Immunogenicity and Safety of Kinrix + (Measles Mumps Rubella) MMR Vaccine With and Without Varicella Vaccine in Healthy Children 4-6 Years
Immunogenicity and Safety Study of Kinrix® Co-administered With Varivax®
1 other identifier
interventional
478
1 country
11
Brief Summary
The purpose of the study is to evaluate the immunogenicity and safety of Kinrix when co-administered with varicella (Varivax® \[varicella virus vaccine live\], Merck and Company) and (measles mumps rubella) MMR vaccines, compared to Kinrix co-administered with MMR vaccine alone. Both Kinrix and the second dose of Varivax are indicated in children 4-6 years of age, and there is great potential for the vaccines to be given concurrently. The aim of this trial is to demonstrate that co-administered Varivax does not negatively affect the immunogenicity or reactogenicity of Kinrix.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2009
Shorter than P25 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2009
CompletedFirst Posted
Study publicly available on registry
March 30, 2009
CompletedStudy Start
First participant enrolled
March 31, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2010
CompletedResults Posted
Study results publicly available
February 10, 2011
CompletedAugust 22, 2018
June 1, 2018
10 months
March 26, 2009
January 13, 2011
July 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Subjects With Booster Responses to Diphteria and Tetanus
Anti-diphteria (anti-D) and anti-tetanus (anti-T) booster response was defined as: * initially seronegative subjects (sero-) (pre-booster antibody concentration below cut-off of \< 0.1 international units per milliliter (IU/mL)) with an increase of at least four times the cut-off one month after vaccination (post-booster antibody concentration ≥0.4 IU/mL) * initially seropositive subjects (sero+) (pre-booster antibody concentration ≥0.1 IU/mL) with an increase of at least four times the pre-booster antibody concentration one month after vaccination
One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (Anti-PRN) Booster Responses, Measured in Enzyme-Linked Immunosorbent Assay Units Per Milliliter (EL.U/mL)
anti-PT, anti-FHA and anti-PRN booster response : * initially sero- (pre-booster antibody concentration below cut-off \< 5.0 EL.U/mL) with increase of at least four times cut-off one month after vaccination (concentration post-booster ≥20.0 EL.U/mL) * initially sero+ with pre-booster antibody concentration ≥5.0 EL.U/mL and \< 20.0 EL.U/mL with increase of at least four times pre-booster concentration one month post-booster * initially sero+ with pre-booster antibody concentration ≥20.0 EL.U/mL with an increase of at least two times the pre-booster antibody concentration one month post-booster
One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
Geometric Mean Titers (GMTs) for Antibodies to Poliovirus Types 1, 2 and 3
Titers are expressed as GMTs.
One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
Secondary Outcomes (11)
Number of Subjects With Anti-D and Anti-T Antibody Concentrations Above Cut-off Value
One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
Geometric Mean Concentrations (GMCs) for Anti-D and Anti-T Antibodies
One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
GMCs for Anti-PT, Anti-FHA, Anti-PRN Antibodies
One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
Number of Subjects With an Anti-polio 1, 2, 3 Booster Response
One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
Number of Subjects Seroprotected Against Diphteria and Tetanus
One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
- +6 more secondary outcomes
Study Arms (2)
Kinrix + M-M-R II + Varivax
EXPERIMENTALSubjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
Kinrix + M-M-R II -> Varivax
ACTIVE COMPARATORSubjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
Interventions
One dose as intramuscular injection at visit 1
One dose as subcutaneous injection at visit 1
One dose as subcutaneous injection at visit 1 or at visit 2
Eligibility Criteria
You may qualify if:
- Subjects for whom the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol.
- A male or female child between 4 and 6 years of age, inclusive.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Having received 4 doses of (Diphtheria, Tetanus Acellular Pertussis) DTaP vaccine using Pediarix and/or Infanrix, and 3 doses of poliovirus vaccine using Pediarix and/or (inactivated poliovirus vaccine, Aventis Pasteur) IPOL in the first 2 years of life.
- Previously received 1 dose of M-M-RII and Varivax (separate or combined) in the second year of life.
You may not qualify if:
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or non-investigational product or device.
- History of previous or intercurrent diphtheria, tetanus, pertussis, polio, measles, mumps, rubella or varicella disease, or of vaccination against these diseases given after the second year of life.
- Known exposure to diphtheria, tetanus, pertussis, or polio, prior to vaccination.
- Poliovirus vaccination with one or more doses of (oral polio virus) OPV vaccine.
- Administration or planned administration of a vaccine not foreseen by the study protocol within 30 days of study vaccination and ending at Day 30.
- Chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period ending at Day 30.
- Administration of immunoglobulins and/or any blood products at any time prior to study vaccination or planned administration during the study period ending at Day 30.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- History of seizures or progressive neurological disorder, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy.
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- History of anaphylactic reaction to egg proteins or previous doses of the vaccine(s).
- Encephalopathy within 7 days of administration of previous dose of Infanrix or Pediarix.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (11)
GSK Investigational Site
Antioch, California, 94509, United States
GSK Investigational Site
Daly City, California, 94015, United States
GSK Investigational Site
Hayward, California, 94545, United States
GSK Investigational Site
Redwood City, California, 94063, United States
GSK Investigational Site
Roseville, California, 95661, United States
GSK Investigational Site
Sacramento, California, 95815, United States
GSK Investigational Site
Sacramento, California, 95823, United States
GSK Investigational Site
San Jose, California, 95119, United States
GSK Investigational Site
Santa Rosa, California, 95403, United States
GSK Investigational Site
Vallejo, California, 94589, United States
GSK Investigational Site
Walnut Creek, California, 94596, United States
Related Publications (1)
Klein NP, Weston WM, Kuriyakose S, Kolhe D, Howe B, Friedland LR, Van Der Meeren O. An open-label, randomized, multi-center study of the immunogenicity and safety of DTaP-IPV (Kinrix) co-administered with MMR vaccine with or without varicella vaccine in healthy pre-school age children. Vaccine. 2012 Jan 11;30(3):668-74. doi: 10.1016/j.vaccine.2011.10.065. Epub 2011 Nov 4.
PMID: 22064267BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2009
First Posted
March 30, 2009
Study Start
March 31, 2009
Primary Completion
January 15, 2010
Study Completion
June 15, 2010
Last Updated
August 22, 2018
Results First Posted
February 10, 2011
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.