Last updated: 11/03/2018 00:45:09
Study to assess safety & immunogenicity of GSK Biologicals’ DTPa/Hib vaccine vs separate administration of DTPa and Hib.
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of seroprotected subjects against diphteria toxoid (D) and tetanus toxoid (T)
Timeframe: At Month 3
Number of seroprotected subjects against polyribosyl-ribitol phosphate (PRP)
Timeframe: At Month 3
Number of subjects with a vaccine response to pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN) antibodies
Timeframe: At Month 3
Secondary outcomes:
Number of subjects with anti-PRP antibody concentrations ≥ 1.0 µg/mL
Timeframe: At Month 3
Concentrations for anti-D and anti-T antibodies
Timeframe: At Month 0 and Month 3
Concentrations for anti-PRP antibodies
Timeframe: At Month 0 and Month 3
Concentrations for anti-PT, anti-FHA and anti-PRN antibodies
Timeframe: At Month 3
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
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
Number of subjects with unsolicited adverse events (AEs)
Timeframe: During the 31-day (Day 0-30) follow-up period after each vaccination
Number of subjects with serious adverse events (SAEs)
Timeframe: From receipt of first dose of study vaccine (Day 0) to study end (Month 3)
Interventions:
Biological/vaccine: Infanrix™/Hib
Biological/vaccine: Infanrix
Biological/vaccine: Hiberix
Enrollment:
660
Observational study model:
Not applicable
Primary completion date:
2007-25-06
Time perspective:
Not applicable
Clinical publications:
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
Medical condition
Tetanus, Diphtheria, acellular pertussis
Product
SB208355
Collaborators
Not applicable
Study date(s)
January 2007 to June 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
90 - 120 days
Accepts healthy volunteers
Yes
- 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
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-25-06
Actual study completion date
2007-25-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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