NCT00316147

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

Phase IIIb, Open, Randomized, Multicenter Study to Assess the Immunogenicity & Safety of GSK Biologicals' Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants When Given at 6-10-14 Weeks of Age or at 2-4-6 Months of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (planned)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 10 Weeks
• Healthy volunteers: Accepted

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

Detailed description

DTPa-HBV-IPV/Hib vaccine will be administered at two schedules (i.e. 6-10-14 weeks of age OR 2-4-6 months of age) in infants who were previously vaccinated with hepatitis B vaccine at birth. The duration of the study will be approximately 3 months for each subject who will receive vaccination at 6-10-14 weeks of age and approximately 5 months for each subject who will receive vaccination at 2-4-6 months of age. Intervention name: Diphteria, tetanus, acellular pertussis, hepatitis B, poliovirus types 1, 2, 3 \& Haemophilus influenzae type b vaccine

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	DTPa-HBV-IPV/Hib vaccine

Timeline

• Start date: 2005-12-01
• Completion: 2006-08-01
• First posted: 2006-04-20
• Last updated: 2016-09-28

Locations

4 sites across 1 country: India