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Protocol Summaries: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine

GSK Study ID	Phase	Title	Status
100478	Phase 3	Study to show non-inferiority of Tritanrix™-HepB/Hib-MenAC (+/- hepatitis B vaccine at birth) vs Tritanrix™-HepB/Hiberix™ without hepatitis B vacc. at birth for antibody response to all vaccine antigens given in healthy infants	Completed
100480	Phase 3	Study to show consistency Hib-MenAC(3 lots) mixed with Tritanrix™-HBV, non-inferiority of study vaccine to Tritanrix™-HBV/Hiberix™ (+/-) Meningitec™ & MenA response in infants (2,4,6M) with hepatitis B birth dose	Completed
100791	Phase 3	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	Completed
104733	Phase 3	Demonstrate lot-to-lot consistency of final production method of GSK Biologicals' Hib-MenAC vaccine mixed extemporaneously with Tritanrix™-HepB & demonstrate its non-inferiority vs Tritanrix™-HepB/Hiberix™ in healthy infants at 2,4&6 months	Completed
759346	Phase 2	Evaluate the feasibility of GSK Biologicals’ Tritanrix™-HepB/Hib-MenAC vaccine administered as a 3 dose primary vaccination course at 6, 10 & 14 weeks of age	Completed
759346/002	Phase 2	Assess immune persistence & memory by giving plain PRP,PSA & PSC (10 mths age), & immunogenicity & safety of a Tritanrix™-HBV/Hib-MenAC/ Tritanrix™-HBV/Hib2.5 booster (15-18 mths age) in previously primed subjects	Completed
759346/004	Phase 3	Assess reactogenicity & safety of GSK Biologicals’ Tritanrix™-HepB/Hib-MenAC compared to Tritanrix™-HepB/Hiberix™ (control) in healthy infants (2,4,6 mths age), after a hepatitis B birth dose	Completed