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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1027 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-09-30

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.

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Detailed Description

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Conditions

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Measles Mumps Rubella Varicella

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group 1: ProQuad™ (V221) + PREVNAR™ (pneumococcal 7-valent conjugate vaccine) followed by ProQuad™ (Day 91)

Group Type EXPERIMENTAL

Comparator: ProQuad™ (V221)

Intervention Type BIOLOGICAL

0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)

Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)

Intervention Type BIOLOGICAL

0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine

2

Group 2: PREVNAR™ followed by ProQuad™ (Day 43) followed by ProQuad™ (Day 133)

Group Type EXPERIMENTAL

Comparator: ProQuad™ (V221)

Intervention Type BIOLOGICAL

0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)

Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)

Intervention Type BIOLOGICAL

0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine

3

Group 3: ProQuad™ followed by PREVNAR™ (Day 43), followed by ProQuad™ (Day 91)

Group Type EXPERIMENTAL

Comparator: ProQuad™ (V221)

Intervention Type BIOLOGICAL

0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)

Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)

Intervention Type BIOLOGICAL

0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine

Interventions

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Comparator: ProQuad™ (V221)

0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)

Intervention Type BIOLOGICAL

Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)

0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

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ProQuad™ V221 PREVNAR™

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

Minimum Eligible Age

12 Months

Maximum Eligible Age

15 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes