Trial · NCT00483574
Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
NCT00483574, Phase 3, Completed, Sanofi Pasteur, a Sanofi Company; results first posted 2011-07-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers. Trials, record NCT00483574. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00483574
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
- NCT number
- NCT00483574
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,378 participants, actual
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Conditions
- Meningococcal Meningitis, Measles, Mumps, Rubella, Varicella
- Interventions
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate, Measles-mumps-rubella-varicella vaccine, Routine paediatric vaccine - Pneumococcal conjugate (PCV), Routine paediatric vaccine - Hepatitis A
- First posted
- 2007-06-07
- Last updated
- 2016-05-16
- Results first posted
- 2011-07-06
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Day 0 to 7 Post-vaccination | Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability |
| Other | Safety Overview After Any Vaccination in Participants Who Received MMR+V | Day 0 to 7 Post-vaccination |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Day 0 to 7 Post-vaccination | Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. Data on 23 participants in Group 1 that received MMR+V vaccines instead of a MMRV single vaccine in addition to the PCV and HepA vaccines were analyzed separately. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Safety Overview After Any Vaccination in Participants Who Received MMR+V | Day 0 to 7 Post-vaccination | Summary of the safety analysis of the 23 participants in Group 1 that received MMR+V vaccines instead of a MMRV single vaccine in addition to the PCV and HepA vaccines. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group133
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Group 1: Menactra and Routine Pediatric Vaccines | Any Injection Site Reaction at 9 Months - Menactra | 52 | Percentage of participants | |
| Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Group 2: Routine Pediatric Vaccines | Any Injection Site Reaction at 9 Months - Menactra | NA | Percentage of participants | |
| Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Group 1: Menactra and Routine Pediatric Vaccines | Any Tenderness at 9 Months - Menactra | 37 | Percentage of participants | |
| Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Group 2: Routine Pediatric Vaccines | Any Tenderness at 9 Months - Menactra | NA | Percentage of participants | |
| Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Group 1: Menactra and Routine Pediatric Vaccines | Grade 3 Tenderness (Cries when limb is moved) | 1 | Percentage of participants | |
| Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Group 2: Routine Pediatric Vaccines | Grade 3 Tenderness (Cries when limb is moved) | NA | Percentage of participants | |
| Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Group 1: Menactra and Routine Pediatric Vaccines | Any Erythema at 9 Months - Menactra | 30 | Percentage of participants | |
| Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Group 2: Routine Pediatric Vaccines | Any Erythema at 9 Months - Menactra | NA | Percentage of participants | |
| Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Group 1: Menactra and Routine Pediatric Vaccines | Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) | 0 | Percentage of participants | |
| Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Group 2: Routine Pediatric Vaccines | Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) | NA | Percentage of participants |
1 to 10 of 133Source ClinicalTrials.gov
See all 133 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: Menactra and Routine Pediatric Vaccines | 1,053 | |
| Overall Study | STARTED | Group 2: Routine Pediatric Vaccines | 321 | |
| Overall Study | COMPLETED | Group 1: Menactra and Routine Pediatric Vaccines | 951 | |
| Overall Study | COMPLETED | Group 2: Routine Pediatric Vaccines | 308 | |
| Overall Study | NOT COMPLETED | Group 1: Menactra and Routine Pediatric Vaccines | 102 | |
| Overall Study | NOT COMPLETED | Group 2: Routine Pediatric Vaccines | 13 |
Source ClinicalTrials.gov
Adverse events70
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 | Diarrhoea | Gastrointestinal disorders | Group 1: Menactra and Routine Pediatric Vaccines | 109 | 1,053 | 126 |
| other | Diarrhoea | Gastrointestinal disorders | Group 2: Routine Pediatric Vaccines | 18 | 321 | 20 |
| other | Injection site bruising | General disorders | Group 1: Menactra and Routine Pediatric Vaccines | 85 | 1,053 | 102 |
| other | Injection site bruising | General disorders | Group 2: Routine Pediatric Vaccines | 18 | 321 | 20 |
| other | Pyrexia | General disorders | Group 1: Menactra and Routine Pediatric Vaccines | 65 | 1,053 | 76 |
| other | Pyrexia | General disorders | Group 2: Routine Pediatric Vaccines | 17 | 321 | 18 |
| other | Otitis media | Infections and infestations | Group 1: Menactra and Routine Pediatric Vaccines | 183 | 1,053 | 210 |
| other | Otitis media | Infections and infestations | Group 2: Routine Pediatric Vaccines | 26 | 321 | 27 |
| other | Upper respiratory tract infection | Infections and infestations | Group 1: Menactra and Routine Pediatric Vaccines | 150 | 1,053 | 165 |
| other | Upper respiratory tract infection | Infections and infestations | Group 2: Routine Pediatric Vaccines | 16 | 321 | 17 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: Menactra and Routine Pediatric Vaccines | ||
| Total, all-cause mortality | Group 2: Routine Pediatric Vaccines | ||
| Total, other adverse events | Group 1: Menactra and Routine Pediatric Vaccines | 530 | 1,053 |
| Total, other adverse events | Group 2: Routine Pediatric Vaccines | 95 | 321 |
| Total, serious adverse events | Group 1: Menactra and Routine Pediatric Vaccines | 42 | 1,053 |
| Total, serious adverse events | Group 2: Routine Pediatric Vaccines | 5 | 321 |
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: Menactra and Routine Pediatric Vaccines vs Group 2: Routine Pediatric Vaccines: 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/NCT00483574
GET https://conductscience.org/api/trials/v1/NCT00483574/results?page=2