Trial · NCT00514709
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants
NCT00514709, Phase 3, Completed, Sanofi Pasteur, a Sanofi Company; results first posted 2013-11-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants. Trials, record NCT00514709. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00514709
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants
- NCT number
- NCT00514709
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,843 participants, actual
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B, Influenza
- Interventions
- DTaP-HB PRP~T Combined Vaccine, DTaP-HB-PRP~T vaccine, Oral Polio Vaccine
- First posted
- 2007-08-10
- Last updated
- 2016-08-02
- Results first posted
- 2013-11-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Day 0 (pre-vaccination) and Day 28 post-booster 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, and serum neutralization (SN) for anti-Diphtheria. Booster responses 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; Pertussis Toxoid and Filamentous Hemagglutinin (FHA) 4-fold increase and booster response. |
| Secondary | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Day 0 (pre-vaccination) and Day 28 post-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, and serum neutralization (SN) for anti-Diphtheria following the booster vaccination. |
| Secondary | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Day 0 up to Day 7 after vaccination | Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Pyrexia (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 ≥ 39.5ºC; 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
Outcomes3
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 Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Day 0 (pre-vaccination) and Day 28 post-booster vaccination | Antibody persistence and immunogenicity booster responses were 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 Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Day 0 (pre-vaccination) and Day 28 post-vaccination | GMTs were assessed in a sub-set of the participants available for the endpoint, the per-protocol population. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Day 0 up to Day 7 after vaccination | Safety was assessed on the safety analysis (intent-to-treat) population. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group86
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 Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Group 1: DTaP-Hep B-PRP~T + OPV | Anti-Hep B Pre-booster (N = 93, 103) | 81 | Participants | |
| Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Group 2: Tritanrix-Hep B/ Hib™ + OPV | Anti-Hep B Pre-booster (N = 93, 103) | 80 | 0 to 0 | Participants |
| Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Group 1: DTaP-Hep B-PRP~T + OPV | Anti-Hep B Post-booster (N = 93, 105) | 91 | Participants | |
| Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Group 2: Tritanrix-Hep B/ Hib™ + OPV | Anti-Hep B Post-booster (N = 93, 105) | 103 | Participants | |
| Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Group 1: DTaP-Hep B-PRP~T + OPV | Anti-PRP Pre-booster (N = 93, 105) | 78 | Participants | |
| Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Group 2: Tritanrix-Hep B/ Hib™ + OPV | Anti-PRP Pre-booster (N = 93, 105) | 105 | 0 to 0 | Participants |
| Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Group 1: DTaP-Hep B-PRP~T + OPV | Anti-PRP Post-booster (N = 93, 105) | 93 | Participants | |
| Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Group 2: Tritanrix-Hep B/ Hib™ + OPV | Anti-PRP Post-booster (N = 93, 105) | 105 | Participants | |
| Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Group 1: DTaP-Hep B-PRP~T + OPV | Anti-Diphtheria Pre-booster (N = 93, 105) | 72 | Participants | |
| Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Group 2: Tritanrix-Hep B/ Hib™ + OPV | Anti-Diphtheria Pre-booster (N = 93, 105) | 68 | 0 to 0 | Participants |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 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 | 1,230 | |
| Overall Study | STARTED | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 613 | |
| Overall Study | COMPLETED | Group 1: DTaP-Hep B-PRP~T + OPV | 1,230 | |
| Overall Study | COMPLETED | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 613 | |
| Overall Study | NOT COMPLETED | Group 1: DTaP-Hep B-PRP~T + OPV | 0 | |
| Overall Study | NOT COMPLETED | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 0 |
Source ClinicalTrials.gov
Adverse events24
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 | 411 | 1,230 | |
| other | Solicited injection site Pain | General disorders | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 216 | 613 | |
| other | Solicited injection site Erythema | General disorders | Group 1: DTaP-Hep B-PRP~T + OPV | 272 | 1,230 | |
| other | Solicited injection site Erythema | General disorders | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 136 | 613 | |
| other | Solicited injection site Swelling | General disorders | Group 1: DTaP-Hep B-PRP~T + OPV | 211 | 1,230 | |
| other | Solicited injection site Swelling | General disorders | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 120 | 613 | |
| other | Pyrexia | General disorders | Group 1: DTaP-Hep B-PRP~T + OPV | 137 | 1,230 | |
| other | Pyrexia | General disorders | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 70 | 613 | |
| other | Vomiting | Gastrointestinal disorders | Group 1: DTaP-Hep B-PRP~T + OPV | 53 | 1,230 | |
| other | Vomiting | Gastrointestinal disorders | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 33 | 613 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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 | 411 | 1,230 |
| Total, other adverse events | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 216 | 613 |
| Total, serious adverse events | Group 1: DTaP-Hep B-PRP~T + OPV | 3 | 1,230 |
| Total, serious adverse events | Group 2: Tritanrix-Hep B/ Hib™ + OPV | 0 | 613 |
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/NCT00514709
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