NCT00158808

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

September 8, 2005

Last Update Submit

May 24, 2017

Conditions

Hib DiseaseHepatitis BPertussisProphylaxis of DiphtheriaTetanus

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

  • 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.

  • +2 more secondary outcomes

Interventions

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

Eligibility Criteria

Age15 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

City of Muntinlupa, 1781, Philippines

Location

Related Publications (1)

  • 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.

    PMID: 20657177DERIVED

MeSH Terms

Conditions

Hepatitis BWhooping CoughTetanus

Interventions

Tetanus ToxoidHepatitis B Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesBordetella InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesRespiratory Tract InfectionsRespiratory Tract DiseasesClostridium InfectionsGram-Positive Bacterial Infections

Intervention Hierarchy (Ancestors)

ToxoidsVaccinesBiological ProductsComplex MixturesViral Hepatitis VaccinesViral Vaccines

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

January 1, 2005

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

PH(1)