Back to resultsV221 Concomitant Use Study With Pneumococcal Conjugate Vaccine (V221-019)
Primary Purpose
Measles, Mumps, Rubella
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: ProQuad™ (V221)
Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)
Sponsored by
About this trial
This is an interventional prevention trial for Measles
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Group 1: ProQuad™ (V221) + PREVNAR™ (pneumococcal 7-valent conjugate vaccine) followed by ProQuad™ (Day 91)
Group 2: PREVNAR™ followed by ProQuad™ (Day 43) followed by ProQuad™ (Day 133)
Group 3: ProQuad™ followed by PREVNAR™ (Day 43), followed by ProQuad™ (Day 91)
Outcomes
Primary Outcome Measures
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.
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.
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.
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
Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4
Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B
Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V
Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14
Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C
Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F
Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00109343
Brief Title
V221 Concomitant Use Study With Pneumococcal Conjugate Vaccine (V221-019)
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Measles, Mumps, Rubella, Varicella
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1027 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Group 1: ProQuad™ (V221) + PREVNAR™ (pneumococcal 7-valent conjugate vaccine) followed by ProQuad™ (Day 91)
Arm Title
2
Arm Type
Experimental
Arm Description
Group 2: PREVNAR™ followed by ProQuad™ (Day 43) followed by ProQuad™ (Day 133)
Arm Title
3
Arm Type
Experimental
Arm Description
Group 3: ProQuad™ followed by PREVNAR™ (Day 43), followed by ProQuad™ (Day 91)
Intervention Type
Biological
Intervention Name(s)
Comparator: ProQuad™ (V221)
Other Intervention Name(s)
ProQuad™, V221
Intervention Description
0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)
Intervention Type
Biological
Intervention Name(s)
Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)
Other Intervention Name(s)
PREVNAR™
Intervention Description
0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine
Primary Outcome Measure Information:
Title
Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL
Description
Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <255 mIU/mL) to Measles at Baseline.
Time Frame
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
Title
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL
Description
Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 ELISA Ab units/mL) to Mumps at Baseline.
Time Frame
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
Title
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
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 in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
Title
Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL
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 in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
Title
Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer
Description
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4
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
Title
Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer
Description
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B
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.
Title
Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer
Description
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V
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
Title
Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer
Description
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14
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
Title
Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer
Description
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C
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
Title
Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer
Description
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F
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
Title
Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer
Description
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F
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
Other Pre-specified Outcome Measures:
Title
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 4
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
Title
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 6B
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
Title
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 9V
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
Title
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 14
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
Title
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 18C
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
Title
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 19F
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
Title
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 23F
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
15 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Citations:
PubMed Identifier
22123890
Citation
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.
Results Reference
result
Learn more about this trial
V221 Concomitant Use Study With Pneumococcal Conjugate Vaccine (V221-019)
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