3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00129116
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: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Conditions: Haemophilus Influenzae Type b
Neisseria Meningitidis
Interventions: Biological: Hib-MenCY-TT vaccine
Biological: Hib-MenC-TT vaccine
Biological: Menjugate ®
Biological: Infanrix penta ®
Biological: Infanrix hexa ®

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

The study is divided in two phases:

  • Primary phase: 3-dose primary vaccination at 2, 3 and 4 months of age = study Months 0, 1, 2. Data were collected up to 1 month after the 3rd dose (study Month 3)
  • Booster phase: booster dose at 12-18 months of age = study Month 0. Data were collected up to 1 month after the booster dose (study Month 1)

Reporting Groups
  Description
Menhibrix F1/Infanrix-penta Group Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Menhibrix F2/Infanrix-penta Group Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Menhibrix F3/Infanrix-penta Group Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Menitorix/Infanrix-penta Group Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Menjugate/Infanrix-hexa Group Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.

Participant Flow for 2 periods

Period 1:   Primary Phase
    Menhibrix F1/Infanrix-penta Group     Menhibrix F2/Infanrix-penta Group     Menhibrix F3/Infanrix-penta Group     Menitorix/Infanrix-penta Group     Menjugate/Infanrix-hexa Group  
STARTED     78     77     78     78     77  
COMPLETED     76     73     77     77     76  
NOT COMPLETED     2     4     1     1     1  
Lost to Follow-up                 1                 1                 0                 1                 1  
Protocol Violation                 0                 1                 0                 0                 0  
Adverse Event                 1                 1                 0                 0                 0  
Withdrawal by Subject                 0                 1                 0                 0                 0  
Unspecified                 0                 0                 1                 0                 0  

Period 2:   Booster Phase
    Menhibrix F1/Infanrix-penta Group     Menhibrix F2/Infanrix-penta Group     Menhibrix F3/Infanrix-penta Group     Menitorix/Infanrix-penta Group     Menjugate/Infanrix-hexa Group  
STARTED     47     42     44     44     44  
COMPLETED     45     42     44     44     43  
NOT COMPLETED     2     0     0     0     1  
Lost to Follow-up                 2                 0                 0                 0                 1  



  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 F1/Infanrix-penta Group Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Menhibrix F2/Infanrix-penta Group Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Menhibrix F3/Infanrix-penta Group Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Menitorix/Infanrix-penta Group Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Menjugate/Infanrix-hexa Group Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Total Total of all reporting groups

Baseline Measures
    Menhibrix F1/Infanrix-penta Group     Menhibrix F2/Infanrix-penta Group     Menhibrix F3/Infanrix-penta Group     Menitorix/Infanrix-penta Group     Menjugate/Infanrix-hexa Group     Total  
Number of Participants  
[units: participants]
  78     77     78     78     77     388  
Age  
[units: Weeks]
Mean ± Standard Deviation
           
Weeks     8.5  ± 1.69     8.8  ± 1.72     8.7  ± 1.55     8.3  ± 1.63     9.0  ± 1.65     8.7  ± 1.65  
Gender  
[units: Subjects]
           
Female     31     37     44     33     40     185  
Male     47     40     34     45     37     203  



  Outcome Measures
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1.  Primary:   Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).   [ Time Frame: One month after dose 3 (at study Month 3 - primary phase) ]

2.  Primary:   Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8   [ Time Frame: One month after dose 3 (at study Month 3 - primary phase) ]

3.  Primary:   Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8   [ Time Frame: One month after dose 3 (at study Month 3 - primary phase) ]

4.  Primary:   Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).   [ Time Frame: One month after the booster vaccination (at study Month 1 – booster phase) ]

5.  Primary:   Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8   [ Time Frame: One month after the booster vaccination (at study Month 1 – booster phase) ]

6.  Primary:   Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8   [ Time Frame: One month after the booster vaccination (at study Month 1 – booster phase) ]

7.  Secondary:   Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8   [ Time Frame: Before the administration of the first dose (at pre-vaccination = study Month 0 – primary phase) ]

8.  Secondary:   Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8   [ Time Frame: Before the administration of the first dose (at pre-vaccination = study Month 0 – primary phase) ]

9.  Secondary:   Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).   [ Time Frame: Before the administration of the first dose (at pre-vaccination = study Month 0 – primary phase) ]

10.  Secondary:   Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).   [ Time Frame: Prior to the booster vaccination (at study Month 0 – booster phase) ]

11.  Secondary:   Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8   [ Time Frame: Prior to the booster vaccination (at study Month 0 – booster phase) ]

12.  Secondary:   Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8   [ Time Frame: Prior to the booster vaccination (at study Month 0 – booster phase) ]

13.  Secondary:   rSBA-MenC Antibody Titres   [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase) ]

14.  Secondary:   rSBA-MenY Antibody Titres   [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase) ]

15.  Secondary:   Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).   [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase) ]

16.  Secondary:   Anti-PRP Antibody Concentrations   [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase) ]

17.  Secondary:   Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)   [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase) ]

18.  Secondary:   Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)   [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase) ]

19.  Secondary:   Anti-PSC Antibody Concentrations   [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase) ]

20.  Secondary:   Anti-PSY Antibody Concentrations   [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase) ]

21.  Secondary:   Anti-tetanus Antibody Concentrations   [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase) ]

22.  Secondary:   Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations   [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase) ]

23.  Secondary:   Number of Seroprotected Subjects for Anti-tetanus Antibodies   [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase) ]

24.  Secondary:   Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL)   [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase) ]

25.  Secondary:   Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).   [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase) ]

26.  Secondary:   Anti-PRP Antibody Concentrations   [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase) ]

27.  Secondary:   Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128   [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase) ]

28.  Secondary:   Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128   [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase) ]

29.  Secondary:   rSBA-MenC Antibody Titres   [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase) ]

30.  Secondary:   rSBA-MenY Antibody Titres   [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase) ]

31.  Secondary:   Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)   [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase) ]

32.  Secondary:   Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL)   [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase) ]

33.  Secondary:   Anti-PSC Antibody Concentrations   [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase) ]

34.  Secondary:   Anti-PSY Antibody Concentrations   [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase) ]

35.  Secondary:   Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL).   [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase) ]

36.  Secondary:   Anti-T Antibody Concentrations   [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase) ]

37.  Secondary:   Anti-diphtheria Antibody Concentrations   [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ]

38.  Secondary:   Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations   [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ]

39.  Secondary:   Anti-poliovirus Types 1, 2, 3 Antibody Titres   [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ]

40.  Secondary:   Number of Seroprotected Subjects for Anti-diphtheria Antibodies   [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ]

41.  Secondary:   Number of Seroprotected Subjects for Anti-hepatitis B Antibodies   [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ]

42.  Secondary:   Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies   [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ]

43.  Secondary:   Number of Subjects With Vaccine Response to PT, FHA and PRN   [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ]

44.  Secondary:   Number of Subjects With Solicited Local Symptoms   [ Time Frame: During the 8-day (Day 0-7) follow-up period (during the primary phase) ]

45.  Secondary:   Number of Subjects With Solicited General Symptoms   [ Time Frame: During the 8-day (Day 0-7) follow-up period (during the primary phase) ]

46.  Secondary:   Number of Subjects With Unsolicited Adverse Events (AEs)   [ Time Frame: During the 31-day (Day 0-30) follow-up period (during the primary phase) ]

47.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs)   [ Time Frame: Over the full course of the primary phase (up to study Month 3 – primary phase) ]

48.  Secondary:   Number of Subjects With Solicited Local Symptoms   [ Time Frame: During the 8-day (Day 0-7) follow-up period (during the booster phase) ]

49.  Secondary:   Number of Subjects With Solicited General Symptoms   [ Time Frame: During the 8-day (Day 0-7) follow-up period (during the booster phase) ]

50.  Secondary:   Number of Subjects With Unsolicited Adverse Events (AEs)   [ Time Frame: During the 31-day (Day 0-30) follow-up period (during the booster phase) ]

51.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs)   [ Time Frame: Over the full course of the booster phase (up to study Month 1 – booster phase) ]


  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


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Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00129116     History of Changes
Other Study ID Numbers: 792014/003, 100381
Study First Received: August 10, 2005
Results First Received: June 15, 2012
Last Updated: June 26, 2014
Health Authority: Germany: Paul-Ehrlich-Institut