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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00109343
First received: April 27, 2005
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Measles
Mumps
Rubella
Varicella
Biological: Comparator: ProQuad™ (V221)
Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone ] [ Designated as safety issue: No ]
    Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 ELISA Ab units/mL) to Mumps at Baseline.

  • Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone ] [ Designated as safety issue: No ]
    Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline.

  • Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone ] [ Designated as safety issue: No ]
    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 4 - Geometric Mean Titer [ 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 ] [ Designated as safety issue: No ]
    Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4

  • Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer [ 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. ] [ Designated as safety issue: No ]
    Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B

  • Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer [ 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 ] [ Designated as safety issue: No ]
    Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V

  • Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer [ 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 ] [ Designated as safety issue: No ]
    Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14

  • Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer [ 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 ] [ Designated as safety issue: No ]
    Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C

  • Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer [ 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 ] [ Designated as safety issue: No ]
    Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F

  • Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer [ 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 ] [ Designated as safety issue: No ]
    Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F


Other Outcome Measures:
  • Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for 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 ] [ Designated as safety issue: No ]
  • Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 6B [ 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 ] [ Designated as safety issue: No ]
  • Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 9V [ 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 ] [ Designated as safety issue: No ]
  • Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 14 [ 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 ] [ Designated as safety issue: No ]
  • Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 18C [ 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 ] [ Designated as safety issue: No ]
  • Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 19F [ 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 ] [ Designated as safety issue: No ]
  • Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 23F [ 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 ] [ Designated as safety issue: No ]

Enrollment: 1027
Study Start Date: March 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Group 1: ProQuad™ (V221) + PREVNAR™ (pneumococcal 7-valent conjugate vaccine) followed by ProQuad™ (Day 91)
Biological: Comparator: ProQuad™ (V221)
0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)
Other Names:
  • ProQuad™
  • V221
Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)
0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine
Other Name: PREVNAR™
Experimental: 2
Group 2: PREVNAR™ followed by ProQuad™ (Day 43) followed by ProQuad™ (Day 133)
Biological: Comparator: ProQuad™ (V221)
0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)
Other Names:
  • ProQuad™
  • V221
Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)
0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine
Other Name: PREVNAR™
Experimental: 3
Group 3: ProQuad™ followed by PREVNAR™ (Day 43), followed by ProQuad™ (Day 91)
Biological: Comparator: ProQuad™ (V221)
0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)
Other Names:
  • ProQuad™
  • V221
Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)
0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine
Other Name: PREVNAR™

  Eligibility

Ages Eligible for Study:   12 Months to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109343

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00109343     History of Changes
Other Study ID Numbers: V221-019, 2005_027
Study First Received: April 27, 2005
Results First Received: September 23, 2009
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 19, 2014