Comparator: VAQTA™ (Hepatitis A vaccine)
BiologicalVAQTA™ 0.5 mL injection
NCT Number: NCT00312858
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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Notify Me12 month–15 month
All sexes
Interventional
Phase 4
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
VAQTA™ 0.5 mL injection
ProQuad™ 0.5 mL injection
Prevnar™ 0.5 mL injection
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
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)
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
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.
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.
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
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.
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.
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.
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.
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.
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.
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
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
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
Time frame: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)
Geometric Mean Titer of hepatitis A antibody, regardless of initial serostatus
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
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
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
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
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
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
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
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
Merck Sharp & Dohme LLC
Industry
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
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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