Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00985166
Recruitment Status : Completed
First Posted : September 28, 2009
Results First Posted : January 29, 2010
Last Update Posted : July 28, 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: ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live)
Biological: Comparator: M-M-R II
Biological: Comparator: Varivax
Biological: Comparator: Placebo
Enrollment 801
Recruitment Details

17 clinical sites in the United States

Date of first participant visit: 24-Aug-2000

Date of last participant visit: 06-May-2002

Pre-assignment Details Prior to entering study, all subjects received primary dose of M-M-R II™ and Varivax™ at less than or equal to 12 months of age.
Arm/Group Title ProQuad™ + Placebo M-M-R™ II + Placebo M-M-R™ II + VARIVAX™
Hide Arm/Group Description ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1. M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1. VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
Period Title: Overall Study
Started 401 [1] 205 195
Vaccinated at Visit 1 399 205 195
Completed 392 201 188
Not Completed 9 4 7
Reason Not Completed
Lost to Follow-up             3             2             2
Withdrawal by Subject             3             2             0
Test not done             2             0             4
Other             1             0             1
[1]
Two randomized subjects withdrew consent before vaccination: no demographic information available.
Arm/Group Title ProQuad™ + Placebo M-M-R™ II + Placebo M-M-R™ II + VARIVAX™ Total
Hide Arm/Group Description ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1. M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1. VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 399 205 195 799
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 399 participants 205 participants 195 participants 799 participants
4.3  (0.5) 4.3  (0.5) 4.3  (0.5) 4.3  (0.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 399 participants 205 participants 195 participants 799 participants
Female
191
  47.9%
105
  51.2%
77
  39.5%
373
  46.7%
Male
208
  52.1%
100
  48.8%
118
  60.5%
426
  53.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 399 participants 205 participants 195 participants 799 participants
African American 49 19 25 93
Asian/Pacific 8 5 3 16
Caucasian 313 162 153 628
Hispanic 15 10 7 32
Other 14 9 7 30
1.Primary Outcome
Title Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Hide Description Postvaccination observed Geometric Mean Titer of antibody to Varicella
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, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.
Arm/Group Title ProQuad™ + Placebo M-M-R™ II + VARIVAX™
Hide Arm/Group Description:
ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
Overall Number of Participants Analyzed 367 171
Geometric Mean (95% Confidence Interval)
Unit of Measure: gpELISA units/mL
322.2
(278.9 to 372.2)
209.3
(171.2 to 255.9)
2.Primary Outcome
Title Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Hide Description Postvaccination observed Geometric Mean Titer of antibody to Measles
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, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.
Arm/Group Title ProQuad™ + Placebo M-M-R™ II + Placebo M-M-R™ II + VARIVAX™
Hide Arm/Group Description:
ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
Overall Number of Participants Analyzed 367 185 171
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
1985.9
(1817.6 to 2169.9)
2046.9
(1815.2 to 2308.2)
2084.3
(1852.3 to 2345.5)
3.Primary Outcome
Title Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Hide Description Postvaccination observed Geometric Mean Titer of antibody to Mumps
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, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.
Arm/Group Title ProQuad™ + Placebo M-M-R™ II + Placebo M-M-R™ II + VARIVAX™
Hide Arm/Group Description:
ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1
Overall Number of Participants Analyzed 367 185 171
Geometric Mean (95% Confidence Interval)
Unit of Measure: ELISA AB units/mL
206.0
(188.2 to 225.4)
308.5
(269.6 to 352.9)
295.9
(262.5 to 333.5)
4.Primary Outcome
Title Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Hide Description Postvaccination observed Geometric Mean Titer of antibody to Rubella
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, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.
Arm/Group Title ProQuad™ + Placebo M-M-R™ II + Placebo M-M-R™ II + VARIVAX™
Hide Arm/Group Description:
ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
Overall Number of Participants Analyzed 367 185 171
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
217.3
(200.1 to 236.0)
174.0
(157.3 to 192.6)
154.1
(138.9 to 170.9)
Time Frame [Not Specified]
Adverse Event Reporting Description

The number of participants listed as "at risk" is the number of participants with follow-up.

0/0 indicates that subjects in this treatment group did not receive the indicated vaccine.

 
Arm/Group Title ProQuad™ + Placebo M-M-R™ II + Placebo M-M-R™ II + VARIVAX™
Hide Arm/Group Description ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1. M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1. VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
All-Cause Mortality
ProQuad™ + Placebo M-M-R™ II + Placebo M-M-R™ II + VARIVAX™
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
ProQuad™ + Placebo M-M-R™ II + Placebo M-M-R™ II + VARIVAX™
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/397 (0.25%)   0/205 (0.00%)   0/193 (0.00%) 
Infections and infestations       
Pyelonephritis - Not other wise Specified (NOS) * 1  1/397 (0.25%)  0/205 (0.00%)  0/193 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
ProQuad™ + Placebo M-M-R™ II + Placebo M-M-R™ II + VARIVAX™
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   292/397 (73.55%)   150/205 (73.17%)   140/193 (72.54%) 
Ear and labyrinth disorders       
Ear pain * 1  9/397 (2.27%)  1/205 (0.49%)  4/193 (2.07%) 
Eye disorders       
Conjunctivitis * 1  5/397 (1.26%)  2/205 (0.98%)  2/193 (1.04%) 
Lacrimation increased * 1  1/397 (0.25%)  0/205 (0.00%)  2/193 (1.04%) 
Gastrointestinal disorders       
Abdominal pain NOS * 1  1/397 (0.25%)  0/205 (0.00%)  2/193 (1.04%) 
Abdominal pain upper * 1  10/397 (2.52%)  4/205 (1.95%)  3/193 (1.55%) 
Diarrhoea NOS * 1  14/397 (3.53%)  7/205 (3.41%)  1/193 (0.52%) 
Dyspepsia * 1  4/397 (1.01%)  1/205 (0.49%)  2/193 (1.04%) 
Vomiting NOS * 1  23/397 (5.79%)  7/205 (3.41%)  8/193 (4.15%) 
General disorders       
Influenza like illness * 1  4/397 (1.01%)  4/205 (1.95%)  0/193 (0.00%) 
Malaise * 1  2/397 (0.50%)  0/205 (0.00%)  2/193 (1.04%) 
Pain NOS * 1  6/397 (1.51%)  1/205 (0.49%)  0/193 (0.00%) 
Pyrexia * 1  41/397 (10.33%)  20/205 (9.76%)  19/193 (9.84%) 
Venipuncture site pain * 1  0/397 (0.00%)  2/205 (0.98%)  2/193 (1.04%) 
Injection site bruising (M-M-R II Injection-site)  1  0/0  5/205 (2.44%)  3/193 (1.55%) 
Injection site erythema (M-M-R II Injection-site)  1  0/0  32/205 (15.61%)  28/193 (14.51%) 
Injection site pain (M-M-R II Injection-site)  1  0/0  75/205 (36.59%)  68/193 (35.23%) 
Injection site swelling (M-M-R II Injection-site)  1  0/0  21/205 (10.24%)  15/193 (7.77%) 
Injection site bruising (ProQuad Injection-site)  1  14/397 (3.53%)  0/0  0/0 
Injection site erythema (ProQuad Injection-site)  1  98/397 (24.69%)  0/0  0/0 
Injection site pain (ProQuad Injection-site)  1  163/397 (41.06%)  0/0  0/0 
Injection site pruritus (ProQuad Injection-site)  1  4/397 (1.01%)  0/0  0/0 
Injection site rash (ProQuad Injection-site)  1  7/397 (1.76%)  0/0  0/0 
Injection site swelling (ProQuad Injection-site)  1  62/397 (15.62%)  0/0  0/0 
Injection site bruising (Varivax Injection-site)  1  0/0  0/205 (0.00%)  4/193 (2.07%) 
Injection site erythema (Varivax Injection-site)  1  0/0  0/205 (0.00%)  31/193 (16.06%) 
Injection site nodule (Varivax Injection-site)  1  0/0  0/205 (0.00%)  2/193 (1.04%) 
Injection site pain (Varivax Injection-site)  1  0/0  0/205 (0.00%)  71/193 (36.79%) 
Injection site pruritus (Varivax Injection-site)  1  0/0  0/205 (0.00%)  2/193 (1.04%) 
Injection site swelling (Varivax Injection-site)  1  0/0  0/205 (0.00%)  21/193 (10.88%) 
Immune system disorders       
Seasonal allergy * 1  0/397 (0.00%)  0/205 (0.00%)  2/193 (1.04%) 
Infections and infestations       
Ear infection NOS * 1  4/397 (1.01%)  1/205 (0.49%)  3/193 (1.55%) 
Gastroenteritis viral NOS * 1  4/397 (1.01%)  1/205 (0.49%)  2/193 (1.04%) 
Nasopharyngitis * 1  52/397 (13.10%)  26/205 (12.68%)  26/193 (13.47%) 
Otitis media NOS * 1  12/397 (3.02%)  9/205 (4.39%)  10/193 (5.18%) 
Pharyngitis * 1  2/397 (0.50%)  7/205 (3.41%)  3/193 (1.55%) 
Pharyngitis streptococcal * 1  6/397 (1.51%)  3/205 (1.46%)  2/193 (1.04%) 
Pneumonia NOS * 1  3/397 (0.76%)  1/205 (0.49%)  2/193 (1.04%) 
Sinusitis NOS * 1  6/397 (1.51%)  6/205 (2.93%)  1/193 (0.52%) 
Upper respiratory tract infection NOS * 1  18/397 (4.53%)  10/205 (4.88%)  9/193 (4.66%) 
Viral infection NOS * 1  1/397 (0.25%)  1/205 (0.49%)  4/193 (2.07%) 
Injury, poisoning and procedural complications       
Arthropod bite * 1  5/397 (1.26%)  4/205 (1.95%)  2/193 (1.04%) 
Excoriation * 1  1/397 (0.25%)  1/205 (0.49%)  2/193 (1.04%) 
Thermal burn * 1  1/397 (0.25%)  0/205 (0.00%)  2/193 (1.04%) 
Metabolism and nutrition disorders       
Appetite decreased NOS * 1  4/397 (1.01%)  0/205 (0.00%)  1/193 (0.52%) 
Musculoskeletal and connective tissue disorders       
Pain in extremity * 1  5/397 (1.26%)  2/205 (0.98%)  1/193 (0.52%) 
Nervous system disorders       
Headache * 1  22/397 (5.54%)  10/205 (4.88%)  12/193 (6.22%) 
Somnolence * 1  1/397 (0.25%)  0/205 (0.00%)  3/193 (1.55%) 
Psychiatric disorders       
Irritability * 1  9/397 (2.27%)  3/205 (1.46%)  4/193 (2.07%) 
Respiratory, thoracic and mediastinal disorders       
Asthma NOS * 1  1/397 (0.25%)  1/205 (0.49%)  3/193 (1.55%) 
Bronchospasm NOS * 1  3/397 (0.76%)  0/205 (0.00%)  2/193 (1.04%) 
Cough * 1  51/397 (12.85%)  18/205 (8.78%)  21/193 (10.88%) 
Nasal congestion * 1  11/397 (2.77%)  11/205 (5.37%)  4/193 (2.07%) 
Pharyngolaryngeal pain * 1  10/397 (2.52%)  7/205 (3.41%)  8/193 (4.15%) 
Rhinorrhoea * 1  17/397 (4.28%)  18/205 (8.78%)  7/193 (3.63%) 
Skin and subcutaneous tissue disorders       
Dermatitis contact * 1  6/397 (1.51%)  0/205 (0.00%)  1/193 (0.52%) 
Eczema * 1  2/397 (0.50%)  0/205 (0.00%)  3/193 (1.55%) 
Heat rash * 1  1/397 (0.25%)  2/205 (0.98%)  3/193 (1.55%) 
Rash NOS * 1  7/397 (1.76%)  6/205 (2.93%)  4/193 (2.07%) 
Rash papular * 1  0/397 (0.00%)  0/205 (0.00%)  2/193 (1.04%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
GMTs (adjusted for prevaccination titer, study center, and primary vaccination history status) have been reported in the literature. One subject received diluent only at visit 1 and was excluded from all immunogenicity/safety summaries.
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
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00985166    
Other Study ID Numbers: V221-014
2009_668
First Submitted: September 24, 2009
First Posted: September 28, 2009
Results First Submitted: December 23, 2009
Results First Posted: January 29, 2010
Last Update Posted: July 28, 2015