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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197015
First received: September 13, 2005
Last updated: April 11, 2013
Last verified: November 2012
Results First Received: March 11, 2010  
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
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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
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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
Total Total of all reporting groups

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
  Show All Outcome Measures

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® ]

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® ]

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® ]

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® ]

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® ]

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® ]

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® ]

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

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® ]

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

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

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

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 ]

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

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) ]

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) ]

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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:
Rinderknecht S et al. (2011) 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. 30(10):e179-185.

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
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: April 11, 2013
Health Authority: United States: Food and Drug Administration