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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158808
• Other study ID #: 101477
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: May 24, 2017
• Start date: January 2005
• Est. completion date: April 2005

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Diphtheria
• Hepatitis B
• Hib Disease
• Pertussis
• Prophylaxis of Diphtheria
• Tetanus

Intervention

Biological:
• Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib

Locations

Country	Name	City	State
Philippines	GSK Investigational Site	Muntinlupa

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Philippines, 

Outcome

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