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Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197002
First received: September 13, 2005
Last updated: December 23, 2016
Last verified: September 2016
Results First Received: December 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Hepatitis A
Intervention: Biological: Hepatitis A

  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
No text entered.

Reporting Groups
  Description
Havrix Group Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
Havrix+Prevnar Group Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
Prevnar Havrix Group Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.

Participant Flow:   Overall Study
    Havrix Group   Havrix+Prevnar Group   Prevnar Havrix Group
STARTED   147   137   149 
COMPLETED   125   119   132 
NOT COMPLETED   22   18   17 
Adverse Event                0                1                0 
Protocol Violation                1                0                2 
Withdrawal by Subject                9                5                7 
Migrated/moved from study area                3                5                1 
Lost to follow-up (incompl. vaccination)                4                4                5 
Lost to follow-up (compl. vaccination)                2                2                1 
Others                3                1                1 



  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
Havrix Group Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
Havrix+Prevnar Group Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
Prevnar Havrix Group Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
Total Total of all reporting groups

Baseline Measures
   Havrix Group   Havrix+Prevnar Group   Prevnar Havrix Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 147   137   149   433 
Age 
[Units: Months]
Mean (Standard Deviation)
 15.0  (0.16)   15.0  (0.09)   15.0  (0.24)   15.0  (0.18) 
Gender 
[Units: Participants]
Count of Participants
       
Female      77  52.4%      66  48.2%      79  53.0%      222  51.3% 
Male      70  47.6%      71  51.8%      70  47.0%      211  48.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Seropositive Subjects for Anti-HAV Antibodies   [ Time Frame: At one month after Dose 2 of Havrix® vaccine (Month 7-10) ]

2.  Primary:   Concentrations for Anti-HAV Antibodies   [ Time Frame: At one month after Dose 2 of Havrix® vaccine (Month 7-10) ]

3.  Secondary:   Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations   [ Time Frame: At one month after Prevnar™ vaccination (Day 30) ]

4.  Secondary:   Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F   [ Time Frame: At one month after Prevnar™ vaccination (Day 30) ]

5.  Secondary:   Number of Seropositive Subjects for Anti-HAV Antibodies   [ Time Frame: At one month after Dose 1 of Havrix® vaccine (Day 30) ]

6.  Secondary:   Concentrations for Anti-HAV Antibodies   [ Time Frame: At one month after Dose 1 of Havrix® vaccine (Day 30) ]

7.  Secondary:   Number of Seropositive Subjects for Anti-HAV Antibodies   [ Time Frame: At one month after Dose 2 of Havrix® vaccine (Month 8-11) ]

8.  Secondary:   Concentrations for Anti-HAV Antibodies   [ Time Frame: At one month after Dose 2 of Havrix® vaccine (Month 8-11) ]

9.  Secondary:   Number of Subjects With Vaccine Response to Anti-HAV Antibodies   [ Time Frame: One month after Dose 2 of Havrix® vaccine (Month 7-10/8-10) ]

10.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms   [ Time Frame: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses ]

11.  Secondary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses ]

12.  Secondary:   Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)   [ Time Frame: During the 31-day (Day 0-30) follow-up period ]

13.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs)   [ Time Frame: During the Active Phase (from Day 0 to Day 30 after final vaccine dose for each subject) ]

14.  Secondary:   Number of Subjects With SAEs, NCIs and MSEs   [ Time Frame: During the Extended Safety Follow-up (ESFU) Phase (from Day 30 to 6 months after final vaccine dose) ]


  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
None reported.


  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:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00197002     History of Changes
Other Study ID Numbers: 208109/220
Study First Received: September 13, 2005
Results First Received: December 23, 2016
Last Updated: December 23, 2016