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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00197015
Other study ID # 208109/231
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 6, 2003
Est. completion date June 9, 2009

Study information

Verified date October 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a measles/mumps/rubella vaccine and a varicella (chickenpox) vaccine in children as young as 15 months of age.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Description:

An open, controlled comparison of Havrix™ administered alone or with MMR II and Varivax™. The three groups evaluated are: 1) Havrix™ alone, 2) Havrix™ + MMR II and Varivax™ and 3) MMR II and Varivax™ followed by Havrix™ one month later.


Recruitment information / eligibility

Status Completed
Enrollment 1474
Est. completion date June 9, 2009
Est. primary completion date June 9, 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 13 Months
Eligibility Inclusion Criteria:

- Subjects whose parents/guardians are believed by the investigator to be willing to comply with the requirements of the protocol

- A male or female child 12 and 13 months of age at the time of entry into the Enrollment Phase

- Written informed consent obtained from the parents or guardian of the subject,

- Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study, and

- Parents/guardian of the subject must have a telephone or be able to be contacted by telephone

Exclusion Criteria:

- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 42 days preceding the first dose of study vaccine, or planned use during the study period, Chronic administration (defined as more than 14 days) of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period. (For corticosteroids, this will mean prednisone, or equivalent, =0.5 mg/kg/day. Inhaled, nasal and topical steroids are allowed.) Planned administration or administration of any vaccine not foreseen by the study protocol during the period 31 days before and 31 days after each dose of study vaccine(s).

- Previous vaccination against hepatitis A,

- History of hepatitis A,

- Known exposure to hepatitis A,

- Previous vaccination against measles, mumps, rubella and/or varicella,

- History of measles, mumps, rubella and/or varicella,

- Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the start of the study,

- Planned chronic use of salicylates during the 6-week period following administration of the doses of study vaccine(s),

- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection,

- A family history of congenital, hereditary or infectious immunodeficiency or parental risk factors for HIV infection,

- History of allergic disease/reactions or hypersensitivity likely to be exacerbated by any component of HavrixTM, M-M-RII or VARIVAXTM, including 2-phenoxyethanol, neomycin and gelatin,

- History of anaphylactic or anaphylactoid reactions to egg proteins,

- History of hypersensitivity/allergic reaction to latex. Note: The tip cap and the rubber plunger of the HavrixTM needleless pre-filled syringes contain dry natural latex rubber.

- Major congenital defects or serious chronic illness,

- Active untreated tuberculosis,

- History of significant blood dyscrasias

- History of any neurologic disorder (a history of febrile seizures not associated with an underlying neurological disorder does not exclude the subject)

- Acute disease at the time of vaccination

- Administration of immunoglobulins and/or any blood products within three months prior to the first dose of study vaccine or planned administration at any time during the entire study period

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Havrix®
2 doses administered intramuscularly
M-M-R®II
1 dose administered subcutaneously
VARIVAX®
1 dose administered subcutaneously

Locations

Country Name City State
United States GSK Investigational Site Albany New York
United States GSK Investigational Site Austin Texas
United States GSK Investigational Site Baltimore Maryland
United States GSK Investigational Site Beaver Falls Pennsylvania
United States GSK Investigational Site Bossier City Louisiana
United States GSK Investigational Site Bristol Tennessee
United States GSK Investigational Site Brooklyn New York
United States GSK Investigational Site Cabot Arkansas
United States GSK Investigational Site Cleveland Ohio
United States GSK Investigational Site Henderson Nevada
United States GSK Investigational Site Huntington Beach California
United States GSK Investigational Site Jacksonville Florida
United States GSK Investigational Site Jonesboro Arkansas
United States GSK Investigational Site Kingsport Tennessee
United States GSK Investigational Site Kingsport Tennessee
United States GSK Investigational Site Las Vegas Nevada
United States GSK Investigational Site Layton Utah
United States GSK Investigational Site Lexington Kentucky
United States GSK Investigational Site Lumberton North Carolina
United States GSK Investigational Site Marietta Georgia
United States GSK Investigational Site Marshfield Wisconsin
United States GSK Investigational Site Norfolk Virginia
United States GSK Investigational Site Norristown Pennsylvania
United States GSK Investigational Site North Little Rock Arkansas
United States GSK Investigational Site Norwich Connecticut
United States GSK Investigational Site Oakland California
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Rochester New York
United States GSK Investigational Site Rolling Hills Estates California
United States GSK Investigational Site Rydal Pennsylvania
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site Sellersville Pennsylvania
United States GSK Investigational Site South Jordan Utah
United States GSK Investigational Site Sylva North Carolina
United States GSK Investigational Site Syracuse New York
United States GSK Investigational Site Temple Texas
United States GSK Investigational Site Tulsa Oklahoma
United States GSK Investigational Site University Heights Ohio
United States GSK Investigational Site Warwick Rhode Island
United States GSK Investigational Site Waterloo Iowa
United States GSK Investigational Site Waukee Iowa

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rinderknecht S, Michaels MG, Blatter M, Gaglani M, Andrews W, Abughali N, Chandreshekaran V, Trofa AF. Immunogenicity and safety of an inactivated hepatitis A vaccine when coadministered with measles-mumps-rubella and varicella vaccines in children less than 2 years of age. Pediatr Infect Dis J. 2011 Oct;30(10):e179-85. doi: 10.1097/INF.0b013e31822256a5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups. Concentrations are given as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL). 31 days following the second dose of Havrix®
Primary Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups Anti-HAV antibody cut-off value assessed include 15 milli-international units per milliliter (mIU/mL). 31 days following the second dose of Havrix®
Primary Number of Subjects Seroconverted for Anti-measle, Anti-mumps and Anti-varicella Antibodies in HAV+MMR+V and MMR+V?HAV Groups Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 150 milli-international units per milliliter (mIU/mL) for anti-measles antibodies, 28 Effective Dose 50 (ED50) for anti-mumps antibodies and 1:5 for anti-varicella antibodies. 42 days following the administration of M-M-R®II and VARIVAX®
Primary Number of Subjects With Vaccine Response for Anti-rubella Antibodies in HAV+MMR+V and MMR+V?HAV Groups Vaccine response is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off value assessed include 10 milli-international units per milliliter (mIU/mL). 42 days following administration of M-M-R®II and VARIVAX®
Secondary Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella Antibody Titers in HAV+MMR+V and MMR+V?HAV Groups Titers are given as geometric mean titers (GMTs). 42 days following the administration of M-M-R®II and VARIVAX®
Secondary Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups Concentrations are given as geometric mean concentrations (GMCs). 42 days following the first dose of Havrix®
Secondary Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups Anti-HAV antibody cut-off value assessed include 15 milli-international units per millilitre (mIU/mL). 42 days following the first dose of Havrix®
Secondary Anti-hepatitis A Virus (HAV) Antibody Concentrations in MMR+V?HAV Group Concentrations are given as geometric mean concentrations (GMCs). 31 days following the second dose of Havrix®
Secondary Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value in MMR+V?HAV Group Anti-HAV antibody cut-off value assessed include 15 milli-international units per millilitre (mIU/mL). 31 days following the second dose of Havrix®
Secondary Number of Subjects With Vaccine Response to Havrix® Vaccine response was defined as: 1) a detectable anti-hepatitis A virus (HAV) antibody concentration 31 days following the second dose in subjects who were initially seronegative; and 2) a 2-fold increase in anti-HAV antibody concentrations above the pre-study concentration 31 days following the second dose in subjects who were initially seropositive. 31 days following the second dose of Havrix®
Secondary Number of Subjects Reporting Solicited Local Symptoms Solicited local symptoms assessed include pain, rash (local), redness and swelling. During the 4-day period following each dose of vaccine
Secondary Number of Subjects Reporting Solicited General Symptoms Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite and rash (general). During the 4-day period following each dose of vaccine
Secondary Number of Subjects Reporting Measles, Mumps, Rubella and Varicella Specific Solicited General Adverse Events Specific adverse events assessed include papules, vesicles, crusts, parotid/salivary gland swelling and suspected signs of meningitis/febrile seizures. During the 43-day period following each dose of vaccine
Secondary Number of Subjects Reporting Unsolicited Adverse Events (AEs) Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms During the 31-day period following each dose of vaccine
Secondary Number of Subjects Reporting Serious Adverse Events (SAEs) SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)
Secondary Number of Subjects Reporting New Chronic Illnesses New Chronic illnesses include autoimmune disorders, asthma, type I diabetes, allergies. During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)
Secondary Number of Subjects Reporting Medically Significant Events Medically significant events include, but are not limited to, diabetes, autoimmune disease, asthma, allergies and/or conditions prompting emergency room or physician office visits that are not related to well-child care, vaccination or common acute illnesses (e.g., upper respiratory infection, otitis media, pharyngitis, gastroenteritis, injury and visits for routine physical examination). During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)
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