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

NCT ID: NCT00454987

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-16
• Study Completion Date: 2007-10-12

Brief Summary

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)

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).

Conditions

Haemophilus Influenzae Type b; Neisseria Meningitidis; Neisseria Meningitidis-Haemophilus Influenzae Type b Vaccine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Infanrix IPV

Intervention Type: BIOLOGICAL

Infanrix IPV was administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.

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.

Group Type: ACTIVE_COMPARATOR

Infanrix IPV

Intervention Type: BIOLOGICAL

Infanrix IPV was administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.

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.

This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.

Group Type: ACTIVE_COMPARATOR

Menitorix

Intervention Type: BIOLOGICAL

Menitorix was only administered to subjects of the group Meningitic+Hiberix group at 40 to 43 months of age.

Infanrix IPV

Intervention Type: BIOLOGICAL

Infanrix IPV was administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.

Interventions

Menitorix

Menitorix was only administered to subjects of the group Meningitic+Hiberix group at 40 to 43 months of age.

Intervention Type: BIOLOGICAL

Infanrix IPV

Infanrix IPV was administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 64 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Bydgoszcz, , Poland

GSK Investigational Site

Gdansk, , Poland

GSK Investigational Site

Kielce, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Poznan, , Poland

GSK Investigational Site

Siemianowice Śląskie, , Poland

GSK Investigational Site

Trzebnica, , Poland

GSK Investigational Site

Łęczna, , Poland

GSK Investigational Site

Oxford, Oxfordshire, United Kingdom

Countries

Poland; United Kingdom

References

Khatami A, Snape MD, John T, Westcar S, Klinger C, Rollinson L, Boutriau D, Mesaros N, Wysocki J, Galaj A, Yu LM, Pollard AJ. 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. 2011 Mar;30(3):197-202. doi: 10.1097/INF.0b013e3181f728fd.

Reference Type: BACKGROUND

PMID: 20844459 (View on PubMed)

Khatami A, Snape MD, Wysocki J, John TM, Westcar S, Mesaros N, Peddiraju K, Boutriau D, Yu LM, Pollard AJ. 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. 2012 Oct;31(10):1069-73. doi: 10.1097/INF.0b013e318262528c.

Reference Type: BACKGROUND

PMID: 22673139 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

109666

Identifier Type: OTHER

Identifier Source: secondary_id

109668

Identifier Type: OTHER

Identifier Source: secondary_id

2006-006460-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

109664

Identifier Type: -

Identifier Source: org_study_id