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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: 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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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   [ 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™) ]
  Show Outcome Measure 1

2.  Primary:   Antibody Response to Varicella - Participants With a Serological Response   [ 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   [ 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   [ 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   [ 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   [ 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   [ 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   [ 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™) ]
  Show Outcome Measure 9

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

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

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

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

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

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

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

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

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

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

Measure Type Primary
Measure Title Participants With 1 or More Serious Vaccine-related Adverse Experience
Measure Description Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Time Frame 6 weeks post dose 1  
Safety Issue Yes  

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.
Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)

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.

Measured Values
  Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed
[units: participants] 		311 274
Participants With 1 or More Serious Vaccine-related Adverse Experience
[units: Participants]
 		0 1

No statistical analysis provided for Participants With 1 or More Serious Vaccine-related Adverse Experience



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

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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