Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children

NCT ID: NCT00611559

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 283 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-14
• Study Completion Date: 2008-06-25

Brief Summary

The new formulation administered as a 4th consecutive dose will be compared to the current formulation of the vaccine in this partially double blind study.

The study will be double-blind with respect to the two DTPa-HBV-IPV/Hib groups. The study will be open with respect to the DTPa-HBV-IPV group.

Conditions

Poliomyelitis; Acellular Pertussis; Tetanus; Diphtheria; Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Infanrix hexa Preservative-Free Formulation Group

Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa

Group Type: EXPERIMENTAL

Infanrix™ hexa

Intervention Type: BIOLOGICAL

Subjects received a booster dose

Infanrix hexa Preservative-Containing Formulation Group

Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa

Group Type: ACTIVE_COMPARATOR

Infanrix™ hexa

Intervention Type: BIOLOGICAL

Subjects received a booster dose

Infanrix penta Preservative-Free Formulation Group

Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta.

Group Type: ACTIVE_COMPARATOR

Infanrix™ penta

Intervention Type: BIOLOGICAL

Subjects received a booster dose

Interventions

Infanrix™ penta

Subjects received a booster dose

Intervention Type: BIOLOGICAL

Infanrix™ hexa

Subjects received a booster dose

Intervention Type: BIOLOGICAL

Other Intervention Names

Pediarix

Eligibility Criteria

Inclusion Criteria

• 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.
• Subjects must have completed full three-dose primary vaccination course with DTPa-HBV-IPV/Hib or DTPa-HBV-IPV in the primary study DTPa-HBV-IPV-109 (study NCT00320463).
• A male or female between, and including 18 and 23 months of age at the time of the booster vaccination.
• 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

• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose.
• Participation in another clinical study, between the primary study NCT00320463 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and hepatitis B since the conclusion visit of study NCT00320463.
• Previous booster vaccination against Haemophilus influenzae diseases in the DTPa-HBV-IPV/Hib groups, since the conclusion visit of study NCT00320463.
• History of exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae disease since the conclusion visit of study NCT00320463.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
• Any of the following adverse events having occurred after previous administration of DTP vaccine:
• Hypersensitivity reaction due to the vaccine.
• Encephalopathy defined as an acute, severe central nervous system disorder of unknown etiology occurring within 7 days following previous vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
• Any of the following adverse events having occurred after previous administration of DTP vaccine:
• Temperature of >= 40.0 °C (axillary temperature), within 48 hours of vaccination.
• Collapse or shock-like state within 48 hours of vaccination.
• Persistent, inconsolable crying lasting >= 3 hours, occurring within 48 hours of vaccination.
• Convulsions with or without fever, occurring within 3 days of vaccination

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 23 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

Murmansk, , Russia

GSK Investigational Site

Perm, , Russia

GSK Investigational Site

Syktyvkar, , Russia

Countries

Russia

Study Documents

Document Type: Annotated Case Report Form

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: Dataset Specification

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: 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

Document Type: Individual Participant Data Set

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

110478

Identifier Type: -

Identifier Source: org_study_id