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

Merck Sharp & Dohme LLC1,027 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,027

Conditions

Measles Mumps Rubella Varicella

Interventions

Comparator: ProQuad™ (V221)BIOLOGICAL

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

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

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

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 15 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

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

Data from ClinicalTrials.gov

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