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

April 27, 2005
March 4, 2014
March 2006
September 2007   (final data collection date for primary outcome measure)
  • 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
Not Provided
Complete list of historical versions of study NCT00109343 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • 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 ]
Not Provided
 
V221 Concomitant Use Study With Pneumococcal Conjugate Vaccine (V221-019)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Measles
  • Mumps
  • Rubella
  • Varicella
  • 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: 1
    Group 1: ProQuad™ (V221) + PREVNAR™ (pneumococcal 7-valent conjugate vaccine) followed by ProQuad™ (Day 91)
    Interventions:
    • Biological: Comparator: ProQuad™ (V221)
    • Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)
  • Experimental: 2
    Group 2: PREVNAR™ followed by ProQuad™ (Day 43) followed by ProQuad™ (Day 133)
    Interventions:
    • Biological: Comparator: ProQuad™ (V221)
    • Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)
  • Experimental: 3
    Group 3: ProQuad™ followed by PREVNAR™ (Day 43), followed by ProQuad™ (Day 91)
    Interventions:
    • Biological: Comparator: ProQuad™ (V221)
    • Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)
Leonardi M, Bromberg K, Baxter R, Gardner JL, Klopfer S, Nicholson O, Brockley M, Trammel J, Leamy V, Williams W, Kuter B, Schödel F. Immunogenicity and safety of MMRV and PCV-7 administered concomitantly in healthy children. Pediatrics. 2011 Dec;128(6):e1387-94. doi: 10.1542/peds.2010-2132. Epub 2011 Nov 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1027
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Both
12 Months to 15 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00109343
V221-019, 2005_027
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP