Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC

NCT ID: NCT00322335

Last Updated: 2016-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2010-09-30

Brief Summary

This protocol posting deals with objectives & outcome measures of the extension phase at Months 18, 30, 42, 54 and 66 post booster. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00352963). The objectives & outcome measures of the Booster phase/study are presented in a separate protocol posting (NCT number =NCT00323050).

The purpose of this study is to evaluate the persistence of meningococcal serogroup C and Hib antibodies on a yearly basis for a period of 5.5 years after booster vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

This multicenter study is open. No vaccine will be administered during this persistence phase of the study. The subjects were randomized in the primary vaccination study 217744/097 (DTPa-HBV-IPV-097) and will not be further randomized in this study. The study has 3 groups with Meningitec™ primed group as control. The protocol was amended to allow for enrollment of subjects of the Meningitec™ primed control group who were boosted with Meningitec™ after the end of the booster study as per new local reccommendation in Spain.

Conditions

Haemophilus Influenzae Type b; Neisseria Meningitidis

Study Design

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

Study Groups

Menitorix/Pediarix Group

Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.

Group Type: EXPERIMENTAL

Haemophilus influenzae type b- and meningococcal (vaccine)

Intervention Type: BIOLOGICAL

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).

Infanrix™ penta

Intervention Type: BIOLOGICAL

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group

Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.

Group Type: ACTIVE_COMPARATOR

Haemophilus influenzae type b- and meningococcal (vaccine)

Intervention Type: BIOLOGICAL

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).

Infanrix™ hexa

Intervention Type: BIOLOGICAL

Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).

Engerix-B

Intervention Type: BIOLOGICAL

Intramuscular injection into the thigh as a birth dose

NeisVac-C™

Intervention Type: BIOLOGICAL

Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.

Infanrix™ IPV/HIB

Intervention Type: BIOLOGICAL

Intramuscular injection into the thigh as primary vaccination at 4 months of age

Infanrix hexa/Meningitec Group

Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.

Group Type: ACTIVE_COMPARATOR

Infanrix™ hexa

Intervention Type: BIOLOGICAL

Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).

Meningitec™

Intervention Type: BIOLOGICAL

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

Interventions

Haemophilus influenzae type b- and meningococcal (vaccine)

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).

Intervention Type: BIOLOGICAL

Infanrix™ penta

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

Intervention Type: BIOLOGICAL

Infanrix™ hexa

Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).

Intervention Type: BIOLOGICAL

Engerix-B

Intramuscular injection into the thigh as a birth dose

Intervention Type: BIOLOGICAL

NeisVac-C™

Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.

Intervention Type: BIOLOGICAL

Infanrix™ IPV/HIB

Intramuscular injection into the thigh as primary vaccination at 4 months of age

Intervention Type: BIOLOGICAL

Meningitec™

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

Intervention Type: BIOLOGICAL

Eligibility 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 in their third year of life at the time of the study initiation for the subjects who enter the study at Visit 1. The subjects who enter the study at Visit 2 should be in their fourth year of life at the time of the study initiation.
• 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 Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050).
• Subjects who are part of the Meningitec™ control group and who were not enrolled at Visit 1 can be enrolled at Visit 2 if they have completed the booster vaccination study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050) and if they have received a fourth dose of Meningitec™ in their second year of life, after the booster study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050)

Exclusion Criteria

• Previous administration of a booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097. Subjects who received a 4th dose of Meningitec™ should be included in the study.
• History of H. influenzae type b, meningococcal serogroup C diseases.

• Minimum Eligible Age: 31 Months
• Maximum Eligible Age: 33 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

Almería, , Spain

GSK Investigational Site

Burgos, , Spain

GSK Investigational Site

Getafe/Madrid, , Spain

GSK Investigational Site

Girona, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Marid, , Spain

GSK Investigational Site

Málaga, , Spain

GSK Investigational Site

Móstoles/Madrid, , Spain

GSK Investigational Site

Valladolid, , Spain

GSK Investigational Site

Vélez-Málaga / Málaga, , Spain

Countries

Spain

References

Tejedor JC, Moro M, Merino JM, Gomez-Campdera JA, Garcia-del-Rio M, Jurado A, Diez-Delgado FJ, Omenaca F, Garcia-Sicilia J, Ruiz-Contreras J, Martin-Ancel A, Roca J, Boceta R, Garcia-Corbeira P, Maechler G, Boutriau D; Spanish 102547 Study Group. Immunogenicity and reactogenicity of a booster dose of a novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine given to toddlers of 13-14 months of age with antibody persistence up to 31 months of age. Pediatr Infect Dis J. 2008 Jul;27(7):579-88. doi: 10.1097/INF.0b013e31816b4561.

Reference Type: BACKGROUND

PMID: 18536619 (View on PubMed)

Tejedor JC, Merino JM, Moro M, Navarro ML, Espin J, Omenaca F, Garcia-Sicilia J, Moreno-Perez D, Ruiz-Contreras J, Centeno F, Barrio F, Cabanillas L, Muro M, Esporrin C, De Torres MJ, Caubet M, Boutriau D, Miller JM, Mesaros N. Five-year antibody persistence and safety following a booster dose of combined Haemophilus influenzae type b-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine. Pediatr Infect Dis J. 2012 Oct;31(10):1074-7. doi: 10.1097/INF.0b013e318269433a.

Reference Type: BACKGROUND

PMID: 22828645 (View on PubMed)

Tejedor JC et al. Antibody persistence 54 months after a booster dose of combined Haemophilus influenzae type b-Neisseria meningitidis serogroup C-tetanus-toxoid (HibMenC-TT) conjugate vaccine. Abstract presented at the 29th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). The Hague, The Netherlands, 7-11 June 2011.

Reference Type: BACKGROUND

Tejedor JC et al. Antibody persistence 66 months after a booster dose of combined Haemophilus influenzae type B-Neisseria meningitidis serogroup C-tetanus-toxoid (Hib-MenC-TT) conjugate vaccine. Abstract presented at the 30th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Thessaloniki, Greece, 8-12 May 2012.

Reference Type: BACKGROUND

Study Documents

Document Type: Statistical Analysis Plan

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: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 106672 are summarised with studies 106673, 106675, 106679, and 106680 on 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: Informed Consent Form

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

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

106673

Identifier Type: OTHER

Identifier Source: secondary_id

106675

Identifier Type: OTHER

Identifier Source: secondary_id

106679

Identifier Type: OTHER

Identifier Source: secondary_id

106680

Identifier Type: OTHER

Identifier Source: secondary_id

106672

Identifier Type: -

Identifier Source: org_study_id