Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Hepatitis A Vaccine Hepatitis A
Interventions:	Biological: Havrix® Biological: M-M-R®II Biological: VARIVAX®

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
While the total numbers of subjects enrolled in the study was 1474, the total number of subjects that entered the study was 1241. The remaining subjects received a subject number but no vaccine dose and were therefore excluded from the analysis and group assignment.

Reporting Groups

	Description
HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Participant Flow: Overall Study

	HAV Group	MMR+V→HAV Group	HAV+MMR+V Group
STARTED	324	455	462
COMPLETED	274	366	385
NOT COMPLETED	50	89	77
Adverse Event	3	0	1
Protocol Violation	0	3	3
Withdrawal by Subject	17	37	34
Lost to Follow-up	28	46	37
Other	2	3	2

Baseline Characteristics

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Reporting Groups

	Description
HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Baseline Measures

	HAV Group	MMR+V→HAV Group	HAV+MMR+V Group	Total
Number of Participants [units: participants]	324	455	462	1241
Age [units: months] Mean ± Standard Deviation	15.0 ± 0.27	15.0 ± 0.22	15.0 ± 0.25	15.0 ± 0.25
Gender [units: participants]
Female	154	208	232	594
Male	170	247	230	647

Outcome Measures

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1. Primary:

Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups. [ Time Frame: 31 days following the second dose of Havrix® ]

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2. Primary:

Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups [ Time Frame: 31 days following the second dose of Havrix® ]

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3. Primary:

Number of Subjects Seroconverted for Anti-measle, Anti-mumps and Anti-varicella Antibodies in HAV+MMR+V and MMR+V→HAV Groups [ Time Frame: 42 days following the administration of M-M-R®II and VARIVAX® ]

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4. Primary:

Number of Subjects With Vaccine Response for Anti-rubella Antibodies in HAV+MMR+V and MMR+V→HAV Groups [ Time Frame: 42 days following administration of M-M-R®II and VARIVAX® ]

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5. Secondary:

Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella Antibody Titers in HAV+MMR+V and MMR+V→HAV Groups [ Time Frame: 42 days following the administration of M-M-R®II and VARIVAX® ]

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6. Secondary:

Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups [ Time Frame: 42 days following the first dose of Havrix® ]

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7. Secondary:

Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups [ Time Frame: 42 days following the first dose of Havrix® ]

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8. Secondary:

Anti-hepatitis A Virus (HAV) Antibody Concentrations in MMR+V→HAV Group [ Time Frame: 31 days following the second dose of Havrix® ]

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9. Secondary:

Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value in MMR+V→HAV Group [ Time Frame: 31 days following the second dose of Havrix® ]

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10. Secondary:

Number of Subjects With Vaccine Response to Havrix® [ Time Frame: 31 days following the second dose of Havrix® ]

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11. Secondary:

Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: During the 4-day period following each dose of vaccine ]

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12. Secondary:

Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During the 4-day period following each dose of vaccine ]

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13. Secondary:

Number of Subjects Reporting Measles, Mumps, Rubella and Varicella Specific Solicited General Adverse Events [ Time Frame: During the 43-day period following each dose of vaccine ]

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14. Secondary:

Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day period following each dose of vaccine ]

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15. Secondary:

Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end) ]

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16. Secondary:

Number of Subjects Reporting New Chronic Illnesses [ Time Frame: During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end) ]

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17. Secondary:

Number of Subjects Reporting Medically Significant Events [ Time Frame: During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end) ]

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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
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Results Point of Contact:

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

No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Rinderknecht S, Michaels MG, Blatter M, Gaglani M, Andrews W, Abughali N, Chandreshekaran V, Trofa AF. Immunogenicity and safety of an inactivated hepatitis A vaccine when coadministered with measles-mumps-rubella and varicella vaccines in children less than 2 years of age. Pediatr Infect Dis J. 2011 Oct;30(10):e179-85.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00197015 History of Changes
Other Study ID Numbers:	208109/231
Study First Received:	September 13, 2005
Results First Received:	March 11, 2010
Last Updated:	January 5, 2012
Health Authority:	United States: Food and Drug Administration