MeaslesPhase 3NCT00566527
Comparative Study of Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA (V221-038)
A Phase 3 study testing ProQuad® manufactured with recombinant Human Albumin (rHA) in people with Measles and Mumps, run by Merck Sharp & Dohme LLC.
Trial summary
The primary study objectives are: To demonstrate that a 2-dose regimen of ProQuad® manufactured with recombinant Human Albumin (rHA) administered at a 3-month interval to healthy children of 11 months of age at the time of Dose 1 is as immunogenic as in healthy children of 12 months of age at the time of Dose 1. Read more about this study
- Who is it for?
- Ages 9 months and olderHealthy volunteers can take part
- What is being tested?
- ProQuad® manufactured with recombinant Human Albumin (rHA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,620 participants
- Where
- No sites listed yet
- Study dates
- 29 Nov 2007to 29 Dec 2008
- Phase
- Phase 3
- 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 9 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy subject of either gender of 9 months of age
- Negative clinical history of measles, mumps, rubella, varicella or zoster
- Informed consent form signed by both parents or legal representative
- Parent(s) or legal representative able to attend all the scheduled visits with the subject and to understand and comply with the study procedures
- Both parent or legal representative are over 18 years of age
- Subject is affiliated to a health social security system
Who cannot join
- Febrile illness in the previous 3 days
- Prior vaccination with a measles, mumps, rubella and/or varicella vaccine either alone or in any combination
- Exposure to measles, mumps, rubella, varicella and/or zoster in the previous 30 days
- Tuberculin test done in the previous 2 days
- Severe chronic disease
- Known active tuberculosis
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- Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition
- Hereditary problems of fructose intolerance
- Prior known sensitivity or allergy to any component of the vaccine
- Known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
- Humoral or cellular immunodeficiency,
- Immunosuppressive therapy [including systemic corticosteroids (a), given daily or on alternate days at high doses (>=2 mg/kg/day prednisone equivalent or >=20 mg/day if the subject's weight was >10 kg) during at least 14 days in the previous 30 days]
- Family history of congenital or hereditary immunodeficiency
- Receipt of immunoglobulins or blood-derived products in the previous 150 days or scheduled to be administered through Visit 5
- Receipt of an inactivated vaccine in the previous 14 days
- Receipt of a live non-study vaccine in the previous 28 days
- Any medical condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives
- Current participation or scheduled participation in any other clinical study through Visit 5
About this study
Official title: An Open-label, Randomised, Comparative, Multi-centre Study of the Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA Administered to Healthy Children From 9 Months of Age
The primary study objectives are:
- To demonstrate that a 2-dose regimen of ProQuad® manufactured with recombinant Human Albumin (rHA) administered at a 3-month interval to healthy children of 11 months of age at the time of Dose 1 is as immunogenic as in healthy children of 12 months of age at the time of Dose 1.
- To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval to healthy children of 9 months of age at the time of Dose 1 is as immunogenic as in healthy children of 12 months of age at the time of Dose 1.
- To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval to healthy children of 11 months of age and 9 months of age at the time of Dose 1 is well-tolerated compared to children of 12 months of age at the time of Dose 1.
Read more
The first primary hypothesis was that a 2-dose regimen of ProQuad® rHA, administered at a 3-month interval to children of 11 months of age, would be non-inferior in terms of antibody response rates to measles, mumps, rubella, and varicella at Day 42 following Dose 2, to the same regimen in children of 12 months of age at the time of Dose 1.
If the first primary hypothesis was demonstrated, the second primary hypothesis was that a 2-dose regimen of ProQuad® rHA, administered at a 3-month interval to children of 9 months of age, would be non-inferior in terms of antibody response rates to measles, mumps, rubella, and varicella at Day 42 following Dose 2, to the same regimen in children of 12 months of age at the time of Dose 1.
The secondary study objectives are:
- To describe the antibody titres to measles, mumps, rubella and varicella at Day 42 following Dose 1 and Dose 2 of ProQuad® rHA administered to healthy children from 9 months of age.
- To evaluate the safety profile of Dose 1 and Dose 2 of ProQuad® rHA administered to healthy children from 9 months of age.
- Being tested
- ProQuad® manufactured with recombinant Human Albumin (rHA)
- Medical subject headings
- Measles, Mumps, Rubella, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProQuad® manufactured with recombinant Human Albumin (rHA)Biological
A 2-dose regimen of ProQuad® (0.5 mL per dose) given via subcutaneous injection into the deltoid muscle at a 3-month interval. Each dose contains measles virus Enders' Edmonston strain (live attenuated), mumps virus Jeryl Lynn™ (Level B) strain (live attenuated), rubella virus Wistar RA 27 or 3 strain (live attenuated), and varicella virus Oka or Merck strain (live attenuated).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: ProQuad® at 9 and 12 months | Experimental | Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 at 12 months of age. Receives: Biological: ProQuad® manufactured with recombinant Human Albumin (rHA) |
| Arm 2: ProQuad® at 11 and 14 months | Experimental | Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 at 14 months of age. Receives: Biological: ProQuad® manufactured with recombinant Human Albumin (rHA) |
| Arm 3: ProQuad at 12 and 15 months | Active comparator | Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 at 15 months of age. Receives: Biological: ProQuad® manufactured with recombinant Human Albumin (rHA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants in Arm 2 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2
Immunogenicity response rates were compared in participants with baseline seronegativity from Arm 2 (received ProQuad® Dose 1 at 11 months) and Arm 3 (received ProQuad® Dose 1 at 12 months). Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA). Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.
Measured: Day 132 (6 weeks after ProQuad® Dose 2)
Percentage of Participants in Arm 1 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2
Immunogenicity response rates were compared in participants with baseline seronegativity from Arm 1 (received ProQuad® Dose 1 at 9 months) and Arm 3 (received ProQuad® Dose 1 at 12 months). Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.
Measured: Day 132 (6 weeks after ProQuad® Dose 2)
Percentage of Participants With Solicited Injection-site Adverse Reactions
The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1.
Measured: Day 1 to Day 4 (up to 4 days after ProQuad® Dose 1)
Percentage of Participants Experiencing Unsolicited Injection-site Adverse Reactions
The percentage of participants with unsolicited injection-site reactions after ProQuad® Dose 1 was determined.
Measured: Up to Day 28 (up to 28 days after ProQuad® Dose 1)
Percentage of Participants Experiencing a Systemic Adverse Event After ProQuad® Dose 1
The percentage of participants with systemic adverse events after ProQuad® Dose 1 was determined.
Measured: Up to Day 28 (up to 28 days after ProQuad® Dose 1)
Percentage of Participants With Rectal (or Rectal Equivalent) Temperature ≥ 39.4°C
The percentage of participants with a rectal (or rectal equivalent) temperature ≥ 39.4°C after ProQuad® Dose 1 was determined.
Measured: Up to Day 28 (up to 28 days after ProQuad® Dose 1)
Secondary outcomes (6)
Geometric Mean Titres (GMT) to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 1
Antibody titres (GMT) to measles, mumps, rubella, and varicella were determined after the first ProQuad® dose in participants with seronegative baseline values. Baseline seronegativity criteria were as follows: measles antibody titre <255 mIU/mL; mumps antibody titre <10 ELISA Ab units mL; rubella antibody titre <10 IU/mL; and varicella antibody titre <1.25 gpELISA units/mL.
Measured: Day 42 (6 weeks after ProQuad® Dose 1)
GMT to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 2
Antibody titres (GMT) to measles, mumps, rubella, and varicella were determined after the second ProQuad® dose in participants with seronegative baseline values. Baseline seronegativity criteria were as follows: measles antibody titre <255 mIU/mL; mumps antibody titre <10 ELISA Ab units mL; rubella antibody titre <10 IU/mL; and varicella antibody titre <1.25 gpELISA units/mL.
Measured: Day 132 (6 weeks after ProQuad® Dose 2)
Percentage of Participants With Varicella Antibody Titre ≥ 1.25 gpELISA Units/mL
The percentage of participants with varicella antibody titre ≥ 1.25 gpELISA units/mL 6 weeks after each ProQuad® dose was determined.
Measured: Day 132 (6 weeks after ProQuad® Dose 2)
Percentage of Baseline Seronegative Participants Meeting Antibody Immunogenicity Response Criteria After ProQuad® Dose 1
The percentage of baseline seronegative participants meeting measles, mumps, rubella, and varicella antibody response criteria after the first ProQuad® dose was determined. Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.
Measured: Day 42 (6 weeks after ProQuad® Dose 1)
Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 1
The percentage of participants with rashes of interest after ProQuad® Dose 1 was determined. Rashes of interest consisted of measles-like rash, rubella-like rash, varicella-like rash, zoster-like rash, and mumps-like rash.
Measured: Up to Day 28 (up to 4 weeks after ProQuad® Dose 1)
Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 2
The percentage of participants with rashes of interest after receiving ProQuad® Dose 2 was determined. Rashes of interest consisted of measles-like rash, rubella-like rash, varicella-like rash, zoster-like rash, and mumps-like rash.
Measured: Day 132 (6 weeks after ProQuad® Dose 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2007 (estimated)
- Study start29 Nov 2007
- Primary completion29 Dec 2008
- Study completion29 Dec 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 MeaslesStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, SPMSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566527
- Sponsor's protocol ID
- V221-038
- Other IDs
- MRV02C
- Status last verified
- Jan 2018
- First submitted
- 29 Nov 2007
- Last updated
- 30 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Vesikari T, Becker T, Gajdos V, Fiquet A, Thomas S, Richard P, Baudin M. Immunogenicity and safety of a two-dose regimen of a combined measles, mumps, rubella and varicella live vaccine (ProQuad((R))) in infants from 9 months of age. Vaccine. 2012 Apr 26;30(20):3082-9. doi: 10.1016/j.vaccine.2012.02.062. Epub 2012 Mar 7.
PubMed 22406278
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomised, Comparative, Multi-centre Study of the Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA Administered to Healthy Children From 9 Months of Age
- ClinicalTrials.gov ID
- NCT00566527
- Acronym / sponsor ID
- V221-038
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,620 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2007 (actual)
- Primary completion
- 29 Dec 2008 (actual)
- Study completion
- 29 Dec 2008 (actual)
- First posted
- 3 Dec 2007 (estimated)
- Results
- Posted 30 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary study objectives are:
- To demonstrate that a 2-dose regimen of ProQuad® manufactured with recombinant Human Albumin (rHA) administered at a 3-month interval to healthy children of 11 months of age at the time of Dose 1 is as immunogenic as in healthy children of 12 months of age at the time of Dose 1.
- To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval to healthy children of 9 months of age at the time of Dose 1 is as immunogenic as in healthy children of 12 months of age at the time of Dose 1.
- To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval to healthy children of 11 months of age and 9 months of age at the time of Dose 1 is well-tolerated compared to children of 12 months of age at the time of Dose 1.
The first primary hypothesis was that a 2-dose regimen of ProQuad® rHA, administered at a 3-month interval to children of 11 months of age, would be non-inferior in terms of antibody response rates to measles, mumps, rubella, and varicella at Day 42 following Dose 2, to the same regimen in children of 12 months of age at the time of Dose 1.
If the first primary hypothesis was demonstrated, the second primary hypothesis was that a 2-dose regimen of ProQuad® rHA, administered at a 3-month interval to children of 9 months of age, would be non-inferior in terms of antibody response rates to measles, mumps, rubella, and varicella at Day 42 following Dose 2, to the same regimen in children of 12 months of age at the time of Dose 1.
The secondary study objectives are:
- To describe the antibody titres to measles, mumps, rubella and varicella at Day 42 following Dose 1 and Dose 2 of ProQuad® rHA administered to healthy children from 9 months of age.
- To evaluate the safety profile of Dose 1 and Dose 2 of ProQuad® rHA administered to healthy children from 9 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: ProQuad® at 9 and 12 months | Experimental | Biological: ProQuad® manufactured with recombinant Human Albumin (rHA)Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 at 12 months of age. |
| Arm 2: ProQuad® at 11 and 14 months | Experimental | Biological: ProQuad® manufactured with recombinant Human Albumin (rHA)Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 at 14 months of age. |
| Arm 3: ProQuad at 12 and 15 months | Active comparator | Biological: ProQuad® manufactured with recombinant Human Albumin (rHA)Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 at 15 months of age. |
Who may qualify
- Ages
- 9 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy subject of either gender of 9 months of age
- Negative clinical history of measles, mumps, rubella, varicella or zoster
- Informed consent form signed by both parents or legal representative
- Parent(s) or legal representative able to attend all the scheduled visits with the subject and to understand and comply with the study procedures
- Both parent or legal representative are over 18 years of age
Key exclusion criteria (18 listed)
- Febrile illness in the previous 3 days
- Prior vaccination with a measles, mumps, rubella and/or varicella vaccine either alone or in any combination
- Exposure to measles, mumps, rubella, varicella and/or zoster in the previous 30 days
- Tuberculin test done in the previous 2 days
- Severe chronic disease
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 |
|---|---|---|
| ProQuad® manufactured with recombinant Human Albumin (rHA)A 2-dose regimen of ProQuad® (0.5 mL per dose) given via subcutaneous injection into the deltoid muscle at a 3-month interval. Each dose contains measles virus Enders' Edmonston strain (live attenuated), mumps virus Jeryl Lynn™ (Level B) strain (live attenuated), rubella virus Wistar RA 27 or 3 strain (live attenuated), and varicella virus Oka or Merck strain (live attenuated). | Biological | Arm 1: ProQuad® at 9 and 12 months, Arm 2: ProQuad® at 11 and 14 months, Arm 3: ProQuad at 12 and 15 months |
Primary outcome
Percentage of Participants in Arm 2 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2
Time frame: Day 132 (6 weeks after ProQuad® Dose 2)
Immunogenicity response rates were compared in participants with baseline seronegativity from Arm 2 (received ProQuad® Dose 1 at 11 months) and Arm 3 (received ProQuad® Dose 1 at 12 months). Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA). Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.
Percentage of Participants in Arm 1 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2
Time frame: Day 132 (6 weeks after ProQuad® Dose 2)
Immunogenicity response rates were compared in participants with baseline seronegativity from Arm 1 (received ProQuad® Dose 1 at 9 months) and Arm 3 (received ProQuad® Dose 1 at 12 months). Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.
Percentage of Participants With Solicited Injection-site Adverse Reactions
Time frame: Day 1 to Day 4 (up to 4 days after ProQuad® Dose 1)
The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1.
Percentage of Participants Experiencing Unsolicited Injection-site Adverse Reactions
Time frame: Up to Day 28 (up to 28 days after ProQuad® Dose 1)
The percentage of participants with unsolicited injection-site reactions after ProQuad® Dose 1 was determined.
Percentage of Participants Experiencing a Systemic Adverse Event After ProQuad® Dose 1
Time frame: Up to Day 28 (up to 28 days after ProQuad® Dose 1)
The percentage of participants with systemic adverse events after ProQuad® Dose 1 was determined.
Percentage of Participants With Rectal (or Rectal Equivalent) Temperature ≥ 39.4°C
Time frame: Up to Day 28 (up to 28 days after ProQuad® Dose 1)
The percentage of participants with a rectal (or rectal equivalent) temperature ≥ 39.4°C after ProQuad® Dose 1 was determined.
6 secondary outcomes
Geometric Mean Titres (GMT) to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 1
Time frame: Day 42 (6 weeks after ProQuad® Dose 1)
GMT to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 2
Time frame: Day 132 (6 weeks after ProQuad® Dose 2)
Percentage of Participants With Varicella Antibody Titre ≥ 1.25 gpELISA Units/mL
Time frame: Day 132 (6 weeks after ProQuad® Dose 2)
Percentage of Baseline Seronegative Participants Meeting Antibody Immunogenicity Response Criteria After ProQuad® Dose 1
Time frame: Day 42 (6 weeks after ProQuad® Dose 1)
Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 1
Time frame: Up to Day 28 (up to 4 weeks after ProQuad® Dose 1)
Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 2
Time frame: Day 132 (6 weeks after ProQuad® Dose 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22406278Vesikari T, Becker T, Gajdos V, Fiquet A, Thomas S, Richard P, Baudin M. Immunogenicity and safety of a two-dose regimen of a combined measles, mumps, rubella and varicella live vaccine (ProQuad((R))) in infants from 9 months of age. Vaccine. 2012 Apr 26;30(20):3082-9. doi: 10.1016/j.vaccine.2012.02.062. Epub 2012 Mar 7.
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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 Director study director
SPMSD
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ProQuad® manufactured with recombinant Human Albumin (rHA) in people with Measles and Mumps, 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 6 inclusion and 18 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 30 Jan 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 30 Jan 2018). 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?
Percentage of Participants in Arm 2 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2 (time frame: Day 132 (6 weeks after ProQuad® Dose 2)). The study lists 6 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 NCT00566527, 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 30 Jan 2018.