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
  Purpose

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 ).


Condition Intervention Phase
Haemophilus Influenzae Type b
Neisseria Meningitidis
Biological: Menitorix
Biological: Infanrix IPV
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Enrollment: 288
Study Start Date: May 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: Infanrix IPV
Infanrix IPV will be administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.
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.
Biological: Infanrix IPV
Infanrix IPV will be administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.
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.
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.

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   24 Months to 64 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454987

Locations
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-021
GSK Investigational Site
Gdansk, Poland, 80-394
GSK Investigational Site
Kielce, Poland, 25-711
GSK Investigational Site
Krakow, Poland, 31-202
GSK Investigational Site
Leczna, Poland, 21-010
GSK Investigational Site
Poznan, Poland, 61-709
GSK Investigational Site
Siemianowice Slaskie, Poland, 41-103
GSK Investigational Site
Trzebnica, Poland, 55-100
United Kingdom
GSK Investigational Site
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Khatami A et al. (2011) Persistence of Immunity Following a Booster Dose of Haemophilus Influenzae Type B-Meningococcal Serogroup C Glycoconjugate Vaccine: Follow-up of a Randomized Controlled Trial. Pediatr Infect Dis J. 30(3):197-202.
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00454987     History of Changes
Other Study ID Numbers: 109664, 109666, 109668
Study First Received: March 30, 2007
Last Updated: June 12, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
antibody persistence
Meningococcal serogroup C vaccine
conjugate vaccine
Haemophilus influenzae type b vaccine

Additional relevant MeSH terms:
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014