search
Back to results

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

Primary Purpose

Hib Disease, Hepatitis B, Pertussis

Status
Completed
Phase
Phase 2
Locations
Philippines
Study Type
Interventional
Intervention
Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hib Disease

Eligibility Criteria

15 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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."

Full Information

First Posted
September 8, 2005
Last Updated
May 24, 2017
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00158808
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hib Disease, Hepatitis B, Pertussis, Prophylaxis of Diphtheria, Tetanus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib
Primary Outcome Measure Information:
Title
Anti-PRP antibody concentration one month after the booster dose (in groups boosted with the DTPw-HBV/Hib vaccine).
Secondary Outcome Measure Information:
Title
Immunology
Title
At the time of the booster dose: concentrations of antibodies against all vaccine antigens (diphtheria, tetanus, pertussis, hepatitis B and Hib antigens)
Title
One month after the booster dose: concentrations of antibodies against all vaccine antigens (diphtheria, tetanus, pertussis, hepatitis B and Hib antigens)
Title
Reactogenicity and Safety
Title
Occurrence of solicited symptoms during the specific follow-up period after the booster dose.
Title
Occurrence of unsolicited symptoms during the specific follow-up period after the booster dose .
Title
Occurrence of serious adverse events (SAEs) during the entire study period."

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Muntinlupa
ZIP/Postal Code
1781
Country
Philippines

12. IPD Sharing Statement

Citations:
PubMed Identifier
20657177
Citation
Gatchalian SR, Ramakrishnan G, Bock HL, Lefevre I, Jacquet JM. Immunogenicity, reactogenicity and safety of three-dose primary and booster vaccination with combined diphtheria-tetanus-whole-cell pertussis-hepatitis B-reduced antigen content Haemophilus influenzae type b vaccine in Filipino children. Hum Vaccin. 2010 Aug;6(8):664-72. doi: 10.4161/hv.6.8.12155.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs