Trial · NCT00348881
Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants
NCT00348881, Phase 3, Completed, Sanofi Pasteur, a Sanofi Company; results first posted 2013-10-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants. Trials, record NCT00348881. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00348881
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants
- NCT number
- NCT00348881
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,133 participants, actual
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B, Influenza
- Interventions
- DTaP-HB-PRP~T combined vaccine, Tritanrix-HepB/Hib™ vaccine, Oral poliomyelitis vaccine (OPV)
- First posted
- 2006-07-06
- Last updated
- 2013-10-22
- Results first posted
- 2013-10-22
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 Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | 1 month post third vaccination | Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination. |
| Primary | Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. | Day 0 to Day 7 post-vaccination | Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections. |
| Secondary | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | 1 month post third vaccination | Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies; enzyme immunoassay (EIA) for anti-Tetanus; serum neutralization (SN) for anti-Diphtheria; and enzyme-linked immunosorbent assay (ELISA) for anti-Pertusiss (PT) and anti-Filamentous Hemagglutinin (FHA) titers at Day 150, 1 month after the third vaccination. |
| Secondary | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Day 0 to Day 7 after vaccination | Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability. Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for \>3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and 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 Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | 1 month post third vaccination | Seroprotection was assessed in a subset of participants available for the endpoint, the per-protocol population. | Participants | NUMBER |
| SECONDARY | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | 1 month post third vaccination | GMTs were assessed in a subset of the participants available for the endpoint, the per-protocol population. | Titers | GEOMETRIC_MEAN |
| PRIMARY | Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. | Day 0 to Day 7 post-vaccination | Safety was assessed on the safety analysis (intent-to-treat) population. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The data were analyzed and presented according to the actual treatment received and with the total number (N) available for the endpoint at each time-point. | Participants | NUMBER |
| SECONDARY | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Day 0 to Day 7 after vaccination | Safety was assessed on the safety analysis (intent-to-treat) population. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The data were analyzed and presented according to the actual treatment received. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group118
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 Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Group 1: DTaP-Hep B-PRP~T + OPV | Anti-Hep Bs (N = 246, 122) | 239 | Participants | |
Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Group 2: Tritanrix-Hep B/ Hib™ + OPV | Anti-Hep Bs (N = 246, 122) | 119 | 0 to 0 | Participants |
Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Group 1: DTaP-Hep B-PRP~T + OPV | Anti-PRP (N = 218, 122) | 210 | Participants | |
Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Group 2: Tritanrix-Hep B/ Hib™ + OPV | Anti-PRP (N = 218, 122) | 121 | 0 to 0 | Participants |
Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Group 1: DTaP-Hep B-PRP~T + OPV | Anti-Diphtheria (N = 246, 123) | 217 | Participants | |
Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Group 2: Tritanrix-Hep B/ Hib™ + OPV | Anti-Diphtheria (N = 246, 123) | 109 | 0 to 0 | Participants |
Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Group 1: DTaP-Hep B-PRP~T + OPV | Anti-Tetanus (N = 246,123) | 246 | Participants | |
Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Group 2: Tritanrix-Hep B/ Hib™ + OPV | Anti-Tetanus (N = 246,123) | 123 | 0 to 0 | Participants |
| Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Group 1: DTaP-Hep B-PRP-T + OPV | Anti-Hep Bs (N = 246, 122) | 464 | 95% Confidence Interval 380 to 567 | Titers |
| Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Group 2: Tritanrix-Hep B/ Hib™ + OPV | Anti-Hep Bs (N = 246, 122) | 343 | 95% Confidence Interval 265 to 444 | Titers |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: DTaP-Hep B-PRP~T + OPV | 1,424 | |
| Overall Study | STARTED | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 709 | |
| Overall Study | COMPLETED | Group 1: DTaP-Hep B-PRP~T + OPV | 1,407 | |
| Overall Study | COMPLETED | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 697 | |
| Overall Study | NOT COMPLETED | Group 1: DTaP-Hep B-PRP~T + OPV | 17 | |
| Overall Study | NOT COMPLETED | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 12 |
Source ClinicalTrials.gov
Adverse events56
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 | Solicited injection site Pain | General disorders | Group 1: DTaP-Hep B-PRP~T + OPV | 958 | 1,425 | |
| other | Solicited injection site Pain | General disorders | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 573 | 708 | |
| other | Solicited injection site Erythema | General disorders | Group 1: DTaP-Hep B-PRP~T + OPV | 543 | 1,425 | |
| other | Solicited injection site Erythema | General disorders | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 353 | 708 | |
| other | Solicited injection site Swelling | General disorders | Group 1: DTaP-Hep B-PRP~T + OPV | 576 | 1,425 | |
| other | Solicited injection site Swelling | General disorders | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 423 | 708 | |
| other | Pyrexia | General disorders | Group 1: DTaP-Hep B-PRP~T + OPV | 282 | 1,425 | |
| other | Pyrexia | General disorders | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 248 | 708 | |
| other | Vomiting | Gastrointestinal disorders | Group 1: DTaP-Hep B-PRP~T + OPV | 193 | 1,425 | |
| other | Vomiting | Gastrointestinal disorders | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 118 | 708 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: DTaP-Hep B-PRP~T + OPV | ||
| Total, all-cause mortality | Group 2: Tritanrix-Hep B/ Hib™ + OPV | ||
| Total, other adverse events | Group 1: DTaP-Hep B-PRP~T + OPV | 1,092 | 1,425 |
| Total, other adverse events | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 636 | 708 |
| Total, serious adverse events | Group 1: DTaP-Hep B-PRP~T + OPV | 31 | 1,425 |
| Total, serious adverse events | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 12 | 708 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| Group 1: DTaP-Hep B-PRP~T + OPV vs Group 2: 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/NCT00348881
GET https://conductscience.org/api/trials/v1/NCT00348881/results?page=2