Clinical trial NCT00316147: Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-04-20
Enrollment: 224
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 1M post-dose 3, vaccine response for pertussis and anti-poliovirus types 1, 2, and 3 titers
Secondary outcomes:
measure: 1M post-dose 3, antibody levels against all antigens
measure: After each dose, solicited (day 0-3, local and general) and unsolicited (day 0-30) events
measure: Serious adverse events (SAEs) for entire study
Other outcomes:
Locations:
city: Bangalore
country: India
facility: GSK Investigational Site
city: Baroda
country: India
facility: GSK Investigational Site
city: Goa
country: India
facility: GSK Investigational Site
city: New Delhi
country: India
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: