Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02184572
• Date of registration: 03/07/2014
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age
• Scientific title: Safety and Immunogenicity Study of GSK Biologicals' Measles-mumps-rubella (MMR) Vaccine (209762) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine, in Healthy Children 12 to 15 Months of Age
• Date of first enrolment: August 25, 2014
• Target sample size: 1742
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02184572
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Estonia, Finland, Puerto Rico, Taiwan, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female child between 12 and 15 months of age (e.g., from the 1 year birthday
until the day before age 16 months) at the time of vaccination.

- Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion
of the investigator, can and will comply, with the requirements of the protocol.

- Written informed consent obtained from the parent(s)/LAR(s) of the child.

- Child is in stable health as determined by investigator's clinical examination and
assessment of child's medical history.

- For US children only: a child who received all routine vaccinations as per ACIP
recommendations prior to study entry: completion of hepatitis B and rotavirus series
and completion of the primary series of diphtheria, tetanus, pertussis, poliovirus,
Haemophilus influenzae type b (Hib) and pneumococcal vaccines. The 3-dose infant
series of Prevnar 13 should be completed at least 60 days prior to study vaccination.

Exclusion Criteria:

- Child in care.

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) during the period starting 30 days before the day of study
vaccination (i.e., 30 days prior to Day 0) or planned use during the entire study
period.

- Concurrently participating in another clinical study, in which the child has been or
will be exposed to an investigational or a non-investigational product (pharmaceutical
product or device).

- Chronic administration (defined as 14 or more consecutive days) of immunosuppressants,
or other immune-modifying drugs during the period starting 180 days prior to the study
vaccination at Visit 1 or any planned administration of immunosuppressive and
immune-modifying drugs during the entire study.

- For corticosteroids, this will mean prednisone =0.5 mg/kg/day or equivalent.

- Inhaled and topical steroids are allowed.

- Planned administration/ administration of a vaccine not foreseen by the study protocol
during the period starting 30 days prior to the day of study vaccination at Visit 1
and ending at Visit 2. Please Note:

- Inactivated influenza (Flu) vaccine and monovalent Haemophilus influenzae type b
conjugate vaccine (Hib) vaccines may be given at any time, including the day of
study vaccination (Flu and Hib vaccines must be administered at a different
location than the study vaccine/s).

- Any other age appropriate vaccine may be given starting at Visit 2 and anytime
thereafter.

- Administration of immunoglobulins and/or any blood products during the period starting
180 days before the study vaccination at Visit 1 or planned administration from the
date of vaccination through the immunogenicity evaluation at Visit 2.

- History of measles, mumps, rubella, varicella/zoster and/or hepatitis A disease.

- Known exposure to measles, mumps, rubella and/or varicella/zoster during the period
starting within 30 days prior to first study vaccination.

- Previous vaccination against measles, mumps, rubella, hepatitis A and/or varicella
virus.

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

- Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms
affecting the bone marrow or lymphatic systems.

- A family history of congenital or hereditary immunodeficiency.

- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccines, including hypersensitivity to neomycin, latex or gelatin.

- Acute disease at the time of enrollment. (Acute disease is defined as the presence of
a moderate or severe illness with or without fever). Fever is defined as temperature
=38.0°C/100.4°F by any age appropriate route. All vaccines can be administered to
persons with a minor illness such as diarrhea, mild upper respiratory infection
without fever.

- Active untreated tuberculosis based on medical history.

- Any other condition which, in the opinion of the investigator, prevents the child from
participating in the study.

- For US children only: a child that previously received a fourth dose of PCV-13
vaccine.



Age minimum: 12 Months
Age maximum: 15 Months
Gender: All

Health Condition(s) or Problem(s) studied

Measles; Mumps; Rubella

Intervention(s)

Biological: Prevnar 13

Biological: Priorix

Biological: Havrix

Biological: Varivax

Biological: M-M-R II

Primary Outcome(s)

Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination [Time Frame: During Day 5 to Day 12 post-vaccination period]

Secondary Outcome(s)

Anti-measles Virus Antibody Concentrations [Time Frame: At Day 42 post vaccination]

Number of Subjects Reporting Any Fever [Time Frame: During the 43-day (Days 0-42) post-vaccination period]

Anti-rubella Virus Antibody Concentrations [Time Frame: At Day 42 post vaccination]

Number of Subjects Reporting Any Rash [Time Frame: During the 43-day (Days 0-42) post-vaccination period]

Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value [Time Frame: At Day 42 post vaccination]

Number of Subjects Reporting Any Unsolicited AEs [Time Frame: During the 43-day (Days 0-42) post-vaccination period]

Anti-mumps Virus Antibody Concentrations [Time Frame: At Day 42 post vaccination]

Number of Subjects Reporting AEs of Specific Interest [Time Frame: Day 0 through the end of the study (Day 180)]

Number of Subjects Reporting MMR Specific Solicited General AEs [Time Frame: During the 43-day (Days 0-42) post-vaccination period]

Number of Subjects With Any Solicited General AEs [Time Frame: During the 15-day (Days 0-14) post-vaccination period]

Number of Subjects With Any Solicited Local Adverse Events (AEs) [Time Frame: During the 4-day (Days 0-3) post-vaccination period]

Number of Subjects Reporting Any Serious Adverse Events (SAEs) [Time Frame: Day 0 through the end of the study (Day 180)]

Number of Subjects Reporting Measles-like Illness [Time Frame: During Day 5 to Day 12 post-vaccination period]

Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value [Time Frame: At Day 42 post vaccination]

Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value [Time Frame: At Day 42 post vaccination]

Secondary ID(s)

115650

2011-006161-18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/07/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02184572