Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00197015

Purpose

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.

Condition	Intervention	Phase
Hepatitis A	Biological: Havrix™ Biological: VARIVAX™ Biological: M-M-RII	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Immunogenicity & Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-administered With Merck & Company, Inc. Measles-Mumps-Rubella Vaccine (M-M-RII) & Merck & Co Varicella Vaccine (VARIVAX™) to Children 15 m of Age

Resource links provided by NLM:

MedlinePlus related topics: Chickenpox Hepatitis Hepatitis A Measles Mumps Rubella Shingles

Drug Information available for: Hepatitis A Vaccines Chickenpox Vaccine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-HAV antibody concentrations in the HAV Group and the HAV+MMR+V Group. [ Time Frame: 31 days following the second dose of Havrix™ ] [ Designated as safety issue: No ]
Anti-measles, anti-mumps and anti-varicella seroconversion rates and anti-rubella seroresponse rate in the HAV+MMR+V Group and the MMR+V→HAV Group, [ Time Frame: 42 days following the administration of M-M-RII and VARIVAX™ ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Anti-measles, anti-mumps, anti-rubella and anti-varicella GMCs in the HAV+MMR+V Group and the MMR+V→HAV Group [ Time Frame: 42 days following the administration of M-M-RII and VARIVAX™ ] [ Designated as safety issue: No ]
Anti-HAV antibody concentrations in the HAV Group and the HAV+MMR+V Group [ Time Frame: 42 days following the first dose of Havrix™ ] [ Designated as safety issue: No ]
Anti-HAV antibody concentrations in the MMR+V→HAV Group [ Time Frame: 31 days following the second dose of Havrix™ ] [ Designated as safety issue: No ]
Vaccine response to Havrix™ in all three groups [ Time Frame: 31 days following the second dose ] [ Designated as safety issue: No ]
Incidence and intensity of solicited local adverse events (AEs) in each group [ Time Frame: During the 4-day period following each dose of study vaccine(s) ] [ Designated as safety issue: No ]
Incidence, intensity and causal relationship to vaccination of solicited general AEs in each group [ Time Frame: During the 4-day period following each dose of study vaccine(s) ] [ Designated as safety issue: No ]
Incidence, intensity and causal relationship to vaccination of MMR+V specific solicited general AEs in each group [ Time Frame: During the 43-day period following each dose of study vaccine(s) ] [ Designated as safety issue: No ]
Incidence, nature, intensity and causal relationship to vaccination of unsolicited AEs in each group [ Time Frame: During the 31-day period following each dose of study vaccine(s) ] [ Designated as safety issue: No ]
Incidence, nature, intensity and causal relationship to vaccination of serious adverse events (SAEs), new chronic illnesses and medically significant events in each group [ Time Frame: During the Active Phase and the Extended Safety Follow-up Phase of the study. ] [ Designated as safety issue: No ]

Enrollment:	1474
Study Start Date:	October 2003
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
HAV Group: Active Comparator	Biological: Havrix™ 2 IM injections, 6 months apart
MMR+V→HAV Group: Active Comparator	Biological: VARIVAX™ 1 SC injection, in the right deltoid Biological: M-M-RII 1 SC injection, in the left deltoid
HAV+MMR+V Group: Experimental	Biological: VARIVAX™ 1 SC injection, in the right deltoid Biological: M-M-RII 1 SC injection, in the left deltoid

Detailed 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.

Eligibility

Ages Eligible for Study:	12 Months to 13 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197015

Show 38 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	208109/231
Study First Received:	September 13, 2005
Last Updated:	October 29, 2009
ClinicalTrials.gov Identifier:	NCT00197015 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Picornaviridae Infections

Hepatitis, Viral, Human
Hepatitis A
Chickenpox
DNA Virus Infections
Enterovirus Infections
Herpesviridae Infections

ClinicalTrials.gov processed this record on November 09, 2009