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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.
First Received: April 7, 2006   Last Updated: November 2, 2009   History of Changes
Sponsor: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00312858
  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 III

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Chickenpox Hepatitis Hepatitis A Measles Mumps Pneumonia Rubella Shingles
Drug Information available for: Heptavalent pneumococcal conjugate vaccine Hepatitis A Vaccines Pneumococcal Vaccines Chickenpox Vaccine
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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Participants With 1 or More Systemic Adverse Experience [ Time Frame: 6 weeks post dose 1 ] [ Designated as safety issue: Yes ]
  • Participants With 1 or More Systemic Adverse Experience [ Time Frame: 4 weeks post dose 2 ] [ Designated as safety issue: Yes ]
  • Participants With 1 or More Systemic Adverse Experience. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Participants With 1 or More Injection-site Adverse Experience [ Time Frame: 6 weeks post dose 1 ] [ Designated as safety issue: Yes ]
  • Participants With 1 or More Injection-site Adverse Experience [ Time Frame: 4 weeks post dose 2 ] [ Designated as safety issue: Yes ]
  • Participants With 1 or More Injection-site Adverse Experience [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Participants With Elevated Temperature (≥102.2F/ ≥39.0C) [ Time Frame: 6 weeks post dose 1 ] [ Designated as safety issue: Yes ]
  • Participants With Elevated Temperature (≥102.2F/ ≥39.0C) [ Time Frame: 4 weeks post dose 2 ] [ Designated as safety issue: Yes ]
  • Participants With Elevated Temperature (≥102.2F/ ≥39.0C) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Participants With 1 or More Serious Vaccine-related Adverse Experience [ Time Frame: 6 weeks post dose 1 ] [ Designated as safety issue: Yes ]
  • Participants With 1 or More Serious Vaccine-related Adverse Experience [ Time Frame: 4 weeks post dose 2 ] [ Designated as safety issue: Yes ]
  • Participants With 1 or More Serious Vaccine-related Adverse Experience [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Antibody Response to Hepatitis A - Geometric Mean Titer [ Time Frame: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™) ] [ Designated as safety issue: No ]
  • Antibody Response to Varicella - Geometric Mean Titer [ Time Frame: 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™) ] [ Designated as safety issue: No ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

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
1: Active Comparator
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
2: Active Comparator
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
PhRMA Clinical Study Results Database - web-based repository for clinical study results  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: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2005_075, V251-067
Study First Received: April 7, 2006
Results First Received: March 24, 2009
Last Updated: November 2, 2009
ClinicalTrials.gov Identifier: NCT00312858     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Hepatitis A Virus

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

ClinicalTrials.gov processed this record on November 30, 2009



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