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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: April 7, 2006   Last Updated: November 2, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Parallel Assignment
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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  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   [ 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™) ]
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2.  Primary:   Antibody Response to Varicella - Participants With a Serological Response   [ 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™) ]
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3.  Primary:   Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response   [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
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4.  Primary:   Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response   [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
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5.  Primary:   Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response   [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
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6.  Primary:   Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response   [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
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7.  Primary:   Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response   [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
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8.  Primary:   Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response   [ 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   [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]
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10.  Primary:   Participants With 1 or More Systemic Adverse Experience   [ 6 weeks post dose 1 ]
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11.  Primary:   Participants With 1 or More Systemic Adverse Experience   [ 4 weeks post dose 2 ]
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12.  Primary:   Participants With 1 or More Systemic Adverse Experience.   [ 6 months ]
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13.  Primary:   Participants With 1 or More Injection-site Adverse Experience   [ 6 weeks post dose 1 ]
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14.  Primary:   Participants With 1 or More Injection-site Adverse Experience   [ 4 weeks post dose 2 ]
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15.  Primary:   Participants With 1 or More Injection-site Adverse Experience   [ 6 months ]
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16.  Primary:   Participants With Elevated Temperature (≥102.2F/ ≥39.0C)   [ 6 weeks post dose 1 ]
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17.  Primary:   Participants With Elevated Temperature (≥102.2F/ ≥39.0C)   [ 4 weeks post dose 2 ]
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18.  Primary:   Participants With Elevated Temperature (≥102.2F/ ≥39.0C)   [ 6 months ]
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19.  Primary:   Participants With 1 or More Serious Vaccine-related Adverse Experience   [ 6 weeks post dose 1 ]
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20.  Primary:   Participants With 1 or More Serious Vaccine-related Adverse Experience   [ 4 weeks post dose 2 ]
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21.  Primary:   Participants With 1 or More Serious Vaccine-related Adverse Experience   [ 6 months ]
  Show Outcome Measure 21

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

23.  Primary:   Antibody Response to Varicella - Geometric Mean Titer   [ 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   [ 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   [ 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   [ 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   [ 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   [ 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   [ 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   [ 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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 & Co., Inc.
phone: 1-800-672-6372


No publications provided


Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2005_075, V251-067
Study First Received: April 7, 2006
Results First Received: March 24, 2009
Last Updated: November 2, 2009
ClinicalTrials.gov Identifier: NCT00312858     History of Changes
Health Authority: United States: Food and Drug Administration





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