Clinical trial NCT00317187: Safety Study of a Vaccine Against Meningitis in Infants (2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.
Official title: Partially Blinded Study to Assess Reactogenicity & Safety of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ in Healthy Infants After a Hepatitis B Birth Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Diphtheria
Whole Cell Pertussis
Tetanus
Haemophilus Influenzae Type b
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-04-24
Enrollment: 500
Sex: ALL
Minimum age (years): 56
Maximum age (years): 83
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the reactogenicity \& safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.

Detailed description: Randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis B vaccine given at birth:

* One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups)
* GSK Biologicals' Tritanrix™-HepB/Hiberix™

Eligibility criteria: Inclusion criteria:

• Healthy infants 56-83 days of age at the time of the first vaccine dose, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks \& has received a birth dose of hepatitis B vaccine within the first 3 days of life.

Exclusion criteria:

* Any confirmed immunodeficient condition, based on medical history and physical examination.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (OPV).
* Use of any investigational or non-registered 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
* Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and/or meningococcal disease.
* History of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease or known exposure to these diseases since birth.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Primary outcomes:
measure: Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1
timeFrame: Days 0-3 post dose 1
measure: Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 2
timeFrame: Days 0-3 post dose 2
measure: Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 3
timeFrame: Days 0-3 post dose 3
Secondary outcomes:
measure: Occurrence of solicited symptoms other than fever >38.5°C (axillary) during the 4-day follow-up period after each dose
timeFrame: Days 0-3 after each dose
measure: Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose
timeFrame: Day 0-30 after each dose
measure: Occurrence of serious adverse events during the entire study period
timeFrame: Day 0 up to Month 5
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Kerdpanich A, Warachit B, Kosuwon P, Gatchalian SR, Watanaveeradej V, Borkird T, Kosalaraksa P, Han HH, Hutagalung Y, Boutriau D, Dobbelaere K. Primary vaccination with a new heptavalent DTPw-HBV/Hib-Neisseria meningitidis serogroups A and C combined vaccine is well tolerated. Int J Infect Dis. 2008 Jan;12(1):88-97. doi: 10.1016/j.ijid.2007.06.002. Epub 2007 Aug 22.