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

Phase 3

Completed

• Conditions: Measles; Mumps; Varicella; Rubella

• Registration Number: NCT00109343
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted QC: 2005-04-26
• Study First Submitted: 2005-04-27
• Study First Posted: 2005-04-27
• Study Start: 2006-03
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Results First Submitted: 2009-09-23
• Results First Submitted QC: 2010-01-25
• Results First Posted: 2010-02-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-15
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1027

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone	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	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone	Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<10 ELISA Ab units/mL) to Mumps at Baseline.
Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone.	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone	Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<10 IU/mL) to Rubella at Baseline.
Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F
Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone	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 9V - Geometric Mean Titer	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V
Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14
Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4
Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C
Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F