MeaslesPhase 3NCT00984295

Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines

A Phase 3 study testing Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, Comparator: Tripedia and Comparator: Comvax 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

Search all trials

Trial summary

This study will assess the safety and immunogenicity of ProQuad when administered concomitantly and nonconcomitantly with Tripedia and Comvax. 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?: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, Comparator: Tripedia and Comparator: Comvax
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,913 participants
Where: No sites listed yet
Study dates: Jun 2000to Dec 2001
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
Negative clinical history of varicella, zoster, measles, mumps, rubella, diptheria, tetanus, pertussis, invasive Hib disease and hepatitis B
Had completed either a 2-dose primary series of PedvaxHIB or COMVAX or any 3-dose primary series of a licensed Hib vaccine
Had received 2 or 3 doses of any hepatitis B vaccine or COMVAX prior to entry into trial

Who cannot join

Previous receipt of measles, mumps, rubella or varicella vaccine either alone or in combination
Any immune impairment or deficiency
Recent household, daycare or school exposure to invasive Hib disease or hepatitis B
Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
Vaccination with an inactive vaccine with in the past 14 days
Vaccination with a live vaccine within the past 30 days
Receipt of immune globulin, blood transfusion or blood-derived product in the past 3 months
Recent history of fever or underlying medical problems

About this study

Official title: An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of Frozen MMRV Given Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines in Healthy Children 12 to 15 Months of Age

This study will assess the safety and immunogenicity of ProQuad when administered concomitantly and nonconcomitantly with Tripedia and Comvax.

Conditions: Measles, Mumps, Rubella, Varicella
Being tested: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, Comparator: Tripedia, Comparator: Comvax, Comparator: Varivax, Comparator: M-M-R II
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.

Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine LiveBiological
Also called ProQuad
A single 0.5 mL subcutaneous injection at Day 0
Comparator: TripediaBiological
A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
Comparator: ComvaxBiological
A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
Comparator: VarivaxBiological
A single 0.5 mL subcutaneous injection at Day 0
Comparator: M-M-R IIBiological
A single 0.5 mL subcutaneous injection at Day 0

Study groups in NCT00984295
Study group	Role	What they receive
1	Experimental	ProQuad + Tripedia + Comvax at Day 0 (Concomitant) Receives: Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live; Biological: Comparator: Tripedia; Biological: Comparator: Comvax
2	Experimental	ProQuad at Day 0, Tripedia + Comvax at Day 42(Nonconcomitant) Receives: Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live; Biological: Comparator: Tripedia; Biological: Comparator: Comvax
3	Active comparator	Varivax + M-M-R II at Day 0, Tripedia + Comvax at Day 42 (Control) Receives: Biological: Comparator: Tripedia; Biological: Comparator: Comvax; Biological: Comparator: Varivax; Biological: Comparator: M-M-R II

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 ≥120 mIU/mL
Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <120 mIU/mL) to Measles at Baseline
Measured: 6 Weeks Postvaccination
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL
Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <10 Ab units/mL) to Mumps at Baseline
Measured: 6 weeks Postvaccination
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline
Measured: 6 weeks Postvaccination
Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL
Antibody Response to Varicella-Zoster Virus (VZV) at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <0.6 gpELISA units/mL) to VZV at Baseline
Measured: 6 weeks Postvaccination
Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL
Antibody response to Diphtheria at 6 weeks postvaccination
Measured: 6 weeks Postvaccination
Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL
Antibody response to Tetanus (tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA)) at 6 weeks postvaccination.
Measured: 6 weeks Postvaccination
Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer
Antibody response to Pertussis Toxin (titers of pertussis toxin antibodies were measured with an indirect, noncompetitive EIA).
Measured: 6 weeks Postvaccination
Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer
Antibody response to pertussis FHA(titers of pertussis filamentous hemagglutinin antibodies were measured with an indirect, noncompetitive EIA).
Measured: 6 weeks Postvaccination
Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL
Antibody response to Hepatitis B (titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA)).
Measured: 6 weeks Postvaccination
Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL
Antibody response to Haemophilus influenzae type B (Hib). (Anti-polyribosylribitol phosphate (PRP) was measured by radioimmunoassay (RIA) using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)
Measured: 6 weeks Postvaccination
Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)
Postvaccination Observed Geometric Mean Titer of Antibody to Measles. (Titers measured using Measles ELISA.)
Measured: 6 weeks Postvaccination
Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT
Postvaccination observed GMT of antibody to mumps. (Titers measured using mumps ELISA.)
Measured: 6 weeks Postvaccination
Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT
Postvaccination Observed Geometric Mean Titer of Antibody to Rubella. (Titers measured using Rubella ELISA.)
Measured: 6 weeks Postvaccination
Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT
Postvaccination Observed Geometric Mean Titer of Antibody to Varicella. (Titers measured using VZV gpELISA.)
Measured: 6 weeks Postvaccination
Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT
Postvaccination Observed Geometric Mean Titer of Antibody to Diphtheria. (Titers measured using Vero Cell Culture Assay.)
Measured: 6 weeks Postvaccination
Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT
Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Toxin (PT). Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).
Measured: 6 weeks Postvaccination
Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT
Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Filamentous Hemagglutinin (FHA). (Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).)
Measured: 6 weeks Postvaccination
Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT
Postvaccination Observed Geometric Mean Titer of Antibody to Hepatitis B. (Titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA).)
Measured: 6 weeks Postvaccination
Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT
Postvaccination observed GMT of antibody to Hib. (Anti-polyribosylribitol phosphate (PRP) was measured by RIA using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)
Measured: 6 weeks Postvaccination
Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT
Postvaccination Observed Geometric Mean Titer of Antibody to Tetanus. (Titers of tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA).)
Measured: 6 weeks Postvaccination

Timeline

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

Jun 2000Dec 2001

First posted25 Sep 2009 (estimated)
Study startJun 2000
Primary completionOct 2001
Study completionDec 2001

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: 1,913 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00984295
Sponsor's protocol ID: V221-013
Other IDs: 2009_666
Status last verified: Jul 2015
First submitted: 23 Sep 2009
Last updated: 7 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Shinefield H, Black S, Thear M, Coury D, Reisinger K, Rothstein E, Xu J, Hartzel J, Evans B, Digilio L, Schodel F, Brown ML, Kuter B; 013 Study Group for ProQuad. Safety and immunogenicity of a measles, mumps, rubella and varicella vaccine given with combined Haemophilus influenzae type b conjugate/hepatitis B vaccines and combined diphtheria-tetanus-acellular pertussis vaccines. Pediatr Infect Dis J. 2006 Apr;25(4):287-92. doi: 10.1097/01.inf.0000207857.10947.1f.
PubMed 16567978

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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All Measles trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2015. 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 Frozen MMRV Given Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines in Healthy Children 12 to 15 Months of Age
ClinicalTrials.gov ID: NCT00984295
Acronym / sponsor ID: V221-013
Conditions: Measles, Mumps, Rubella, Varicella
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,913 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jun 2000
Primary completion: Oct 2001 (actual)
Study completion: Dec 2001 (actual)
First posted: 25 Sep 2009 (estimated)
Results: Posted 25 Feb 2010

Clinical summary

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

This study will assess the safety and immunogenicity of ProQuad when administered concomitantly and nonconcomitantly with Tripedia and Comvax.

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: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, Biological: Comparator: Tripedia, Biological: Comparator: ComvaxProQuad + Tripedia + Comvax at Day 0 (Concomitant)
2	Experimental	Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, Biological: Comparator: Tripedia, Biological: Comparator: ComvaxProQuad at Day 0, Tripedia + Comvax at Day 42(Nonconcomitant)
3	Active comparator	Biological: Comparator: Tripedia, Biological: Comparator: Comvax, Biological: Comparator: Varivax, Biological: Comparator: M-M-R IIVarivax + M-M-R II at Day 0, Tripedia + Comvax at Day 42 (Control)

Who may qualify

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

Key inclusion criteria (4 listed)

In good health
Negative clinical history of varicella, zoster, measles, mumps, rubella, diptheria, tetanus, pertussis, invasive Hib disease and hepatitis B
Had completed either a 2-dose primary series of PedvaxHIB or COMVAX or any 3-dose primary series of a licensed Hib vaccine
Had received 2 or 3 doses of any hepatitis B vaccine or COMVAX prior to entry into trial

Key exclusion criteria (8 listed)

Previous receipt of measles, mumps, rubella or varicella vaccine either alone or in combination
Any immune impairment or deficiency
Recent household, daycare or school exposure to invasive Hib disease or hepatitis B
Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
Vaccination with an inactive vaccine with in the past 14 days

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
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine LiveAlso: ProQuadA single 0.5 mL subcutaneous injection at Day 0	Biological	1, 2
Comparator: TripediaA single 0.5 mL intramuscular injection (at Day 0 or Day 42)	Biological	1, 2, 3
Comparator: ComvaxA single 0.5 mL intramuscular injection (at Day 0 or Day 42)	Biological	1, 2, 3
Comparator: VarivaxA single 0.5 mL subcutaneous injection at Day 0	Biological	3
Comparator: M-M-R IIA single 0.5 mL subcutaneous injection at Day 0	Biological	3

Primary outcome

Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL
Time frame: 6 Weeks Postvaccination
Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <120 mIU/mL) to Measles at Baseline
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL
Time frame: 6 weeks Postvaccination
Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <10 Ab units/mL) to Mumps at Baseline
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
Time frame: 6 weeks Postvaccination
Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline
Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL
Time frame: 6 weeks Postvaccination
Antibody Response to Varicella-Zoster Virus (VZV) at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <0.6 gpELISA units/mL) to VZV at Baseline
Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL
Time frame: 6 weeks Postvaccination
Antibody response to Diphtheria at 6 weeks postvaccination
Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL
Time frame: 6 weeks Postvaccination
Antibody response to Tetanus (tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA)) at 6 weeks postvaccination.
Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer
Time frame: 6 weeks Postvaccination
Antibody response to Pertussis Toxin (titers of pertussis toxin antibodies were measured with an indirect, noncompetitive EIA).
Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer
Time frame: 6 weeks Postvaccination
Antibody response to pertussis FHA(titers of pertussis filamentous hemagglutinin antibodies were measured with an indirect, noncompetitive EIA).
Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL
Time frame: 6 weeks Postvaccination
Antibody response to Hepatitis B (titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA)).
Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL
Time frame: 6 weeks Postvaccination
Antibody response to Haemophilus influenzae type B (Hib). (Anti-polyribosylribitol phosphate (PRP) was measured by radioimmunoassay (RIA) using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)
Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)
Time frame: 6 weeks Postvaccination
Postvaccination Observed Geometric Mean Titer of Antibody to Measles. (Titers measured using Measles ELISA.)
Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT
Time frame: 6 weeks Postvaccination
Postvaccination observed GMT of antibody to mumps. (Titers measured using mumps ELISA.)
Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT
Time frame: 6 weeks Postvaccination
Postvaccination Observed Geometric Mean Titer of Antibody to Rubella. (Titers measured using Rubella ELISA.)
Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT
Time frame: 6 weeks Postvaccination
Postvaccination Observed Geometric Mean Titer of Antibody to Varicella. (Titers measured using VZV gpELISA.)
Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT
Time frame: 6 weeks Postvaccination
Postvaccination Observed Geometric Mean Titer of Antibody to Diphtheria. (Titers measured using Vero Cell Culture Assay.)
Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT
Time frame: 6 weeks Postvaccination
Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Toxin (PT). Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).
Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT
Time frame: 6 weeks Postvaccination
Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Filamentous Hemagglutinin (FHA). (Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).)
Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT
Time frame: 6 weeks Postvaccination
Postvaccination Observed Geometric Mean Titer of Antibody to Hepatitis B. (Titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA).)
Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT
Time frame: 6 weeks Postvaccination
Postvaccination observed GMT of antibody to Hib. (Anti-polyribosylribitol phosphate (PRP) was measured by RIA using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)
Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT
Time frame: 6 weeks Postvaccination
Postvaccination Observed Geometric Mean Titer of Antibody to Tetanus. (Titers of tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA).)

Results and safety

Results posted to the registry on 25 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
Concomitant Group	949	884
Nonconcomitant Group	485	453
Control Group	479	442

Primary outcome: Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL

Time frame: 6 Weeks Postvaccination. Number. Unit: Participants

Measure	Concomitant Group n = 758	Nonconcomitant Group n = 388	Control Group n = 126
Value	741	383	124

Population analysed: The per-protocol analysis set included participants who had pre- and post-randomization 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. Number. Unit: Participants

Measure	Concomitant Group n = 811	Nonconcomitant Group n = 415	Control Group n = 145
Value	774	395	143

Population analysed: The per-protocol analysis set included participants who had pre- and post-randomization 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. Number. Unit: Participants

Measure	Concomitant Group n = 829	Nonconcomitant Group n = 421	Control Group n = 148
Value	817	418	148

Population analysed: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.

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

Time frame: 6 weeks Postvaccination. Number. Unit: Participants

Measure	Concomitant Group n = 757	Nonconcomitant Group n = 383	Control Group n = 139
Value	679	348	130

Population analysed: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to varicella at baseline, and followed protocol procedures.

Adverse events

Time frame: Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Concomitant Group	11 of 929 (1.2%)	831 of 929 (89.5%)	Not reported
Nonconcomitant Group	3 of 479 (0.6%)	435 of 479 (90.8%)	Not reported
Control Group	1 of 467 (0.2%)	411 of 467 (88%)	Not reported

Limitations and caveats (from the sponsor): Two participants were incorrectly vaccinated and are not included in the efficacy/safety analyses. One received M-M-R™II+TRIPEDIA™+COMVAX™ and 1 received VARIVAX™+TRIPEDIA™+COMVAX™ instead of ProQuad™+TRIPEDIA™+COMVAX™

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 16567978Shinefield H, Black S, Thear M, Coury D, Reisinger K, Rothstein E, Xu J, Hartzel J, Evans B, Digilio L, Schodel F, Brown ML, Kuter B; 013 Study Group for ProQuad. Safety and immunogenicity of a measles, mumps, rubella and varicella vaccine given with combined Haemophilus influenzae type b conjugate/hepatitis B vaccines and combined diphtheria-tetanus-acellular pertussis vaccines. Pediatr Infect Dis J. 2006 Apr;25(4):287-92. doi: 10.1097/01.inf.0000207857.10947.1f.

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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?

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 4 inclusion and 8 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 7 Aug 2015. 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 25 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 ≥120 mIU/mL (time frame: 6 Weeks Postvaccination). The study lists 20 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 NCT00984295, 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 7 Aug 2015.