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Hepatitis APhase 3NCT00197015

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

A Phase 3 study testing Havrix®, M-M-R®II and VARIVAX® in people with Hepatitis A, run by GlaxoSmithKline at 42 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 12 to 13 monthsHealthy volunteers can take part
Conditions the study is for
Hepatitis A
What is being tested?
Havrix®, M-M-R®II and VARIVAX®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,474 participants
Where
42 sitesUnited States
Study dates
6 Oct 2003to 9 Jun 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 13 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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,
Show all 19Show fewer
  • 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

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

United States42 sites

  • GSK Investigational Site

    Albany, New York, 12208

  • GSK Investigational Site

    Austin, Texas, 78758

  • GSK Investigational Site

    Baltimore, Maryland, 21201

  • GSK Investigational Site

    Beaver Falls, Pennsylvania, 15010

  • GSK Investigational Site

    Bossier City, Louisiana, 71111

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Brooklyn, New York, 11203

  • GSK Investigational Site

    Cabot, Arkansas, 72023

  • GSK Investigational Site

    Cleveland, Ohio, 44109

  • GSK Investigational Site

    Henderson, Nevada, 89015

  • GSK Investigational Site

    Huntington Beach, California, 92647

  • GSK Investigational Site

    Jacksonville, Florida, 32209

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    Kingsport, Tennessee, 37660

  • GSK Investigational Site

    Kingsport, Tennessee, 37664

  • GSK Investigational Site

    Las Vegas, Nevada, 89014

  • GSK Investigational Site

    Layton, Utah, 84041

  • GSK Investigational Site

    Lexington, Kentucky, 40503

  • GSK Investigational Site

    Lumberton, North Carolina, 28358

  • GSK Investigational Site

    Marietta, Georgia, 30062

  • GSK Investigational Site

    Marshfield, Wisconsin, 54449

  • GSK Investigational Site

    Norfolk, Virginia, 23510

  • GSK Investigational Site

    Norristown, Pennsylvania, 19401

  • GSK Investigational Site

    North Little Rock, Arkansas, 72117

  • GSK Investigational Site

    Norwich, Connecticut, 06360

  • GSK Investigational Site

    Oakland, California, 94609

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15241

  • GSK Investigational Site

    Rochester, New York, 14620

  • GSK Investigational Site

    Rolling Hills Estates, California, 90274

  • GSK Investigational Site

    Rydal, Pennsylvania, 19046

  • GSK Investigational Site

    San Antonio, Texas, 78205-2489

  • GSK Investigational Site

    Sellersville, Pennsylvania, 18960

  • GSK Investigational Site

    South Jordan, Utah, 84095

  • GSK Investigational Site

    Sylva, North Carolina, 28779

  • GSK Investigational Site

    Syracuse, New York, 13210

  • GSK Investigational Site

    Temple, Texas, 76508

  • GSK Investigational Site

    Tulsa, Oklahoma, 74104

  • GSK Investigational Site

    University Heights, Ohio, 44118

  • GSK Investigational Site

    Warwick, Rhode Island, 02886

  • GSK Investigational Site

    Waterloo, Iowa, 50702

  • GSK Investigational Site

    Waukee, Iowa, 50263

Other trials in United States

About this 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 Months 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.

Read the 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.

Conditions
Hepatitis A
Being tested
Havrix®, M-M-R®II, VARIVAX®
Medical subject headings
Hepatitis A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Havrix®Biological

    2 doses administered intramuscularly

  • M-M-R®IIBiological

    1 dose administered subcutaneously

  • VARIVAX®Biological

    1 dose administered subcutaneously

Study groups in NCT00197015
Study groupRoleWhat they receive
HAV GroupActive comparatorSubjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
Receives: Biological: Havrix®
HAV+MMR+V GroupExperimentalSubjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
Receives: Biological: Havrix®; Biological: M-M-R®II; Biological: VARIVAX®
MMR+V→HAV GroupActive comparatorSubjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
Receives: Biological: Havrix®; Biological: M-M-R®II; Biological: VARIVAX®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 31 days following the second dose of Havrix®

  2. 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).

    Measured: 31 days following the second dose of Havrix®

  3. 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.

    Measured: 42 days following the administration of M-M-R®II and VARIVAX®

  4. 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).

    Measured: 42 days following administration of M-M-R®II and VARIVAX®

Secondary outcomes (13)

  1. 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).

    Measured: 42 days following the administration of M-M-R®II and VARIVAX®

  2. Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups

    Concentrations are given as geometric mean concentrations (GMCs).

    Measured: 42 days following the first dose of Havrix®

  3. 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).

    Measured: 42 days following the first dose of Havrix®

  4. Anti-hepatitis A Virus (HAV) Antibody Concentrations in MMR+V→HAV Group

    Concentrations are given as geometric mean concentrations (GMCs).

    Measured: 31 days following the second dose of Havrix®

  5. 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).

    Measured: 31 days following the second dose of Havrix®

  6. 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.

    Measured: 31 days following the second dose of Havrix®

  7. Number of Subjects Reporting Solicited Local Symptoms

    Solicited local symptoms assessed include pain, rash (local), redness and swelling.

    Measured: During the 4-day period following each dose of vaccine

  8. Number of Subjects Reporting Solicited General Symptoms

    Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite and rash (general).

    Measured: During the 4-day period following each dose of vaccine

  9. 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.

    Measured: During the 43-day period following each dose of vaccine

  10. 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

    Measured: During the 31-day period following each dose of vaccine

  11. 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.

    Measured: 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)

  12. Number of Subjects Reporting New Chronic Illnesses

    New Chronic illnesses include autoimmune disorders, asthma, type I diabetes, allergies.

    Measured: 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)

  13. 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).

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study start6 Oct 2003
  3. Primary completion9 Jun 2009
  4. Study completion9 Jun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,474 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00197015
Sponsor's protocol ID
208109/231
Status last verified
Oct 2016
First submitted
13 Sep 2005
Last updated
31 Jul 2018
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • 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.

    PubMed 21617573

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Havrix®, M-M-R®II and VARIVAX® in people with Hepatitis A, run by GlaxoSmithKline at 42 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups. (time frame: 31 days following the second dose of Havrix®). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00197015, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.

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