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
175
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
101477
Responsible Party
Sponsor
Study Sponsor
GlaxoSmithKline
Study Sponsor
GSK Clinical Trials, Study Director, GlaxoSmithKline
Verification Date
May 2017