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
Sponsor study identifier
Secondary identifiers
interventional
653
0 countries
N/A
Study Start
April 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2008
Actual (reported)Study Completion
March 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2006
Date type not reportedThis date has not been verified as actual or estimated.
April 7, 2006
Actual (reported)April 11, 2006
Actual (reported)March 2008
Actual (reported)March 2008
Actual (reported)August 3, 2009
Actual (reported)Antibody Response to Hepatitis A - Participants With a Serological Response
Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus
4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)
Antibody Response to Varicella - Participants With a Serological Response
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)
6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)
Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers
Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay
6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Participants With 1 or More Systemic Adverse Experience
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.
6 weeks post dose 1
Antibody Response to Hepatitis A - Geometric Mean Titer
4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)
Antibody Response to Varicella - Geometric Mean Titer
6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)
Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response
6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
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.
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.
VAQTA™ 0.5 mL injection
ProQuad™ 0.5 mL injection
Yetman RJ, Shepard JS, Duke A, Stek JE, Petrecz M, Klopfer SO, Kuter BJ, Schodel FP, Lee AW. Concomitant administration of hepatitis A vaccine with measles/mumps/rubella/varicella and pneumococcal vaccines in healthy 12- to 23-month-old children. Hum Vaccin Immunother. 2013 Aug;9(8):1691-7. doi: 10.4161/hv.24873. Epub 2013 Jun 6.
Medical Monitor
Merck Sharp & Dohme LLC
653 participants (actual enrollment reported by the registry).
First Submitted
April 7, 2006
First Posted
April 11, 2006
Study Start
April 2006
Date type not reportedThis date has not been verified as actual or estimated.
Participants With 1 or More Systemic Adverse Experience
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.
4 weeks post dose 2
Participants With 1 or More Systemic Adverse Experience.
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
6 months
Participants With 1 or More Injection-site Adverse Experience
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.
6 weeks post dose 1
Participants With 1 or More Injection-site Adverse Experience
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.
4 weeks post dose 2
Participants With 1 or More Injection-site Adverse Experience
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.
6 months
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
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.
6 weeks post dose 1
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
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.
4 weeks post dose 2
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
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.
6 months
Participants With 1 or More Serious Vaccine-related Adverse Experience
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
6 weeks post dose 1
Participants With 1 or More Serious Vaccine-related Adverse Experience
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
4 weeks post dose 2
Participants With 1 or More Serious Vaccine-related Adverse Experience
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
6 months
Prevnar™ 0.5 mL injection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 2008
Actual (reported)Study Completion
March 2008
Actual (reported)Last Updated
April 13, 2017
Results First Posted
August 3, 2009
Record last verified: 2017-03
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
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Source: ClinicalTrials.gov.
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