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Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00806195
First Posted: December 10, 2008
Last Update Posted: July 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
Results First Submitted: May 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Meningitis
Meningococcal Infection
Interventions: Biological: MenACWY-CRM197
Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
Biological: Hib (Haemophilus influenza b) Vaccine
Biological: IPV (Inactivated Polio Vaccine) Vaccine
Biological: Pneumococcal conjugate Vaccine
Biological: MMR (Measles, Mumps, and Rubella) Vaccine
Biological: Varicella Vaccine
Biological: Hepatitis A Virus

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects enrolled were included in the trial.

Reporting Groups
  Description
MenACWY-CRM197 + Routine Vaccines (Non-detailed)

Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Non-Detailed - subjects who only provided Serious Adverse Events (SAEs) and medically attended Adverse (AE).

Routine Vaccines (Non-detailed)

Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Non-Detailed - subjects who only provided SAEs and medically attended AEs.

MenACWY-CRM197 + Routine Vaccines (Detailed)

Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.

Routine Vaccines (Detailed)

Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Detailed - subjects who provided Reactogenicity, all AEs for 7 days, SAEs and medically attended AEs.


Participant Flow:   Overall Study
    MenACWY-CRM197 + Routine Vaccines (Non-detailed)   Routine Vaccines (Non-detailed)   MenACWY-CRM197 + Routine Vaccines (Detailed)   Routine Vaccines (Detailed)
STARTED   4363   1483   1409   489 
COMPLETED   3849   1321   1139   383 
NOT COMPLETED   514   162   270   106 
Death                6                0                1                0 
Adverse Event                25                5                11                2 
Withdrawal by Subject                119                31                76                35 
Lost to Follow-up                217                66                90                34 
Inappropriate Enrollment                0                1                0                0 
Administrative Reason                113                35                66                26 
Protocol Violation                34                24                26                9 



  Baseline Characteristics
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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
MenACWY-CRM197 + Routine Vaccines (Non-Detailed)

Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Non-Detailed - subjects who only provided SAEs and medically attended AEs.

Routine Vaccines (Non-Detailed)

Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Non-Detailed - subjects who only provided SAEs and medically attended AEs.

MenACWY-CRM197 + Routine Vaccines (Detailed)

Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.

Routine Vaccines (Detailed)

Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.

Total Total of all reporting groups

Baseline Measures
   MenACWY-CRM197 + Routine Vaccines (Non-Detailed)   Routine Vaccines (Non-Detailed)   MenACWY-CRM197 + Routine Vaccines (Detailed)   Routine Vaccines (Detailed)   Total 
Overall Participants Analyzed 
[Units: Participants]
 4363   1483   1409   489   7744 
Age 
[Units: Days]
Mean (Standard Deviation)
 64.9  (7.4)   64.7  (7.1)   65.5  (6.5)   65.2  (6.3)   65.0  (7.1) 
Gender 
[Units: Participants]
         
Female   2135   703   716   232   3786 
Male   2228   780   693   257   3958 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination   [ Time Frame: 15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age ]

2.  Secondary:   Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period   [ Time Frame: Day 1 (2 months of age) to 18 months of age ]

3.  Secondary:   Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination   [ Time Frame: 15 minutes to Day 7 ]

4.  Secondary:   Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination   [ Time Frame: Day 1 (2 months of age) to 18 months of age ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
e-mail: RegistryContactVaccinesUS@novartis.com



Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00806195     History of Changes
Other Study ID Numbers: V59P23
First Submitted: December 9, 2008
First Posted: December 10, 2008
Results First Submitted: May 13, 2013
Results First Posted: July 9, 2013
Last Update Posted: July 9, 2013