Immune Memory Foll Pry Vaccination With DTPw-HBV/Hib Vaccine Formulation; Immuno & Reacto of Booster Dose at 15-18 Mths

May 24, 2017 updated by: GlaxoSmithKline

Assess the Immunogenicity &d Reactogenicity of a Booster Dose of a Formulation of GSK Biologicals' DTPw-HBV/Hib Vaccine at 15-18 Mths of Age in Infants Previously Primed With the Same Vaccine

To assess the anti-PRP antibody response one month after vaccination in the groups receiving a fourth consecutive dose of two formulations of DTPw-HBV/Hib vaccine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All subjects were previously primed with one of the two formulations of the combined DTPw-HBV/Hib vaccine. At the age of 10 months, 50% of each group received a plain PRP challenge to assess the immune memory to PRP. In this booster study in the second year of life, all subjects who received DTPw-HBV/Hib and plain PRP will receive DTPw-HBV as a booster vaccination. All other subjects will receive as booster the same vaccine they received in the primary vaccination study.

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
      • Muntinlupa, Philippines, 1781
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 of at least 15 months of age at the time of the booster vaccination, who had previously received 3-dose primary vaccination and, if applicable, plain-PRP vaccination.
  • Free of obvious health problems as established by medical history and clinical examination before entering the study.

Exclusion criteria for enrolment

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after administration of study vaccines with the exception of oral polio vaccine (OPV).
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
  • Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B or Hib with the exception of plain PRP challenge.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Anti-PRP antibody concentration one month after the booster dose (in groups boosted with the DTPw-HBV/Hib vaccine).

Secondary Outcome Measures

Outcome Measure
Immunology
At the time of the booster dose: concentrations of antibodies against all vaccine antigens (diphtheria, tetanus, pertussis, hepatitis B and Hib antigens)
One month after the booster dose: concentrations of antibodies against all vaccine antigens (diphtheria, tetanus, pertussis, hepatitis B and Hib antigens)
Reactogenicity and Safety
Occurrence of solicited symptoms during the specific follow-up period after the booster dose.
Occurrence of unsolicited symptoms during the specific follow-up period after the booster dose .
Occurrence of serious adverse events (SAEs) during the entire study period."

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101477

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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