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Trial · NCT00326183

Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)

NCT00326183, Phase 4, Completed, Merck Sharp & Dohme LLC; results first posted 2008-11-20

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED). Trials, record NCT00326183. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00326183

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)
NCT number
NCT00326183
Status
Completed
Phases
Phase 4
Enrollment
1,800 participants, actual
Lead sponsor
Merck Sharp & Dohme LLC
Conditions
Hepatitis A, Measles, Mumps, Rubella, Chickenpox
Interventions
VAQTA®, ProQuad
First posted
2006-05-16
Last updated
2019-02-04
Results first posted
2008-11-20

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryParticipants With 1 or More Serious Vaccine-Related Adverse ExperiencesDays 1 to 14 after any vaccination
PrimaryParticipants With 1 or More Injection-Site Adverse ExperiencesDays 1 to 14 after any vaccination
PrimaryParticipants With Measles-Like Rash After First VaccinationDays 1 to 28 After First Vaccination
PrimaryParticipants With Measles-Like Rash After Second VaccinationDays 1 to 28 After Second Vaccination
PrimaryParticipants With Mumps-Like Symptoms After First VaccinationDays 1 to 28 After First Vaccination
PrimaryParticipants With Mumps-Like Symptoms After Second VaccinationDays 1 to 28 After Second Vaccination
PrimaryParticipants With Rubella-Like Rash After First VaccinationDays 1 to 28 After First Vaccination
PrimaryParticipants With Rubella-Like Rash After Second VaccinationDays 1 to 28 After Second Vaccination
PrimaryParticipants With Varicella/Zoster-Like Rash After First VaccinationDays 1 to 28 After First Vaccination
PrimaryParticipants With Varicella/Zoster-Like Rash After Second VaccinationDays 1 to 28 After Second Vaccination

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYParticipants With 1 or More Serious Vaccine-Related Adverse ExperiencesDays 1 to 14 after any vaccinationIncludes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.participantsNUMBER
SECONDARYParticipants With 1 or More Systemic Adverse ExperiencesDays 1 to 14 After Any VaccinationIncludes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.participantsNUMBER
PRIMARYParticipants With 1 or More Injection-Site Adverse ExperiencesDays 1 to 14 after any vaccinationIncludes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.participantsNUMBER
PRIMARYParticipants With Measles-Like Rash After First VaccinationDays 1 to 28 After First VaccinationIncludes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ +ProQuad™ group was followed for rashes.participantsNUMBER
PRIMARYParticipants With Measles-Like Rash After Second VaccinationDays 1 to 28 After Second VaccinationIncludes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.participantsNUMBER
PRIMARYParticipants With Mumps-Like Symptoms After First VaccinationDays 1 to 28 After First VaccinationIncludes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for mumps-like symptoms.participantsNUMBER
PRIMARYParticipants With Mumps-Like Symptoms After Second VaccinationDays 1 to 28 After Second VaccinationIncludes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for mumps-like symptoms.participantsNUMBER
PRIMARYParticipants With Rubella-Like Rash After First VaccinationDays 1 to 28 After First VaccinationIncludes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.participantsNUMBER
PRIMARYParticipants With Rubella-Like Rash After Second VaccinationDays 1 to 28 After Second VaccinationIncludes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.participantsNUMBER
PRIMARYParticipants With Varicella/Zoster-Like Rash After First VaccinationDays 1 to 28 After First VaccinationIncludes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.participantsNUMBER

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Participants With 1 or More Serious Vaccine-Related Adverse ExperiencesArm 1: VAQTA™0participants
Participants With 1 or More Serious Vaccine-Related Adverse ExperiencesArm 2: VAQTA™ +ProQuad™1participants
Participants With 1 or More Systemic Adverse ExperiencesArm 1: VAQTA™782participants
Participants With 1 or More Systemic Adverse ExperiencesArm 2: VAQTA™ +ProQuad™197participants
Participants With 1 or More Injection-Site Adverse ExperiencesArm 1: VAQTA™701participants
Participants With 1 or More Injection-Site Adverse ExperiencesArm 2: VAQTA™ +ProQuad™164participants
Participants With Measles-Like Rash After First VaccinationArm 2: VAQTA™ +ProQuad™13participants
Participants With Measles-Like Rash After Second VaccinationArm 2: VAQTA™ +ProQuad™5participants
Participants With Mumps-Like Symptoms After First VaccinationArm 2: VAQTA™ +ProQuad™0participants
Participants With Mumps-Like Symptoms After Second VaccinationArm 2: VAQTA™ +ProQuad™0participants

Participant flow14

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDArm 1: VAQTA™1,453
Overall StudySTARTEDArm 2: VAQTA™ +ProQuad™347
Overall StudyVaccination 1 + Safety Follow-upArm 1: VAQTA™1,453
Overall StudyVaccination 1 + Safety Follow-upArm 2: VAQTA™ +ProQuad™347
Overall StudyPostvaccination 1 Post-safety Follow-upArm 1: VAQTA™1,393
Overall StudyPostvaccination 1 Post-safety Follow-upArm 2: VAQTA™ +ProQuad™325
Overall StudyVaccination 2 + Safety Follow-upArm 1: VAQTA™1,301
Overall StudyVaccination 2 + Safety Follow-upArm 2: VAQTA™ +ProQuad™292
Overall StudyPostvaccination 2 Post-safety Follow-upArm 1: VAQTA™1,265
Overall StudyPostvaccination 2 Post-safety Follow-upArm 2: VAQTA™ +ProQuad™271

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
30431383BACKGROUND

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 comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Arm 1: VAQTA™ vs Arm 2: VAQTA™ +ProQuad™: Participants With Elevated Temperature (>=102.2F/39.0C)Trial comparisons
Arm 1: VAQTA™ vs Arm 2: VAQTA™ +ProQuad™: Participants With 1 or More Injection-Site Adverse ExperiencesTrial comparisons
Arm 1: VAQTA™ vs Arm 2: VAQTA™ +ProQuad™: Participants With 1 or More Serious Vaccine-Related Adverse ExperiencesTrial comparisons
Arm 1: VAQTA™ vs Arm 2: VAQTA™ +ProQuad™: Participants With 1 or More Systemic Adverse ExperiencesTrial 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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT00326183

GET https://conductscience.org/api/trials/v1/NCT00326183/registered