A phase I/II, double-blind, randomized, multicentre study to evaluate the safety and immunogenicity of new formulations of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine when administered to healthy infants as a primary vaccination course at 2, 3 and 4 months of age. - DTPA-HBV-IPV-124 PRI

GlaxoSmithKline Biologicals0 sites720 target enrollmentOctober 14, 2010

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Primary immunization of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) diseases.
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 720
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

October 14, 2010

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- A male or female between, and including, 60 and 90 days of age at the time of the first vaccination.
•\- Born after a gestation period of 37 to 42 weeks inclusive.
•\- Subjects who the investigator believes that their parent(s)/LAR(s) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow\-up visits).
•\- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
•\- Healthy subjects as established by medical history and clinical examination before entering into the study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 720
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no

•\-Child in care.
•\-Use of any investigational or non\-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•\-Chronic administration (defined as more than 14 days in total) of
•immunosuppressants or other immune\-modifying drugs since birth. For
•corticosteroids, this will mean prednisone \= 0\.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
•\-Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral rotavirus vaccination which is allowed at any time during the study.
•\-Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non\-investigational product (pharmaceutical product or device).
•\-Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Hib and/or pneumococcal vaccination or disease, with the exception of hepatitis B vaccination at birth.
•\-Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•\-Family history of congenital or hereditary immunodeficiency.