A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Given to Healthy Children 4 to 6 Years of Age

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age4-6
SponsorGlaxoSmithKline

About this trial

The purpose of this study is to evaluate how consistently 3 different manufacturing lots of the GSK's investigational measles, mumps, rubella, and varicella (MMRVNS) vaccine will produce an immune response. It will also compare the overall immune response to the MMRVNS vaccine with that of the Merck licensed measles, mumps, rubella, and varicella (MMRV) vaccine.

The vaccines will be given as a second dose to children aged 4 to 6 years who have previously received a first dose of any combination of measles, mumps, rubella, and varicella-containing vaccine(s).

The study will also assess the immune response and safety of the MMRVNS and MMRV vaccines when given at the same time as a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus (DTaP-IPV) vaccine. The DTaP-IPV vaccine used is licensed as Kinrix in the United States.

Eligibility criteria

Qualifiers

INC#1 Participant's parent(s)/LAR(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiaries, return for follow-up visits).

INC#2 Written or witnessed/thumb printed or digital informed consent obtained from the participant's parent(s)/LAR(s) prior to performance of any study specific procedure.

INC#3 Informed assent obtained from the participants in line with local rules and regulations.

INC#4 Healthy participants as established by medical history and clinical examination at screening.

Disqualifiers

EXC#1 History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, including hypersensitivity to neomycin or gelatin.

EXC#2 Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

EXC#3 Hypersensitivity to latex.

EXC#4 Unstable chronic conditions as determined by medical history and physical examination.

Trial design

Treatments tested in this trial

  • MMRVNS vaccine
  • MMRV vaccine
  • DTaP-IPV vaccine

Treatment groups

1,860 Participants
are divided into 4 treatment groups

Sponsors and collaborators