Trial · NCT00304265
Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine
NCT00304265, Phase 4, Completed, Sanofi Pasteur, a Sanofi Company; results first posted 2011-04-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine. Trials, record NCT00304265. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00304265
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine
- NCT number
- NCT00304265
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 215 participants, actual
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Conditions
- Pertussis, Diphtheria, Tetanus, Poliomyelitis
- Interventions
- COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®)
- First posted
- 2006-03-17
- Last updated
- 2016-04-14
- Results first posted
- 2011-04-07
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Days 0 to 14 Post-vaccination | Solicited injection site reactions: Pain, Erythema, Swelling, and Arm circumference. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Days 0 to 14 Post-vaccination | Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | 6th Dose Pertussis Vaccine Group | Any Local Reactions After Vaccination | 89 | Participants | |
| Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | 5th Dose Pertussis Vaccine Group | Any Local Reactions After Vaccination | 87 | Participants | |
| Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | 6th Dose Pertussis Vaccine Group | Any Pain | 85 | Participants | |
| Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | 5th Dose Pertussis Vaccine Group | Any Pain | 87 | Participants | |
| Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | 6th Dose Pertussis Vaccine Group | Grade 3 Pain (Incapacitating) | 7 | Participants | |
| Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | 5th Dose Pertussis Vaccine Group | Grade 3 Pain (Incapacitating) | 8 | Participants | |
| Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | 6th Dose Pertussis Vaccine Group | Any Erythema | 19 | Participants | |
| Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | 5th Dose Pertussis Vaccine Group | Any Erythema | 27 | Participants | |
| Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | 6th Dose Pertussis Vaccine Group | Grade 3 Erythema (> 5.0 cm) | 10 | Participants | |
| Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | 5th Dose Pertussis Vaccine Group | Grade 3 Erythema (> 5.0 cm) | 10 | Participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 6th Dose Pertussis Vaccine Group | 117 | |
| Overall Study | STARTED | 5th Dose Pertussis Vaccine Group | 98 | |
| Overall Study | COMPLETED | 6th Dose Pertussis Vaccine Group | 117 | |
| Overall Study | COMPLETED | 5th Dose Pertussis Vaccine Group | 98 | |
| Overall Study | NOT COMPLETED | 6th Dose Pertussis Vaccine Group | 0 | |
| Overall Study | NOT COMPLETED | 5th Dose Pertussis Vaccine Group | 0 |
Source ClinicalTrials.gov
Adverse events14
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 pain | General disorders | 6th Dose Pertussis Vaccine Group | 89 | 117 | |
| other | Injection site pain | General disorders | 5th Dose Pertussis Vaccine Group | 87 | 97 | |
| other | Injection site erythema | General disorders | 6th Dose Pertussis Vaccine Group | 19 | 117 | |
| other | Injection site erythema | General disorders | 5th Dose Pertussis Vaccine Group | 27 | 97 | |
| other | Injection site swelling | General disorders | 6th Dose Pertussis Vaccine Group | 24 | 117 | |
| other | Injection site swelling | General disorders | 5th Dose Pertussis Vaccine Group | 17 | 97 | |
| other | Headache | Nervous system disorders | 6th Dose Pertussis Vaccine Group | 40 | 117 | |
| other | Headache | Nervous system disorders | 5th Dose Pertussis Vaccine Group | 50 | 97 | |
| other | Malaise | General disorders | 6th Dose Pertussis Vaccine Group | 40 | 117 | |
| other | Malaise | General disorders | 5th Dose Pertussis Vaccine Group | 44 | 97 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 6th Dose Pertussis Vaccine Group | ||
| Total, all-cause mortality | 5th Dose Pertussis Vaccine Group | ||
| Total, other adverse events | 6th Dose Pertussis Vaccine Group | 89 | 117 |
| Total, other adverse events | 5th Dose Pertussis Vaccine Group | 87 | 97 |
| Total, serious adverse events | 6th Dose Pertussis Vaccine Group | 0 | 117 |
| Total, serious adverse events | 5th Dose Pertussis Vaccine Group | 0 | 98 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20616762 | 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 |
|---|
| 6th Dose Pertussis Vaccine Group vs 5th Dose Pertussis Vaccine Group: 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/NCT00304265
GET https://conductscience.org/api/trials/v1/NCT00304265/results?page=2