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

Brief Title

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

Official Title

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

Brief Summary

      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

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 Immunology

Condition

Hib Disease

Intervention

Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

Start Date

January 2005

Completion Date

April 2005

Primary Completion Date

April 2005

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 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.

Gender

All

Ages

15 Months - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

GSK Clinical Trials, ,

Location Countries

Philippines

Location Countries

Philippines

Administrative Informations

NCT ID

NCT00158808

Organization ID

Responsible Party

Sponsor

Study Sponsor

GlaxoSmithKline

Study Sponsor

GSK Clinical Trials, Study Director, GlaxoSmithKline

Verification Date

May 2017