Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life

Summary

The purpose of this study is to evaluate end of shelf-life potency in terms of the immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to Merck \& Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).

Timeline

Start

2012-10-10

Primary completion

2015-02-03

Completion

2015-08-18

Outcome

Mixed primary results

registry The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv\_MMR\_Min/Inv\_MMR\_Med was to be ≥ 90% for antibodies to measles virus. NCT01681992 ↗

registry NUMBER Inv_MMR_Min Group: Anti-measles ≥ 200 mIU/mL: 90.8 (88.9 to 92.5) Percentage of subjects NCT01681992 ↗

registry NUMBER Inv_MMR_Med Group: Anti-measles ≥ 200 mIU/mL: 94.2 (92.6 to 95.5) Percentage of subjects NCT01681992 ↗

Publications

• Background MMR-161 Study Group. Immunogenicity and safety of measles-mumps-rubella vaccine at two different potency levels administered to healthy children aged 12-15 months: A phase III, randomized, non-inferiority trial. Vaccine. 2018 Sep 11;36(38):5781-5788. doi: 10.1016/j.vaccine.2018.07.076. Epub 2018 Aug 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	M-M-R II	Vaccine	—	Subcutaneous
Subject	Priorix	Vaccine	—	Subcutaneous
Background	Havrix	Vaccine	—	Intramuscular
Background	Prevnar 13	Vaccine	—	Intramuscular
Background	Varivax	Vaccine	—	Subcutaneous

Indications