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CompletedNCT00326183Updated Feb 4, 2019Results posted

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

A Phase 4 interventional study of VAQTA® and ProQuad in Hepatitis A, Measles and Mumps, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 12 Months to 17 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-04.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
1,800
Allocation
Randomized
Ages
12 Months to 17 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatitis A
  • Measles
  • Mumps
  • Rubella
  • Chickenpox
03

In context

Hepatitis A

82 studies on the registry are indexed under Hepatitis A; 9 are open to participants now.

This study's enrollment of 1,800 is above the median of 278 across 59 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.

Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.

Browse Merck Sharp & Dohme LLC studies →All Merck & Co., Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 17 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,800 participants (actual)

Study arms

  • Active comparator
    1

    Arm 1: vaccine

    Biological: VAQTA®

  • Active comparator
    2

    Arm 2: Active comparator

    Biological: VAQTA® · Biological: ProQuad

Interventions

  • BiologicalVAQTA®

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

    Also known as: V251

  • BiologicalProQuad

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

06

What researchers measure

Primary outcomes

  1. Participants With 1 or More Serious Vaccine-Related Adverse Experiences

    Time frame: Days 1 to 14 after any vaccination

  2. Participants With 1 or More Injection-Site Adverse Experiences

    Time frame: Days 1 to 14 after any vaccination

  3. Participants With Measles-Like Rash After First Vaccination

    Time frame: Days 1 to 28 After First Vaccination

  4. Participants With Measles-Like Rash After Second Vaccination

    Time frame: Days 1 to 28 After Second Vaccination

  5. Participants With Mumps-Like Symptoms After First Vaccination

    Time frame: Days 1 to 28 After First Vaccination

  6. Participants With Mumps-Like Symptoms After Second Vaccination

    Time frame: Days 1 to 28 After Second Vaccination

  7. Participants With Rubella-Like Rash After First Vaccination

    Time frame: Days 1 to 28 After First Vaccination

  8. Participants With Rubella-Like Rash After Second Vaccination

    Time frame: Days 1 to 28 After Second Vaccination

  9. Participants With Varicella/Zoster-Like Rash After First Vaccination

    Time frame: Days 1 to 28 After First Vaccination

  10. Participants With Varicella/Zoster-Like Rash After Second Vaccination

    Time frame: Days 1 to 28 After Second Vaccination

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

    Time frame: Days 1 to 5 After Any Vaccination

Secondary outcomes

  1. Participants With 1 or More Systemic Adverse Experiences

    Time frame: Days 1 to 14 After Any Vaccination

07

Results

Posted Nov 20, 2008

Participant flow

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

Participant flow — Overall Study
MilestoneArm 1: VAQTA™Arm 2: VAQTA™ +ProQuad™
Started1453347
Vaccination 1 + safety follow-up1453347
Postvaccination 1 post-safety follow-up1393325
Vaccination 2 + safety follow-up1301292
Postvaccination 2 post-safety follow-up1265271
Completed1253264
Not completed20083
Withdrew: Lost to follow-up10456
Withdrew: Protocol violation63
Withdrew: Withdrawal by subject357
Withdrew: Subject moved74
Withdrew: Other4713
Withdrew: Adverse event10

Outcome measures

PrimaryParticipants With 1 or More Serious Vaccine-Related Adverse Experiences
Time frame:
Days 1 to 14 after any vaccination
Reported as:
Number · participants
Participants With 1 or More Serious Vaccine-Related Adverse Experiences
participantsArm 1: VAQTA™Arm 2: VAQTA™ +ProQuad™
Participants With 1 or More Serious Vaccine-Related Adverse Experiences01
SecondaryParticipants With 1 or More Systemic Adverse Experiences
Time frame:
Days 1 to 14 After Any Vaccination
Reported as:
Number · participants
Participants With 1 or More Systemic Adverse Experiences
participantsArm 1: VAQTA™Arm 2: VAQTA™ +ProQuad™
Participants With 1 or More Systemic Adverse Experiences782197
PrimaryParticipants With 1 or More Injection-Site Adverse Experiences
Time frame:
Days 1 to 14 after any vaccination
Reported as:
Number · participants
Participants With 1 or More Injection-Site Adverse Experiences
participantsArm 1: VAQTA™Arm 2: VAQTA™ +ProQuad™
Participants With 1 or More Injection-Site Adverse Experiences701164
PrimaryParticipants With Measles-Like Rash After First Vaccination
Time frame:
Days 1 to 28 After First Vaccination
Reported as:
Number · participants
Participants With Measles-Like Rash After First Vaccination
participantsArm 1: VAQTA™Arm 2: VAQTA™ +ProQuad™
Participants With Measles-Like Rash After First Vaccination—13
PrimaryParticipants With Measles-Like Rash After Second Vaccination
Time frame:
Days 1 to 28 After Second Vaccination
Reported as:
Number · participants
Participants With Measles-Like Rash After Second Vaccination
participantsArm 1: VAQTA™Arm 2: VAQTA™ +ProQuad™
Participants With Measles-Like Rash After Second Vaccination—5
PrimaryParticipants With Mumps-Like Symptoms After First Vaccination
Time frame:
Days 1 to 28 After First Vaccination
Reported as:
Number · participants
Participants With Mumps-Like Symptoms After First Vaccination
participantsArm 1: VAQTA™Arm 2: VAQTA™ +ProQuad™
Participants With Mumps-Like Symptoms After First Vaccination—0
PrimaryParticipants With Mumps-Like Symptoms After Second Vaccination
Time frame:
Days 1 to 28 After Second Vaccination
Reported as:
Number · participants
Participants With Mumps-Like Symptoms After Second Vaccination
participantsArm 1: VAQTA™Arm 2: VAQTA™ +ProQuad™
Participants With Mumps-Like Symptoms After Second Vaccination—0
PrimaryParticipants With Rubella-Like Rash After First Vaccination
Time frame:
Days 1 to 28 After First Vaccination
Reported as:
Number · participants
Participants With Rubella-Like Rash After First Vaccination
participantsArm 1: VAQTA™Arm 2: VAQTA™ +ProQuad™
Participants With Rubella-Like Rash After First Vaccination—1
PrimaryParticipants With Rubella-Like Rash After Second Vaccination
Time frame:
Days 1 to 28 After Second Vaccination
Reported as:
Number · participants
Participants With Rubella-Like Rash After Second Vaccination
participantsArm 1: VAQTA™Arm 2: VAQTA™ +ProQuad™
Participants With Rubella-Like Rash After Second Vaccination—0
PrimaryParticipants With Varicella/Zoster-Like Rash After First Vaccination
Time frame:
Days 1 to 28 After First Vaccination
Reported as:
Number · participants
Participants With Varicella/Zoster-Like Rash After First Vaccination
participantsArm 1: VAQTA™Arm 2: VAQTA™ +ProQuad™
Participants With Varicella/Zoster-Like Rash After First Vaccination—0
PrimaryParticipants With Varicella/Zoster-Like Rash After Second Vaccination
Time frame:
Days 1 to 28 After Second Vaccination
Reported as:
Number · participants
Participants With Varicella/Zoster-Like Rash After Second Vaccination
participantsArm 1: VAQTA™Arm 2: VAQTA™ +ProQuad™
Participants With Varicella/Zoster-Like Rash After Second Vaccination—0
PrimaryParticipants With Elevated Temperature (>=102.2F/39.0C)
Time frame:
Days 1 to 5 After Any Vaccination
Reported as:
Number · participants
Participants With Elevated Temperature (>=102.2F/39.0C)
participantsArm 1: VAQTA™Arm 2: VAQTA™ +ProQuad™
Participants With Elevated Temperature (>=102.2F/39.0C)5613

Baseline characteristics

Age, Continuous
Age, Continuous(months)Arm 1: VAQTA™Arm 2: VAQTA™ +ProQuad™Total
Mean13.3 ± 1.4912.5 ± 0.9013.2 ± 1.43
Sex: Female, Male
Sex: Female, Male(Participants)Arm 1: VAQTA™Arm 2: VAQTA™ +ProQuad™Total
Female703176879
Male750171921
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Petrecz M, Acosta CJ, Klopfer SO, Kuter BJ, Goveia MG, Stek JE, Schodel FP, Lee AW. Safety and immunogenicity of VAQTA(R) in children 12-to-23 months of age with and without administration of other US pediatric vaccines. Hum Vaccin Immunother. 2019;15(2):426-432. doi: 10.1080/21645515.2018.1530934. Epub 2018 Nov 15. PubMed 30431383 ↗

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Data sharing details ↗ · engagezone.msd.com

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00326183
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
May 16, 2006
Start date
Mar 26, 2007
Primary completion
Jan 15, 2008
Completion
Jan 15, 2008
Results posted
Nov 20, 2008
Last update
Feb 4, 2019

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Measles, mumps, rubella, varicella vaccine

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