Clinical trial 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)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis A Virus
Keywords: Hepatitis A Virus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-04-11
Enrollment: 653
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: Antibody Response to Hepatitis A - Participants With a Serological Response
timeFrame: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)
measure: Antibody Response to Varicella - Participants With a Serological Response
timeFrame: 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)
measure: Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers
timeFrame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
measure: Participants With 1 or More Systemic Adverse Experience
timeFrame: 6 weeks post dose 1
measure: Participants With 1 or More Systemic Adverse Experience
timeFrame: 4 weeks post dose 2
measure: Participants With 1 or More Systemic Adverse Experience.
timeFrame: 6 months
measure: Participants With 1 or More Injection-site Adverse Experience
timeFrame: 6 weeks post dose 1
measure: Participants With 1 or More Injection-site Adverse Experience
timeFrame: 4 weeks post dose 2
measure: Participants With 1 or More Injection-site Adverse Experience
timeFrame: 6 months
measure: Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
timeFrame: 6 weeks post dose 1
measure: Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
timeFrame: 4 weeks post dose 2
measure: Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
timeFrame: 6 months
measure: Participants With 1 or More Serious Vaccine-related Adverse Experience
timeFrame: 6 weeks post dose 1
measure: Participants With 1 or More Serious Vaccine-related Adverse Experience
timeFrame: 4 weeks post dose 2
measure: Participants With 1 or More Serious Vaccine-related Adverse Experience
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Antibody Response to Hepatitis A - Geometric Mean Titer
timeFrame: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)
measure: Antibody Response to Varicella - Geometric Mean Titer
timeFrame: 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)
measure: Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response
timeFrame: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
measure: Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response
timeFrame: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
measure: Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response
timeFrame: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
measure: Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response
timeFrame: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
measure: Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response
timeFrame: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
measure: Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response
timeFrame: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
measure: Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response
timeFrame: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.