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

Measles Clinical Trial

Official title:

Follow-up to Evaluate the the Immunogenicity & Safety of GSK Biologicals' MMRV Vaccine Given as a Two-dose Schedule in the Second Year of Life, as Compared to Separate Administration of GSK Biologicals' Priorix® & Varilrix®.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00406211
• Other study ID #: 208136/039
• Secondary ID: 208136/040208136
• Status: Completed
• Phase: Phase 3
• First received: December 1, 2006
• Last updated: September 14, 2016
• Start date: July 2004
• Est. completion date: December 2004

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 18 Months

Eligibility

Inclusion Criteria:

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

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

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

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Measles
• Mumps
• Rubella
• Varicella

Intervention

Biological:
• MMRV

• MMR (Priorix®)

• Varicella (Varilrix®)

Locations

Country	Name	City	State
Austria	GSK Investigational Site	Klagenfurt
Austria	GSK Investigational Site	Neufeld/Leitha
Austria	GSK Investigational Site	Salzburg
Austria	GSK Investigational Site	Villach
Germany	GSK Investigational Site	Altenholz	Schleswig-Holstein
Germany	GSK Investigational Site	Bad Camberg	Hessen
Germany	GSK Investigational Site	Bad Kreuznach	Rheinland-Pfalz
Germany	GSK Investigational Site	Bad Sobernheim	Rheinland-Pfalz
Germany	GSK Investigational Site	Bindlach	Bayern
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bredstedt	Schleswig-Holstein
Germany	GSK Investigational Site	Brunsbuettel	Schleswig-Holstein
Germany	GSK Investigational Site	Detmold	Nordrhein-Westfalen
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Frankenthal	Rheinland-Pfalz
Germany	GSK Investigational Site	Fulda	Hessen
Germany	GSK Investigational Site	Gau-Algesheim	Rheinland-Pfalz
Germany	GSK Investigational Site	Guetersloh	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hochheim	Hessen
Germany	GSK Investigational Site	Husum	Schleswig-Holstein
Germany	GSK Investigational Site	Kirchlengern	Nordrhein-Westfalen
Germany	GSK Investigational Site	Loehne	Nordrhein-Westfalen
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Marburg/Lahn	Hessen
Germany	GSK Investigational Site	Marktredwitz	Bayern
Germany	GSK Investigational Site	Muenster	Nordrhein-Westfalen
Germany	GSK Investigational Site	Neumuenster	Schleswig-Holstein
Germany	GSK Investigational Site	Nidderau	Hessen
Germany	GSK Investigational Site	Olching	Bayern
Germany	GSK Investigational Site	Ruesselsheim	Hessen
Germany	GSK Investigational Site	Salzgitter	Niedersachsen
Germany	GSK Investigational Site	Schoeneberg - Kuebelberg	Rheinland-Pfalz
Germany	GSK Investigational Site	Tegernsee	Bayern
Germany	GSK Investigational Site	Trier	Rheinland-Pfalz
Germany	GSK Investigational Site	Tutzing	Bayern
Germany	GSK Investigational Site	Wiesbaden	Hessen
Germany	GSK Investigational Site	Wolfenbuettel	Niedersachsen
Germany	GSK Investigational Site	Worms	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (4)

Habermehl P, Zepp F, Sänger R, Otto W, Helm K, Meister N, Knuf M, Kindler K, Willems P. Assessment of Varicella Breakthrough Cases One Year after Administration of Two Doses of a Measles, Mumps, Rubella, Varicella Vaccine in the Second Year of Life. Abstract presented at the 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 03-05 May 2006.

Knuf M, Faber J, Barth I, Habermehl P. A combination vaccine against measles, mumps, rubella and varicella. Drugs Today (Barc). 2008 Apr;44(4):279-92. Review. — View Citation

Knuf M, Zepp F, Helm K, Maurer H, Prieler A, Kieninger-Baum D, Douha M, Willems P. Antibody persistence for 3 years following two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children. Eur J Pediatr. 2012 Mar;171(3):463-70. doi: 10.1007/s00431-011-1569-4. Epub 2011 Sep 21. — View Citation

Zepp F et al. Persistence of Functional Antibodies against Mumps Remains High One Year after Administration of Two Doses of a Measles, Mumps, Rubella, Varicella (MMRV) Vaccine in the Second Year of Life. Presented at 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 03-05 May 2006.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year			No
Primary	Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination			No

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