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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316147
• Other study ID #: 104005
• Status: Completed
• Phase: Phase 3
• First received: February 21, 2006
• Last updated: September 27, 2016
• Start date: December 2005
• Est. completion date: August 2006

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India (DCGI)
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 10 Weeks

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Biological:
• DTPa-HBV-IPV/Hib vaccine

Locations

Country	Name	City	State
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Baroda
India	GSK Investigational Site	Goa
India	GSK Investigational Site	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1M post-dose 3, vaccine response for pertussis and anti-poliovirus types 1, 2, and 3 titers
Secondary	1M post-dose 3, antibody levels against all antigens
Secondary	After each dose, solicited (day 0-3, local and general) and unsolicited (day 0-30) events
Secondary	Serious adverse events (SAEs) for entire study

External Links

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