MeaslesPhase 3NCT00109343

V221 Concomitant Use Study With Pneumococcal Conjugate Vaccine (V221-019)

A Phase 3 study testing Comparator: ProQuad™ (V221) and Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine) in people with Measles and Mumps, run by Merck Sharp & Dohme LLC.

Completed

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

Official record

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Trial summary

The study is being conducted to demonstrate that V221 may be administered concomitantly with pneumococcal conjugate vaccine without impairing the safety or immunogenicity of measles, mumps, rubella, varicella, or the 7 serotypes of S. pneumoniae. Read more about this study

Who is it for?: Ages 12 to 15 monthsHealthy volunteers can take part
Conditions the study is for: Measles, Mumps, Rubella
What is being tested?: Comparator: ProQuad™ (V221) and Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,027 participants
Where: No sites listed yet
Study dates: Mar 2006to Sep 2007
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 12 to 15 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

In good health
12 to 15 months of age
Negative clinical history to measles, mumps, rubella, varicella and/or zoster
Received only the 3-dose primary series of a pneumococcal conjugate vaccine with at least 2 months prior to the receipt of any of the study vaccines
Signed consent

Who cannot join

Previous administration of any measles, mumps, rubella, or varicella vaccine either alone or in any combination
Any condition resulting in depressed immunity
Any allergy to any vaccine component as stated in the package circulars
Exposure to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination
History of seizure disorder
Receipt of an inactivated vaccine within 14 days prior to enrollment or live vaccine within 30 days
Recent febrile illness

About this study

Official title: An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of V221 Given Concomitantly With Pneumococcal Conjugate Vaccine in Healthy Children 12 to 15 Months of Age

Conditions: Measles, Mumps, Rubella, Varicella
Being tested: Comparator: ProQuad™ (V221), Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)
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.

Comparator: ProQuad™ (V221)Biological
Also called ProQuad™, V221
0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)
Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)Biological
Also called PREVNAR™
0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine

Study groups in NCT00109343
Study group	Role	What they receive
1	Experimental	Group 1: ProQuad™ (V221) + PREVNAR™ (pneumococcal 7-valent conjugate vaccine) followed by ProQuad™ (Day 91) Receives: Biological: Comparator: ProQuad™ (V221); Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)
2	Experimental	Group 2: PREVNAR™ followed by ProQuad™ (Day 43) followed by ProQuad™ (Day 133) Receives: Biological: Comparator: ProQuad™ (V221); Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)
3	Experimental	Group 3: ProQuad™ followed by PREVNAR™ (Day 43), followed by ProQuad™ (Day 91) Receives: Biological: Comparator: ProQuad™ (V221); Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)

What is being measured

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

Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL
Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <255 mIU/mL) to Measles at Baseline.
Measured: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL
Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 ELISA Ab units/mL) to Mumps at Baseline.
Measured: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline.
Measured: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline
Measured: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4
Measured: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B
Measured: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone.
Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V
Measured: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14
Measured: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C
Measured: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F
Measured: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F
Measured: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

Timeline

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

Mar 2006Sep 2007

First posted27 Apr 2005 (estimated)
Study startMar 2006
Primary completionSep 2007
Study completionSep 2007

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: 1,027 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00109343
Sponsor's protocol ID: V221-019
Other IDs: 2005_027
Status last verified: Mar 2017
First submitted: 27 Apr 2005
Last updated: 12 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Leonardi M, Bromberg K, Baxter R, Gardner JL, Klopfer S, Nicholson O, Brockley M, Trammel J, Leamy V, Williams W, Kuter B, Schodel F. Immunogenicity and safety of MMRV and PCV-7 administered concomitantly in healthy children. Pediatrics. 2011 Dec;128(6):e1387-94. doi: 10.1542/peds.2010-2132. Epub 2011 Nov 28.
PubMed 22123890

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

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Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of V221 Given Concomitantly With Pneumococcal Conjugate Vaccine in Healthy Children 12 to 15 Months of Age
ClinicalTrials.gov ID: NCT00109343
Acronym / sponsor ID: V221-019
Conditions: Measles, Mumps, Rubella, Varicella
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,027 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Mar 2006
Primary completion: Sep 2007 (actual)
Study completion: Sep 2007 (actual)
First posted: 27 Apr 2005 (estimated)
Results: Posted 10 Feb 2010

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: 3

Arm	Type	Receives
1	Experimental	Biological: Comparator: ProQuad™ (V221), Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)Group 1: ProQuad™ (V221) + PREVNAR™ (pneumococcal 7-valent conjugate vaccine) followed by ProQuad™ (Day 91)
2	Experimental	Biological: Comparator: ProQuad™ (V221), Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)Group 2: PREVNAR™ followed by ProQuad™ (Day 43) followed by ProQuad™ (Day 133)
3	Experimental	Biological: Comparator: ProQuad™ (V221), Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)Group 3: ProQuad™ followed by PREVNAR™ (Day 43), followed by ProQuad™ (Day 91)

Who may qualify

Ages: 12 to 15 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

In good health
12 to 15 months of age
Negative clinical history to measles, mumps, rubella, varicella and/or zoster
Received only the 3-dose primary series of a pneumococcal conjugate vaccine with at least 2 months prior to the receipt of any of the study vaccines
Signed consent

Key exclusion criteria (7 listed)

Previous administration of any measles, mumps, rubella, or varicella vaccine either alone or in any combination
Any condition resulting in depressed immunity
Any allergy to any vaccine component as stated in the package circulars
Exposure to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination
History of seizure disorder

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
Comparator: ProQuad™ (V221)Also: ProQuad™, V2210.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)	Biological	1, 2, 3
Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)Also: PREVNAR™0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine	Biological	1, 2, 3

Primary outcome

Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL
Time frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <255 mIU/mL) to Measles at Baseline.
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL
Time frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 ELISA Ab units/mL) to Mumps at Baseline.
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
Time frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline.
Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL
Time frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline
Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer
Time frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4
Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer
Time frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone.
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B
Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer
Time frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V
Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer
Time frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14
Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer
Time frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C
Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer
Time frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F
Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer
Time frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F

Results and safety

Results posted to the registry on 10 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 - ProQuad™ + PREVNAR™	510	446
Group 2 - PREVNAR™ Followed by ProQuad™	258	221
Group 3 - ProQuad™ Followed by PREVNAR™	259	229

Primary outcome: Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL

Time frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone. Number. Unit: Participants

Measure	Group 1 - ProQuad™ + PREVNAR™ n = 406	Group 3 - ProQuad™ Followed by PREVNAR™ n = 204
Value	395	203

Population analysed: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.

Primary outcome: Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL

Time frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone. Number. Unit: Participants

Measure	Group 1 - ProQuad™ + PREVNAR™ n = 403	Group 3 - ProQuad™ Followed by PREVNAR™ n = 208
Value	390	205

Population analysed: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.

Primary outcome: Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL

Time frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone. Number. Unit: Participants

Measure	Group 1 - ProQuad™ + PREVNAR™ n = 377	Group 3 - ProQuad™ Followed by PREVNAR™ n = 195
Value	372	191

Population analysed: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.

Primary outcome: Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL

Time frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone. Number. Unit: Participants

Measure	Group 1 - ProQuad™ + PREVNAR™ n = 379	Group 3 - ProQuad™ Followed by PREVNAR™ n = 192
Number of Participants ≥1.25 gpELISA units/mL	374	187
Number of Participants ≥5 gpELISA units/mL	350	169

Population analysed: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer \<1.25 gpELISA units/mL at baseline, and followed protocol procedures.

Adverse events

Time frame: 28 days post-dose. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ProQuad™ + Prevnar™ (After Dose 1)	4 of 498 (0.8%)	367 of 498 (73.7%)	Not reported
ProQuad™ Alone (After Dose 1)	3 of 495 (0.6%)	311 of 495 (62.8%)	Not reported
ProQuad™ (After Dose 2)	0 of 910 (0%)	499 of 910 (54.8%)	Not reported

Limitations and caveats (from the sponsor): One subject (Group 3-ProQuad™ followed by PREVNAR™) was diagnosed (Day 8) with Stage IV neuroblastoma (considered not related to study vaccine by investigator) and discontinued from the study. Subject died (Day 218) due to neuroblastoma.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22123890Leonardi M, Bromberg K, Baxter R, Gardner JL, Klopfer S, Nicholson O, Brockley M, Trammel J, Leamy V, Williams W, Kuter B, Schodel F. Immunogenicity and safety of MMRV and PCV-7 administered concomitantly in healthy children. Pediatrics. 2011 Dec;128(6):e1387-94. doi: 10.1542/peds.2010-2132. Epub 2011 Nov 28.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

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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 Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Comparator: ProQuad™ (V221) and Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine) 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 5 inclusion and 7 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 12 Apr 2017. 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 10 Feb 2010). 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?

Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL (time frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone). 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 NCT00109343, 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 12 Apr 2017.