Hepatitis APhase 4NCT00326183

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

A Phase 4 study testing VAQTA® and ProQuad in people with Hepatitis A and Measles, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 12 to 17 monthsHealthy volunteers can take part
Conditions the study is for: Hepatitis A, Measles, Mumps
What is being tested?: VAQTA® and ProQuad
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,800 participants
Where: No sites listed yet
Study dates: 26 Mar 2007to 15 Jan 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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)

Who cannot join

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.

About this study

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

Conditions: Hepatitis A, Measles, Mumps, Rubella, Chickenpox
Being tested: VAQTA®, ProQuad
Medical subject headings: Hepatitis A, Measles, Mumps, Rubella, Chickenpox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VAQTA®Biological
Also called V251
0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.
ProQuadBiological
0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.

Study groups in NCT00326183
Study group	Role	What they receive
1	Active comparator	Arm 1: vaccine Receives: Biological: VAQTA®
2	Active comparator	Arm 2: Active comparator Receives: Biological: VAQTA®; Biological: ProQuad

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

Participants With 1 or More Systemic Adverse Experiences
Measured: Days 1 to 14 After Any Vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 200715 Jan 2008

First posted16 May 2006 (estimated)
Study start26 Mar 2007
Primary completion15 Jan 2008
Study completion15 Jan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis AStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,800 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00326183
Sponsor's protocol ID: V251-066
Other IDs: 2006_023
Status last verified: Jan 2019
First submitted: 12 May 2006
Last updated: 4 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users

All Hepatitis A trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open, Multicenter Study of the Safety and Tolerability of VAQTA(TM) and ProQuad(TM) in Healthy Children 12 to 23 Months of Age
ClinicalTrials.gov ID: NCT00326183
Acronym / sponsor ID: V251-066
Conditions: Hepatitis A, Measles, Mumps, Rubella, Chickenpox
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,800 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 26 Mar 2007 (actual)
Primary completion: 15 Jan 2008 (actual)
Study completion: 15 Jan 2008 (actual)
First posted: 16 May 2006 (estimated)
Results: Posted 20 Nov 2008

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Biological: VAQTA®Arm 1: vaccine
2	Active comparator	Biological: VAQTA®, Biological: ProQuadArm 2: Active comparator

Who may qualify

Ages: 12 to 17 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

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)

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VAQTA®Also: V2510.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.	Biological	1, 2
ProQuad0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.	Biological	2

Primary outcome

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

1 secondary outcome

Participants With 1 or More Systemic Adverse Experiences
Time frame: Days 1 to 14 After Any Vaccination

Results and safety

Results posted to the registry on 20 Nov 2008, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: VAQTA™	1,453	1,253
Arm 2: VAQTA™ +ProQuad™	347	264

Primary outcome: Participants With 1 or More Serious Vaccine-Related Adverse Experiences

Time frame: Days 1 to 14 after any vaccination. Number. Unit: participants

Measure	Arm 1: VAQTA™ n = 1415	Arm 2: VAQTA™ +ProQuad™ n = 334
Value	0	1

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

Primary outcome: Participants With 1 or More Injection-Site Adverse Experiences

Time frame: Days 1 to 14 after any vaccination. Number. Unit: participants

Measure	Arm 1: VAQTA™ n = 1415	Arm 2: VAQTA™ +ProQuad™ n = 334
Value	701	164

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

Primary outcome: Participants With Measles-Like Rash After First Vaccination

Time frame: Days 1 to 28 After First Vaccination. Number. Unit: participants

Measure	Arm 1: VAQTA™ n = 0	Arm 2: VAQTA™ +ProQuad™ n = 328
Value	–	13

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

Primary outcome: Participants With Measles-Like Rash After Second Vaccination

Time frame: Days 1 to 28 After Second Vaccination. Number. Unit: participants

Measure	Arm 1: VAQTA™ n = 0	Arm 2: VAQTA™ +ProQuad™ n = 263
Value	–	5

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

1 secondary outcome is reported in the full results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30431383Petrecz 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.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Related trials for Hepatitis A

RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing VAQTA® and ProQuad in people with Hepatitis A and Measles, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2008). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With 1 or More Serious Vaccine-Related Adverse Experiences (time frame: Days 1 to 14 after any vaccination). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00326183, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.