A Phase 3 interventional study of ProQuad® in Measles, Mumps and Rubella, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 12 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-13.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Prevention
Primary objective:
To demonstrate that two doses of ProQuad® administered by IM route are as immunogenic as two doses of ProQuad® administered by SC route to healthy children 12 to 18 months of age in terms of antibody response rates to measles, mumps, rubella and to varicella at 42 days following the second dose of ProQuad®
Secondary objectives:
134 studies on the registry are indexed under Measles; 17 are open to participants now.
This study's enrollment of 405 is below the median of 852 across 105 interventional studies indexed under Measles.
Browse Measles studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.
Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive doses of ProQuad® by IM injection on Day 1 and Day 30 into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm.
Biological: ProQuad®
Participants will receive doses of ProQuad® by SC injection on Day 1 and Day 30 in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm.
Biological: ProQuad®
Each dose (0.5 mL) contains live attenuated versions of measles virus Enders' Edmonston strain, mumps virus Jeryl Lynn™ (Level B) strain, rubella virus Wistar RA 27/3 strain, and varicella virus Oka/Merck strain.
Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment
Antibody response rates were determined 6 weeks after the second dose of IM or SC ProQuad®. 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 rates were determined 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.
Time frame: Week 10 (6 weeks after Dose 2 on Week 4)
Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose
Antibody response rates were determined 4 weeks after the first dose of IM or SC ProQuad®. Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response rates were determined 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.
Time frame: Week 4
Antibody Geometric Mean Titres (GMT) to Measles Four Weeks After the First ProQuad® Dose
Antibody titre levels to measles were determined 4 weeks after the first dose of IM or SC ProQuad®. Measles antibody levels were determined using ELISA. Titre levels were determined in participants with baseline measles titre \<255 mIU/mL.
Time frame: Week 4
Antibody GMT to Mumps Four Weeks After the First ProQuad® Dose
Antibody titre levels to mumps were determined 4 weeks after the first dose of IM or SC ProQuad®. Mumps antibody levels were determined using ELISA. Titre levels were determined in participants with baseline mumps titres \<10 ELISA Ab units mL.
Time frame: Week 4
Antibody GMT to Rubella Four Weeks After the First ProQuad® Dose
Antibody titre levels to rubella were determined 4 weeks after the first dose of IM or SC ProQuad®. Rubella antibody levels were determined using ELISA. Titre levels were determined in participants with baseline rubella titre \<10 IU/mL.
Time frame: Week 4
Antibody GMT to Varicella Four Weeks After the First ProQuad® Dose
Antibody titre levels to varicella were determined 4 weeks after the first dose of IM or SC ProQuad®. Varicella antibody levels were determined with gpELISA. Titre levels were determined in participants with baseline varicella antibody titre \<1.25 gpELISA units/mL.
Time frame: Week 4
Antibody GMT to Measles Six Weeks After Completing ProQuad® Treatment
Antibody titre levels to measles were determined 6 weeks after the second dose of IM or SC ProQuad®. Measles antibody levels were determined using ELISA. Titre levels were determined in participants with baseline measles titre \<255 mIU/mL.
Time frame: Week 10 (6 weeks after Dose 2 on Week 4)
Antibody GMT to Mumps Six Weeks After Completing ProQuad® Treatment
Antibody titre levels to mumps were determined 6 weeks after the second dose of IM or SC ProQuad®. Mumps antibody levels were determined using ELISA. Titre levels were determined in participants with baseline mumps titre \<10 ELISA Ab units mL.
Time frame: Week 10 (6 weeks after Dose 2 on Week 4)
Antibody GMT to Rubella Six Weeks After Completing ProQuad® Treatment
Antibody titre levels to rubella were determined 6 weeks after the second dose of IM or SC ProQuad®. Rubella antibody levels were determined using ELISA. Titre levels were determined in participants with baseline rubella titre \<10 IU/mL.
Time frame: Week 10 (6 weeks after Dose 2 on Week 4)
Antibody GMT to Varicella Six Weeks After Completing ProQuad® Treatment
Antibody titre levels to varicella were determined 6 weeks after the second dose of IM or SC ProQuad®. Varicella antibody levels were determined with gpELISA. Titre levels were determined in participants with baseline varicella antibody titre \<1.25 gpELISA units/mL.
Time frame: Week 10 (6 weeks after Dose 2 on Week 4)
Percentage of Participants Experiencing an Injection-site Adverse Event (AE) or Vaccine-related Systemic AE After the First ProQuad® Dose
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Injection-site AEs (e.g., erythema, swelling, pain) and systemic vaccine-related AEs (e.g., pyrexia) were AEs of interest.
Time frame: From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose)
Percentage of Participants Experiencing an Injection-site AE or Vaccine-related Systemic AE After the Second ProQuad® Dose
An AE is any untoward medical occurrence in a participant administered an IMP and which does not necessarily have a causal relationship with the IMP. Injection-site AEs (e.g., erythema, swelling, pain) and systemic vaccine-related AEs (e.g., pyrexia) were AEs of interest.
Time frame: From Day 30 up to Day 58 (up to 28 days after the second ProQuad® dose)
Percentage of Participants Discontinuing From Study Therapy Due to an AE After the First ProQuad® Dose
An AE is any untoward medical occurrence in a participant administered an IMP and which does not necessarily have a causal relationship with the IMP.
Time frame: From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose)
A total of 411 male and female participants (12 to 18 months of age) were selected for study entry at 33 sites in France. A total of 405 participants were randomized and received 2 doses of study drug.
| Milestone | Intramuscular ProQuad® | Subcutaneous ProQuad® |
|---|---|---|
| Started | 202 | 203 |
| Proquad® dose 1 (day 1) | 202 | 203 |
| Proquad® dose 1 (day 30) | 202 | 203 |
| Completed | 201 | 200 |
| Not completed | 1 | 3 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Non-compliance with protocol | 0 | 1 |
Antibody response rates were determined 6 weeks after the second dose of IM or SC ProQuad®. 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 rates were determined 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 | Intramuscular ProQuad® | Subcutaneous ProQuad® |
|---|---|---|
| Measles | 100 (97.6 to 100) | 100 (97.5 to 100) |
| Mumps | 99.3 (96.4 to 100) | 99.3 (96.3 to 100) |
| Rubella | 100 (97.2 to 100) | 99.2 (95.9 to 100) |
| Varicella | 100 (97.4 to 100) | 99.3 (95.9 to 100) |
Antibody response rates were determined 4 weeks after the first dose of IM or SC ProQuad®. Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response rates were determined 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 | Intramuscular ProQuad® | Subcutaneous ProQuad® |
|---|---|---|
| Measles | 100 (97.6 to 100) | 97.3 (93.2 to 99.3) |
| Mumps | 97.4 (93.4 to 99.3) | 91.3 (85.5 to 95.3) |
| Rubella | 98.4 (94.5 to 99.8) | 100 (97.3 to 100) |
| Varicella | 98.6 (94.9 to 99.8) | 98.5 (94.8 to 99.8) |
Antibody titre levels to measles were determined 4 weeks after the first dose of IM or SC ProQuad®. Measles antibody levels were determined using ELISA. Titre levels were determined in participants with baseline measles titre \<255 mIU/mL.
| Antibody titres (mIU/mL) | Intramuscular ProQuad® | Subcutaneous ProQuad® |
|---|---|---|
| Antibody Geometric Mean Titres (GMT) to Measles Four Weeks After the First ProQuad® Dose | 4058.7 (3643.1 to 4521.8) | 3327.0 (2835.4 to 3903.9) |
Antibody titre levels to mumps were determined 4 weeks after the first dose of IM or SC ProQuad®. Mumps antibody levels were determined using ELISA. Titre levels were determined in participants with baseline mumps titres \<10 ELISA Ab units mL.
| Antibody titres (ELISA Ab units/mL) | Intramuscular ProQuad® | Subcutaneous ProQuad® |
|---|---|---|
| Antibody GMT to Mumps Four Weeks After the First ProQuad® Dose | 120.0 (102.2 to 140.9) | 101.9 (84.2 to 123.2) |
Antibody titre levels to rubella were determined 4 weeks after the first dose of IM or SC ProQuad®. Rubella antibody levels were determined using ELISA. Titre levels were determined in participants with baseline rubella titre \<10 IU/mL.
| Antibody titres (IU/mL) | Intramuscular ProQuad® | Subcutaneous ProQuad® |
|---|---|---|
| Antibody GMT to Rubella Four Weeks After the First ProQuad® Dose | 46.9 (39.7 to 55.4) | 50.9 (44.9 to 57.7) |
Antibody titre levels to varicella were determined 4 weeks after the first dose of IM or SC ProQuad®. Varicella antibody levels were determined with gpELISA. Titre levels were determined in participants with baseline varicella antibody titre \<1.25 gpELISA units/mL.
| Antibody titres (gpELISA units/mL) | Intramuscular ProQuad® | Subcutaneous ProQuad® |
|---|---|---|
| Antibody GMT to Varicella Four Weeks After the First ProQuad® Dose | 25.0 (22.5 to 27.7) | 23.6 (20.9 to 26.7) |
Antibody titre levels to measles were determined 6 weeks after the second dose of IM or SC ProQuad®. Measles antibody levels were determined using ELISA. Titre levels were determined in participants with baseline measles titre \<255 mIU/mL.
| Antibody titres (mIU/mL) | Intramuscular ProQuad® | Subcutaneous ProQuad® |
|---|---|---|
| Antibody GMT to Measles Six Weeks After Completing ProQuad® Treatment | 3953.7 (3497.2 to 4469.9) | 3748.6 (3270.9 to 4296.0) |
Antibody titre levels to mumps were determined 6 weeks after the second dose of IM or SC ProQuad®. Mumps antibody levels were determined using ELISA. Titre levels were determined in participants with baseline mumps titre \<10 ELISA Ab units mL.
| Antibody titres (ELISA Ab units/mL) | Intramuscular ProQuad® | Subcutaneous ProQuad® |
|---|---|---|
| Antibody GMT to Mumps Six Weeks After Completing ProQuad® Treatment | 157.9 (138.6 to 180.0) | 168.8 (146.9 to 194.0) |
Antibody titre levels to rubella were determined 6 weeks after the second dose of IM or SC ProQuad®. Rubella antibody levels were determined using ELISA. Titre levels were determined in participants with baseline rubella titre \<10 IU/mL.
| Antibody titres (IU/mL) | Intramuscular ProQuad® | Subcutaneous ProQuad® |
|---|---|---|
| Antibody GMT to Rubella Six Weeks After Completing ProQuad® Treatment | 92.8 (82.4 to 104.5) | 94.2 (83.2 to 106.6) |
Antibody titre levels to varicella were determined 6 weeks after the second dose of IM or SC ProQuad®. Varicella antibody levels were determined with gpELISA. Titre levels were determined in participants with baseline varicella antibody titre \<1.25 gpELISA units/mL.
| Antibody titres (gpELISA units/mL) | Intramuscular ProQuad® | Subcutaneous ProQuad® |
|---|---|---|
| Antibody GMT to Varicella Six Weeks After Completing ProQuad® Treatment | 358.1 (300.1 to 427.4) | 261.8 (216.7 to 316.4) |
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Injection-site AEs (e.g., erythema, swelling, pain) and systemic vaccine-related AEs (e.g., pyrexia) were AEs of interest.
| Percentage of participants | Intramuscular ProQuad® | Subcutaneous ProQuad® |
|---|---|---|
| Injection-site AEs | 17.8 | 28.6 |
| Vaccine-related systemic AEs | 8.9 | 8.4 |
An AE is any untoward medical occurrence in a participant administered an IMP and which does not necessarily have a causal relationship with the IMP. Injection-site AEs (e.g., erythema, swelling, pain) and systemic vaccine-related AEs (e.g., pyrexia) were AEs of interest.
| Percentage of participants | Intramuscular ProQuad® | Subcutaneous ProQuad® |
|---|---|---|
| Injection-site AEs | 20.4 | 29.5 |
| Vaccine-related systemic AEs | 6.0 | 5.0 |
An AE is any untoward medical occurrence in a participant administered an IMP and which does not necessarily have a causal relationship with the IMP.
| Percentage of participants | Intramuscular ProQuad® | Subcutaneous ProQuad® |
|---|---|---|
| Percentage of Participants Discontinuing From Study Therapy Due to an AE After the First ProQuad® Dose | 0 | 0 |
Collected over Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IM ProQuad® Arm: Dose 1 | — | 2/202 (1%) | 153/202 (75.7%) |
| SC ProQuad® Arm: Dose 1 | — | 2/203 (1%) | 166/203 (81.8%) |
| IM ProQuad® Arm: Dose 2 | — | 1/201 (0.5%) | 141/201 (70.1%) |
| SC ProQuad® Arm: Dose 2 | — | 1/200 (0.5%) | 137/200 (68.5%) |
| Event | IM ProQuad® Arm: Dose 1 | SC ProQuad® Arm: Dose 1 | IM ProQuad® Arm: Dose 2 | SC ProQuad® Arm: Dose 2 |
|---|---|---|---|---|
| Limb traumatic amputationInjury, poisoning and procedural complications | 0/202 | 0/203 | 0/201 | 1/200 |
| GastroenteritisInfections and infestations | 0/202 | 1/203 | 1/201 | 0/200 |
| Gastroenteritis viralInfections and infestations | 1/202 | 0/203 | 0/201 | 0/200 |
| Viral tonsillitisInfections and infestations | 1/202 | 0/203 | 0/201 | 0/200 |
| Febrile convulsionNervous system disorders | 0/202 | 1/203 | 0/201 | 0/200 |
| Event | IM ProQuad® Arm: Dose 1 | SC ProQuad® Arm: Dose 1 | IM ProQuad® Arm: Dose 2 | SC ProQuad® Arm: Dose 2 |
|---|---|---|---|---|
| PyrexiaGeneral disorders | 115/202 | 125/203 | 89/201 | 82/200 |
| Injection site erythemaGeneral disorders | 14/202 | 40/203 | 31/201 | 54/200 |
| Injection site swellingGeneral disorders | 0/202 | 0/203 | 12/201 | 25/200 |
| Injection site painGeneral disorders | 23/202 | 12/203 | 20/201 | 20/200 |
| Ear infectionInfections and infestations | 22/202 | 19/203 | 21/201 | 22/200 |
| BronchitisInfections and infestations | 20/202 | 16/203 | 9/201 | 12/200 |
| TeethingGastrointestinal disorders | 19/202 | 17/203 | 11/201 | 12/200 |
| NasopharyngitisInfections and infestations | 19/202 | 18/203 | 15/201 | 17/200 |
| TracheitisInfections and infestations | 0/202 | 0/203 | 15/201 | 6/200 |
| RhinitisInfections and infestations | 14/202 | 13/203 | 0/201 | 0/200 |
| Age, Continuous(Months) | Intramuscular ProQuad® | Subcutaneous ProQuad® | Total |
|---|---|---|---|
| Mean | 13.72 ± 1.44 | 13.65 ± 1.53 | 13.68 ± 1.48 |
| Sex: Female, Male(Participants) | Intramuscular ProQuad® | Subcutaneous ProQuad® | Total |
|---|---|---|---|
| Female | 105 | 94 | 199 |
| Male | 97 | 109 | 206 |
No study locations are listed for this record.
Plan to share: Yes — http://www.merck.com/clinicaltrials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
Data sharing details ↗ · engagezone.msd.com
Ran from Oct 2006 to primary completion in May 2007, 7 months.
Results were first posted in Aug 2018, 11 years 3 months after primary completion.
Of 16 phase 3 interventional studies under Measles, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 24. This study's 7 months is below that.
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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Measles, mumps, rubella, varicella vaccine