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)

Merck Sharp & Dohme LLC653 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

653

Conditions

Hepatitis A Virus

Interventions

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

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 15 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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)

Time frame: 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

Time frame: 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.

Time frame: 6 weeks post dose 1

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.

Time frame: 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

Data from ClinicalTrials.gov

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