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Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035)

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ClinicalTrials.gov Identifier: NCT00432042
Recruitment Status : Completed
First Posted : February 6, 2007
Results First Posted : March 19, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Varicella
Measles
Mumps
Rubella
Diphtheria
Tetanus
Pertussis
Poliomyelitis
Hepatitis B
Haemophilus Infections
Interventions: Biological: ProQuad®
Biological: Infanrix® hexa

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 963 participants were screened at study centers in Italy and Germany.

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: ProQuad® + Infanrix® Hexa Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
Arm 2: ProQuad® Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
Arm 3: Infanrix® Hexa Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).

Participant Flow:   Overall Study
    Arm 1: ProQuad® + Infanrix® Hexa   Arm 2: ProQuad®   Arm 3: Infanrix® Hexa
STARTED   479 [1]   235 [1]   241 [1] 
Vaccinated   477   235   240 
COMPLETED   472   234   239 
NOT COMPLETED   7   1   2 
Protocol Violation                2                0                0 
Withdrawal by Subject                0                0                2 
Lost to Follow-up                5                1                0 
[1] Number randomized.



  Baseline Characteristics

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
Arm 1: ProQuad® + Infanrix® Hexa Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
Arm 2: ProQuad® Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
Arm 3: Infanrix® Hexa Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
Total Total of all reporting groups

Baseline Measures
   Arm 1: ProQuad® + Infanrix® Hexa   Arm 2: ProQuad®   Arm 3: Infanrix® Hexa   Total 
Overall Participants Analyzed 
[Units: Participants]
 479   235   241   955 
Age 
[Units: Months]
Mean (Standard Deviation)
 13.6  (1.9)   13.4  (1.5)   13.5  (1.7)   13.5  (1.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      222  46.3%      112  47.7%      114  47.3%      448  46.9% 
Male      257  53.7%      123  52.3%      127  52.7%      507  53.1% 


  Outcome Measures

1.  Primary:   Percentage of Participants Meeting Antibody Response Rate Criteria to Measles, Mumps, Rubella, and Varicella   [ Time Frame: Day 42 ]

2.  Primary:   Percentage of Participants Meeting Post-vaccination Antibody Response Rates to Hepatitis B and Haemophilus Influenzae Type B   [ Time Frame: Day 42 ]

3.  Primary:   Post-vaccination Geometric Mean Titres (GMT) to Pertussis   [ Time Frame: Day 42 ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00432042     History of Changes
Other Study ID Numbers: V221-035
X06-MMRV-302 ( Other Identifier: Sanofi Pasteur MSD Protocol Number )
2006-004129-27 ( EudraCT Number )
First Submitted: February 5, 2007
First Posted: February 6, 2007
Results First Submitted: September 1, 2017
Results First Posted: March 19, 2018
Last Update Posted: March 19, 2018