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: June 12, 2014
Last verified: September 2011

March 30, 2007
June 12, 2014
May 2007
May 2010   (final data collection date for primary outcome measure)
  • SBA-MenC titre [ Time Frame: In all subjects of groups HibMenC and LicMenC at Visit 1, Visit 2 and Visit 3 (i.e. at 12, 24 and 48 months, respectively, after the Hib-MenC booster) and in all subjects of group NoBoost at 40-43 months of age (Visit 2) ] [ Designated as safety issue: No ]
  • Anti-PRP concentration [ Time Frame: In all subjects of groups HibMenC and LicMenC at Visit 1, Visit 2 and Visit 3 (i.e. at 12, 24 and 48 months, respectively, after the Hib-MenC booster) and in all subjects of group NoBoost at 40-43 months of age (Visit 2) ] [ Designated as safety issue: No ]
  • Anti-PSC concentration. [ Time Frame: In all subjects of groups HibMenC and LicMenC at Visit 1, Visit 2 and Visit 3 (i.e. at 12, 24 and 48 months, respectively, after the Hib-MenC booster) and in all subjects of group NoBoost at 40-43 months of age (Visit 2) ] [ Designated as safety issue: No ]
  • Anti-FHA concentration [ Time Frame: In all UK subjects of groups HibMenC and LicMenC at Visit 2 (24 months after Hib-MenC booster and prior to Infanrix-IPV booster) and at Visit 3 (48 months after Hib-MenC booster and 24 months after Infanrix-IPV booster) ] [ Designated as safety issue: No ]
  • anti-PRN concentration [ Time Frame: In all UK subjects of groups HibMenC and LicMenC at Visit 2 (24 months after Hib-MenC booster and prior to Infanrix-IPV booster) and at Visit 3 (48 months after Hib-MenC booster and 24 months after Infanrix-IPV booster) ] [ Designated as safety issue: No ]
  • anti-PT concentration [ Time Frame: In all UK subjects of groups HibMenC and LicMenC at Visit 2 (24 months after Hib-MenC booster and prior to Infanrix-IPV booster) and at Visit 3 (48 months after Hib-MenC booster and 24 months after Infanrix-IPV booster) ] [ Designated as safety issue: No ]
  • All SAEs considered related to vaccination by the investigator in all subjects of groups HibMen and LicMenC. [ Time Frame: From last study contact of booster phase to end of this persistence study ] [ Designated as safety issue: No ]
  • SAEs occurring after administration of to Infanrix™ IPV and Menitorix™ vaccines to UK subjects. [ Time Frame: Up to 30 days after vaccination ] [ Designated as safety issue: No ]
In all subjects at 12, 24 & 48 months after booster: Immunogenicity to vaccine antigens
Complete list of historical versions of study NCT00454987 on ClinicalTrials.gov Archive Site
Not Provided
Related SAEs from last study contact of booster study to end of this persistence study.
Not Provided
Not Provided
 
Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine
Assessment of Long-term Antibody Persistence After a Booster Dose of GSK Biologicals' Hib & Meningococcal C Vaccine (Menitorix™) 811936 Given at 12-15 Months of Age to Subjects Primed With 3 Doses of Menitorix™ at 2, 3, 4 Months of Age

The purpose of this study is to evaluate the long-term antibody persistence at 12, 24 and 48 months after the administration of a booster dose of Menitorix™, given at 12-15 months of age. The children had previously received 3 doses of Menitorix™ and Infanrix™ IPV or Meningitec™ and Pediacel™ in infancy. In addition, the antibody persistence is to be investigated in children of 40-43 months of age who received a 3-dose primary vaccination of a MenC conjugate vaccine and a Hib containing vaccine in infancy without a booster dose of MenC conjugate and Hib vaccine in the second year of life.

This protocol posting deals with objectives & outcome measures of the extension phases at 12, 24 and 48 months after the booster phase. The objectives & outcome measures of the primary phase & booster phase at 12 to 15 months are presented in a separate protocol posting (NCT number =00258700 ).

This multicentre & multicountry study is open and has 2 study groups at Visits 1 and 3 (HibMenC and LicMenC). An additional control group in the UK at the time of the second year follow-up for persistence (subjects aged 40-43 months primed with MenC conjugate and Hib vaccines in infancy with no subsequent booster dose, group NoBoost at Visit 2). These subjects will receive a Hib catch-up vaccine at 40-43 months of age. The subjects of groups HibMenC and LicMenC were randomized in the primary vaccination study 103974 and will not be further randomized. The subjects of group NoBoost will not be randomized. All subjects at the UK centre will receive Infanrix™-IPV at the second visit (i.e. 24 months after Menitorix™ booster or at 40-43 months of age). In addition, the subjects of group NoBoost will receive a Hib catch-up vaccine (Menitorix™) at the same visit.

Subjects of groups HibMenC and LicMenC will have 3 blood samples taken for immunogenicity analyses: at 12, 24 & 48 months after the booster vaccination. Subjects of group NoBoost will have 1 blood sample taken for immunogenicity analyses at 40-43 months of age. 75 new subjects will be enrolled in this study (group NoBoost).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Haemophilus Influenzae Type b
  • Neisseria Meningitidis
  • Biological: Menitorix
    Menitorix will only be administered to subjects of the group NoBoost at 40 to 43 months of age.
  • Biological: Infanrix IPV
    Infanrix IPV will be administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.
  • Experimental: Group HibMenC
    Previously primed in infancy with Hib-MenC and Infanrix-IPV and boosted with Hib-MenC (Priorix co-administered). All UK subjects will received a booster dose of Infanrix IPV at 40 to 43 months of age.
    Intervention: Biological: Infanrix IPV
  • Active Comparator: Group LicMenC
    Previously primed in infancy with Meningitec and Pediacel and boosted with Hib-MenC (Priorix co-administered). All UK subjects will received a booster dose of Infanrix IPV at 40 to 43 months of age.
    Intervention: Biological: Infanrix IPV
  • Active Comparator: Group NoBoost
    Previously primed (according to the routine UK immunisation schedule) with 3 doses of a MenC conjugate vaccine and a Hib containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects will received a booster dose of Infanrix IPV and Menitorix at 40 to 43 months of age.
    Interventions:
    • Biological: Menitorix
    • Biological: Infanrix IPV

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
288
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

Subjects of groups HibMenC and LicMenC at Visits 1, 2 and 3:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between and including 24 and 31 months of age at the time of Visit 1, between and including 40 and 43 months of age at Visit 2 and between and including 60 and 64 months at Visit 3.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Having completed the booster vaccination study 104056.

Subjects of group NoBoost at Visit 2 (UK only):

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between and including 40 and 43 months of age at Visit 2.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Having received a 3-dose primary vaccination with a MenC conjugate vaccine and a Hib containing vaccine before the age of 8 months.

Exclusion Criteria:

  • Previous administration of booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study 104056.
  • History of H. influenzae type b or meningococcal diseases.
  • For UK subjects of groups HibMenC and LicMenC only: previous administration of a booster dose of a pertussis-containing vaccine except booster study vaccines during the study 104056.
Both
24 Months to 64 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Poland,   United Kingdom
 
NCT00454987
109664, 109666, 109668
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP