3 Extensive limb swelling (N=2666, 598) | 8 Participants |
| DAPTACEL®+IPOL® | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Change in limb circumference (N=2500, 464) | 302 Participants |
| DAPTACEL®+IPOL® | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Grade 3 Change in limb circumference (N=2500, 464) | 0 Participants |
| DAPTACEL®+IPOL® | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Fever (N=2668, 598) | 41 Participants |
| DAPTACEL®+IPOL® | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Grade 3 Fever (N=2668, 598) | 12 Participants |
| DAPTACEL®+IPOL® | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Headache (N=2688, 603) | 100 Participants |
| DAPTACEL®+IPOL® | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Grade 3 Headache (N=2688, 603) | 4 Participants |
| DAPTACEL®+IPOL® | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Malaise (N=2687, 603) | 200 Participants |
| DAPTACEL®+IPOL® | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Grade 3 Malaise (N=2687, 603) | 20 Participants |
| DAPTACEL®+IPOL® | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Myalgia (N=2688, 603) | 317 Participants |
Other Pre-specified
Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose
Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Four-fold rise in booster responses between groups was defined as post/pre-vaccination ≥4.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Booster responses to polio antigens following IPV vaccine as 4th or 5th dose were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV | Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose | Anti-Polio 1 4th dose (N=238, 235) | 205 Participants |
| DTaP-IPV | Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose | Anti-Polio 1 5th dose (N=10, 12) | 8 Participants |
| DTaP-IPV | Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose | Anti-Polio 2 4th dose (N=238, 235) | 188 Participants |
| DTaP-IPV | Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose | Anti-Polio 2 5th dose (N=10, 12) | 7 Participants |
| DTaP-IPV | Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose | Anti-Polio 3 4th dose (N=236, 235) | 203 Participants |
| DTaP-IPV | Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose | Anti-Polio 3 5th dose (N=10, 12) | 6 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose | Anti-Polio 3 4th dose (N=236, 235) | 202 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose | Anti-Polio 1 4th dose (N=238, 235) | 199 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose | Anti-Polio 2 5th dose (N=10, 12) | 5 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose | Anti-Polio 1 5th dose (N=10, 12) | 4 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose | Anti-Polio 3 5th dose (N=10, 12) | 7 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose | Anti-Polio 2 4th dose (N=238, 235) | 190 Participants |
Other Pre-specified
Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Seroprotection for anti-polio types was defined as antibody titers ≥1:8 dilution.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Seroprotection (antibody titers ≥1:8 dilution) against polio antigens was assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV | Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 1 pre-vaccination (N=254, 248) | 250 Participants |
| DTaP-IPV | Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 1 post-vaccinatin (N=258, 253) | 258 Participants |
| DTaP-IPV | Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 2 pre-vaccination (N=254, 248) | 253 Participants |
| DTaP-IPV | Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 2 post-vaccination (N=258, 253) | 258 Participants |
| DTaP-IPV | Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 3 pre-vaccination (N=252, 248) | 244 Participants |
| DTaP-IPV | Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 3 post-vaccination (N=258, 252) | 258 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 3 pre-vaccination (N=252, 248) | 231 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 1 pre-vaccination (N=254, 248) | 245 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 2 post-vaccination (N=258, 253) | 253 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 1 post-vaccinatin (N=258, 253) | 252 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 3 post-vaccination (N=258, 252) | 252 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Polio 2 pre-vaccination (N=254, 248) | 247 Participants |
Other Pre-specified
Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Tetanus antibodies were measured by ELISA. Anti diphtheria antibodies were measured by a toxin neutralization test. Seroprotection for anti-tetanus and anti-diphtheria was defined as antibody concentrations ≥0.1 IU/ml and ≥1.0 IU/ml.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Seroprotection against tetanus and diphtheria antigens was assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV | Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Tetanus pre-vacc. ≥0.1 IU/ml (N=254, 248) | 233 Participants |
| DTaP-IPV | Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Tetanus pre-vacc. ≥1.0 IU/ml (N=254, 248) | 93 Participants |
| DTaP-IPV | Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Tetanus post-vacc. ≥0.1 IU/ml (N=262, 253) | 262 Participants |
| DTaP-IPV | Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Tetanus post-vacc. ≥1.0 IU/ml (N=262, 253) | 259 Participants |
| DTaP-IPV | Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Diphtheria pre-vacc. ≥0.1 IU/ml (N=257, 249) | 233 Participants |
| DTaP-IPV | Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Diphtheria pre-vacc. ≥1.0 IU/ml (N=257, 249) | 78 Participants |
| DTaP-IPV | Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Diphtheria post-vacc. ≥0.1 IU/ml (N=262, 253) | 262 Participants |
| DTaP-IPV | Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Diphtheria post-vacc. ≥1.0 IU/ml (N=262, 253) | 261 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Diphtheria post-vacc. ≥1.0 IU/ml (N=262, 253) | 252 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Tetanus pre-vacc. ≥0.1 IU/ml (N=254, 248) | 221 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Diphtheria pre-vacc. ≥0.1 IU/ml (N=257, 249) | 207 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Tetanus pre-vacc. ≥1.0 IU/ml (N=254, 248) | 89 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Diphtheria post-vacc. ≥0.1 IU/ml (N=262, 253) | 252 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Tetanus post-vacc. ≥0.1 IU/ml (N=262, 253) | 251 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Diphtheria pre-vacc. ≥1.0 IU/ml (N=257, 249) | 72 Participants |
| DAPTACEL®+IPOL® | Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | Anti-Tetanus post-vacc. ≥1.0 IU/ml (N=262, 253) | 245 Participants |
Other Pre-specified
Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose
Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay.
Time frame: Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
Population: Anti-Polio geometric mean titers were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTaP-IPV | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 1 post-4th dose (N=247, 240) | 3471 Titers |
| DTaP-IPV | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 2 pre-5th dose (N=10, 12) | 274 Titers |
| DTaP-IPV | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 1 post-5th dose (N=10, 12) | 3327 Titers |
| DTaP-IPV | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 2 post-5th dose (N=10, 12) | 3566 Titers |
| DTaP-IPV | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 1 pre-4th dose (N=243, 235) | 134 Titers |
| DTaP-IPV | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 3 pre-4th dose (N=241, 235) | 99.5 Titers |
| DTaP-IPV | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 2 pre-4th dose (N=243, 235) | 210 Titers |
| DTaP-IPV | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 3 post-4th dose (N=247, 239) | 4773 Titers |
| DTaP-IPV | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 1 pre-5th dose (N=10, 12) | 194 Titers |
| DTaP-IPV | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 2 post-4th dose (N=247, 240) | 3495 Titers |
| DTaP-IPV | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 3 post-5th dose (N=10, 12) | 1663 Titers |
| DTaP-IPV | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 3 pre-5th dose (N=10, 12) | 239 Titers |
| DAPTACEL®+IPOL® | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 3 post-5th dose (N=10, 12) | 2436 Titers |
| DAPTACEL®+IPOL® | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 1 pre-4th dose (N=243, 235) | 123 Titers |
| DAPTACEL®+IPOL® | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 1 post-4th dose (N=247, 240) | 2774 Titers |
| DAPTACEL®+IPOL® | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 1 pre-5th dose (N=10, 12) | 342 Titers |
| DAPTACEL®+IPOL® | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 1 post-5th dose (N=10, 12) | 1773 Titers |
| DAPTACEL®+IPOL® | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 2 pre-4th dose (N=243, 235) | 181 Titers |
| DAPTACEL®+IPOL® | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 2 post-4th dose (N=247, 240) | 3991 Titers |
| DAPTACEL®+IPOL® | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 2 pre-5th dose (N=10, 12) | 431 Titers |
| DAPTACEL®+IPOL® | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 2 post-5th dose (N=10, 12) | 2048 Titers |
| DAPTACEL®+IPOL® | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 3 pre-4th dose (N=241, 235) | 86.3 Titers |
| DAPTACEL®+IPOL® | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 3 post-4th dose (N=247, 239) | 3500 Titers |
| DAPTACEL®+IPOL® | Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose | Anti-Polio 3 pre-5th dose (N=10, 12) | 323 Titers |