Clinical trial NCT00412854: Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.
Official title: Phase IIIb, Multicentre Study to Assess Safety & Immunogenicity of GSK Biologicals' Combined DTPa/Hib (Infanrix/Hib) Vaccine vs Separate Administration of DTPa (Infanrix) & Hib (Hiberix) Vaccines in Healthy Infants 3,4,&5 Months of Age as Compared With the Separate Administration of DTPa and Hib Vaccines at Different Injection Sites.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tetanus
Diphtheria
Acellular Pertussis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-12-19
Enrollment: 660
Sex: ALL
Minimum age (years): 90
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese infants 3, 4 \& 5 months of age, in terms of safety and immunogenicity.


Eligibility criteria: Inclusion Criteria:

* A male or female between, and including, 90 and 120 days of age at the time of the first vaccination,
* written informed consent obtained from the parent or guardian of the subject

Exclusion Criteria:

* Subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate,
* Subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b diseases can not participate.

Primary outcomes:
measure: Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T)
timeFrame: At Month 3
measure: Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP)
timeFrame: At Month 3
measure: Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies
timeFrame: At Month 3
Secondary outcomes:
measure: Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL
timeFrame: At Month 3
measure: Concentrations for Anti-D and Anti-T Antibodies
timeFrame: At Month 0 and Month 3
measure: Concentrations for Anti-PRP Antibodies
timeFrame: At Month 0 and Month 3
measure: Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies
timeFrame: At Month 3
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Day 0-30) follow-up period after each vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From receipt of first dose of study vaccine (Day 0) to study end (Month 3)
Other outcomes:
Locations:
city: Mengshan
country: China
facility: GSK Investigational Site
city: Wuzhou
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Yan-Ping Li, Shumin Zhang, Qiang Ye, Qiming Hou, Yanan Li, Hong Li, Yinghua Xu, Xiao Ma, Youping Liu, Xiaoling Chen, Lirong Huang, Gunasekaran Ramakrishnan, Richard Zhao, Haiwen Tang, Olivier Van Der Meeren, Hans L Bock.Combined diphtheria-tetanus-acellular pertussis vaccine mixed with Haemophilus influenzae type b conjugate vaccine is safe and immunogenic in two studies in Chinese infants.Chinese Journal of Vaccines - Zhongguo Yi Miao He Mian Yi (Zhongguo Ji Hua Mian Yi). Zhongguo Yi Miao He Mian Yi. 2010 Apr;16(2):97-104