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Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067)

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ClinicalTrials.gov Identifier: NCT00312858
Recruitment Status : Completed
First Posted : April 11, 2006
Results First Posted : August 3, 2009
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE April 7, 2006
First Posted Date  ICMJE April 11, 2006
Results First Submitted Date  ICMJE March 24, 2009
Results First Posted Date  ICMJE August 3, 2009
Last Update Posted Date April 13, 2017
Study Start Date  ICMJE April 2006
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2014)
  • Antibody Response to Hepatitis A - Participants With a Serological Response [ Time Frame: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™) ]
    Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus
  • Antibody Response to Varicella - Participants With a Serological Response [ Time Frame: 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™) ]
    Participants with varicella baseline antibody titer <1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection)
  • Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
    Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay
  • Participants With 1 or More Systemic Adverse Experience [ Time Frame: 6 weeks post dose 1 ]
    Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 6 week study period.
  • Participants With 1 or More Systemic Adverse Experience [ Time Frame: 4 weeks post dose 2 ]
    Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 4 week study period.
  • Participants With 1 or More Systemic Adverse Experience. [ Time Frame: 6 months ]
    Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTA™) (Days 1 to 14), given 6 months apart
  • Participants With 1 or More Injection-site Adverse Experience [ Time Frame: 6 weeks post dose 1 ]
    Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
  • Participants With 1 or More Injection-site Adverse Experience [ Time Frame: 4 weeks post dose 2 ]
    Injection-site adverse experiences collected the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.
  • Participants With 1 or More Injection-site Adverse Experience [ Time Frame: 6 months ]
    Injection-site adverse experiences collected the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.
  • Participants With Elevated Temperature (≥102.2F/ ≥39.0C) [ Time Frame: 6 weeks post dose 1 ]
    Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
  • Participants With Elevated Temperature (≥102.2F/ ≥39.0C) [ Time Frame: 4 weeks post dose 2 ]
    Elevated temperatures measured the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.
  • Participants With Elevated Temperature (≥102.2F/ ≥39.0C) [ Time Frame: 6 months ]
    Elevated temperatures measured the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.
  • Participants With 1 or More Serious Vaccine-related Adverse Experience [ Time Frame: 6 weeks post dose 1 ]
    Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
  • Participants With 1 or More Serious Vaccine-related Adverse Experience [ Time Frame: 4 weeks post dose 2 ]
    Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
  • Participants With 1 or More Serious Vaccine-related Adverse Experience [ Time Frame: 6 months ]
    Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Original Primary Outcome Measures  ICMJE
 (submitted: April 7, 2006)
Antibody responses to Hepatitis A (4 weeks Post dose 2), Varicella (6 weeks Post dose 1), and S. Pneumoniae (6 weeks Postvaccination). Safety profile of concomitant use of Hepatitis A vaccine with other study vaccines.
Change History Complete list of historical versions of study NCT00312858 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: December 2, 2014)
  • Antibody Response to Hepatitis A - Geometric Mean Titer [ Time Frame: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™) ]
    Geometric Mean Titer of hepatitis A antibody, regardless of initial serostatus
  • Antibody Response to Varicella - Geometric Mean Titer [ Time Frame: 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™) ]
    Geometric Mean Titer of varicella antibody, baseline antibody titer was <1.25 gpELISA units/mL
  • Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response [ Time Frame: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
    Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 4
  • Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response [ Time Frame: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
    Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 6B
  • Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response [ Time Frame: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
    Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 9V
  • Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response [ Time Frame: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
    Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 14
  • Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response [ Time Frame: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
    Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 18C
  • Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response [ Time Frame: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
    Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 19F
  • Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response [ Time Frame: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
    Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 23F
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067)
Official Title  ICMJE An Open, Randomized, Multicenter Study of the Safety, Tolerability, & Immunogenicity of VAQTA™ Given Concomitantly With PROQUAD™ and PREVNAR™ in Healthy Children 12 Months of Age
Brief Summary Hepatitis A vaccine will be given either alone or together with measles, mumps, rubella, and varicella vaccine and pneumococcal 7-valent conjugate vaccine at the first dose and together with measles, mumps, rubella, and varicella [Oka/Merck] virus vaccine at the second dose. Immunogenicity and safety data will be collected after each dose of vaccine.
Detailed Description

Vaccines: V251, Hepatitis A Vaccine, Inactivated (VAQTA™) administered with Measles, Mumps, Rubella and Varicella Vaccine (ProQuad™) and Pneumococcal 7-Valent Conjugate Vaccine (Prevnar™) will have a Duration of Treatment: 2 Doses, 6 months apart.

Vaccine: Hepatitis A Vaccine, Inactivated (VAQTA™), administered alone will have a Duration of Treatment: 2 Doses, 6 months apart.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hepatitis A Virus
Intervention  ICMJE
  • Biological: Comparator: VAQTA™ (Hepatitis A vaccine)
    VAQTA™ 0.5 mL injection
  • Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)
    ProQuad™ 0.5 mL injection
  • Biological: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)
    Prevnar™ 0.5 mL injection
Study Arms  ICMJE
  • Active Comparator: 1
    Arm 1: VAQTA™ 0.5 mL injection (2 doses 6 months apart), ProQuad™ 0.5 mL injection (2 doses 6 months apart), Prevnar™ 0.5 mL injection (one dose), all vaccines administered concomitantly. 28 weeks of study duration.
    Interventions:
    • Biological: Comparator: VAQTA™ (Hepatitis A vaccine)
    • Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)
    • Biological: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)
  • Active Comparator: 2
    Arm 2: ProQuad™ 0.5 mL injection (2 doses ~8 months apart), Prevnar™ 0.5 mL injection (one dose), both administered concomitantly, VAQTA™ 0.5 mL injection (2 doses 6 months apart) administered alone. 34 weeks of study duration.
    Interventions:
    • Biological: Comparator: VAQTA™ (Hepatitis A vaccine)
    • Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)
    • Biological: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)
Publications * Yetman RJ, Shepard JS, Duke A, Stek JE, Petrecz M, Klopfer SO, Kuter BJ, Schödel FP, Lee AW. Concomitant administration of hepatitis A vaccine with measles/mumps/rubella/varicella and pneumococcal vaccines in healthy 12- to 23-month-old children. Hum Vaccin Immunother. 2013 Aug;9(8):1691-7. doi: 10.4161/hv.24873. Epub 2013 Jun 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2008)
653
Original Enrollment  ICMJE
 (submitted: April 7, 2006)
600
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 12- to 15-month-old males and females with no active liver disease
  • A negative history of hepatitis A, measles, mumps, rubella, chickenpox, and/or zoster

Exclusion Criteria:

  • Males and females previously vaccinated with hepatitis A, measles, mumps, rubella, and/or chickenpox vaccine
  • Any immune deficiency
  • History of allergy to any of the vaccine components
  • History of any seizure disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 15 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Puerto Rico,   United States
 
Administrative Information
NCT Number  ICMJE NCT00312858
Other Study ID Numbers  ICMJE V251-067
2005_075
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date March 2017

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