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

An Open, Multicenter Study of the Safety and Tolerability of VAQTA(TM) and ProQuad(TM) in Healthy Children 12 to 23 Months of Age

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00326183
Enrollment
1800
Registered
2006-05-16
Start date
2007-03-26
Completion date
2008-01-15
Last updated
2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis A, Measles, Mumps, Rubella, Chickenpox

Brief summary

Two doses each of Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella \[Oka/Merck\] Virus Vaccine Live will be given concomitantly or non-concomitantly. Safety data will be collected following each vaccination.

Interventions

BIOLOGICALVAQTA®

0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.

BIOLOGICALProQuad

0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Months to 17 Months
Healthy volunteers
Yes

Inclusion criteria

* Negative clinical history of hepatitis A, measles, mumps, rubella, varicella (chickenpox), and/or zoster * No other vaccinations scheduled to be administered at the time of the first or second doses of VAQTA(TM) and ProQuad(TM)

Exclusion criteria

* Previously vaccinated with any hepatitis A vaccine, measles, mumps, rubella, and/or varicella vaccine either alone or in any combination * History of allergy to any vaccine component * History of seizure disorder * Immunosuppressed including congenial and acquired conditions and immunosuppressive therapy * Known severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injections * Recent (\<72 hours) febrile illness (\>100.3 degrees F \[\>37.9 degrees C\] oral equivalent) prior to study vaccination.

Design outcomes

Primary

MeasureTime frame
Participants With Elevated Temperature (>=102.2F/39.0C)Days 1 to 5 After Any Vaccination
Participants With 1 or More Serious Vaccine-Related Adverse ExperiencesDays 1 to 14 after any vaccination
Participants With 1 or More Injection-Site Adverse ExperiencesDays 1 to 14 after any vaccination
Participants With Measles-Like Rash After First VaccinationDays 1 to 28 After First Vaccination
Participants With Measles-Like Rash After Second VaccinationDays 1 to 28 After Second Vaccination
Participants With Mumps-Like Symptoms After First VaccinationDays 1 to 28 After First Vaccination
Participants With Mumps-Like Symptoms After Second VaccinationDays 1 to 28 After Second Vaccination
Participants With Rubella-Like Rash After First VaccinationDays 1 to 28 After First Vaccination
Participants With Rubella-Like Rash After Second VaccinationDays 1 to 28 After Second Vaccination
Participants With Varicella/Zoster-Like Rash After First VaccinationDays 1 to 28 After First Vaccination
Participants With Varicella/Zoster-Like Rash After Second VaccinationDays 1 to 28 After Second Vaccination

Secondary

MeasureTime frame
Participants With 1 or More Systemic Adverse ExperiencesDays 1 to 14 After Any Vaccination

Participant flow

Recruitment details

18 investigators in the United States; Date of first subject visit: 26-Mar-2007. Date of last subject visit: 14-Nov-2007.

Participants by arm

ArmCount
Arm 1: VAQTA™
Hepatitis A vaccine, inactivated
1,453
Arm 2: VAQTA™ +ProQuad™
Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
347
Total1,800

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event10
Overall StudyLost to Follow-up10456
Overall StudyOther4713
Overall StudyProtocol Violation63
Overall StudySubject Moved74
Overall StudyWithdrawal by Subject357

Baseline characteristics

CharacteristicArm 1: VAQTA™Arm 2: VAQTA™ +ProQuad™Total
Age, Continuous13.3 months
STANDARD_DEVIATION 1.49
12.5 months
STANDARD_DEVIATION 0.9
13.2 months
STANDARD_DEVIATION 1.43
Sex: Female, Male
Female
703 Participants176 Participants879 Participants
Sex: Female, Male
Male
750 Participants171 Participants921 Participants

Outcome results

Primary

Participants With 1 or More Injection-Site Adverse Experiences

Time frame: Days 1 to 14 after any vaccination

Population: Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.

ArmMeasureValue (NUMBER)
Arm 1: VAQTA™Participants With 1 or More Injection-Site Adverse Experiences701 participants
Arm 2: VAQTA™ +ProQuad™Participants With 1 or More Injection-Site Adverse Experiences164 participants
Primary

Participants With 1 or More Serious Vaccine-Related Adverse Experiences

Time frame: Days 1 to 14 after any vaccination

Population: Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.

ArmMeasureValue (NUMBER)
Arm 1: VAQTA™Participants With 1 or More Serious Vaccine-Related Adverse Experiences0 participants
Arm 2: VAQTA™ +ProQuad™Participants With 1 or More Serious Vaccine-Related Adverse Experiences1 participants
Primary

Participants With Elevated Temperature (>=102.2F/39.0C)

Time frame: Days 1 to 5 After Any Vaccination

Population: Includes all subjects who provided body temperature follow-up data after any dose of vaccine.

ArmMeasureValue (NUMBER)
Arm 1: VAQTA™Participants With Elevated Temperature (>=102.2F/39.0C)56 participants
Arm 2: VAQTA™ +ProQuad™Participants With Elevated Temperature (>=102.2F/39.0C)13 participants
Primary

Participants With Measles-Like Rash After First Vaccination

Time frame: Days 1 to 28 After First Vaccination

Population: Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ +ProQuad™ group was followed for rashes.

ArmMeasureValue (NUMBER)
Arm 2: VAQTA™ +ProQuad™Participants With Measles-Like Rash After First Vaccination13 participants
Primary

Participants With Measles-Like Rash After Second Vaccination

Time frame: Days 1 to 28 After Second Vaccination

Population: Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.

ArmMeasureValue (NUMBER)
Arm 2: VAQTA™ +ProQuad™Participants With Measles-Like Rash After Second Vaccination5 participants
Primary

Participants With Mumps-Like Symptoms After First Vaccination

Time frame: Days 1 to 28 After First Vaccination

Population: Includes 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.

ArmMeasureValue (NUMBER)
Arm 2: VAQTA™ +ProQuad™Participants With Mumps-Like Symptoms After First Vaccination0 participants
Primary

Participants With Mumps-Like Symptoms After Second Vaccination

Time frame: Days 1 to 28 After Second Vaccination

Population: Includes 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.

ArmMeasureValue (NUMBER)
Arm 2: VAQTA™ +ProQuad™Participants With Mumps-Like Symptoms After Second Vaccination0 participants
Primary

Participants With Rubella-Like Rash After First Vaccination

Time frame: Days 1 to 28 After First Vaccination

Population: Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.

ArmMeasureValue (NUMBER)
Arm 2: VAQTA™ +ProQuad™Participants With Rubella-Like Rash After First Vaccination1 participants
Primary

Participants With Rubella-Like Rash After Second Vaccination

Time frame: Days 1 to 28 After Second Vaccination

Population: Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.

ArmMeasureValue (NUMBER)
Arm 2: VAQTA™ +ProQuad™Participants With Rubella-Like Rash After Second Vaccination0 participants
Primary

Participants With Varicella/Zoster-Like Rash After First Vaccination

Time frame: Days 1 to 28 After First Vaccination

Population: Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.

ArmMeasureValue (NUMBER)
Arm 2: VAQTA™ +ProQuad™Participants With Varicella/Zoster-Like Rash After First Vaccination0 participants
Primary

Participants With Varicella/Zoster-Like Rash After Second Vaccination

Time frame: Days 1 to 28 After Second Vaccination

Population: Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.

ArmMeasureValue (NUMBER)
Arm 2: VAQTA™ +ProQuad™Participants With Varicella/Zoster-Like Rash After Second Vaccination0 participants
Secondary

Participants With 1 or More Systemic Adverse Experiences

Time frame: Days 1 to 14 After Any Vaccination

Population: Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.

ArmMeasureValue (NUMBER)
Arm 1: VAQTA™Participants With 1 or More Systemic Adverse Experiences782 participants
Arm 2: VAQTA™ +ProQuad™Participants With 1 or More Systemic Adverse Experiences197 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026