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

NCT00320463 | Completed Phase 3

• 1 other identifier: 105910
• Study Type: interventional
• Target: 415
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Diphtheria; Hepatitis B; Poliomyelitis; Tetanus; Acellular Pertussis

Outcome Measures

Primary Outcomes (1)

• One month after vaccination, measurement of antibodies against all vaccine antigens.

Secondary Outcomes (2)

• 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)."

Interventions

DTPa-HBV-IPV/Hib vaccine BIOLOGICAL

Eligibility Criteria

• Age: 11 Weeks - 17 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Murmansk, 183046, Russia

Location

GSK Investigational Site

Perm, 614022, Russia

Location

GSK Investigational Site

Syktyvkar, 167002, Russia

Location

GSK Investigational Site

Syktyvkar, 167011, Russia

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Diphtheria; Hepatitis B; Poliomyelitis; Tetanus

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Clostridium Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2006
• First Posted: May 3, 2006
• Study Start: April 1, 2006
• Study Completion: January 1, 2007
• Last Updated: October 12, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

RU (4)