Trial · NCT01346293
Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age
NCT01346293, Phase 3, Completed, Sanofi Pasteur, a Sanofi Company; results first posted 2015-05-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age. Trials, record NCT01346293. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01346293
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age
- NCT number
- NCT01346293
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,372 participants, actual
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Conditions
- Tetanus, Diphtheria, Pertussis, Measles, Polio
- Interventions
Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus, Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus, Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus, Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
- First posted
- 2011-05-02
- Last updated
- 2015-06-03
- Results first posted
- 2015-05-29
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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). |
| Primary | 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. |
| Primary | 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). |
| Primary | 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. |
| Primary | 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). |
| Other | 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. |
| Other | 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. |
| Other | 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. |
| Other | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Anti-pertussis booster responses were assessed in the Per-Protocol Analysis Set. | Participants | NUMBER |
| PRIMARY | 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 were assessed in the Per-Protocol Analysis Set. | Titers | GEOMETRIC_MEAN |
| PRIMARY | 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 and anti-diphtheria booster responses were assessed in the Per-Protocol Analysis Set. | Participants | NUMBER |
| PRIMARY | 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 of tetanus and diptheria antibodies were assessed in the Per Protocol Analysis Set. | Titers | GEOMETRIC_MEAN |
| PRIMARY | 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-polio booster responses were assessed in the Per-Protocol Analysis Set. | Participants | NUMBER |
| PRIMARY | 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 of poliovirus antibodies were assessed in the Per-Protocol Analysis Set. | Titers | GEOMETRIC_MEAN |
| 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 | Day 0 (pre-vaccination) and Day 28 post-vaccination | Seroprotection against tetanus and diphtheria antigens was assessed in the Per-Protocol Analysis Set. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | 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 | Seroprotection (antibody titers ≥1:8 dilution) against polio antigens was assessed in the Per-Protocol Analysis Set. | Participants | NUMBER |
| 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 | Day 0 (pre-vaccination) and Day 28 post-vaccination | Booster responses to polio antigens following IPV vaccine as 4th or 5th dose were assessed in the Per-Protocol Analysis Set. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | 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-Polio geometric mean titers were assessed in the Per-Protocol Analysis Set. | Titers | GEOMETRIC_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group154
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | DTaP-IPV | Anti-Pertussis toxoid (N=252, 247) | 240 | Participants | |
| Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | DAPTACEL®+IPOL® | Anti-Pertussis toxoid (N=252, 247) | 222 | Participants | |
| Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | DTaP-IPV | Anti-Filamentous hemagglutinin (N=255, 248) | 242 | Participants | |
| Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | DAPTACEL®+IPOL® | Anti-Filamentous hemagglutinin (N=255, 248) | 217 | Participants | |
| Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | DTaP-IPV | Anti-Pertactin (N=254, 248) | 246 | Participants | |
| Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | DAPTACEL®+IPOL® | Anti-Pertactin (N=254, 248) | 231 | Participants | |
| Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | DTaP-IPV | Anti-Fimbriae types 2 and 3 (N=250, 249) | 243 | Participants | |
| Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | DAPTACEL®+IPOL® | Anti-Fimbriae types 2 and 3 (N=250, 249) | 230 | Participants | |
| Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | DTaP-IPV | Anti-PT pre-vaccination (N=254, 248) | 5.16 | 95% Confidence Interval 4.48 to 5.94 | Titers |
| Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine | DAPTACEL®+IPOL® | Anti-PT pre-vaccination (N=254, 248) | 4.74 | 95% Confidence Interval 4.18 to 5.39 | Titers |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DTaP-IPV | 2,743 | |
| Overall Study | STARTED | DAPTACEL®+IPOL® | 629 | |
| Overall Study | COMPLETED | DTaP-IPV | 2,676 | |
| Overall Study | COMPLETED | DAPTACEL®+IPOL® | 608 | |
| Overall Study | NOT COMPLETED | DTaP-IPV | 67 | |
| Overall Study | NOT COMPLETED | DAPTACEL®+IPOL® | 21 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site induration | General disorders | DTaP-IPV | 139 | 2,733 | 142 |
| other | Injection site induration | General disorders | DAPTACEL®+IPOL® | 20 | 621 | 20 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | DTaP-IPV | 142 | 2,733 | 147 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | DAPTACEL®+IPOL® | 26 | 621 | 26 |
| other | Injection site Pain | General disorders | DTaP-IPV | 2,081 | 2,689 | 2,081 |
| other | Injection site Pain | General disorders | DAPTACEL®+IPOL® | 461 | 603 | 461 |
| other | Injection site Erythema | General disorders | DTaP-IPV | 1,587 | 2,687 | 1,587 |
| other | Injection site Erythema | General disorders | DAPTACEL®+IPOL® | 322 | 603 | 322 |
| other | Injection site Swelling | General disorders | DTaP-IPV | 1,076 | 2,678 | 1,076 |
| other | Injection site Swelling | General disorders | DAPTACEL®+IPOL® | 219 | 602 | 219 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DTaP-IPV | ||
| Total, all-cause mortality | DAPTACEL®+IPOL® | ||
| Total, other adverse events | DTaP-IPV | 2,081 | 2,733 |
| Total, other adverse events | DAPTACEL®+IPOL® | 461 | 621 |
| Total, serious adverse events | DTaP-IPV | 21 | 2,733 |
| Total, serious adverse events | DAPTACEL®+IPOL® | 3 | 621 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27879555 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| DTaP-IPV vs DAPTACEL®+IPOL®: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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