Last updated: 07/18/2020 12:13:53
Study of long-term antibody persistence after a booster dose of Menitorix vaccine
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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 links to objectives and outcome measures of the primary phase & booster phase at 12 to 15 months are provided below:https://www.gsk-studyregister.com/study/2747 (Primary phase)https://www.gsk-studyregister.com/study/2755 (Booster phase)
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of subjects with serum bactericidal assay using baby rabbit complement (rSBA-MenC) antibody titers equal to or above 1:8
Timeframe: At Year 1
Number of subjects with rSBA-MenC antibody titers ≥ 1:128
Timeframe: At Year 1
rSBA-MenC antibody titers
Timeframe: At Year 1
Number of subjects with rSBA-MenC antibody titers ≥1:8
Timeframe: At Year 2
Number of subjects with rSBA-MenC antibody titers ≥ 1:8 for Meningitec+Hiberix group
Timeframe: At Year 2
Number of subjects with rSBA-MenC antibody titers ≥ 1:128
Timeframe: At Year 2
Number of subjects with rSBA-MenC antibody titers ≥ 1:128 for Meningitec+Hiberix group
Timeframe: At Year 2
rSBA-MenC antibody titers
Timeframe: At Year 2
rSBA-MenC antibody titers for Meningitec+Hiberix group
Timeframe: At Year 2
Number of subjects with rSBA-MenC antibody titers ≥ 1:8
Timeframe: At Year 4
Number of subjects with rSBA-MenC antibody titers ≥ 1:128
Timeframe: At Year 4
rSBA-MenC antibody titers
Timeframe: At Year 4
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)
Timeframe: At Year 1
Concentration of anti-PRP antibodies
Timeframe: At Year 1
Number of subjects with anti-PRP antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Timeframe: At Year 2
Number of subjects with anti-PRP antibodies ≥0.15 µg/mL and ≥1 µg/mL for Meningitec+Hiberix group
Timeframe: At Year 2
Concentration of anti-PRP antibodies
Timeframe: At Year 2
Concentration of anti-PRP antibodies for Meningitec+Hiberix group
Timeframe: At Year 2
Number of subjects with anti-PRP antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Timeframe: At Year 4
Concentration of anti-PRP antibodies
Timeframe: At Year 4
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)
Timeframe: At Year 1
Concentration of anti-PSC antibodies
Timeframe: At Year 1
Number of subjects with anti-PSC antibody concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Timeframe: At Year 2
Number of subjects with anti-PSC antibody concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL for Meningitec+Hiberix group
Timeframe: At Year 2
Concentration of anti-PSC antibodies
Timeframe: At Year 2
Concentration of anti-PSC antibodies for Meningitec+Hiberix group
Timeframe: At Year 2
Number of subjects with anti-PSC antibody concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Timeframe: At Year 4
Concentration of anti-PSC antibodies
Timeframe: At Year 4
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)
Timeframe: At Year 2
Concentration of anti-PT, anti-FHA and anti-PRN antibodies
Timeframe: At Year 2
Number of subjects with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5.0 EL.U/mL
Timeframe: At Year 4
Concentration of anti-PT, anti-FHA and anti-PRN antibodies
Timeframe: At Year 4
Number of subjects with Serious adverse events (SAEs)
Timeframe: Up to Month 12 (Booster vaccination)
Number of subjects with SAE(s)
Timeframe: Up to Month 24 (Booster vaccination)
Number of subjects with SAE(s)
Timeframe: Up to Month 48 (Booster vaccination)
Number of subjects with SAE(s)
Timeframe: Within (31-Days) at Year 2
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
288
Primary completion date:
2007-12-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical 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.
Khatami A et al. (2012) Persistence of antibody response following a booster dose of Hib-MenC-TT glycoconjugate vaccine to five years: A follow-up study. Pediatr Infect Dis J. 31(10):1069-1073.
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.
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.
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.
Medical condition
Haemophilus influenzae type b, Neisseria Meningitidis
Product
SB811936
Collaborators
Not applicable
Study date(s)
May 2007 to October 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
24 - 64 months
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Subjects of groups HibMenC and LicMenC at Visits 1, 2 and 3:
Exclusion criteria:
- 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.
Previous administration of booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study 104056.
Trial location(s)
Location
GSK Investigational Site
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Status
Study Complete
Showing 1 - 6 of 9 Results
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2007-12-10
Actual study completion date
2007-12-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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