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)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00312858
First received: April 7, 2006
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis A Virus
Biological: Comparator: VAQTA™ (Hepatitis A vaccine)
Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)
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: Open, Randmzd., Multictr Study of the Safety, Tolerability, & Immunogenicity of Hepatitis A Vaccine, Inactivated Given Concomitantly With Measles, Mumps, Rubella, & Varicella [Oka/Merck] Virus Vaccine Live & Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM197 Protein) in Healthy 12-Month-Olds

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Antibody Response to Hepatitis A - Participants With a Serological Response [ Time Frame: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™) ] [ Designated as safety issue: No ]
    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™) ] [ Designated as safety issue: No ]
    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 S. Pneumoniae Serotype 4 - Participants With a Serological Response [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ Designated as safety issue: No ]
    Number of participants with 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™) ] [ Designated as safety issue: No ]
    Number of participants with 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™) ] [ Designated as safety issue: No ]
    Number of participants with 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™) ] [ Designated as safety issue: No ]
    Number of participants with 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™) ] [ Designated as safety issue: No ]
    Number of participants with 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™) ] [ Designated as safety issue: No ]
    Number of participants with 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™) ] [ Designated as safety issue: No ]
    Number of participants with postvaccination titer ≥0.2 mcg/mL for S. Pneumoniae serotype 23F

  • Participants With 1 or More Systemic Adverse Experience [ Time Frame: 6 weeks post dose 1 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

  • Antibody Response to Hepatitis A - Geometric Mean Titer [ Time Frame: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™) ] [ Designated as safety issue: No ]
    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™) ] [ Designated as safety issue: No ]
    Geometric Mean Titer of varicella antibody, baseline antibody titer was <1.25 gpELISA units/mL

  • Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ 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 of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ 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 of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ 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 of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ 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 of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ 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 of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ 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 of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ Designated as safety issue: No ]
    Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F


Enrollment: 653
Study Start Date: April 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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.

  Eligibility

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

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
  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: NCT00312858

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

Additional Information:
No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00312858     History of Changes
Other Study ID Numbers: V251-067, 2005_075
Study First Received: April 7, 2006
Results First Received: March 24, 2009
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Hepatitis A Virus

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Digestive System Diseases
Enterovirus Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014