Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01702428
Other study ID # 115648
Secondary ID 2011-004891-12
Status Completed
Phase Phase 3
First received
Last updated
Start date November 9, 2012
Est. completion date April 16, 2015

Study information

Verified date November 2019
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate consistency in terms of the immune response to three different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies, and compare its immunogenicity to Merck & Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).


Description:

This study will evaluate the consistency of the immune response to three different lots of GSK Biologicals' trivalent investigational MMR vaccine (referred to as INV_MMR vaccine, throughout this document) and compare its immunogenicity to the US standard of care comparator vaccine (M-M-R II, Merck and Co., Inc., referred to as COM_MMR throughout this document) in children during their second year of life. The INV_MMR vaccine will be given as one of three consistency lots manufactured to target potencies designated as INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3. The COM_MMR vaccine will be given as one of two lots designated COM_MMR_L1 and COM_MMR_L2 and will be analysed as pooled lots within the study. The MMR vaccine will be co-administered with Varivax (VV), Havrix (HAV) and (in the US sub-cohort only) Prevnar 13 (PCV-13) which are routinely administered to children of this age in the US.


Recruitment information / eligibility

Status Completed
Enrollment 5016
Est. completion date April 16, 2015
Est. primary completion date November 25, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 15 Months
Eligibility Inclusion Criteria:

- Male or female child between 12 and 15 months of age at the time of vaccination.

- The investigator believes that the parent(s) or Legally Acceptable Representative(s) (LAR(s)) of the child, 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:

• Child that previously received a 3-dose series of Prevnar 13 only (i.e., no doses given as Prevnar/Prevenar), with the last dose at least 60 days prior to study entry.

Exclusion Criteria:

- Child in care.

- Use of any investigational or non-registered product 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.

- Chronic administration of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose 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 study vaccination at Visit 1 and ending at Visit 2. Please Note:

- Inactivated influenza (Flu) vaccine and 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 prior to 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.

- 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.

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

- Acute disease at the time of enrollment. 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:

- Child that previously received a vaccination with heptavalent Prevnar/Prevenar (prior vaccination should be with 3 doses of Prevnar 13 only).

- Child that previously received a fourth dose of any pneumococcal conjugate vaccine.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Priorix
Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.
M-M-R II
Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.
Varivax
Subjects receive 1 dose of VV vaccine which is administered subcutaneously in the triceps region of the right arm.
Havrix
Subjects receive 1 dose of HAV vaccine which is administered intramuscularly in the anterolateral region of the right thigh.
Prevnar 13
US subjects receive 1 dose of PCV-13 vaccine which is administered intramuscularly in the anterolateral region of the left thigh.

Locations

Country Name City State
Estonia GSK Investigational Site Tallinn
Estonia GSK Investigational Site Tallinn
Estonia GSK Investigational Site Tallinn
Estonia GSK Investigational Site Tallinn
Estonia GSK Investigational Site Tartu
Finland GSK Investigational Site Espoo
Finland GSK Investigational Site Helsinki
Finland GSK Investigational Site Helsinki
Finland GSK Investigational Site Jarvenpaa
Finland GSK Investigational Site Kokkola
Finland GSK Investigational Site Oulu
Finland GSK Investigational Site Pori
Finland GSK Investigational Site Seinajoki
Finland GSK Investigational Site Tampere
Finland GSK Investigational Site Turku
Mexico GSK Investigational Site Durango
Mexico GSK Investigational Site Mexico
Puerto Rico GSK Investigational Site San Juan
Spain GSK Investigational Site Castellón
Spain GSK Investigational Site Castellón
Spain GSK Investigational Site L'Eliana, Valencia
Spain GSK Investigational Site Quart De Poblet, Valencia
Spain GSK Investigational Site Valencia
Spain GSK Investigational Site Valencia
Spain GSK Investigational Site Valencia
Spain GSK Investigational Site Valencia
Spain GSK Investigational Site Valencia
Spain GSK Investigational Site Valencia
United States GSK Investigational Site Ames Iowa
United States GSK Investigational Site Anaheim California
United States GSK Investigational Site Augusta Kansas
United States GSK Investigational Site Barnwell South Carolina
United States GSK Investigational Site Bossier City Louisiana
United States GSK Investigational Site Boston Massachusetts
United States GSK Investigational Site Bronx New York
United States GSK Investigational Site Charlottesville Virginia
United States GSK Investigational Site Cincinnati Ohio
United States GSK Investigational Site Cleveland Ohio
United States GSK Investigational Site Colorado Springs Colorado
United States GSK Investigational Site Colorado Springs Colorado
United States GSK Investigational Site Columbia Maryland
United States GSK Investigational Site Daly City California
United States GSK Investigational Site Dothan Alabama
United States GSK Investigational Site Erie Pennsylvania
United States GSK Investigational Site Evergreen Park Illinois
United States GSK Investigational Site Fall River Massachusetts
United States GSK Investigational Site Falls Church Virginia
United States GSK Investigational Site Fayetteville Arkansas
United States GSK Investigational Site Fort Worth Texas
United States GSK Investigational Site Fresno California
United States GSK Investigational Site Hayward California
United States GSK Investigational Site Hermitage Pennsylvania
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Ithaca New York
United States GSK Investigational Site Kansas City Missouri
United States GSK Investigational Site Kingsport Tennessee
United States GSK Investigational Site Layton Utah
United States GSK Investigational Site League City Texas
United States GSK Investigational Site Los Gatos California
United States GSK Investigational Site Louisville Kentucky
United States GSK Investigational Site Madison Wisconsin
United States GSK Investigational Site Marshfield Wisconsin
United States GSK Investigational Site Mission Hills California
United States GSK Investigational Site Nampa Idaho
United States GSK Investigational Site Niles Michigan
United States GSK Investigational Site Overland Park Kansas
United States GSK Investigational Site Paramount California
United States GSK Investigational Site Payson Utah
United States GSK Investigational Site Phoenix Arizona
United States GSK Investigational Site Pleasanton California
United States GSK Investigational Site Provo Utah
United States GSK Investigational Site Richmond Virginia
United States GSK Investigational Site Roy Utah
United States GSK Investigational Site Sacramento California
United States GSK Investigational Site Sacramento California
United States GSK Investigational Site Saint George Utah
United States GSK Investigational Site Salt Lake City Utah
United States GSK Investigational Site Salt Lake City Utah
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site Santa Clara California
United States GSK Investigational Site Seattle Washington
United States GSK Investigational Site Sellersville Pennsylvania
United States GSK Investigational Site Stevensville Michigan
United States GSK Investigational Site Syracuse New York
United States GSK Investigational Site Syracuse Utah
United States GSK Investigational Site Tomball Texas
United States GSK Investigational Site Topeka Kansas
United States GSK Investigational Site Walnut Creek California
United States GSK Investigational Site Warwick Rhode Island
United States GSK Investigational Site West Jordan Utah

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Estonia,  Finland,  Mexico,  Puerto Rico,  Spain, 

References & Publications (1)

Klein NP, Abu-Elyazeed R, Povey M, Macias Parra M, Diez-Domingo J, Ahonen A, Korhonen T, Tinoco JC, Weiner L, Marshall GS, Silas PE, Sarpong KO, Ramsey KP, Fling JA, Speicher D, Campos M, Munjal I, Peltier C, Vesikari T, Baccarini C, Caplanusi A, Gillard P, Carryn S, Henry O. Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study. J Pediatric Infect Dis Soc. 2019 Mar 8. pii: piz010. doi: 10.1093/jpids/piz010. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value Seroresponse was defined as post-vaccination anti-measles virus antibody concentration =200 milli International Unit/Milliliter (mIU/mL) among subjects who were seronegative (antibody concentration <150 mIU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine. At Day 42
Primary Anti-measles Virus Antibody Concentrations Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine. At Day 42
Primary Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration =10 ELISA Unit/Milliliter (EU/mL) among subjects who were seronegative (antibody concentrations <5 EU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine. At Day 42
Primary Anti-mumps Virus Antibody Concentration Antibody concentrations were expressed as GMCs in EU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine. At Day 42
Primary Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration =10 International Unit/Milliliter (IU/mL) among subjects who were seronegative (antibody concentrations <4 IU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine. At Day 42
Primary Anti-rubella Virus Antibody Concentration Antibody concentrations were expressed as GMCs in IU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine. At Day 42
Primary Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups Seroresponse was defined as post-vaccination anti-measles virus antibody concentration =200 mIU/mL among subjects who were seronegative (antibody concentration <150 mIU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to measles virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is =90% for antibodies to measles virus. At Day 42
Primary Anti-measles Virus Antibody Concentrations in Pooled MMR Groups Antibody concentrations were expressed as GMCs in mIU/mL. At Day 42
Primary Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration =10 EU/mL among subjects who were seronegative (antibody concentrations <5 EU/mL) before vaccination. At Day 42
Primary Anti-mumps Virus Antibody Concentration in Pooled MMR Groups Antibody concentrations were expressed as GMCs in EU/mL. At Day 42
Primary Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration =10 IU/mL among subjects who were seronegative (antibody concentrations <4 IU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to rubella virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is =90% for antibodies to rubella virus. At Day 42
Primary Anti-rubella Virus Antibody Concentration in Pooled MMR Groups Antibody concentrations were expressed as GMCs in IU/mL. At Day 42
Secondary Percentage of Subjects With an Anti-Varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups Seroresponse was defined as post-vaccination anti-VZV antibody concentration =75 mIU/mL among subjects who were seronegative (antibody concentration <25 mIU/mL) before vaccination. At Day 42
Secondary Anti-VZV Virus Antibody Concentration in US Sub-cohort of Pooled MMR Groups Antibody concentrations were expressed as GMCs in mIU/mL. At Day 42
Secondary Percentage of Subjects With an Anti-HAV Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups Percentage of subjects with an Anti-HAV antibody concentration equal to or above 15 mIU/mL were reported. At Day 42
Secondary Anti-HAV Antibody Concentrations in US Sub-cohort of Pooled MMR Groups Antibody concentrations were expressed as GMCs in mIU/mL. At Day 42
Secondary Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups Antibody concentrations were expressed as GMCs in microgram/Milliliter (µg/mL). At Day 42
Secondary Number of Subjects With Any Solicited Local Adverse Events (AEs) Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination. During the 4-days (Days 0-3) post-vaccination period
Secondary Number of Subjects With Any Solicited General AEs Assessed solicited general AEs were drowsiness, irritability and loss of appetite. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination. During the 15-days (Days 0-14) post-vaccination period
Secondary Number of Subjects Reporting Any Fever Any fever = Fever = 38°C. During the 43-days (Days 0-42) post-vaccination period
Secondary Number of Subjects Reporting Any Rash Assessed were any localized or generalized rash, rash with fever, varicella-like rash, measles/rubella-like rash. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination. During the 43-days (Days 0-42) post-vaccination period
Secondary Number of Subjects Reporting Any MMR Specific Solicited AEs Assessed MMR specific solicited AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination. During the 43-days (Days 0-42) post-vaccination period
Secondary Number of Subjects Reporting Any Unsolicited AEs Unsolicited adverse event (AE) was defined as any adverse event reported in addition to those solicited during the clinical study and also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination. During the 43-days (Days 0-42) post-vaccination period
Secondary Number of Subjects Reporting AEs of Specific Interest AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits. From Day 0 through the end of study (Day 180)
Secondary Number of Subjects Reporting Any Serious Adverse Events (SAEs) SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity. Any SAE = Occurrence of SAE regardless of intensity grade or relation to vaccination. From Day 0 through the end of study (Day 180)
See also
  Status Clinical Trial Phase
Completed NCT04183114 - Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study) Phase 2/Phase 3
Completed NCT00092430 - Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016) Phase 3
Completed NCT02196285 - Study to Evaluate Safety and Imunogenicity of Double Viral Vaccine (MR) for Measles and Rubella Phase 1
Completed NCT00384397 - A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers Phase 3
Completed NCT00313950 - Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine Phase 4
Completed NCT00402831 - ProQuad® Intramuscular vs Subcutaneous Phase 3
Completed NCT00560755 - Safety Study of ProQuad® rHA in Infants (V221-037) Phase 3
Completed NCT01878435 - Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya N/A
Completed NCT01777529 - Comparative Study of the Immunogenicity of MMR (Measles, Mumps and Rubella) Single Dose and Multidose Presentations Phase 4
Terminated NCT00258726 - Immune Responses to Two Dose Varivax +/- MMR-II Phase 1/Phase 2
Completed NCT00109278 - A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED) Phase 2
Not yet recruiting NCT05771779 - Co-administration Study of OCV, TCV and MR Phase 3
Completed NCT02880865 - Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine Phase 4
Completed NCT01681992 - Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life Phase 3
Completed NCT00751348 - Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136 Phase 3
Completed NCT00969436 - Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM Phase 3
Completed NCT00566527 - Comparative Study of Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA (V221-038) Phase 3
Completed NCT00127010 - Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases Phase 3
Completed NCT00388440 - Assess GSK Biologicals' MMR Vaccine (Priorix) When Given to Healthy Children at the Age of 12 to 18 Months in Singapore. Phase 4
Completed NCT03148990 - Study to Evaluate the Immunogenicity, Reatogenicity and Safety of Double Viral Vaccine (MR) for Measles and Rubella Phase 2/Phase 3