Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules

NCT00316147 | Completed Phase 3

• 1 other identifier: 104005
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 4

Brief Summary

In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups:

• one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine at 6-10-14 weeks of age
• the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine at 2-4-6 months of age

Conditions

Diphtheria; Acellular Pertussis; Tetanus; Haemophilus Influenzae Type b; Hepatitis B; Poliomyelitis

Keywords

diphtheria; tetanus; poliomyelitis; pertussis; hepatitis B; Prophylaxis; Haemophilus influenza type b diseases

Outcome Measures

Primary Outcomes (1)

• 1M post-dose 3, vaccine response for pertussis and anti-poliovirus types 1, 2, and 3 titers

Secondary Outcomes (3)

• 1M post-dose 3, antibody levels against all antigens

• After each dose, solicited (day 0-3, local and general) and unsolicited (day 0-30) events

• Serious adverse events (SAEs) for entire study

Interventions

DTPa-HBV-IPV/Hib vaccine BIOLOGICAL

Eligibility Criteria

• Age: 6 Weeks - 10 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• A healthy male or female infant between, and including, 6 to 10 weeks of age at the time of the first vaccination.
• Written informed consent obtained from the parent or guardian of the subject.
• Born after a normal gestation period (between 36 and 42 weeks).
• Should have received a birth dose of hepatitis B vaccine, as evidenced by vaccination/immunisation certificate.

You may not qualify if:

• Use of any investigational or non-registered product (vaccine or drug) other than the study vaccine 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) of immunosuppressants or other immune-modifying drugs 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 30 days before the administration of the first vaccine dose and ending 30 days after the last dose (with the exception of oral polio vaccine as a birth dose or for a pulse polio program, as per local, regional, or national requirements).
• Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases.
• Known exposure to diphtheria, tetanus, Bordetella pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases since birth.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Bangalore, 560034, India

Location

GSK Investigational Site

Baroda, 390 001, India

Location

GSK Investigational Site

Goa, 403202, India

Location

GSK Investigational Site

New Delhi, 110002, India

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; Tetanus; Haemophilus Infections; Hepatitis B; Poliomyelitis; Whooping Cough

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Pasteurellaceae Infections; Gram-Negative Bacterial 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; Bordetella Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2006
• First Posted: April 20, 2006
• Study Start: December 1, 2005
• Study Completion: August 1, 2006
• Last Updated: September 28, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

IN (4)