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Study Results
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Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children
This study has been completed.
Study NCT00312858   Information provided by Merck

First Received on April 7, 2006.   Last Updated on April 7, 2010   History of Changes
Results First Received: March 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Hepatitis A Virus
Interventions: Biological: Comparator: VAQTA™ (Hepatitis A vaccine)
Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)
Biological: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)

  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

39 clinical sites in the United States

Date first participant visit: 14-Apr-2006

Date last participant visit: 25-Mar-2008

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
Arm 1: VAQTA™ + ProQuad™ + Prevnar™ VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™ VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Participant Flow:   Overall Study
    Arm 1: VAQTA™ + ProQuad™ + Prevnar™     Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™  
STARTED     330     323  
Visit 1     330     323  
Visit 2     305     294  
Visit 3     273     261  
Visit 4     262     240  
COMPLETED     262     230  
NOT COMPLETED     68     93  
Adverse Event                 0                 1  
Lost to Follow-up                 25                 42  
Protocol Violation                 3                 8  
Withdraw by Participant                 20                 20  
Participant Moved                 11                 10  
Unspecified                 9                 12  



  Baseline Characteristics
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Reporting Groups
  Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™ VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™ VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Baseline Measures
    Arm 1: VAQTA™ + ProQuad™ + Prevnar™     Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™     Total  
Number of Participants  
[units: participants]
 		  330     323     653  
Age  
[units: years]
Mean ± Standard Deviation 		  12.4  ± 0.80     12.5  ± 0.89     12.4  ± 0.85  
Gender  
[units: participants]
 		     
Female     156     166     322  
Male     174     157     331  



  Outcome Measures
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1.  Primary:   Antibody Response to Hepatitis A - Participants With a Serological Response   [ Time Frame: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™) ]
  Show Outcome Measure 1

2.  Primary:   Antibody Response to Varicella - Participants With a Serological Response   [ Time Frame: 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™) ]
  Show Outcome Measure 2

3.  Primary:   Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response   [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
  Show Outcome Measure 3

4.  Primary:   Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response   [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
  Show Outcome Measure 4

5.  Primary:   Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response   [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
  Show Outcome Measure 5

6.  Primary:   Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response   [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
  Show Outcome Measure 6

7.  Primary:   Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response   [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
  Show Outcome Measure 7

8.  Primary:   Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response   [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
  Show Outcome Measure 8

9.  Primary:   Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response   [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
  Show Outcome Measure 9

10.  Primary:   Participants With 1 or More Systemic Adverse Experience   [ Time Frame: 6 weeks post dose 1 ]
  Show Outcome Measure 10

11.  Primary:   Participants With 1 or More Systemic Adverse Experience   [ Time Frame: 4 weeks post dose 2 ]
  Show Outcome Measure 11

12.  Primary:   Participants With 1 or More Systemic Adverse Experience.   [ Time Frame: 6 months ]
  Show Outcome Measure 12

13.  Primary:   Participants With 1 or More Injection-site Adverse Experience   [ Time Frame: 6 weeks post dose 1 ]
  Show Outcome Measure 13

14.  Primary:   Participants With 1 or More Injection-site Adverse Experience   [ Time Frame: 4 weeks post dose 2 ]
  Show Outcome Measure 14

15.  Primary:   Participants With 1 or More Injection-site Adverse Experience   [ Time Frame: 6 months ]
  Show Outcome Measure 15

16.  Primary:   Participants With Elevated Temperature (≥102.2F/ ≥39.0C)   [ Time Frame: 6 weeks post dose 1 ]
  Show Outcome Measure 16

17.  Primary:   Participants With Elevated Temperature (≥102.2F/ ≥39.0C)   [ Time Frame: 4 weeks post dose 2 ]
  Show Outcome Measure 17

18.  Primary:   Participants With Elevated Temperature (≥102.2F/ ≥39.0C)   [ Time Frame: 6 months ]
  Show Outcome Measure 18

19.  Primary:   Participants With 1 or More Serious Vaccine-related Adverse Experience   [ Time Frame: 6 weeks post dose 1 ]
  Show Outcome Measure 19

20.  Primary:   Participants With 1 or More Serious Vaccine-related Adverse Experience   [ Time Frame: 4 weeks post dose 2 ]
  Show Outcome Measure 20

21.  Primary:   Participants With 1 or More Serious Vaccine-related Adverse Experience   [ Time Frame: 6 months ]
  Show Outcome Measure 21

22.  Primary:   Antibody Response to Hepatitis A – Geometric Mean Titer   [ Time Frame: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™) ]
  Show Outcome Measure 22

23.  Primary:   Antibody Response to Varicella - Geometric Mean Titer   [ Time Frame: 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™) ]
  Show Outcome Measure 23

24.  Primary:   Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer   [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
  Show Outcome Measure 24

25.  Primary:   Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer   [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
  Show Outcome Measure 25

26.  Primary:   Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer   [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
  Show Outcome Measure 26

27.  Primary:   Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer   [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
  Show Outcome Measure 27

28.  Primary:   Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer   [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
  Show Outcome Measure 28

29.  Primary:   Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer   [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
  Show Outcome Measure 29

30.  Primary:   Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer   [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
  Show Outcome Measure 30


  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:
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.


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: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


No publications provided


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00312858     History of Changes
Other Study ID Numbers: 2005_075, V251-067
Study First Received: April 7, 2006
Results First Received: March 24, 2009
Last Updated: April 7, 2010
Health Authority: United States: Food and Drug Administration





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