Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine

Last updated: September 14, 2016
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Herpes Simplex Infections

Rash

Throat And Tonsil Infections

Treatment

N/A

Clinical Study ID

NCT00406211
208136/039
208136/041
208136/040
  • Ages 12-18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Follow-up to evaluate the immunogenicity and safety of three production lots of GSK Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GSK Biologicals' measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine (Varilrix®) in Germany & Austria. Blood samples were collected at three time points during the follow-up period (Year 1, 2 & 3). No new subjects will be enrolled in these follow-up phases of the study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent from the parents/guardians of the child before participatingin the long-term follow-up.

  • Subjects must have received their complete vaccination course according to the groupallocation (i.e. subjects must have received either two doses of MMRV combinedvaccine, or two doses of Priorix vaccine and one dose of Varilrix vaccine as separateinjections in the primary vaccination study.

  • Subjects were aged between 12 to 18 months of age at the time of the first vaccinationin the primary study.

Exclusion

Exclusion Criteria:

  • Subjects must not have received an additional dose of measles, mumps, rubella orvaricella containing vaccines.

Study Design

Total Participants: 398
Study Start date:
July 01, 2004
Estimated Completion Date:
December 31, 2004

Connect with a study center

  • GSK Investigational Site

    Klagenfurt, A-9020
    Austria

    Site Not Available

  • GSK Investigational Site

    Neufeld/Leitha, A 2491
    Austria

    Site Not Available

  • GSK Investigational Site

    Salzburg, A-5020
    Austria

    Site Not Available

  • GSK Investigational Site

    Villach, A-9500
    Austria

    Site Not Available

  • GSK Investigational Site

    Bindlach, Bayern 95463
    Germany

    Site Not Available

  • GSK Investigational Site

    Marktredwitz, Bayern 95615
    Germany

    Site Not Available

  • GSK Investigational Site

    Olching, Bayern 82140
    Germany

    Site Not Available

  • GSK Investigational Site

    Tegernsee, Bayern 83684
    Germany

    Site Not Available

  • GSK Investigational Site

    Tutzing, Bayern 82327
    Germany

    Site Not Available

  • GSK Investigational Site

    Bad Camberg, Hessen 65520
    Germany

    Site Not Available

  • GSK Investigational Site

    Fulda, Hessen 36037
    Germany

    Site Not Available

  • GSK Investigational Site

    Hochheim, Hessen 65239
    Germany

    Site Not Available

  • GSK Investigational Site

    Marburg/Lahn, Hessen 35039
    Germany

    Site Not Available

  • GSK Investigational Site

    Nidderau, Hessen 61130
    Germany

    Site Not Available

  • GSK Investigational Site

    Ruesselsheim, Hessen 65428
    Germany

    Site Not Available

  • GSK Investigational Site

    Wiesbaden, Hessen 65205
    Germany

    Site Not Available

  • GSK Investigational Site

    Salzgitter, Niedersachsen 38226
    Germany

    Site Not Available

  • GSK Investigational Site

    Wolfenbuettel, Niedersachsen 38302
    Germany

    Site Not Available

  • GSK Investigational Site

    Bochum, Nordrhein-Westfalen 44791
    Germany

    Site Not Available

  • GSK Investigational Site

    Detmold, Nordrhein-Westfalen 32756
    Germany

    Site Not Available

  • GSK Investigational Site

    Guetersloh, Nordrhein-Westfalen 33332
    Germany

    Site Not Available

  • GSK Investigational Site

    Kirchlengern, Nordrhein-Westfalen 32278
    Germany

    Site Not Available

  • GSK Investigational Site

    Loehne, Nordrhein-Westfalen 32584
    Germany

    Site Not Available

  • GSK Investigational Site

    Muenster, Nordrhein-Westfalen 48159
    Germany

    Site Not Available

  • GSK Investigational Site

    Bad Kreuznach, Rheinland-Pfalz 55543
    Germany

    Site Not Available

  • GSK Investigational Site

    Bad Sobernheim, Rheinland-Pfalz 55566
    Germany

    Site Not Available

  • GSK Investigational Site

    Frankenthal, Rheinland-Pfalz 67227
    Germany

    Site Not Available

  • GSK Investigational Site

    Gau-Algesheim, Rheinland-Pfalz 55435
    Germany

    Site Not Available

  • GSK Investigational Site

    Mainz, Rheinland-Pfalz 55116
    Germany

    Site Not Available

  • GSK Investigational Site

    Schoeneberg - Kuebelberg, Rheinland-Pfalz 66901
    Germany

    Site Not Available

  • GSK Investigational Site

    Trier, Rheinland-Pfalz 54290
    Germany

    Site Not Available

  • GSK Investigational Site

    Worms, Rheinland-Pfalz 67547
    Germany

    Site Not Available

  • GSK Investigational Site

    Altenholz, Schleswig-Holstein 24161
    Germany

    Site Not Available

  • GSK Investigational Site

    Bredstedt, Schleswig-Holstein 25821
    Germany

    Site Not Available

  • GSK Investigational Site

    Brunsbuettel, Schleswig-Holstein 25541
    Germany

    Site Not Available

  • GSK Investigational Site

    Flensburg, Schleswig-Holstein 24937
    Germany

    Site Not Available

  • GSK Investigational Site

    Husum, Schleswig-Holstein 25813
    Germany

    Site Not Available

  • GSK Investigational Site

    Neumuenster, Schleswig-Holstein 24534
    Germany

    Site Not Available

  • GSK Investigational Site

    Hamburg, 22089
    Germany

    Site Not Available

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