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Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age (V251-068)
This study has been completed.
Study NCT00289913   Information provided by Merck

First Received on February 8, 2006.   Last Updated on June 9, 2011   History of Changes
Results First Received: June 9, 2011  
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™
Biological: Comparator: Infanrix™
Biological: Comparator: PedvaxHIB™

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
In Stage I, a total of 620 participants were randomized to receive study vaccinations. However for 3 participants, the Health Insurance Portability and Accountability Act (HIPAA) and/or Informed Consent Form was not signed by the parents in error. Therefore a total of 617 participants were included in Stage I. 654 participants started Stage II.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
For this study: Visit 1 was on Day 1 (for Stage I and Stage II). Visit 2 was at Week 4 (Stage I) and Week 2 (Stage II). Visit 3 was at Week 24/Week 28 (Stage I) and Week 24 (Stage II). Visit 4 was at Week 28/Week 32 (Stage I) and Week 26 (Stage II). For safety, participants were followed for 14 days after each vaccination (safety follow-up [F/U]).

Reporting Groups
  Description
VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)

Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.

Week 24: The second dose of VAQTA™ was administered.
PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)

Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.

Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered.
VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)

Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.

Week 24: The second dose of VAQTA™ was administered.
PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1) Day 1: PedvaxHIB™ was administered. Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered.
VAQTA™/ VAQTA™ (Stage 2) Day 1: The first dose of VAQTA™ was administered. Week 24: The second dose of VAQTA™ was administered.

Participant Flow for 4 periods

 Period 1:   Visit 1 (Stage I and Stage II)
    VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)     PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)     VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)     PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)     VAQTA™/ VAQTA™ (Stage 2)  
STARTED     155     151     159     152     654 [1]
COMPLETED     146     135     150     141     645  
NOT COMPLETED     9     16     9     11     9  
Protocol deviation during safety F/U                 0                 1                 0                 0                 0  
Lost during safety F/U                 3                 2                 2                 2                 1  
Withdrew consent during safety F/U                 2                 2                 0                 2                 2  
Moved during safety F/U                 0                 0                 0                 0                 1  
Other reasons during safety F/U                 0                 0                 0                 1                 0  
Protocol deviation after safety F/U                 1                 2                 0                 0                 0  
Lost after safety F/U                 2                 1                 0                 0                 5  
Withdrew consent after safety F/U]                 0                 8                 5                 6                 0  
Other reasons after safety F/U                 1                 0                 2                 0                 0  
[1] Participants were enrolled during Stage II.

Period 2:   Visit 2 (Stage I and Stage II)
    VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)     PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)     VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)     PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)     VAQTA™/ VAQTA™ (Stage 2)  
STARTED     146     135     150     141     645 [1]
COMPLETED     131     114     140     135     605  
NOT COMPLETED     15     21     10     6     40  
Protocol deviation during safety F/U                 0                 0                 1                 0                 0  
Lost during safety F/U                 8                 11                 2                 2                 0  
Subject moved during safety F/U                 0                 1                 0                 0                 0  
Withdrew consent during safety F/U                 3                 2                 1                 0                 0  
Other reasons during safety F/U                 1                 0                 1                 0                 0  
Protocol deviation after safety F/U                 0                 1                 3                 1                 0  
Lost after safety F/U                 2                 5                 0                 3                 0  
Withdrew consent after safety F/U                 0                 1                 2                 0                 0  
Other reasons after safety F/U]                 1                 0                 0                 0                 0  
Protocol deviation (Stage II)                 0                 0                 0                 0                 7  
Lost (Stage II)                 0                 0                 0                 0                 11  
Moved (Stage II)                 0                 0                 0                 0                 6  
Withdrew consent (Stage II)                 0                 0                 0                 0                 7  
Other reasons (Stage II)                 0                 0                 0                 0                 9  
[1] No vaccine administered at Visit 2 (Stage II), therefore there was no safety F/U period.

Period 3:   Visit 3 (Stage I and Stage II)
    VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)     PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)     VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)     PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)     VAQTA™/ VAQTA™ (Stage 2)  
STARTED     131     114     140     135     605  
COMPLETED     122     106     138     131     597  
NOT COMPLETED     9     8     2     4     8  
Protocol deviation during safety F/U                 0                 1                 0                 0                 0  
Lost during safety F/U                 8                 3                 1                 2                 2  
Withdrew consent during safety F/U                 0                 0                 0                 1                 0  
Other reasons during safety F/U                 0                 0                 0                 0                 1  
Lost after safety F/U                 1                 2                 0                 1                 4  
Withdrew consent after safety F/U]                 0                 1                 1                 0                 0  
Moved after safety F/U                 0                 0                 0                 0                 1  
Other reasons after safety F/U                 0                 1                 0                 0                 0  

Period 4:   Visit 4 (Stage I and Stage II)
    VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)     PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)     VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)     PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)     VAQTA™/ VAQTA™ (Stage 2)  
STARTED     122     106     138     131     597  
COMPLETED     122     106     138     131     597  
NOT COMPLETED     0     0     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)

Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.

Week 24: The second dose of VAQTA™ was administered.
PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)

Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.

Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered.
VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)

Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.

Week 24: The second dose of VAQTA™ was administered.
PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1) Day 1: PedvaxHIB™ was administered. Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered.
VAQTA™/ VAQTA™ (Stage 2) Day 1: The first dose of VAQTA™ was administered. Week 24: The second dose of VAQTA™ was administered.

Baseline Measures
    VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)     PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)     VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)     PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)     VAQTA™/ VAQTA™ (Stage 2)     Total  
Number of Participants  
[units: participants]
 		  155     151     159     152     654     1271  
Age, Customized [1]
[units: participants]
 		           
Between 12 and 18 months     155     151     159     152     654     1271  
Gender  
[units: participants]
 		           
Female     74     67     70     73     319     603  
Male     81     84     89     79     335     668  
[1] Months between the birthdate and consent date.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Seropositivity Rate (SPR) to Hepatitis A   [ Time Frame: 4 weeks after dose 2 of VAQTA™ ]
  Show Outcome Measure 1

2.  Primary:   Antibody Response Rate to Haemophilus Influenzae Type b (Hib)   [ Time Frame: 4 weeks postvaccination with PedvaxHIB™ ]
  Show Outcome Measure 2

3.  Primary:   Number of Participants With Adverse Events (AE)   [ Time Frame: Days 1 to 14 after any dose of VAQTA™ for systemic AEs, and Days 1 to 5 after any dose of VAQTA™ for injection-site AEs ]
  Show Outcome Measure 3

4.  Primary:   Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™   [ Time Frame: 4 weeks postvaccination with Infanrix™ ]
  Show Outcome Measure 4


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00289913     History of Changes
Other Study ID Numbers: V251-068, 2005_076
Study First Received: February 8, 2006
Results First Received: June 9, 2011
Last Updated: June 9, 2011
Health Authority: United States: Food and Drug Administration





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