Trial · NCT00313911
Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
NCT00313911, Phase 3, Completed, Sanofi Pasteur, a Sanofi Company; results first posted 2012-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months. Trials, record NCT00313911. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00313911
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
- NCT number
- NCT00313911
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,133 participants, actual
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b, Hepatitis B
- Interventions
- DTaP-IPV-HB-PRP~T, Tritanrix-HepB/Hib
- First posted
- 2006-04-12
- Last updated
- 2014-04-21
- Results first posted
- 2012-11-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | Day 0 up to Day 7 post-injection | High fever was defined as rectal temperature equivalent to ≥ 39.6ºC. |
| Secondary | Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo | Day 30 post-dose 3 | Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. |
| Secondary | Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo | Day 30 post-dose 3 | Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively. |
| Secondary | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Day 0 up to Day 7 Post-injection | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, \>3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; Irritability, inconsolable. |
Source ClinicalTrials.gov
Outcomes4
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 High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | Day 0 up to Day 7 post-injection | The occurrence of high fever was assessed for all enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants in each group adjusted for the participant that got a vaccine assigned for the other group. | Participants | NUMBER |
| SECONDARY | Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo | Day 30 post-dose 3 | Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo | Day 30 post-dose 3 | Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Day 0 up to Day 7 Post-injection | Solicited injection site and systemic reactions were assessed in the enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants (N) in each group adjusted for the participant that got a vaccine assigned for the other group. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group122
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 High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | DTaP-IPV-Hep B-PRP~T | Post Any Dose (N = 1411, 703) | 56 | Participants | |
| Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | Tritanrix-Hep B/Hib™ + OPV | Post Any Dose (N = 1411, 703) | 39 | 0 to 0 | Participants |
| Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | DTaP-IPV-Hep B-PRP~T | Post Dose 1 (N = 1408, 703) | 5 | Participants | |
| Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | Tritanrix-Hep B/Hib™ + OPV | Post Dose 1 (N = 1408, 703) | 4 | 0 to 0 | Participants |
| Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | DTaP-IPV-Hep B-PRP~T | Post Dose 2 (N = 1348, 681) | 25 | Participants | |
| Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | Tritanrix-Hep B/Hib™ + OPV | Post Dose 2 (N = 1348, 681) | 15 | 0 to 0 | Participants |
| Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | DTaP-IPV-Hep B-PRP~T | Post Dose 3 (N = 1328, 672) | 26 | Participants | |
| Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | Tritanrix-Hep B/Hib™ + OPV | Post Dose 3 (N = 1328, 672) | 23 | 0 to 0 | Participants |
| Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo | DTaP-IPV-Hep B-PRP~T | 1075 | 95% Confidence Interval 891 to 1298 | Titers | |
| Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo | Tritanrix-Hep B/Hib™ + OPV | 3376 | 95% Confidence Interval 2672 to 4338 | Titers |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 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-Hep B-PRP~T | 1,422 | |
| Overall Study | STARTED | Tritanrix-Hep B/Hib™ + OPV | 711 | |
| Overall Study | COMPLETED | DTaP-IPV-Hep B-PRP~T | 1,328 | |
| Overall Study | COMPLETED | Tritanrix-Hep B/Hib™ + OPV | 670 | |
| Overall Study | NOT COMPLETED | DTaP-IPV-Hep B-PRP~T | 94 | |
| Overall Study | NOT COMPLETED | Tritanrix-Hep B/Hib™ + OPV | 41 |
Source ClinicalTrials.gov
Adverse events116
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 | Abdominal Pain | Gastrointestinal disorders | DTaP-IPV-Hep B-PRP~T | 131 | 1,411 | 131 |
| other | Abdominal Pain | Gastrointestinal disorders | Tritanrix-Hep B/Hib™ + OPV | 70 | 703 | 70 |
| other | Diarrhoea | Gastrointestinal disorders | DTaP-IPV-Hep B-PRP~T | 264 | 1,411 | 264 |
| other | Diarrhoea | Gastrointestinal disorders | Tritanrix-Hep B/Hib™ + OPV | 123 | 703 | 123 |
| other | Solicited Vomiting Post-dose 1 | Gastrointestinal disorders | DTaP-IPV-Hep B-PRP~T | 230 | 1,410 | 230 |
| other | Solicited Vomiting Post-dose 1 | Gastrointestinal disorders | Tritanrix-Hep B/Hib™ + OPV | 120 | 703 | 120 |
| other | Solicited Injection site Erythema Post-dose 3 | General disorders | DTaP-IPV-Hep B-PRP~T | 587 | 1,410 | 587 |
| other | Solicited Injection site Erythema Post-dose 3 | General disorders | Tritanrix-Hep B/Hib™ + OPV | 340 | 703 | 340 |
| other | Injection Site Haemorrhage | General disorders | DTaP-IPV-Hep B-PRP~T | 39 | 1,411 | 39 |
| other | Injection Site Haemorrhage | General disorders | Tritanrix-Hep B/Hib™ + OPV | 63 | 703 | 63 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DTaP-IPV-Hep B-PRP~T | ||
| Total, all-cause mortality | Tritanrix-Hep B/Hib™ + OPV | ||
| Total, other adverse events | DTaP-IPV-Hep B-PRP~T | 945 | 1,423 |
| Total, other adverse events | Tritanrix-Hep B/Hib™ + OPV | 576 | 710 |
| Total, serious adverse events | DTaP-IPV-Hep B-PRP~T | 91 | 1,423 |
| Total, serious adverse events | Tritanrix-Hep B/Hib™ + OPV | 46 | 710 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22531237 | RESULT |
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-Hep B-PRP~T vs Tritanrix-Hep B/Hib™ + OPV: 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.
GET https://conductscience.org/api/trials/v1/NCT00313911
GET https://conductscience.org/api/trials/v1/NCT00313911/results?page=2