Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants

Condition(s) targeted: Poliomyelitis; Haemophilus Influenzae Type b Disease; Hepatitis B; Diphtheria; Pertussis; Tetanus

Intervention: DTPa-HBV-IPV/Hib vaccine (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

In this study, infants will be randomly allocated into three groups:

- one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation)

- the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current

formulation)

- the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be

double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine.

Official title: Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Primary outcome: One month after vaccination, measurement of antibodies against all vaccine antigens.

Secondary outcome:

"Immunogenicity: One month after vaccination, vaccine response for the pertussis antigens.

Reactogenicity & safety: After each dose, solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (SAEs)."

Detailed description: A study to compare the immunogenicity & safety of 2 formulations of GlaxoSmithKline (GSK) Biologicals' DTPa-HBV-IPV/Hib vaccine given in healthy infants at 3,4 & 5 months age. The immunogenicity & safety of DTPa-HBV-IPV vaccine will also be evaluated in a 3rd group of subjects Subjects in the group that will receive DTPa-HBV-IPV/Hib vaccine (current formulation) will be the control group for the group that will receive DTPa-HBV-IPV/Hib vaccine (new formulation)

Minimum age: 11 Weeks. Maximum age: 17 Weeks. Gender(s): Both.

Criteria:

"Inclusion criteria:

- A healthy male or female infant between, and including, 11 and 17 weeks of age at the

time of the first vaccination.

- Infant born to known hepatitis B surface antigen (HBsAg) seronegative mother

(documented laboratory result of HBsAg assay from the maternal blood sample is available).

- Born after a normal gestation period (between 36 and 42 weeks).

- Written informed consent obtained from the parent or guardian of the subject.

Exclusion criteria:

- Use of any investigational or non-registered product (drug or vaccine) other than the

study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

- Chronic administration of immunosuppressants or other immune-modifying drugs within

six months prior to the first vaccine dose.

- Any chronic drug therapy to be continued during the study period.

- Planned administration/ administration of a vaccine not foreseen by the study

protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after the last vaccine dose.

- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis

B and/or Haemophilus influenzae diseases.

- Known history of or exposure to diphtheria, tetanus, pertussis, poliomyelitis,

hepatitis B and/or Haemophilus influenzae diseases since birth.

- History of allergic disease or reactions likely to be exacerbated by any component of

the vaccines. "

GSK Investigational Site, Murmansk 183046, Russian Federation

GSK Investigational Site, Perm 614022, Russian Federation

GSK Investigational Site, Syktyvkar 167011, Russian Federation

Starting date: April 2006
Last updated: November 21, 2012