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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00158808
Other study ID # 101477
Secondary ID
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
Health authority
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.

Study Design


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."
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