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OpenTrials
Completed

NCT Number: NCT00312858

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)

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.

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Key information

Age range

12 month–15 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: VAQTA™ (Hepatitis A vaccine)

Biological

VAQTA™ 0.5 mL injection

Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)

Biological

ProQuad™ 0.5 mL injection

Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)

Biological

Prevnar™ 0.5 mL injection

Primary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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

  15. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 11, 2006
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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