Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00454987
First received: March 30, 2007
Last updated: November 12, 2015
Last verified: October 2015
Results First Received: November 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Haemophilus Influenzae Type b
Neisseria Meningitidis
Interventions: Biological: Menitorix
Biological: Infanrix IPV

  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
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Reporting Groups
  Description
Menitorix Group Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
Meningitec Group Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
Meningitec+Hiberix Group Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.

Participant Flow for 4 periods

Period 1:   Booster Period
    Menitorix Group     Meningitec Group     Meningitec+Hiberix Group  
STARTED     359     117     0  
COMPLETED     357     116     0  
NOT COMPLETED     2     1     0  
Adverse Event                 1                 0                 0  
Withdrawal by Subject                 0                 1                 0  
Lost to Follow-up                 1                 0                 0  

Period 2:   Year 1
    Menitorix Group     Meningitec Group     Meningitec+Hiberix Group  
STARTED     221     67     0  
COMPLETED     221     67     0  
NOT COMPLETED     0     0     0  

Period 3:   Year 2
    Menitorix Group     Meningitec Group     Meningitec+Hiberix Group  
STARTED     235     77     74  
COMPLETED     235     77     74  
NOT COMPLETED     0     0     0  

Period 4:   Year 4
    Menitorix Group     Meningitec Group     Meningitec+Hiberix Group  
STARTED     206     62     0  
COMPLETED     206     62     0  
NOT COMPLETED     0     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.
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Reporting Groups
  Description
Menitorix Group Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
Meningitec Group Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
Meningitec+Hiberix Group Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
Total Total of all reporting groups

Baseline Measures
    Menitorix Group     Meningitec Group     Meningitec+Hiberix Group     Total  
Number of Participants  
[units: participants]
  235     77     74     386  
Age  
[units: Months]
Mean (Standard Deviation)
  40.6  (0.76)     40.6  (0.74)     40.5  (0.71)     40.58  (0.75)  
Gender  
[units: Subjects]
       
Female     117     37     28     182  
Male     118     40     46     204  



  Outcome Measures
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1.  Primary:   Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8   [ Time Frame: At Year 1 ]

2.  Primary:   Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128   [ Time Frame: At Year 1 ]

3.  Primary:   rSBA-MenC Antibody Titers   [ Time Frame: At Year 1 ]

4.  Primary:   Number of Subjects With rSBA-MenC Antibody Titers ≥1:8   [ Time Frame: At Year 2 ]

5.  Primary:   Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8   [ Time Frame: At Year 2 ]

6.  Primary:   Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128   [ Time Frame: At Year 2 ]

7.  Primary:   Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128   [ Time Frame: At Year 2 ]

8.  Primary:   rSBA-MenC Antibody Titers   [ Time Frame: At Year 2 ]

9.  Primary:   rSBA-MenC Antibody Titers   [ Time Frame: At Year 2 ]

10.  Primary:   Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8   [ Time Frame: At Year 4 ]

11.  Primary:   Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128   [ Time Frame: At Year 4 ]

12.  Primary:   rSBA-MenC Antibody Titers   [ Time Frame: At Year 4 ]

13.  Primary:   Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL)   [ Time Frame: At Year 1 ]

14.  Primary:   Concentration of Anti-PRP Antibodies   [ Time Frame: At Year 1 ]

15.  Primary:   Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL   [ Time Frame: At Year 2 ]

16.  Primary:   Number of Subjects With Anti-PRP Antibodies ≥0.15 µg/mL and ≥1 µg/mL   [ Time Frame: At Year 2 ]

17.  Primary:   Concentration of Anti-PRP Antibodies   [ Time Frame: At Year 2 ]

18.  Primary:   Concentration of Anti-PRP Antibodies   [ Time Frame: At Year 2 ]

19.  Primary:   Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL   [ Time Frame: At Year 4 ]

20.  Primary:   Concentration of Anti-PRP Antibodies   [ Time Frame: At Year 4 ]

21.  Primary:   Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL)   [ Time Frame: At Year 1 ]

22.  Primary:   Concentration of Anti-PSC Antibodies   [ Time Frame: At Year 1 ]

23.  Primary:   Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL   [ Time Frame: At Year 2 ]

24.  Primary:   Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL   [ Time Frame: At Year 2 ]

25.  Primary:   Concentration of Anti-PSC Antibodies   [ Time Frame: At Year 2 ]

26.  Primary:   Concentration of Anti-PSC Antibodies   [ Time Frame: At Year 2 ]

27.  Primary:   Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL   [ Time Frame: At Year 4 ]

28.  Primary:   Concentration of Anti-PSC Antibodies   [ Time Frame: At Year 4 ]

29.  Primary:   Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)   [ Time Frame: At Year 2 ]

30.  Primary:   Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies   [ Time Frame: At Year 2 ]

31.  Primary:   Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL   [ Time Frame: At Year 4 ]

32.  Primary:   Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies   [ Time Frame: At Year 4 ]

33.  Primary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: Up to Month 12 (Booster vaccination) ]

34.  Primary:   Number of Subjects With SAE(s)   [ Time Frame: Up to Month 24 (Booster vaccination) ]

35.  Primary:   Number of Subjects With SAE(s)   [ Time Frame: Up to Month 48 (Booster vaccination) ]

36.  Primary:   Number of Subjects With SAE(s)   [ Time Frame: Within (31-Days) at Year 2 ]


  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:
Khatami A et al. Persistence of antibody response following a booster dose of Hib-MenC-TT glycoconjugate vaccine: A phase IV open randomized controlled trial. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
Khatami A et al. Antibody concentrations against pertussis antigens at age 5 years following infant and pre-school immunisation: follow-on of a randomized controlled trial. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID). Melbourne, Australia, 16-19 November 2011.
Snape MD et al. Persistence of antibody response following a booster dose of Hib-MenC-TT glycoconjugate vaccine to five years: a follow-on study. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID). Melbourne, Australia, 16-19 November 2011.


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00454987     History of Changes
Other Study ID Numbers: 109664
109666 ( Other Identifier: GSK )
109668 ( Other Identifier: GSK )
Study First Received: March 30, 2007
Results First Received: November 12, 2015
Last Updated: November 12, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency