Immunogenicity and Safety of Kinrix + (Measles Mumps Rubella) MMR Vaccine With and Without Varicella Vaccine in Healthy Children 4-6 Years

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00871117

First received: March 26, 2009

Last updated: February 17, 2011

Last verified: February 2011

History of Changes

Results First Received: January 13, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Diphtheria Pertussis and/or Poliomyelitis Diseases Tetanus
Interventions:	Biological: GSK Biologicals'Kinrix® Biological: Merck and Company's MMRII Biological: Merck and Company's Varivax

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
478 subjects were enrolled, but 2 subjects who received a subject number were not vaccinated. Therefore the total amount of subjects used for the analysis is 476.

Reporting Groups

	Description
Kinrix + M-M-R II + Varivax	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.
Kinrix + M-M-R II -> Varivax	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.

Participant Flow: Overall Study

	Kinrix + M-M-R II + Varivax	Kinrix + M-M-R II -> Varivax
STARTED	239	237
COMPLETED	234	227
NOT COMPLETED	5	10
Lost to Follow-up	5	10

Baseline Characteristics

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Reporting Groups

	Description
Kinrix + M-M-R II + Varivax	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.
Kinrix + M-M-R II -> Varivax	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.
Total	Total of all reporting groups

Baseline Measures

	Kinrix + M-M-R II + Varivax	Kinrix + M-M-R II -> Varivax	Total
Number of Participants [units: participants]	239	237	476
Age [units: Years] Mean ± Standard Deviation	4.2 ± 0.41	4.2 ± 0.37	4.2 ± 0.39
Gender [units: subjects]
Female	129	123	252
Male	110	114	224

Outcome Measures

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1. Primary:

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. ]

Show Outcome Measure 1

2. Primary:

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. ]

Show Outcome Measure 2

3. Primary:

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. ]

Show Outcome Measure 3

4. Secondary:

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. ]

Show Outcome Measure 4

5. Secondary:

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. ]

Show Outcome Measure 5

6. Secondary:

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. ]

Show Outcome Measure 6

7. Secondary:

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. ]

Show Outcome Measure 7

8. Secondary:

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. ]

Show Outcome Measure 8

9. Secondary:

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. ]

Show Outcome Measure 9

10. Secondary:

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. ]

Show Outcome Measure 10

11. Secondary:

Number of Subjects With Solicited Local and 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 ]

Show Outcome Measure 11

12. Secondary:

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 ]

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13. Secondary:

Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Day 0 to 6 months post-vaccination) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00871117 History of Changes
Other Study ID Numbers:	111852
Study First Received:	March 26, 2009
Results First Received:	January 13, 2011
Last Updated:	February 17, 2011
Health Authority:	United States: Food and Drug Administration

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