TetanusPhase 3NCT00871117
Immunogenicity and Safety of Kinrix + (Measles Mumps Rubella) MMR Vaccine With and Without Varicella Vaccine in Healthy Children 4-6 Years
A Phase 3 study testing GSK Biologicals'Kinrix®, Merck and Company's MMRII and Merck and Company's Varivax in people with Tetanus and Acellular Pertussis, run by GlaxoSmithKline at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Tetanus, Acellular Pertussis, Diphtheria
- What is being tested?
- GSK Biologicals'Kinrix®, Merck and Company's MMRII and Merck and Company's Varivax
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 478 participants
- Where
- 11 sitesUnited States
- Study dates
- 31 Mar 2009to 15 Jun 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Fever >=40.5°C or 104.9°F (rectal temperature) (39.5°C or 103.1°F, oral/axillary) within 48 hours of previous dose of Infanrix or Pediarix not due to another identifiable cause.
- Collapse or shock-like state within 48 hours of previous dose of DTaP or DTaP-containing vaccine.
- Persistent, severe, inconsolable screaming or crying lasting ³3 hours occurring within 48 hours of administration of previous dose of DTaP or DTaP-containing vaccine.
- Thrombocytopenia following a previous dose of M-M-RII or its component vaccines
- Inability to contact a parent/guardian of the subject by telephone.
- Blood dyscrasias, leukemia, lymphomas or other malignant neoplasms affecting the bone marrow or lymphatic systems.
- Family history of congenital or hereditary immunodeficiency, unless the immune competence of the subject has been demonstrated.
- Residence in the same household as the following persons:
- New-born infants (0-4 weeks of age).
- Pregnant mother/women without documented positive history of chickenpox disease or laboratory evidence of prior varicella vaccination.
- Pregnant women at or beyond 28 weeks gestation regardless of varicella vaccination status or varicella disease history.
- Persons with known immunodeficiency.
- Active untreated tuberculosis.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
GSK Investigational Site
Antioch, California, 94509
GSK Investigational Site
Daly City, California, 94015
GSK Investigational Site
Hayward, California, 94545
GSK Investigational Site
Redwood City, California, 94063
GSK Investigational Site
Roseville, California, 95661
GSK Investigational Site
Sacramento, California, 95815
GSK Investigational Site
Sacramento, California, 95823
GSK Investigational Site
San Jose, California, 95119
GSK Investigational Site
Santa Rosa, California, 95403
GSK Investigational Site
Vallejo, California, 94589
GSK Investigational Site
Walnut Creek, California, 94596
About this study
Official title: Immunogenicity and Safety Study of Kinrix® Co-administered With Varivax®
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.
Read the detailed description
Subjects 4-6 years of age will be randomized into two groups to receive either Kinrix, Varivax and M-M-RII on day 0 (Group 1) or Kinrix and M-M-RII on day 0 and Varivax at month 1(Group 2).
All subjects in both groups to provide blood samples prior to vaccination on day 0 and at month 1 (for Group 2, blood sampling is prior to vaccination with Varivax).
Duration of the study will be approximately 6 months for each subject with a safety telephone contact 6 months after vaccinations.
- Conditions
- Tetanus, Acellular Pertussis, Diphtheria
- Being tested
- GSK Biologicals'Kinrix®, Merck and Company's MMRII, Merck and Company's Varivax
- Keywords
- Co-administration, Immunization, Preschool, Booster
- Medical subject headings
- Tetanus, Diphtheria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK Biologicals'Kinrix®Biological
One dose as intramuscular injection at visit 1
Merck and Company's MMRIIBiological
One dose as subcutaneous injection at visit 1
Merck and Company's VarivaxBiological
One dose as subcutaneous injection at visit 1 or at visit 2
| Study group | Role | What they receive |
|---|---|---|
| Kinrix + M-M-R II + Varivax | Experimental | Subjects 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. Receives: Biological: GSK Biologicals'Kinrix®; Biological: Merck and Company's MMRII; Biological: Merck and Company's Varivax |
| Kinrix + M-M-R II -> Varivax | Active comparator | Subjects 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. Receives: Biological: GSK Biologicals'Kinrix®; Biological: Merck and Company's MMRII; Biological: Merck and Company's Varivax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Cut-off value was defined as greater than or equal to 1.0 international units per milliliter (IU/mL).
Measured: 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
Concentrations were expressed as GMCs in IU/mL.
Measured: 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
Concentrations are expressed as GMCs in Enzyme-Linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
Measured: 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
Anti-poliovirus 1, anti-poliovirus 2 and anti-poliovirus 3 booster response:
- initially seronegative subjects (pre-booster antibody titer below cut-off of 8 ED50) with an antibody titer ≥ 32 ED50 one month after vaccination
- initially seropositive subjects (pre-booster antibody titers ≥ 8 ED50) with an increase at least four times the pre-booster antibody titer one month after vaccination.
ED50 is defined here as the reverse of the dilution resulting in 50% inhibition. The lowest dilution at which serum samples were tested is 1:8 from which a test was considered positive.
Measured: 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
Seroprotection status was defined as:
- anti-D antibody concentration greater than or equal to 0.1 IU/mL
- anti-T antibody concentration greater than or equal to 0.1 IU/mL
Measured: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
Number of Subjects Protected Against Poliovirus 1, 2 and 3
Seroprotection was defined:
- anti-poliovirus type 1, 2 or 3 antibody titer greater than or equal to 8 ED50.
ED50 is defined here as the reverse of the dilution resulting in 50% inhibition.
Measured: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
Number of Subjects Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Seropositivity was defined as a concentration greater than or equal to 5.0 EL.U/mL
Measured: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
Number of Subjects With Any Solicited Local Symptoms
Solicited local symptoms included pain, redness and swelling at the injection site. Any was defined as incidence of a particular symptom regardless of intensity grade.
Measured: Within 4 days (Day 0 to 3) after booster immunization * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax
Number of Subjects With Any Solicited General Symptoms
Solicited general symptoms included fever [temperature equal to or greater than 37.5 degrees Celsius (°C)], drowsiness and loss of appetite. Any was defined as incidence of a particular symptom regardless of intensity grade.
Measured: Within 4 days (Day 0 to 3) after booster immunization * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax
Number of Subjects With Unsolicited Adverse Events
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Measured: Up to 31 days (Day 0 through Day 30) after booster vaccination * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: During the entire study period (from Day 0 to 6 months post-vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study start31 Mar 2009
- Primary completion15 Jan 2010
- Study completion15 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TetanusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 478 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871117
- Sponsor's protocol ID
- 111852
- Status last verified
- Jun 2018
- First submitted
- 26 Mar 2009
- Last updated
- 22 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
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.
PubMed 22064267
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of Kinrix® Co-administered With Varivax®
- ClinicalTrials.gov ID
- NCT00871117
- Acronym / sponsor ID
- 111852
- Conditions
- Tetanus, Acellular Pertussis, Diphtheria
- Keywords
- Co-administration, Immunization, Preschool, Booster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2009
- Primary completion
- 15 Jan 2010 (actual)
- Study completion
- 15 Jun 2010 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Posted 10 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects 4-6 years of age will be randomized into two groups to receive either Kinrix, Varivax and M-M-RII on day 0 (Group 1) or Kinrix and M-M-RII on day 0 and Varivax at month 1(Group 2).
All subjects in both groups to provide blood samples prior to vaccination on day 0 and at month 1 (for Group 2, blood sampling is prior to vaccination with Varivax).
Duration of the study will be approximately 6 months for each subject with a safety telephone contact 6 months after vaccinations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinrix + M-M-R II + Varivax | Experimental | Biological: GSK Biologicals'Kinrix®, Biological: Merck and Company's MMRII, Biological: Merck and Company's VarivaxSubjects 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 comparator | Biological: GSK Biologicals'Kinrix®, Biological: Merck and Company's MMRII, Biological: Merck and Company's VarivaxSubjects 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. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK Biologicals'Kinrix®One dose as intramuscular injection at visit 1 | Biological | Kinrix + M-M-R II + Varivax, Kinrix + M-M-R II -> Varivax |
| Merck and Company's MMRIIOne dose as subcutaneous injection at visit 1 | Biological | Kinrix + M-M-R II + Varivax, Kinrix + M-M-R II -> Varivax |
| Merck and Company's VarivaxOne dose as subcutaneous injection at visit 1 or at visit 2 | Biological | Kinrix + M-M-R II + Varivax, Kinrix + M-M-R II -> Varivax |
Primary outcome
Number of Subjects With Booster Responses to Diphteria and Tetanus
Time frame: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
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
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)
Time frame: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
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
Geometric Mean Titers (GMTs) for Antibodies to Poliovirus Types 1, 2 and 3
Time frame: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
Titers are expressed as GMTs.
11 secondary outcomes
Number of Subjects With Anti-D and Anti-T Antibody Concentrations Above Cut-off Value
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
Number of Subjects Protected Against Poliovirus 1, 2 and 3
Time frame: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
Number of Subjects Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Time frame: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
Number of Subjects With Any Solicited Local Symptoms
Time frame: Within 4 days (Day 0 to 3) after booster immunization * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax
Number of Subjects With Any Solicited General Symptoms
Time frame: Within 4 days (Day 0 to 3) after booster immunization * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax
Number of Subjects With Unsolicited Adverse Events
Time frame: Up to 31 days (Day 0 through Day 30) after booster vaccination * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Day 0 to 6 months post-vaccination)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22064267Klein 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GSK Biologicals'Kinrix®, Merck and Company's MMRII and Merck and Company's Varivax in people with Tetanus and Acellular Pertussis, run by GlaxoSmithKline at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Booster Responses to Diphteria and Tetanus (time frame: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00871117, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.