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ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00975507
Recruitment Status : Completed
First Posted : September 11, 2009
Results First Posted : February 10, 2010
Last Update Posted : October 6, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Measles
Mumps
Rubella
Varicella
Interventions Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
Biological: Comparator: Placebo
Biological: Comparator: Varivax
Biological: Comparator: M-M-R II
Enrollment 480
Recruitment Details

2 clinical sites in the United States

Date of first participant visit: 24-Mar-1998

Date of last participant visit: 05-Jan-1999

Pre-assignment Details  
Arm/Group Title ProQuad™ + Placebo Followed by ProQuad™ M-M-R™ II + VARIVAX™
Hide Arm/Group Description ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose. VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
Period Title: Overall Study
Started 323 157
Vaccinated at Visit 1 323 157
Vaccinated at Visit 2 310 0 [1]
Completed 303 153
Not Completed 20 4
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             7             1
Protocol Violation             2             0
Withdrawal by Subject             10             3
[1]
Per-protocol, subjects receiving M-M-R™ II + VARIVAX™ at Visit 1 were not vaccinated at Visit 2
Arm/Group Title ProQuad™ + Placebo Followed by ProQuad™ M-M-R™ II + VARIVAX™ Total
Hide Arm/Group Description ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose. VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 323 157 480
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 323 participants 157 participants 480 participants
14.1  (1.9) 14.0  (1.7) 14.1  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 323 participants 157 participants 480 participants
Female
173
  53.6%
87
  55.4%
260
  54.2%
Male
150
  46.4%
70
  44.6%
220
  45.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 323 participants 157 participants 480 participants
African American 41 21 62
Asian/Pacific 30 9 39
Caucasian 211 107 318
Hispanic 30 16 46
Other 11 4 15
1.Primary Outcome
Title Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline
Hide Description Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of <0.6 gpELISA units/mL) to Varicella at Baseline
Time Frame 6 weeks Postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to varicella at baseline, and followed protocol procedures.
Arm/Group Title ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™) ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™) M-M-R™ II + VARIVAX™ (1 Injection)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 250 239 128
Measure Type: Number
Unit of Measure: Participants
228 237 118
2.Secondary Outcome
Title Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL
Hide Description Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <207.8 mIU/mL) to Measles at Baseline
Time Frame 6 weeks Postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™) ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™) M-M-R™ II + VARIVAX™ (1 Injection)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 302 288 145
Measure Type: Number
Unit of Measure: Participants
290 284 145
3.Secondary Outcome
Title Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline
Hide Description Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline
Time Frame 6 weeks Postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™) ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™) M-M-R™ II + VARIVAX™ (1 Injection)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 290 278 145
Measure Type: Number
Unit of Measure: Participants
264 275 134
4.Secondary Outcome
Title Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL
Hide Description Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <2.0 Ab Units/mL) to Mumps at Baseline
Time Frame 6 weeks Postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™) ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™) M-M-R™ II + VARIVAX™ (1 Injection)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 295 283 150
Measure Type: Number
Unit of Measure: Participants
292 283 148
5.Secondary Outcome
Title Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
Hide Description Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline
Time Frame 6 weeks Postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™) ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™) M-M-R™ II + VARIVAX™ (1 Injection)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 304 290 153
Measure Type: Number
Unit of Measure: Participants
289 275 142
Time Frame [Not Specified]
Adverse Event Reporting Description The number of participants listed as "at risk" is the number of participants with follow-up.
 
Arm/Group Title ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (1 Injection) ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (2 Injections) M-M-R™ II + VARIVAX™ (1 Injection)
Hide Arm/Group Description ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose. VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
All-Cause Mortality
ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (1 Injection) ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (2 Injections) M-M-R™ II + VARIVAX™ (1 Injection)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (1 Injection) ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (2 Injections) M-M-R™ II + VARIVAX™ (1 Injection)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/321 (0.00%)   1/308 (0.32%)   1/156 (0.64%) 
Gastrointestinal disorders       
Gastroenteritis * 1  0/321 (0.00%)  0/308 (0.00%)  1/156 (0.64%) 
Infections and infestations       
Infection, rotovirus * 1  0/321 (0.00%)  0/308 (0.00%)  1/156 (0.64%) 
Infection, viral * 1  0/321 (0.00%)  1/308 (0.32%)  0/156 (0.00%) 
Metabolism and nutrition disorders       
Dehydration * 1  0/321 (0.00%)  0/308 (0.00%)  1/156 (0.64%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Merck CRISP
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (1 Injection) ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (2 Injections) M-M-R™ II + VARIVAX™ (1 Injection)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   238/321 (74.14%)   190/308 (61.69%)   110/156 (70.51%) 
Ear and labyrinth disorders       
Otitis * 1  7/321 (2.18%)  1/308 (0.32%)  3/156 (1.92%) 
Otitis * 1  19/321 (5.92%)  13/308 (4.22%)  4/156 (2.56%) 
Eye disorders       
Conjunctivitis * 1  4/321 (1.25%)  5/308 (1.62%)  1/156 (0.64%) 
Gastrointestinal disorders       
Diarrhea * 1  29/321 (9.03%)  19/308 (6.17%)  13/156 (8.33%) 
Gastroenteritis * 1  4/321 (1.25%)  3/308 (0.97%)  2/156 (1.28%) 
Nausea * 1  4/321 (1.25%)  0/308 (0.00%)  0/156 (0.00%) 
Stomatitis * 1  1/321 (0.31%)  2/308 (0.65%)  3/156 (1.92%) 
Teething * 1  0/321 (0.00%)  0/308 (0.00%)  2/156 (1.28%) 
Vomiting * 1  18/321 (5.61%)  5/308 (1.62%)  12/156 (7.69%) 
General disorders       
Fever  1  129/321 (40.19%)  72/308 (23.38%)  54/156 (34.62%) 
Infections and infestations       
Infection, Viral * 1  8/321 (2.49%)  6/308 (1.95%)  7/156 (4.49%) 
Gastroenteritis, Infectious * 1  0/321 (0.00%)  1/308 (0.32%)  2/156 (1.28%) 
Infection, Respiratory, Upper * 1  34/321 (10.59%)  73/308 (23.70%)  11/156 (7.05%) 
Injury, poisoning and procedural complications       
Trauma * 1  1/321 (0.31%)  4/308 (1.30%)  3/156 (1.92%) 
Hemorrhage, Venipuncture Site * 1  0/321 (0.00%)  0/308 (0.00%)  2/156 (1.28%) 
Bite/Sting, Non-Venomous * 1  6/321 (1.87%)  1/308 (0.32%)  2/156 (1.28%) 
Burn * 1  0/321 (0.00%)  1/308 (0.32%)  2/156 (1.28%) 
Metabolism and nutrition disorders       
Anorexia * 1  14/321 (4.36%)  8/308 (2.60%)  1/156 (0.64%) 
Nervous system disorders       
Headache * 1  0/321 (0.00%)  0/308 (0.00%)  2/156 (1.28%) 
Psychiatric disorders       
Insomnia * 1  6/321 (1.87%)  3/308 (0.97%)  3/156 (1.92%) 
Irritability * 1  39/321 (12.15%)  23/308 (7.47%)  16/156 (10.26%) 
Somnolence * 1  4/321 (1.25%)  2/308 (0.65%)  3/156 (1.92%) 
Respiratory, thoracic and mediastinal disorders       
Bronchitis * 1  0/321 (0.00%)  2/308 (0.65%)  2/156 (1.28%) 
Congestion, Nasal * 1  1/321 (0.31%)  11/308 (3.57%)  2/156 (1.28%) 
Congestion, Respiratory * 1  12/321 (3.74%)  11/308 (3.57%)  4/156 (2.56%) 
Cough * 1  21/321 (6.54%)  25/308 (8.12%)  6/156 (3.85%) 
Pharyngitis * 1  3/321 (0.93%)  6/308 (1.95%)  2/156 (1.28%) 
Rhinitis * 1  0/321 (0.00%)  6/308 (1.95%)  0/156 (0.00%) 
Rhinorrhea * 1  18/321 (5.61%)  18/308 (5.84%)  8/156 (5.13%) 
Sinusitis * 1  1/321 (0.31%)  7/308 (2.27%)  3/156 (1.92%) 
Sneezing * 1  4/321 (1.25%)  2/308 (0.65%)  0/156 (0.00%) 
Wheezing * 1  3/321 (0.93%)  5/308 (1.62%)  0/156 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatitis, Contact * 1  5/321 (1.56%)  1/308 (0.32%)  1/156 (0.64%) 
Dermatomycosis * 1  2/321 (0.62%)  0/308 (0.00%)  2/156 (1.28%) 
Eczema * 1  7/321 (2.18%)  2/308 (0.65%)  0/156 (0.00%) 
Miliaria Rubra * 1  9/321 (2.80%)  1/308 (0.32%)  8/156 (5.13%) 
Rash * 1  29/321 (9.03%)  13/308 (4.22%)  16/156 (10.26%) 
Rash, Measles/Rubella-Like  1  18/321 (5.61%)  4/308 (1.30%)  3/156 (1.92%) 
Rash, Varicella-Like  1  7/321 (2.18%)  0/308 (0.00%)  3/156 (1.92%) 
Urticaria * 1  6/321 (1.87%)  5/308 (1.62%)  2/156 (1.28%) 
Viral Exanthema * 1  17/321 (5.30%)  4/308 (1.30%)  9/156 (5.77%) 
Erythema (ProQuad Injection-site)  1  9/321 (2.80%)  7/308 (2.27%)  0/0 
Pain/Tenderness/Soreness (ProQuad Injection-site)  1  9/321 (2.80%)  9/308 (2.92%)  0/0 
Rash (ProQuad Injection-site) * 1  5/321 (1.56%)  0/308 (0.00%)  0/0 
Swelling (ProQuad Injection-site)  1  6/321 (1.87%)  3/308 (0.97%)  0/0 
Ecchymosis (Varivax Injection-site) * 1  0/0  0/0  5/156 (3.21%) 
Erythema (Varivax Injection-site)  1  0/0  0/0  8/156 (5.13%) 
Pain/Tenderness/Soreness (Varivax Injection-site)  1  0/0  0/0  3/156 (1.92%) 
Swelling (Varivax Injection-site)  1  0/0  0/0  2/156 (1.28%) 
Pain/Tenderness/Soreness (M-M-R II Injection-site)  1  0/0  0/0  3/156 (1.92%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Merck CRISP
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00975507     History of Changes
Other Study ID Numbers: V221-009
2009_660
First Submitted: September 10, 2009
First Posted: September 11, 2009
Results First Submitted: September 23, 2009
Results First Posted: February 10, 2010
Last Update Posted: October 6, 2015