V221 Concomitant Use Study With Pneumococcal Conjugate Vaccine (V221-019)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Measles, Mumps, Rubella, Varicella

Intervention / Treatment
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* Biological: Comparator: ProQuad™ (V221)
* Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 15 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Group 1: ProQuad™ (V221) + PREVNAR™ (pneumococcal 7-valent conjugate vaccine) followed by ProQuad™ (Day 91) | Biological: Comparator: ProQuad™ (V221)<br>* 0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)<br>* Other names: V221;Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)<br>* 0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine<br>* Other names: PREVNAR™;|
| Experimental: 2<br>Group 2: PREVNAR™ followed by ProQuad™ (Day 43) followed by ProQuad™ (Day 133) | Biological: Comparator: ProQuad™ (V221)<br>* 0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)<br>* Other names: V221;Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)<br>* 0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine<br>* Other names: PREVNAR™;|
| Experimental: 3<br>Group 3: ProQuad™ followed by PREVNAR™ (Day 43), followed by ProQuad™ (Day 91) | Biological: Comparator: ProQuad™ (V221)<br>* 0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)<br>* Other names: V221;Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)<br>* 0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine<br>* Other names: PREVNAR™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone | 
| 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. | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone | 
| 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. | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone | 
| 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 | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone | 
| Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4 | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone | 
| Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone. | 
| Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone | 
| Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14 | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone | 
| Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone | 
| Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone | 
| Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |