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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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00312858
First received: April 7, 2006
Last updated: April 7, 2010
Last verified: April 2010
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00312858

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00312858     History of Changes
Other Study ID Numbers: 2005_075, V251-067
Study First Received: April 7, 2006
Results First Received: March 24, 2009
Last Updated: April 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Hepatitis A Virus

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

ClinicalTrials.gov processed this record on May 23, 2013