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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Rubella; Varicella; Mumps; Measles

Treatments: Biological: Comparator: ProQuad™ (V221); Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00109343

2005_027

V221-019

Details and patient eligibility

About

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.

Enrollment: 1,027 patients

Sex: All

Ages: 12 to 15 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,027 participants in 3 patient groups

1

Experimental group

Description:

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

Treatment:

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

Biological: Comparator: ProQuad™ (V221)

2

Experimental group

Description:

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

Treatment:

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

Biological: Comparator: ProQuad™ (V221)

3

Experimental group

Description:

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

Treatment:

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

Biological: Comparator: ProQuad™ (V221)