Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants

NCT ID: NCT00871338

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-24
• Study Completion Date: 2010-12-09

Brief Summary

The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals' GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a booster dose of GSK Biologicals' Menitorix™ at 12 months of age.

Detailed Description

This protocol posting has been updated following Protocol amendment 1, 11-February-2010; The Study design section is impacted by this amendment.

Conditions

Neisseria Meningitidis; Haemophilus Influenzae Type b

Study Design

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

Study Groups

GSK2197870A Group

Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.

Group Type: EXPERIMENTAL

GSK2197870A

Intervention Type: BIOLOGICAL

3 doses given at 2, 3 and 4 months of age

Prevenar™

Intervention Type: BIOLOGICAL

3 co-administered doses, intramuscular into right thigh

Menitorix™

Intervention Type: BIOLOGICAL

1 booster dose at 12 months of age

Pediacel Group

Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.

Group Type: ACTIVE_COMPARATOR

Prevenar™

Intervention Type: BIOLOGICAL

3 co-administered doses, intramuscular into right thigh

Menitorix™

Intervention Type: BIOLOGICAL

1 booster dose at 12 months of age

Pediacel™

Intervention Type: BIOLOGICAL

3 doses given at 2, 3 and 4 months of age

Menjugate™

Intervention Type: BIOLOGICAL

2 doses given at 3 and 4 months of age

Interventions

GSK2197870A

3 doses given at 2, 3 and 4 months of age

Intervention Type: BIOLOGICAL

Prevenar™

3 co-administered doses, intramuscular into right thigh

Intervention Type: BIOLOGICAL

Menitorix™

1 booster dose at 12 months of age

Intervention Type: BIOLOGICAL

Pediacel™

3 doses given at 2, 3 and 4 months of age

Intervention Type: BIOLOGICAL

Menjugate™

2 doses given at 3 and 4 months of age

Intervention Type: BIOLOGICAL

Other Intervention Names

GSK Biologicals' combined diphtheria; tetanus; acellular pertussis; polio; HiB and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine.; Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine; GSK Biologicals' combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine.; Sanofi-Pasteur-MSD's combined DTPa-inactivated polio-Haemophilus influenzae type b vaccine.; Novartis' meningococcal serogroup C CRM197 protein conjugated vaccine.

Eligibility Criteria

Inclusion Criteria

All subjects must satisfy the following criteria at study entry:

• A male or female infant between, and including, 6 and 12 weeks of age at the time of the first vaccination.
• Born after 36 to 42 weeks of gestation.
• Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• 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.

Exclusion Criteria

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product .
• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Hib, pneumococcal and/or group C meningococcal vaccination or disease.
• History of seizures or progressive neurological disease (one episode of febrile convulsion does not constitute an exclusion criterion).
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness.

• Current febrile illness or axillary temperature ≥37.5ºC or other moderate to severe illness within 24 hours of study vaccine administration

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 12 Weeks
• 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

Ely, Cambridgeshire, United Kingdom

GSK Investigational Site

Southampton, Hampshire, United Kingdom

GSK Investigational Site

Oxford, Oxfordshire, United Kingdom

GSK Investigational Site

Bristol, , United Kingdom

GSK Investigational Site

London, , United Kingdom

Countries

United Kingdom

References

Khatami A, Snape MD, Ohene-Kena B, Young K, Oeser C, Michaelis LJ, Macleod E, Smee H, Van Der Meeren O, Leyssen M, Caubet M, Yu LM, Heath PT, Faust SN, Finn A, Pollard AJ. Phase II study of a three-dose primary vaccination course of DTPa-IPV/Hib-MenC-TT followed by a 12-month Hib-MenC-TT booster in healthy infants. Pediatr Infect Dis J. 2013 Jun;32(6):675-81. doi: 10.1097/INF.0b013e31828672a7.

Reference Type: BACKGROUND

PMID: 23348809 (View on PubMed)

Khatami A et al. Phase II study of a three-dose primary vaccination course of DTPa-IPV/Hib-MenC-TT followed by a 12-month Hib-MenC-TT booster in healthy infants. Abstract presented at the 7th World Congress 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: Statistical Analysis Plan

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: Annotated Case Report 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

Document Type: Informed Consent Form

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

111709

Identifier Type: -

Identifier Source: org_study_id