| September 13, 2005 |
| October 29, 2009 |
| October 2003 |
| January 2009 (final data collection date for primary outcome measure) |
- 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 ]
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- "Immune response for Havrix following the second dose of Havrix in both the Havrix group and the Havrix + MMR II and Varivax group.
- Immune responses for MMR II and Varivax following vaccination in both the Havrix + MMR II and Varivax group and the MMR II and Varivax followed by Havrix group. "
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| Complete list of historical versions of study NCT00197015 on ClinicalTrials.gov Archive Site |
- 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 ]
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| Immune response for Havrix following the first dose of Havrix in all groups. The other secondary outcome measure is safety of the study vaccines |
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| Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children |
| 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 |
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. |
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. |
| Phase III |
| Interventional |
| Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Hepatitis A |
- Biological: Havrix™
- Biological: VARIVAX™
- Biological: M-M-RII
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| |
| |
| |
| Completed |
| 1474 |
| January 2009 |
| January 2009 (final data collection date for primary outcome measure) |
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
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| Both |
| 12 Months to 13 Months |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00197015 |
| Study Director, GSK |
| 208109/231 |
| GlaxoSmithKline |
|
| Study Director: |
GSK Clinical Trials |
GlaxoSmithKline |
|
|
| GlaxoSmithKline |
| October 2009 |