Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00134719
First received: August 10, 2005
Last updated: June 26, 2014
Last verified: June 2014
Results First Received: June 15, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Neisseria Meningitidis
Haemophilus Influenzae Type b
Interventions: Biological: MenHibrix (Hib-MenCY-TT)
Biological: Infanrix® Penta
Biological: Prevenar®
Biological: ActHIB®
Biological: Meningitec®
Biological: M-M-R®II
Biological: Varivax®
Biological: PedvaxHIB®

  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 randomised at the beginning of the primary vaccination phase and kept their group assignment during the fourth dose vaccination phase. Not all subjects who completed the primary vaccination phase returned for participation in the fourth dose vaccination phase.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One subject who had a subject number allocated, was not vaccinated.

Reporting Groups
  Description
MenHibrix Group Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Participant Flow for 2 periods

Period 1:   Primary Vaccination Phase
    MenHibrix Group     ActHIB + Meningitec Group     ActHIB/PedvaxHIB Group  
STARTED     661     221     221  
COMPLETED     647     215     216  
NOT COMPLETED     14     6     5  
Adverse Event                 4                 0                 0  
Protocol Violation                 1                 0                 0  
Withdrawal by Subject                 2                 3                 2  
Lost to Follow-up                 7                 3                 3  

Period 2:   Fourth Dose Vaccination Phase
    MenHibrix Group     ActHIB + Meningitec Group     ActHIB/PedvaxHIB Group  
STARTED     625     206     204  
COMPLETED     623     203     203  
NOT COMPLETED     2     3     1  
Lost to Follow-up                 1                 3                 1  
Mother just delivered a new baby                 1                 0                 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.
No text entered.

Reporting Groups
  Description
MenHibrix Group Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
Total Total of all reporting groups

Baseline Measures
    MenHibrix Group     ActHIB + Meningitec Group     ActHIB/PedvaxHIB Group     Total  
Number of Participants  
[units: participants]
  661     221     221     1103  
Age  
[units: Days]
Mean ± Standard Deviation
       
Days     61.0  ± 7.38     61.5  ± 7.22     61.5  ± 7.95     61.2  ± 7.46  
Gender  
[units: Subjects]
       
Female     328     118     103     549  
Male     333     103     118     554  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL)   [ Time Frame: One month after the 3-dose primary vaccination course ]

2.  Primary:   Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128   [ Time Frame: One month after the 3-dose primary vaccination course ]

3.  Primary:   Number of Subjects Seroconverted for Anti-measles Antibodies   [ Time Frame: 42 days after the fourth dose vaccination ]

4.  Primary:   Number of Subjects Seroconverted for Anti-mumps Antibodies   [ Time Frame: 42 days after the fourth dose vaccination ]

5.  Primary:   Number of Subjects With an Anti-rubella Seroresponse   [ Time Frame: 42 days after the fourth dose vaccination ]

6.  Primary:   Number of Subjects Seroconverted for Anti-varicella Antibodies   [ Time Frame: 42 days after the fourth dose vaccination ]

7.  Secondary:   Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values   [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

8.  Secondary:   rSBA-MenC Titers   [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

9.  Secondary:   Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values   [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

10.  Secondary:   rSBA-MenY Titers   [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

11.  Secondary:   Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values   [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

12.  Secondary:   hSBA-MenC Titers   [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

13.  Secondary:   Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values   [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

14.  Secondary:   hSBA-MenY Titers   [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

15.  Secondary:   Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values   [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

16.  Secondary:   Anti-PSC Concentrations   [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

17.  Secondary:   Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values   [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

18.  Secondary:   Anti-PSY Concentrations   [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

19.  Secondary:   Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values   [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

20.  Secondary:   Anti-PRP Concentrations   [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

21.  Secondary:   Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL   [ Time Frame: Just prior to the fourth dose and 42 days after the fourth dose ]

22.  Secondary:   Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50   [ Time Frame: Just prior to the fourth dose and 42 days after the fourth dose ]

23.  Secondary:   Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL   [ Time Frame: Just prior to the fourth dose and 42 days after the fourth dose ]

24.  Secondary:   Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5   [ Time Frame: Just prior to the fourth dose and 42 days after the fourth dose ]

25.  Secondary:   Number of Subjects With a Fourth Dose Response for hSBA-MenC   [ Time Frame: 42 days after the fourth dose ]

26.  Secondary:   Number of Subjects With a Fourth Dose Response for hSBA-MenY   [ Time Frame: 42 days after the fourth dose ]

27.  Secondary:   Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects   [ Time Frame: 42 days after the fourth dose ]

28.  Secondary:   Anti-measles Concentrations in Initially Seronegative Subjects   [ Time Frame: 42 days after the fourth dose ]

29.  Secondary:   Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects   [ Time Frame: 42 days after the fourth dose ]

30.  Secondary:   Anti-rubella Concentrations in Initially Seronegative Subjects   [ Time Frame: 42 days after the fourth dose ]

31.  Secondary:   Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination   [ Time Frame: 42 days after the fourth dose ]

32.  Secondary:   Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects   [ Time Frame: 42 days after the fourth dose ]

33.  Secondary:   Anti-mumps Titers in Initially Seronegative Subjects   [ Time Frame: 42 days after the fourth dose ]

34.  Secondary:   Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects   [ Time Frame: 42 days after the fourth dose ]

35.  Secondary:   Anti-varicella Titers in Initially Seronegative Subjects   [ Time Frame: 42 days after the fourth dose ]

36.  Secondary:   Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase   [ Time Frame: During a 4-day period (Day 0-3) after any vaccine dose in the primary vaccination phase ]

37.  Secondary:   Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase   [ Time Frame: During a 4-day period (Day 0-3) after the fourth dose vaccination phase ]

38.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events   [ Time Frame: During the 31-day (Day 0-30) post-primary and post-fourth dose vaccination period ]

39.  Secondary:   Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine   [ Time Frame: During a 43-day (Day 0-42) after the fourth dose ]

40.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase   [ Time Frame: From enrolment through the day preceding the fourth dose ]

41.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase   [ Time Frame: From the day of administration of the fourth dose until the end of the extended safety follow-up period (last study contact at 18-21 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
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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 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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:
Nolan T et al. (2011) Immunogenicity and Safety of an Investigational Combined Haemophilus influenzae Type B-Neisseria meningitidis Serogroups C and Y-Tetanus Toxoid Conjugate Vaccine. Pediatr Infect Dis J. 30(3):190-196.

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00134719     History of Changes
Obsolete Identifiers: NCT00787046
Other Study ID Numbers: 102370 (primary study), 102371
Study First Received: August 10, 2005
Results First Received: June 15, 2012
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration