Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00381615
First received: September 27, 2006
Last updated: September 11, 2015
Last verified: September 2015
Results First Received: February 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Healthy
Interventions: Biological: rMenB
Biological: rMenB+OMV
Biological: DTaP-Hib-IPV
Biological: PC7
Biological: MenC-CRM
Biological: MenC-Hib
Biological: MMR

  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
Subjects were enrolled at three study centers in the United Kingdom (UK).

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

Reporting Groups
  Description
rMenB

Infants received 4 doses of recombinant meningococcal serogroup B (rMenB) vaccine without Outer Membrane Vesicle (OMV-NZ) at 2, 4, 6 and 12 months of age.

Infants also received routine vaccines - 3 doses each of diphtheria-tetanus-acellular pertussis vaccine (DTaP-Hib-IPV) (at 2, 3, and 4 months) and Heptavalent Pneumococcal Conjugate (PC7) (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and Measles Mumps Rubella (MMR) (at 13 months).

rMenB+OMV

Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.

Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).

Routine

Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).

Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.

Routine+OMV

Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).

Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.


Participant Flow:   Overall Study
    rMenB     rMenB+OMV     Routine     Routine+OMV  
STARTED     48     50     25     24  
COMPLETED     44     45     24     22  
NOT COMPLETED     4     5     1     2  
Withdrawal by Subject                 1                 3                 0                 1  
Lost to Follow-up                 3                 2                 0                 1  
Protocol Violation                 0                 0                 1                 0  



  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.
Analysis was performed on all enrolled subjects.

Reporting Groups
  Description
rMenB

Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.

Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).

rMenB+OMV

Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.

Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).

Routine

Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).

Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.

Routine+OMV

Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).

Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.

Total Total of all reporting groups

Baseline Measures
    rMenB     rMenB+OMV     Routine     Routine+OMV     Total  
Number of Participants  
[units: participants]
  48     50     25     24     147  
Age  
[units: Days]
Mean (Standard Deviation)
  59.0  (3.4)     60.9  (5.9)     60.4  (5.9)     60.9  (6.1)     60.2  (5.3)  
Gender  
[units: Subjects]
         
Female     24     22     9     7     62  
Male     24     28     16     17     85  



  Outcome Measures
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1.  Primary:   Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization   [ Time Frame: Baseline and one month after third-dose of infants series ]

2.  Primary:   Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ   [ Time Frame: Baseline and one month after third-dose of infants series ]

3.  Primary:   Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV   [ Time Frame: Day 1 through day 7 after each vaccination ]

4.  Primary:   Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7   [ Time Frame: Day 1 through day 7 after each vaccination ]

5.  Primary:   Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine   [ Time Frame: Day 1 through day 7 after each vaccination ]

6.  Primary:   Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib   [ Time Frame: Day 1 through day 7 after each vaccination ]

7.  Primary:   Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study   [ Time Frame: Day 1 through day 7 after each vaccination ]

8.  Primary:   Percentage of Subjects With Fourfold Rises in Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination or rMenB Vaccine With and Without OMV-NZ.   [ Time Frame: 30 days after the third vaccination ]

9.  Primary:   Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization.   [ Time Frame: At baseline (pre-vaccination) and 30 days after the third vaccination ]

10.  Secondary:   Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination   [ Time Frame: 1 month after first vaccination ]

11.  Secondary:   Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age   [ Time Frame: prior 1st dose, 30 days post-2nd vaccination, 12 months age to 1 month post 4th vaccination ]

12.  Secondary:   Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ   [ Time Frame: pre-first vaccination and 1 month after first vaccination ]

13.  Secondary:   Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination   [ Time Frame: 30 days after the second vaccination and 1 month after fourth (booster) vaccination ]

14.  Secondary:   Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age   [ Time Frame: pre-first vaccination and 1 month after first vaccination ]

15.  Secondary:   Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After a Single Dose Administered at 12 Months of Age   [ Time Frame: 1 month after first vaccination ]

16.  Secondary:   Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age   [ Time Frame: At pre-vaccination and 30 days post the 2nd vaccination and at 12 months age, and 1 month post 4th (booster) vaccination. ]

17.  Secondary:   Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age   [ Time Frame: At baseline (pre-vaccination) and 30 days after the second vaccination and at 12 months 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
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  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 ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00381615     History of Changes
Other Study ID Numbers: V72P6
Study First Received: September 27, 2006
Results First Received: February 4, 2015
Last Updated: September 11, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency